12 results
·
21ms
·
Sources: EU EUDAMED, US FDA
Multi4 System
FDA 510(k)
FDA Class 2
·Gastroenterology, Urology
TRULIANT TIB IMP PSC INSERT SZ 2, 9MM
FDA Adverse Event
Injury
·EXACTECH, INC.·Product code JWH·September 18, 2024
NA
FDA UDI
aap Implantate AG·04042409097195·Parallel guide for K-wires, CS 5.8
RZ Medizintechnik GmbH
FDA UDI
RZ-Medizintechnik GmbH·04049197441117·Micro Hook
45°, s...
G7 Dual Mobility System
FDA 510(k)
FDA Class 2
·Orthopedic
AERO CHROME* Breathable Performance Surgical Gowns
FDA 510(k)
FDA Class 2
·General, Plastic Surgery
NA
FDA UDI
aap Implantate AG·04042409445163·Cannulated Headless Bone Screw 2.5, L 22, TL 5 ...
RINGLOC-X E1 H/W 56/32MM
FDA Adverse Event
Injury
·BIOMET UK LTD.·Product code LPH·April 11, 2025
INTERMATE
FDA Adverse Event
Malfunction
·BAXTER HEALTHCARE - IRVINE·Product code FRN·November 14, 2014
MANUAL ORTHOPEDIC SURGICAL INSTRUMENT
FDA Adverse Event
Malfunction
·WARSAW ORTHOPEDIC, INC.·Product code HXX·September 16, 2011
POWERED WHEELCHAIR
FDA Adverse Event
Malfunction
·INVACARE TAYLOR STREET·Product code ITI·July 26, 2013
BioGX SARS-CoV-2 Reagents for BD MAX System-IVD PCR test intended for the qualitative detection of nucleic acid from the SARS-CoV-2 in nasopharyngeal specimens Catalog Number: 444213
FDA Enforcement
Class II
·Terminated·Becton Dickinson & Co.·April 21, 2021