36 results
·
23ms
·
Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
×
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