61 results
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21ms
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Sources: EU EUDAMED, US FDA
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Regulation: Us FDA
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ACCU NEWS Drug Screening Test Card/Urine Cup
FDA 510(k)
FDA Class 2
·Clinical Toxicology
BR2000 BLADES
FDA UDI
Peter Brasseler Holdings, LLC·00887919739159·K5-2590-58
BR2000 BLADES
FDA UDI
Peter Brasseler Holdings, LLC·00887919100317·K5-2590-50
BR2000 BLADES
FDA UDI
Peter Brasseler Holdings, LLC·00887919100300·K5-2590-47
Endo-Model Knee System - Instruments
FDA UDI
WALDEMAR LINK GmbH & Co. KG·04026575313716·Radiographic image marker, manual - Endo Model ...
BR2000 BLADES
FDA UDI
Peter Brasseler Holdings, LLC·00887919100294·K5-2590-39
Endo-Model Knee System - Instruments
FDA UDI
WALDEMAR LINK GmbH & Co. KG·04026575403059·Orthopaedic implant inserter/extractor, reusabl...
BR2000 BLADES
FDA UDI
Peter Brasseler Holdings, LLC·00887919739128·K5-2590-35
RADIFOCUS GLIDEWIRE ADVANTAGE, RADIFOCUS GLIDEWIRE ADVANTAGE
FDA 510(k)
FDA Class 2
·Cardiovascular
FLEBOSET DOUBLE
FDA 510(k)
FDA Class 2
·General Hospital
TARGET TIP
FDA Adverse Event
Malfunction
·MPRI·Product code DTB·June 7, 2013
OCTRODE PERCUTANEOUS LEAD
FDA Adverse Event
Malfunction
·ST. JUDE MEDICAL - NEUROMODULATION·Product code LGW·June 27, 2011
RECIPROCATING/OSCILLATING SAW/MODULAT HANDPIECE
FDA Adverse Event
Injury
·CONMED LINVATEC·Product code HBC·October 2, 2014
RADIFOCUS GLIDEWIRE ADVANTAGE
FDA Adverse Event
Malfunction
·TERUMO CORPORATION, ASHITAKA·Product code DQX·May 1, 2020
GMK-SPHERE TIBIAL TRAY FIXED CEMENTED SIZE 5 L
FDA Adverse Event
Injury
·MEDACTA INTERNATIONAL SA·Product code JWH·February 28, 2020
GLIDEWIRE ADVANTAGE
FDA Adverse Event
Injury
·TERUMO CORPORATION, ASHITAKA·Product code DQX·July 9, 2025
RADIFOCUS GLIDEWIRE ADVANTAGE
FDA Adverse Event
Malfunction
·TERUMO CORPORATION, ASHITAKA·Product code DQX·June 23, 2022
GUIDE WIRE w/ BALL TIP 2.0MMX98CM; 469040 Intended to be used as a guide pin for insertion of implants (cannulated screws and/or intramedullary nails). Bone nail guidewire. Intended for drilling bone.
FDA Enforcement
Class II
·Terminated·Zimmer Biomet, Inc.·June 27, 2018
CAPIOX RX OXYGENATOR
FDA Adverse Event
Injury
·TERUMO CORPORATION, ASHITAKA·Product code DTZ·March 28, 2019
RADIFOCUS GLIDEWIRE ADVANTAGE
FDA Adverse Event
Injury
·TERUMO CORPORATION, ASHITAKA·Product code DQX·February 3, 2025