SEARCH RESULTS FOR: 新聞總覽APP加固要多少钱(电报super4dog)ios超级签名.epd(2708 results)
https://gudid.fda.gov/gudid/app/admin/udi/recordDetails.xhtml?pageType=manageDI&pageDataLoaded=false&pageMode=read+only&deviceRecordKey=419548#
SINTEA PLUSTEK SRL
PLS-6070T55
In Commercial Distribution
- 08057432564954 ()
- Trans-facet-screw internal spinal fixation system, sterile
https://gudid.fda.gov/gudid/app/admin/udi/recordDetails.xhtml?pageType=manageDI&pageDataLoaded=false&pageMode=read+only&deviceRecordKey=419548#
SINTEA PLUSTEK SRL
PLS-6065T55
In Commercial Distribution
- 08057432564947 ()
- Trans-facet-screw internal spinal fixation system, sterile
https://gudid.fda.gov/gudid/app/admin/udi/recordDetails.xhtml?pageType=manageDI&pageDataLoaded=false&pageMode=read+only&deviceRecordKey=419548#
SINTEA PLUSTEK SRL
PLS-6080T540
In Commercial Distribution
- 08057432564893 ()
- Trans-facet-screw internal spinal fixation system, sterile
https://gudid.fda.gov/gudid/app/admin/udi/recordDetails.xhtml?pageType=manageDI&pageDataLoaded=false&pageMode=read+only&deviceRecordKey=419548#
SINTEA PLUSTEK SRL
PLS-650T540
In Commercial Distribution
- 08057432564831 ()
- Trans-facet-screw internal spinal fixation system, sterile
https://gudid.fda.gov/gudid/app/admin/udi/recordDetails.xhtml?pageType=manageDI&pageDataLoaded=false&pageMode=read+only&deviceRecordKey=290070#
BEST MEDICAL INTERNATIONAL, INC.
1192-20
In Commercial Distribution
- 00841365116841 ()
- General-purpose brachytherapy system applicator, remote-afterloading
https://gudid.fda.gov/gudid/app/admin/udi/recordDetails.xhtml?pageType=manageDI&pageDataLoaded=false&pageMode=read+only&deviceRecordKey=290070#
BEST MEDICAL INTERNATIONAL, INC.
1192-4
In Commercial Distribution
- 00841365116292 ()
- General-purpose brachytherapy system applicator, remote-afterloading
https://gudid.fda.gov/gudid/app/admin/udi/recordDetails.xhtml?pageType=manageDI&pageDataLoaded=false&pageMode=read+only&deviceRecordKey=290070#
BEST MEDICAL INTERNATIONAL, INC.
1192-15
In Commercial Distribution
- 00841365114991 ()
- General-purpose brachytherapy system applicator, remote-afterloading
https://gudid.fda.gov/gudid/app/admin/udi/recordDetails.xhtml?pageType=manageDI&pageDataLoaded=false&pageMode=read+only&deviceRecordKey=305583#
BEST MEDICAL INTERNATIONAL, INC.
530-12
In Commercial Distribution
- 00841365114328 ()
- General-purpose brachytherapy system applicator, manual
Micro Injection Needle Style II 11ga x 9cm Luer Lockhttps://gudid.fda.gov/gudid/app/admin/udi/recordDetails.xhtml#
Ebner Medical, LLC
AA7771109
In Commercial Distribution
- 00840217906166 ()
- Length: 9 Centimeter
- Outer Diameter: 3.048 Millimeter
- Surgical/emergency suction cannula, non-illuminating, reusable
ASSURE patient app is a component of the ASSURE WCD System and transmits information to CareStation
Kestra Medical Technologies, Inc.
80315-005
In Commercial Distribution
- 00840241600214 ()
80315-005
- Medical equipment clinical data interfacing software
UTM ROOM TEMP. 1 ML W/O APP Medium for Virus, Chlamydia, Mycoplasma and Ureaplasma specimens
COPAN ITALIA SPA
3C030N.HL
In Commercial Distribution
- 58053326009117 ()
- 38053326009113 ()
- 08053326009112 ()
3C030N.HL
- General specimen container IVD, additive/medium
UTM ROOM TEMP.3 ML W/O APP Medium For Virus, Chlamydia, Mycoplasma and Ureaplasma Specimens
COPAN ITALIA SPA
330C.HL
In Commercial Distribution
- 58053326008974 ()
- 38053326008970 ()
- 08053326008979 ()
330C.HL
- General specimen container IVD, additive/medium
https://gudid.fda.gov/gudid/app/admin/udi/recordDetails.xhtml?pageType=manageDI&pageDataLoaded=false&pageMode=read+only&deviceRecordKey=680752#
SPES MEDICA SPA
TFDN452501
In Commercial Distribution
- 18054655015154 ()
- 08054655015157 ()
- Electromyographic needle electrode, single-use
CEREC® Essentials with Celtra® Chairside Consumables Kit
DENTSPLY INTERNATIONAL INC.
61N002
Not in Commercial Distribution
- D00261N0021 ()
- 12 Blocks, 3 Firing Pads, 1 Syr. Calibra Ceram w/10 mix tips, 1 bottle Prime&Bond elect, 25 flocked app. tips, 1 disp. well, 1 syr. Coupling Agent w/25 disp. app. needles, 1 Stain & Glaze Kit
61N002
- Dental appliance fabrication material, ceramic
Pressure PreventionGroup 1 Surfaces Product Description: Enf.,Dlx APP w/Pad w/End Flaps,1/ea, RTL
Drive Devilbiss Healthcare
E-14001EFD
In Commercial Distribution
- 50822383524530 ()
- 00822383524535 ()
- Alternating-pressure bed mattress overlay system
- Alternating-pressure inflator
- Alternating-pressure bed mattress overlay, reusable
Pressure PreventionGroup 1 Surfaces Product Description: Dlx APP w/Pad w/End Flaps,1/CV, 6/CT
Drive Devilbiss Healthcare
14001EFD
In Commercial Distribution
- 00822383145457 ()
- 50822383145452 ()
- Alternating-pressure bed mattress overlay, reusable
- Alternating-pressure inflator
- Alternating-pressure bed mattress overlay system
1.5 mm x 14.0 mm self-tapping titanium alloy bone fixation screwhttps://gudid.fda.gov/gudid/app/admin/udi/recordDetails.xhtml#
Osteogenics Biomedical Inc
PFB14
In Commercial Distribution
- D765PFB140 ()
- Length: 14.0 Millimeter
- Craniofacial bone screw, non-bioabsorbable
The Glooko Mobile application for iOS and Android displays retrospective data that is captured from BG meters, insulin pumps and continuous glucose monitors (CGM)
GLOOKO, INC.
5.xx
In Commercial Distribution
- 00855093008033 ()
- Clinical management support software
No Description
STARKEY LABORATORIES, INC.
Thrive Hearing Control for iOS
In Commercial Distribution
- 00842318130792 ()
- Audiometric/hearing device software
A clinical information and medical device data system for patient engagement and monitoring of treatment outcomes that can be customised by healthcare professionals to match their treatment pathways. The system can be configured to have diagnostic functionality but does not allow or enable direct diagnosis. No decisive information for making a diagnosis can be provided by the system on its own and it cannot provide diagnosis by itself, nor does it perform as a clinician or provide an indicative diagnosis to the lay user.
FUTURE HEALTH WORKS LTD
MD
In Commercial Distribution
- G333OUG001 ()
- Configurable electronic form web-based application software
A clinical information system with a digital goniometer. The system can be configured to have diagnostic functionality but does not allow or enable direct diagnosis. No decisive information for making a diagnosis can be provided by the system on its own and it cannot provide diagnosis by itself, nor does it perform as a clinician or provide an indicative diagnosis to the lay user.
FUTURE HEALTH WORKS LTD
MD
In Commercial Distribution
- G333KQX001 ()
- Electronic goniometer/kinesiology sensor
Rely•a•Bond® is intended for use in bonding metal, composite and ceramic orthodontic brackets.
This is a 1.1 gm push syringe of Rely A Bond Paste.
RELIANCE ORTHODONTIC PRODUCTS INC
1.1GRPP
In Commercial Distribution
- D79811GRPP0 ()
1.1GRPP
- Orthodontic bracket adhesive
Opti-Free Pure Moist Multi-Purpose Disinfecting Solution Twin Pack 2 x 10 ozhttps://gudid.fda.gov/gudid/app/admin/udi/recordDetails.xhtml#
Alcon Laboratories, Inc.
OPTI-FREE PUREMOIST 2x10oz
In Commercial Distribution
- 00300650361057 ()
- 20300650362539 ()
- 20300650370077 ()
- Multi-purpose soft contact lens solution
Intense Pulsed Light handpiece 625 nm 25x13 (for Discohttps://gudid.fda.gov/gudid/app/admin/udi/recordDetails.xhtml#very Pico family)
QUANTA SYSTEM SPA
OAM002020
In Commercial Distribution
- 08059173390168 ()
- Light-energy skin surface treatment system applicator
Orthex Half Ring110mm SBhttps://gudid.fda.gov/gudid/app/admin/udi/recordDetails.xhtml?pageType=draftDI&pageDataLoaded=false&pageMode=edit&deviceRecordKey=1091626#
VILEX IN TENNESSEE, INC.
C050-110
In Commercial Distribution
- 00841731111937 ()
- External orthopaedic fixation system, single-use
Dedicated speech generating device utilizing synthesized speech, permitting multiple methods of message formulation and multiple methods of device access based on Apple iOS operating system.
RM SPEECH
RMNXS
In Commercial Distribution
- B660RMNXS0 ()
- Voice synthesizer/digitizer
Dedicated speech generating device utilizing synthesized speech, permitting multiple methods of message formulation and multiple methods of device access based on Apple iOS operating system.
RM SPEECH
RMNXL
In Commercial Distribution
- B660RMNXL0 ()
- Voice synthesizer/digitizer
Dedicated speech generating device utilizing synthesized speech, permitting multiple methods of message formulation and multiple methods of device access based on Apple iOS operating system.
RM SPEECH
RMNS
In Commercial Distribution
- B660RMNS0 ()
- Voice synthesizer/digitizer
Dedicated speech generating device utilizing synthesized speech, permitting multiple methods of message formulation and multiple methods of device access based on Apple iOS operating system.
RM SPEECH
RMN
In Commercial Distribution
- B660RMN0 ()
- Voice synthesizer/digitizer
Glooko Mobile Insulin Dosing System (MIDS) is an insulin dose calculator. The Glooko MIDS Mobile Application is only available to patients who have been prescribed MIDS by their heath care provider. The mobile application can be downloaded by patients from the Google Play Store for Android and from the Apple App Store for iOS operating systems.
GLOOKO, INC.
5.x
In Commercial Distribution
- 00855093008002 ()
- Clinical management support software
Touchscreen tablet computer configured with Nova-Link app for use with OtoNova Pro. Android/Windows/iPadOS as per customer requirement.
OTODYNAMICS LIMITED
NOVA-TABLET
In Commercial Distribution
- 05060396171512 ()
- Otoacoustic emission system, battery-powered
- Evoked-potential audiometer
Mobile app for recording breath sounds and snoring during sleep, along with file transfer from Bluetooth sleep recording devices
ENSODATA, INC.
8.0
In Commercial Distribution
- 00864458000452 ()
- Sleep disorder interpretive software, professional-only
A convenience kit consisting of 15 Digital Ovulation Tests, Digital Basal Thermometer and 3 month subscription to Natural Cycles app
SPD SWISS PRECISION DIAGNOSTICS GMBH
Birth Control Kit
In Commercial Distribution
- 10633472602372 ()
- 00633472602375 ()
N/A
- Natural conception assistance kit
https://gudid.fda.gov/gudid/app/admin/udi/recordDetails.xhtml?pageType=manageDI&pageDataLoaded=false&pageSize=25&pageMode=read+only¤tPage=0&deviceRecordKey=141332#
BEST MEDICAL INTERNATIONAL, INC.
1164-1-40
In Commercial Distribution
- 00841365115394 ()
- General-purpose brachytherapy system applicator, remote-afterloading
NON STERILE 316L stainless steel screw, for use with mini-invasive OTIS-C PLUS plate. https://gudid.fda.gov/gudid/app/admin/udi/recordDetails.xhtml#
S.B.M
NON STERILE Screw for OTIS-C PLUS plate fixation
Not in Commercial Distribution
- 03760154004152 ()
- Outer Diameter: 6.5 Millimeter
- Length: 70 Millimeter
EVONS66070
- Orthopaedic bone screw, non-bioabsorbable, non-sterile
The OR Base Station subsystem is intended to send and receive data to and from the CTE implant over a wireless communication interface. Data sent to the CTE implant from the OR Base Station activates the CTE implant on the day of surgery.
Canary Medical USA LLC
43-5570-002-14
In Commercial Distribution
- 00860003118313 ()
- Medical networking interface unit
The ECG Monitor App intended for adults 22 years and older analyzes pulse rate data to identify episodes of irregular heart rhythms suggestive of AFib and provides a notification suggesting the user record an ECG to analyze the heart rhythm. The IHRN feature is not intended to provide a notification on every episode of irregular rhythm suggestive of AFib and the absence of a notification is not intended to indicate no disease process is present; rather the feature is intended to opportunistically acquire pulse rate data when the user is still and analyze the data when determined sufficient toward surfacing a notification. The ECG Monitor App is not intended to replace traditional methods of diagnosis or treatment. The ECG app is not intended for users with known arrhythmias other than AFib or users under 22 years old. Users should not interpret or take clinical action based on the device output without consultation of a qualified healthcare professional.
Samsung Electronics Co., Ltd.
1.3
In Commercial Distribution
- 08806094948240 ()
- Self-care monitoring/reporting software
The ECG Monitor App intended for adults 22 years and older analyzes pulse rate data to identify episodes of irregular heart rhythms suggestive of AFib and provides a notification suggesting the user record an ECG to analyze the heart rhythm. The IHRN feature is not intended to provide a notification on every episode of irregular rhythm suggestive of AFib and the absence of a notification is not intended to indicate no disease process is present; rather the feature is intended to opportunistically acquire pulse rate data when the user is still and analyze the data when determined sufficient toward surfacing a notification. The ECG Monitor App is not intended to replace traditional methods of diagnosis or treatment. The ECG app is not intended for users with known arrhythmias other than AFib or users under 22 years old. Users should not interpret or take clinical action based on the device output without consultation of a qualified healthcare professional.
Samsung Electronics Co., Ltd.
1.3
In Commercial Distribution
- 08806094948233 ()
- Self-care monitoring/reporting software
The Samsung ECG Monitor Application with Irregular Heart Rhythm Notification is an over-the-counter (OTC) software-only, mobile medical application operating on a compatible Samsung Galaxy Watch and Phone for informational use only in adults 22 years and older. The app analyzes pulse rate data to identify episodes of irregular heart rhythms suggestive of atrial fibrillation (AFib) and provides a notification suggesting the user record an ECG to analyze the heart rhythm. The Irregular Heart Rhythm Notification Feature is not intended to provide a notification on every episode of irregular rhythm suggestive of AFib and the absence of a notification is not intended to indicate no disease process is present; rather the feature is intended to opportunistically acquire pulse rate data when the user is still and analyze the data when determined sufficient toward surfacing a notification.
Samsung Electronics Co., Ltd.
1.X
In Commercial Distribution
- 08806094940763 ()
- Self-care monitoring/reporting software
The Samsung ECG Monitor Application with Irregular Heart Rhythm Notification is an over-the-counter (OTC) software-only, mobile medical application operating on a compatible Samsung Galaxy Watch and Phone for informational use only in adults 22 years and older. The app analyzes pulse rate data to identify episodes of irregular heart rhythms suggestive of atrial fibrillation (AFib) and provides a notification suggesting the user record an ECG to analyze the heart rhythm. The Irregular Heart Rhythm Notification Feature is not intended to provide a notification on every episode of irregular rhythm suggestive of AFib and the absence of a notification is not intended to indicate no disease process is present; rather the feature is intended to opportunistically acquire pulse rate data when the user is still and analyze the data when determined sufficient toward surfacing a notification.
Samsung Electronics Co., Ltd.
1.X
In Commercial Distribution
- 08806094940756 ()
- Self-care monitoring/reporting software
reSET-O® Mobile Application running on Android. reSET-O is a prescription-only digital therapy intended to deliver cognitive behavioral therapy (CBT) to patients with opioid use disorder (OUD). The Introductory Access Limited Version provides limited access to the reSET-O product.
PEAR THERAPEUTICS, INC.
1
Not in Commercial Distribution
- 10851580008187 ()
- Mental health/function therapeutic software, screen-viewed
reSET® Mobile Application running on Android. reSET is a prescription-only digital therapy intended to deliver cognitive behavioral therapy (CBT) to patients with substance use disorder (SUD). The Introductory Access Limited Version provides limited access to the reSET product.
PEAR THERAPEUTICS, INC.
1
Not in Commercial Distribution
- 10851580008156 ()
- Mental health/function therapeutic software, screen-viewed
RESET-O is an iOS application intended to increase retention of opioid use disorder patients in outpatient treatment by providing cognitive behavioral therapy as an adjunct to outpatient treatment.
Harvest Bio LLC
2.0.2
In Commercial Distribution
- 00850074433019 ()
- Mental health/function therapeutic software, screen-viewed
The Spect Ophthalmic Camera is a product consisting of an Apple iPhone, a mobile application (app), and an optical lens attachment and illumination source. The mobile app is accessible to users via the Apple App Store (Apple Inc.) for use on Spect issued iPhone devices. The Spect Ophthalmic Camera consists of a mechanical adaptor with a telescopic feature that houses a high-quality glass fundoscopic lens, and a white-light LED illumination source.
Spect Inc.
BOM001
In Commercial Distribution
- 00853501008002 ()
- Ophthalmic fundus camera
ENHANCED ALGORITHM ECG EVENT RECORDER
https://gudid.fda.gov/gudid/app/admin/udi/recordDetails.xhtml?pageType=manageDI&pageDataLoaded=false&pageMode=read+only&deviceRecordKey=1058652#
BRAEMAR MANUFACTURING, LLC
900-0557-01
In Commercial Distribution
- B146ER9B0 ()
- Electrocardiography telemetric monitoring system
B-P KNEE TIBIA PLATFORM COMPONENT, W/O BIOCOAT, W/ULTRACOAT, TYPE 0, SIZE 2
https://gudid.fda.gov/gudid/app/admin/udi/recordDetails.xhtml#
ENDOTEC, INC.
04-32-0462
Not in Commercial Distribution
- 00814193021519 ()
- SIZE 2, TYPE 0
04-32-0462
- Cruciate-retaining total knee prosthesis
LAP-Instrument, Ø10mm, l=450mm, detach.
Grasping forceps TENACULUM, d/a
Stainl.steel handle, insul., w/o ratchethttps://gudid.fda.gov/gudid/app/admin/udi/recordDetails.xhtml#
DANNORITZER Medizintechnik GmbH & Co. KG
LMC-148-345
Not in Commercial Distribution
- 04251351105326 ()
LMC-148-345
- Rigid endoscopic tissue manipulation forceps, reusable
RESET Mobile Application runs on iOS and is intended to provide cognitive behavioral therapy, as an adjunct to a contingency management system, for patients 18 years of age and older.
Harvest Bio LLC
2.0.2
In Commercial Distribution
- 00850074433002 ()
- Mental health/function therapeutic software, screen-viewed
OtoNova Pro system for ABR hearing screening. Includes OtoNova Pro instrument, ear probe, system items, and ABR Screener licence for the Nova-link app
OTODYNAMICS LIMITED
NPRO-SCR-A
In Commercial Distribution
- 05060396173127 ()
- Evoked-potential audiometer
OtoNova Pro system for DPOAE hearing screening. Includes OtoNova Pro instrument, ear probe, system items, and DP Screener licence for the Nova-link app
OTODYNAMICS LIMITED
NPRO-SCR-D
In Commercial Distribution
- 05060396173110 ()
- Otoacoustic emission system, battery-powered