25 results
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21ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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TRC-50DX RETINAL CAMERA
FDA 510(k)
FDA Class 2
·Ophthalmic
N/A
FDA UDI
TETRA MEDICAL SUPPLY CORP.·00614138003408·DELUXE ABDOMINAL BINDER 9IN SMALL
LEONE SPA
FDA UDI
LEONE SPA·08033707002932·COIL SPRINGS MEMORIA ENDS/LIG CLOSED M
CosmoLock Pedicle Screw System
FDA UDI
Kalitec Direct LLC·B07311K1230010·Rod Holder, Straight, 5.5 mm
Halyard
FDA UDI
O&M HALYARD, INC.·10680651412314·ACM,SPEC,SRGDRP,-,LRG,18
Surgical Direct
FDA UDI
Surgical Direct, Inc.·B382SD800561231010·5 1/2" Adson Specialty Bipolar Forceps, Silver ...
AMEDICA DRUG SCREEN METHAPHETAMINE TEST
FDA 510(k)
FDA Class 2
·Clinical Toxicology
HI-TORQUE BALANCE MIDDLEWEIGHT ELITE
FDA 510(k)
FDA Class 2
·Cardiovascular
ZENIX
FDA UDI
Zoll Medical Corporation·00198843000094·ZENIX, EMS FIRE CONFIGURATION
POWERED WHEELCHAIR
FDA Adverse Event
Malfunction
·INVACARE SUZHOU·Product code ITI·May 21, 2013
PORTABLE OXYGEN GENERATOR (CONCENTRATOR, HOMEFILL)
FDA Adverse Event
Malfunction
·INVACARE FLORIDA OPERATIONS·Product code CAW·September 26, 2014
DUROM HIP
FDA Adverse Event
Injury
·ZIMMER GMBH·Product code KWA·June 6, 2011
OMNIFIX®
FDA Adverse Event
Malfunction
·B BRAUN MELSUNGEN AG·Product code FMF·March 6, 2026
8100 ALARIS PUMP MODULE
FDA Adverse Event
Malfunction
·CAREFUSION SD·Product code FRN·December 18, 2020
T15 HEXALOBE DRIVE SILVER
FDA Adverse Event
Malfunction
·BIOMET MICROFIXATION·Product code HWR·March 18, 2025
T15 HEXALOBE DRIVE SILVER
FDA Adverse Event
Malfunction
·BIOMET MICROFIXATION·Product code HWR·March 18, 2025
TOSOH ST AIA 25-OH VITAMIN D PRETREATMENT SET
FDA Adverse Event
Malfunction
·TOSOH CORPORATION·Product code MRG·April 19, 2018
8100 ALARIS PUMP MODULE
FDA Adverse Event
Malfunction
·CAREFUSION SD·Product code FRN·December 20, 2020
8100 ALARIS PUMP MODULE
FDA Adverse Event
Malfunction
·CAREFUSION SD·Product code FRN·December 20, 2020
dS Breast 7ch 3.0T
FDA Enforcement
Class II
·Ongoing·Philips North America Llc·December 4, 2024