16 results
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21ms
·
Sources: EU EUDAMED, US FDA
FRESHKON 1-DAY ALLURING EYES (ETAFILCON A) SOFT (HYDROPHILIC) CONTACT LENS FOR DAILY WEAR FRESHKON 1-DAY MOSAIC (ETAFILC
FDA 510(k)
FDA Class 2
·Ophthalmic
Bernafon
FDA UDI
Bernafon AG·05711584022726·MD1 NR, PS GB MONDO 1
JOBST UltraSheer
FDA UDI
BSN MEDICAL, INC.·00035664223151·ULTRA SHEER 20-30 MM HG THIGH W/DOT BAND CLOSED...
Concorde Lift Torque Limiting Handle. Must be used with supplemental internal spinal fixation systems that have been cleared for use in the lumbar spine.
FDA Enforcement
Class II
·Terminated·DePuy Orthopaedics, Inc.·March 14, 2018
SCHWERT
FDA UDI
A. Schweickhardt GmbH & Co. KG·E8961223150·Atraumatic forceps DEBAKEY 15cm
straig...
UniTip High Resolution Catheter
FDA UDI
Unisensor AG·07640172970508·
HOME PREGNANCY TEST
FDA 510(k)
FDA Class 2
·Clinical Chemistry
STAXX XDL SYSTEM
FDA 510(k)
FDA Class 2
·Orthopedic
INTERCHANGEABLE ULNAR ASSEMBLY
FDA Adverse Event
Injury
·ZIMMER BIOMET, INC.·Product code JDC·October 22, 2019
PROXIMATE** LINEAR CUTTER RELOAD - STANDARD
FDA Adverse Event
Malfunction
·ETHICON ENDO-SURGERY, LLC.·Product code GDW·May 21, 2013
MERIT CUSTOM KIT
FDA Adverse Event
Injury
·MERIT MEDICAL SYSTEMS, INC.·Product code DQO·September 18, 2014
ROTATING MULTIPLE CLIP APPLIER
FDA Adverse Event
Malfunction
·ETHICON ENDO-SURGERY, LLC.·Product code FZP·June 13, 2011
INTERCHANGEABLE HUMERAL ASSEMBLY
FDA Adverse Event
Injury
·ZIMMER BIOMET, INC.·Product code JDC·October 22, 2019
BD CONNECTA¿ STOPCOCK
FDA Adverse Event
Malfunction
·BD INFUSION THERAPY SYSTEMS INC. S.A. DE C.V.·Product code FMG·April 14, 2023
UNITIP CATHETER FOR HR GI
FDA Adverse Event
Malfunction
·UNISENSOR USA INC·Product code FFX·January 16, 2015
Viva-E, Catalog # 6002-380, UDI # 03661540600050 Product Usage: automated chemistry analyzer intended for clinical use
FDA Enforcement
Class II
·Terminated·Vital Scientific N.V.·October 23, 2019