Company Name Brand Name GMDN Term Name GMDN Term Status FDA Product Code Name FDA Product Code Device Packaged As Sterile Sterilization Prior To Use Issuing Agency Device Size Device Size Type Device Class Implantable

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MIS 16CM Hooded
STRYKER CORPORATION
5407-120-970H
In Commercial Distribution

  • 07613327402230 ()
5407120970H

  • Drilling power tool attachment, basic
No Description
STRYKER CORPORATION
3005S3HT2
In Commercial Distribution

  • 07613327347456 ()
3005S3HT2

  • Basic electric hospital bed
Probe
FUJIFILM CORPORATION
UST-2266-5
In Commercial Distribution



  • Extracorporeal ultrasound imaging transducer, hand-held
Probe
FUJIFILM CORPORATION
L51K
In Commercial Distribution



  • Surgical ultrasound imaging transducer
Magna R3 LOGIQ F Basic console
GE Medical Systems (China) Co.,Ltd.
LOGIQ F R3
In Commercial Distribution

  • 00195278722430 ()


  • General-purpose ultrasound imaging system
No Description
GE Medical Systems (China) Co.,Ltd.
Premier SW R1.1.x UPG
In Commercial Distribution

  • 00840682146296 ()


  • General-purpose ultrasound imaging system
No Description
GE Vingmed Ultrasound AS
E80 v203 with OLED
In Commercial Distribution

  • 00840682141550 ()


  • Cardiovascular ultrasound imaging system
No Description
GE Medical Systems (China) Co.,Ltd.
Premier VA
In Commercial Distribution

  • 00840682141178 ()


  • General-purpose ultrasound imaging system
No Description
GE Medical Systems (China) Co.,Ltd.
Premier VS
In Commercial Distribution

  • 00840682141147 ()


  • General-purpose ultrasound imaging system
No Description
GE Ultrasound Korea Ltd.
P6 BT18
In Commercial Distribution

  • 00840682138208 ()


  • General-purpose ultrasound imaging system
No Description
GE Vingmed Ultrasound AS
E90 v201
In Commercial Distribution

  • 00840682102735 ()


  • Cardiovascular ultrasound imaging system
No Description
PARALLEL DESIGN
LK760-RS
In Commercial Distribution

  • 00840682112772 ()


  • Extracorporeal ultrasound imaging transducer, hand-held
No Description
GE PARALLEL DESIGN, INC.
C4-8-D
In Commercial Distribution

  • 00840682108676 ()


  • Extracorporeal ultrasound imaging transducer, hand-held
No Description
GE Healthcare Austria GmbH & Co OG
RIC5-9-D
In Commercial Distribution

  • 00840682108430 ()


  • Rectal/vaginal ultrasound imaging transducer
  • Rectal ultrasound imaging system transducer
MySign® S wo/power supply FDA
Honeywell Healthcare Solutions GmbH
wo/power supply FDA
In Commercial Distribution

  • 04036616009874 ()

  • Height: 42 Millimeter
  • Length: 166 Millimeter
  • Width: 242 Millimeter
1002197

  • Pulse oximeter
e360 Ventilator with Accessories T Model
Newport Medical Instruments, Inc.
E360TH-SY-IN
Not in Commercial Distribution

  • 10884521510791 ()
E360TH-SY-IN

  • Neonatal/adult intensive-care ventilator
e360 Ventilator with Accessories;T Model
Newport Medical Instruments, Inc.
E360TH-SY-IN
Not in Commercial Distribution

  • 10884521541245 ()
E360TH-SY-IN

  • Neonatal/adult intensive-care ventilator
Audio Processor Kit (without headband)
Med-El Elektromedizinische Geräte Gesellschaft m.b.H.
38203
Not in Commercial Distribution

  • 09008737382032 ()


  • Bone-conduction hearing aid, head-worn
Audio Processor Kit (without headband)
Med-El Elektromedizinische Geräte Gesellschaft m.b.H.
38202
Not in Commercial Distribution

  • 09008737382025 ()


  • Bone-conduction hearing aid, head-worn
Audio Processor Kit (without headband)
Med-El Elektromedizinische Geräte Gesellschaft m.b.H.
38201
Not in Commercial Distribution

  • 09008737382018 ()


  • Bone-conduction hearing aid, head-worn
Audio Processor Kit (without headband)
Med-El Elektromedizinische Geräte Gesellschaft m.b.H.
38200
Not in Commercial Distribution

  • 09008737382001 ()


  • Bone-conduction hearing aid, head-worn
Audio Processor Kit
Med-El Elektromedizinische Geräte Gesellschaft m.b.H.
38199
In Commercial Distribution

  • 09008737381998 ()


  • Bone-conduction hearing aid, head-worn
Audio Processor Kit
Med-El Elektromedizinische Geräte Gesellschaft m.b.H.
38198
In Commercial Distribution

  • 09008737381981 ()


  • Bone-conduction hearing aid, head-worn
Audio Processor Kit
Med-El Elektromedizinische Geräte Gesellschaft m.b.H.
38197
In Commercial Distribution

  • 09008737381974 ()


  • Bone-conduction hearing aid, head-worn
Audio Processor Kit
Med-El Elektromedizinische Geräte Gesellschaft m.b.H.
38196
In Commercial Distribution

  • 09008737381967 ()


  • Bone-conduction hearing aid, head-worn
Supra R2 basic console for Balance VA
GE Medical Systems (China) Co.,Ltd.
Balance R2 VA
In Commercial Distribution

  • 00195278300096 ()


  • General-purpose ultrasound imaging system
Supra R2 basic console for Balance VS
GE Medical Systems (China) Co.,Ltd.
Balance R2 VS
In Commercial Distribution

  • 00195278300034 ()


  • General-purpose ultrasound imaging system
Magna R3 LOTUS 5pp Basic console
GE Medical Systems (China) Co.,Ltd.
Premier LOTUS 5PP
In Commercial Distribution

  • 00195278690418 ()


  • General-purpose ultrasound imaging system
Magna R3 LOTUS 4pp Basic console
GE Medical Systems (China) Co.,Ltd.
Premier LOTUS 4PP
In Commercial Distribution

  • 00195278690401 ()


  • General-purpose ultrasound imaging system
Magna R3 VS Basic console
GE Medical Systems (China) Co.,Ltd.
Premier R3 VS
In Commercial Distribution

  • 00195278690388 ()


  • General-purpose ultrasound imaging system
OBALON® Navigation Console - component to visualize the OBALON® Balloon
Reshape Lifesciences Inc.
7402-0001
Not in Commercial Distribution

  • 00859810006180 ()


  • Gastrointestinal catheter/endoscope tracking system
Power Assist with Display Assembly for microTargeting(TM) Controller
FHC, INC.
66-DA-ME-00440
In Commercial Distribution

  • 00873263004401 ()
66-DA-ME

  • Neurosurgical micro targeting drive
Storage and Transport Case for mT Controller
FHC, INC.
66-DA-SC-00438
Not in Commercial Distribution

  • 00873263004388 ()
66-DA-SC

  • Neurosurgical micro targeting drive
microTargeting(TM) Controller Power Assist System for use with mT Drive or STar Drive M/E
FHC, INC.
66-DS-PA-00427
In Commercial Distribution

  • 00873263004272 ()
66-DS-PA

  • Neurosurgical micro targeting drive
microTargeting(TM) Controller
FHC, INC.
66-EL-MS-00419
In Commercial Distribution

  • 00873263004197 ()
66-EL-MS

  • Neurosurgical micro targeting drive
microTargeting(TM) handheld remote control
FHC, INC.
66-EL-RM-00395
In Commercial Distribution

  • 00873263003954 ()
66-EL-RM

  • Neurosurgical micro targeting drive
Guidline 4000 ™ 5.0 1.5m Special-use Lead, 1x For use with microTargeting ™ Electrodes
FHC, INC.
C0232-00781
In Commercial Distribution

  • 00873263007815 ()

  • Length: 1.5 Meter
C0232

  • Depth electrode
GL5 UE Patient Lead, 1.5m, presterile
FHC, INC.
C0231-00691
In Commercial Distribution

  • 00873263006917 ()

  • Length: 1.5 Meter
C0231

  • Depth electrode
GL5 UE Patient Lead, 3m, presterile
FHC, INC.
C0230-00690
In Commercial Distribution

  • 00873263006900 ()
C0230

  • Depth electrode
GL5 Notebook Computer
FHC, INC.
C0216-00675
In Commercial Distribution

  • 00873263006757 ()
C0216

  • Neurophysiologic monitoring system
  • Electroencephalograph
GL5 Main Processing Unit
FHC, INC.
C0215-00674
In Commercial Distribution

  • 00873263006740 ()
C0215

  • Electroencephalograph
  • Neurophysiologic monitoring system
microTargeting(TM) Controller for use with LeadPoint
FHC, INC.
66-EL-MS-04-00541
In Commercial Distribution

  • 00873263005415 ()
66-EL-MS-04

  • Neurosurgical micro targeting drive
No Description
Humeca B.V.
4.D80STS
In Commercial Distribution

  • 08717903490419 ()
  • 08717903490365 ()
4.D80STS

  • Dermatome handpiece, electrically-powered
DRSHD 1080p System, Rev 7
Nds Surgical Imaging LLC
DRSHD.7
Not in Commercial Distribution

  • 00817613020383 ()


  • Endoscopic video image processing unit
DRSHD 1080p System, Rev 7https://gudid.fda.gov/gudid/app/admin/udi/recordDetails.xhtml#
Nds Surgical Imaging LLC
DRSHD.7
Not in Commercial Distribution

  • 00817613020000 ()


  • Endoscopic video image processing unit
No Description
NDD Medizintechnik AG
2500
In Commercial Distribution

  • 07640142190431 ()


  • Diagnostic spirometer, professional
The Profile Smart Body Scale measures weight and uses bioelectrical impedance analysis (BIA) technology to estimate body fat, total body water percentage, bone mass, and muscle mass in generally healthy adults 18 years of age or older. It is intended for use in the home/domestic setting only.
PROFILE PRODUCTS, LLC
LS206-E
In Commercial Distribution

  • 10811392021026 ()
  • 00811392021029 ()

  • Width: 12.5 Inch
  • Length: 12.5 Inch
  • Height: 1 Inch


  • Stand-on floor scale, electronic
Reusable Powered Handle
Covidien LP
IDRVULTRA1
Not in Commercial Distribution

  • 10884521142794 ()


  • Open-surgery manual linear stapler, reusable
LE Charging System
ST. JUDE MEDICAL, INC.
6722
In Commercial Distribution

  • 05414734405591 ()
6722

  • Noninvasive device battery charger
The products are sterile with a Sterility Assurance Level (SAL) of 10-6, non-pyrogenic and single-use devices. There has several models. Different models are distinguished by needle gauge and length. The Blood Lancet consists of needle tube and needle hub. The products are for OTC use, and they are external communication, blood indirect devices. The contact duration for both subjected devices is within 24h, and they belong to limited contact device according ISO 10993-1.
Promisemed Hangzhou Meditech Co., Ltd.
11G-2091-K
In Commercial Distribution

  • 86971227402543 ()
  • 06971227402547 ()


  • Autoinjector needle
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