21 results
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24ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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Truliant Femoral Components
FDA 510(k)
FDA Class 2
·Orthopedic
TRULIANT TIB IMP CRC INSERT SZ 4, 15MM
FDA Adverse Event
Injury
·EXACTECH, INC.·Product code JWH·August 30, 2022
TRULIANT TIB IMP PS INSERT SZ 3.5 9MM
FDA Adverse Event
Injury
·EXACTECH, INC.·Product code JWH·August 23, 2024
TRULIANT PS CEM FEM PS CEM LEFT SZ 4
FDA Adverse Event
Injury
·EXACTECH, INC.·Product code JWH·December 19, 2022
ADVANCED PATELLA 29M 3 PEG IMPLANT
FDA Adverse Event
Injury
·EXACTECH, INC.·Product code JWH·August 15, 2024
TRULIANT PS CEM FEM PS CEM RIGHT SZ 4
FDA Adverse Event
Injury
·EXACTECH, INC.·Product code JWH·December 19, 2022
PIVOX™ Oblique Lateral Spinal System
FDA UDI
MEDTRONIC SOFAMOR DANEK, INC.·00643169595712·TRIAL 2170240 O25 IB 20MM 0 DEG 10X40
Reicodent
FDA UDI
devemed GmbH·04061644050635·Filling instrument, pear-shaped
2.0 / 2.5 mm
Oc...
BV Medical
FDA UDI
BV Medical·00845821010452·Utility scissors 5.5", stainless steel with red...
devemed
FDA UDI
devemed GmbH·04061644022663·Filling instrument, pear-shaped
2.0 / 2.5 mm
F-...
RZ Medizintechnik GmbH
FDA UDI
RZ-Medizintechnik GmbH·04049197452489·McCulloch Blade
4 teet...
CARTO XP EP NAVIGATION SYSTEM, VERSION 9
FDA 510(k)
FDA Class 2
·Cardiovascular
ORTHOPEDIATRICS PEDILOC TIBIA PLATE SYSTEM
FDA 510(k)
FDA Class 2
·Orthopedic
Reicodent
FDA UDI
devemed GmbH·04061644035397·Filling instrument, pear-shaped
2.0 / 2.5 mm
CO...
ILAB POLARIS MULTI-MODALITY GUIDANCE SYSTEM
FDA Adverse Event
Malfunction
·BOSTON SCIENTIFIC CORPORATION·Product code DQK·March 3, 2025
Anjon Bremer Molded Crown. bone fixation fastener for spinal use. REF number 100048 - Product Usage: Smooth or threaded metallic bone fixation fastener. Provides cervical spine immobilization and therapeutic traction for treatment of patients with cervical trauma or other neck conditions.
FDA Enforcement
Class II
·Terminated·Anjon Holdings·August 19, 2020
ILAB? POLARIS MULTI-MODALITY GUIDANCE SYSTEM
FDA Adverse Event
Malfunction
·BOSTON SCIENTIFIC CORPORATION·Product code DQK·May 14, 2026
FORTIFY DR
FDA Adverse Event
Injury
·ST. JUDE MEDICAL INC., CARDIAC RHYTHM MANAGEMENT D·Product code LWS·January 13, 2014
TENSION FREE VAGINAL TAPE
FDA Adverse Event
Injury
·ETHICON, INC.·Product code OTN·June 14, 2013
CENTRICITY
FDA Adverse Event
Malfunction
·GE MEDICAL SYSTEMS, LLC·Product code LLZ·July 19, 2011