9 results
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23ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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OMNIFLEX-C UHMWPE MID-SHAFT RESTRICTOR
FDA 510(k)
FDA Class 2
·General, Plastic Surgery
PORTABLE ULTRASONIC DIAGNOSTIC SYSTEM
FDA 510(k)
FDA Class 2
·Radiology
PHYSIOLOGICAL MONITOR, MODEL 3000 (SERIES)
FDA 510(k)
FDA Class 2
·Cardiovascular
PEDICLE SCREW ENH. POLY-AXIAL PEDICLE SCREW - CANNULATED 7X35MM
FDA Adverse Event
Injury
·MEDACTA INTERNATIONAL SA·Product code NKB·March 10, 2021
AC-POWERED ADJUSTABLE HOSPITAL BED, INCLUDING RAILS
FDA Adverse Event
Malfunction
·INVACARE FLORIDA OPERATIONS·Product code FNL·January 22, 2013
ASR ACETABULAR CUPS 58
FDA Adverse Event
Injury
·DEPUY INT'L LTD·Product code KWA·December 9, 2010
HOMECHOICE AUTOMATED PD SET WITH CASSETTE
FDA Adverse Event
Malfunction
·BAXTER HEALTHCARE - MOUNTAIN HOME·Product code FKX·July 9, 2014
OT VERIO IQ METER
FDA Adverse Event
Injury
·LIFESCAN EUROPE, A DIVISION OF CILAG GMBH INTL·Product code NBW·June 12, 2016
GXL acetabular liners, orthopedic hip implant component. Product Line Numbers: a. GXL NEUTRAL LINER, G0 28MM ID, 130-28-50; b. GXL NEUTRAL LINER, G00 22MM ID, 130-22-70; c. NOVATION GXL LIPPED LINER, G0 28MM ID, 132-28-50; d. NOVATION GXL LIPPED LINER, G00 22MM ID, 132-22-70;
FDA Enforcement
Class II
·Ongoing·Exactech, Inc.·September 21, 2022