36 results · 23ms · Sources: EU EUDAMED, US FDA

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BONEOPTIMIZER

FDA 510(k)
FDA Class 2 ·Orthopedic

Bur PM2-70 50K steel Ø1.4x80

FDA UDI
Bien-Air Surgery SA·17630055512830·

Endo Carry-On Procedure Kit

FDA UDI
MEDIVATORS INC.·00677964056697·Endo Carry-On Procedure Kit

DIETHRICH MICRO BULLDOG CLAMP

FDA UDI
SONTEC INSTRUMENTS, INC.·B09921008410·DIETHRICH MICRO BULLDOG CLAMP SERRATED CURVED JAW

DIETHRICH MICRO BULLDOG CLAMP

FDA UDI
SONTEC INSTRUMENTS, INC.·00192896010536·DIETHRICH MICRO BULLDOG CLAMP SERRATED CURVED JAW

Monoblock Tibial Trial UC Insert

FDA UDI
SIGNATURE ORTHOPAEDICS PTY LTD·09348215043353·

N/A

FDA UDI
Doppkon GmbH & Co. KG·04262494463280·Kerrison Punch length 200mm, width 2mm, 90° do...

ACON COC ONE STEP COCAINE TEST STRIP, ACON COC ONE STEP COCAINE TEST DEVICE

FDA 510(k)
FDA Class 2 ·Clinical Toxicology

14-CHANNEL EXTREMITY COIL FOR MAGNETOM ESSENZA

FDA 510(k)
FDA Class 2 ·Radiology

Widex

FDA UDI
Widex A/S·05706069729757·Widex EVOKE E-FP (Sporty red S-440 ) Telecoil, ...

Widex

FDA UDI
Widex A/S·05706069727357·Widex EVOKE E-FM (Sporty red S-440 ) RC coil

Widex

FDA UDI
Widex A/S·05706069727753·Widex EVOKE E-FA (Sporty red S-440 ) Telecoil, ...

PERCLOSE PROGLIDE 6F SUTURE MEDIATED CLOSURE (SMC) SYSTEM

FDA Adverse Event
Malfunction ·AV-TEMECULA-CT·Product code MGB·March 23, 2016

PREVENA PLUS¿ INCISION MANAGEMENT SYSTEM

FDA Adverse Event
Injury ·KINETIC CONCEPTS, INC.·Product code OMP·July 19, 2019

ENTERPRISE VASCULAR RECONSTRUCTION DEVICE AND DELIVERY SYSTEM

FDA Adverse Event
Injury ·CORDIS NEUROVASCULAR, INC.·Product code NJE·May 8, 2013

PULSE GEN MODEL 102

FDA Adverse Event
Malfunction ·LIVANOVA USA, INC.·Product code LYJ·September 19, 2014

7700

FDA Adverse Event
Malfunction ·GE OEC MEDICAL SYSTEMS GMBH·Product code JAA·May 12, 2011

FEMORAL MODULAR HEAD - L Ø36MM

FDA Adverse Event
Injury ·LIMACORPORATE S.P.A.·Product code LPH·August 9, 2022

IVEA Product Part Number 16100 Model 500A

FDA Enforcement
Class II ·Terminated·Firefly Medical, Inc.·October 11, 2017

CME America T-Syringe Pump - T34 - Product Usage: infusion of medications or fluids requiring continuous or intermittent delivery at precisely-controlled infusion rates through clinically acceptable routes of administration, including intravenous, subcutaneous, percutaneous, intra-arterial, epidural, in close proximity to nerves, and into an intra-operative site (soft tissue/body cavity/surgical wound site).

FDA Enforcement
Class II ·Terminated·CME America, LLC·December 9, 2020