14 results
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23ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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Kent Camera
FDA 510(k)
FDA Class 2
·Cardiovascular
MEGA SPINE SYSTEM
FDA UDI
BK MEDITECH CO.,LTD.·08809763492259·Multi Screw Driver
OCT CATHETER
FDA Adverse Event
Malfunction
·ABBOTT MEDICAL·Product code DQO·November 15, 2023
GPS TM, G SURGICAL ANTERIOR CERVICAL PLATE SYSTEM +
FDA 510(k)
FDA Class 2
·Orthopedic
APERFIX TIBIAL IMPLANT WITH INSERTER
FDA 510(k)
FDA Class 2
·Orthopedic
Widex
FDA UDI
Widex A/S·05706069819502·Widex UNIQUE U-FS (Copper brown ) 50, Telecoil,...
Widex
FDA UDI
Widex A/S·05706069792805·Widex UNIQUE U-PA (Copper brown ) 50, RC coil
CUSA EXCEL 23KHZ CEM NOSECONE
FDA Adverse Event
Malfunction
·INTEGRA LIFESCIENCES(IRELAND)·Product code LFL·May 10, 2017
GMK-SPHERE TIBIAL INSERT FIXED SPHERE FLEX SIZE 3/12 MM R
FDA Adverse Event
Injury
·MEDACTA INTERNATIONAL SA·Product code JWH·December 17, 2020
COLLEAGUE PRE P1.7
FDA Adverse Event
Malfunction
·BAXTER HEALTHCARE - SINGAPORE·Product code FRN·July 15, 2011
PINN CAN BONE SCREW 6.5MMX15MM
FDA Adverse Event
Injury
·DEPUY ORTHOPAEDICS INC US·Product code NDJ·June 11, 2013
PRESEP-CENTRAL VENOUS OXIMETRY CATHETER KIT
FDA Adverse Event
Injury
·EDWARDS LIFESCIENCES, PR·Product code DQE·September 15, 2008
XP-XP Tibial Tray - Interlok 79 mm Item # 195758
FDA Enforcement
Class II
·Terminated·Zimmer Biomet, Inc.·September 18, 2019
RECLAIM DISTAL TAPERED Distal Stem, various sizes. Taper Protector Sleeve. RECLAIM Revision Hip System Orthopedic Manual Surgical Instrument, used to ensure the locking taper surface of the Distal Stem is protected during proximal preparation.
FDA Enforcement
Class II
·Terminated·DePuy Orthopaedics, Inc.·July 30, 2014