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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
No Description
NT-Trading GmbH & Co. KG
UTG 80334200
Not in Commercial Distribution
- ENTTUTG803342001 ()
- Diameter: Ø 3,3 - 4,25 mm Compatible with implant system: Sweden & Martina Implantology™/ Premium TG® Implant
UTG 80334200
- Dental prosthesis/implant abutment screw
- Dental implant suprastructure, permanent, preformed
No Description
NT-Trading GmbH & Co. KG
UTG 603342
Not in Commercial Distribution
- ENTTUTG6033421 ()
- Diameter: Ø 3,3 - 4,25 mm Compatible with implant system: Sweden & Martina Implantology™/ Premium TG® Implant
UTG 603342
- Dental prosthesis/implant abutment screw
- Dental implant suprastructure, permanent, preformed
TraumaGuard Intra-abdominal Pressure-Sensing Catheter (“TG”). TG is a urine drainage catheter that provides continuous biometric monitoring of Intra-abdominal Pressure (“IAP”) and Core Body Temperature (CBT). TG is a silicone catheter with polyurethane sensing balloons.
IAP UO Temp is also intended for use in the monitoring of intra-abdominal pressure. The measured pressures can be used as an aid in the diagnosis of intra-abdominal hypertension (IAH) and the associated clinical syndrome of abdominal compartment syndrome (ACS). The TraumaGuard Intra-abdominal Pressure-Sensing System Catheter is a single-use device intended for short-term use (less than 30 days).
SENTINEL MEDICAL TECHNOLOGIES
TraumaGuard Intra-abdominal Pressure-Sensing System Single Catheter
In Commercial Distribution
- 00860003478707 ()
000-0219
- Multi-parameter urinary monitoring system catheter set
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
Hemostatic Gauze Pads: The device is indicated for: temporary external use to control moderate to severe bleeding. Hemostatic gauze is for temporary external use only
MEDTRADE PRODUCTS LIMITED
FG08834291
In Commercial Distribution
- 35060206630162 ()
- 15060206630168 ()
- 75060206630160 ()
- 25060206630165 ()
- Two 4in by 4in dressing pads per supplied folded 2in x20in
- Length: 4 Inch
- Width: 4 Inch
FG08834291
- Chitosan haemostatic agent, professional, non-bioabsorbable
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
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
H&H H*VENT Vented Chest Seal Two Pack, containing two individually packaged vented chest seals for sealing open chest wounds and reducing the risk of tension pneumothorax.
H&H MEDICAL CORPORATION
1
In Commercial Distribution
- 00857048006460 ()
HVS02
- Pneumothorax dressing