33 results
·
19ms
·
Sources: EU EUDAMED, US FDA
ISLAND BIOSURGICAL BOLSTER
FDA 510(k)
FDA Class 2
·General, Plastic Surgery
P.F.C. SIGMA
FDA UDI
DEPUY (IRELAND)·10603295232612·P.F.C. SIGMA OVAL DOME PATELLA 3-PEG 35mm CEMENTED
APEX Knee System
FDA UDI
Omni Life Science, Inc.·00841690190820·FEMORAL CUT TEST GAGE SZ 2-3
Peerless Buccal Tube
FDA UDI
ORMCO CORPORATION·00889989022988·CAST 10DEG UFM CONV B/T-10TX022 045RT
Fresh Cells
FDA UDI
DIAGNOSTIC HYBRIDS, INC.·30014613334828·R-MIX SV WITHOUT CS
HA Bone Screws
FDA UDI
ORTHOFIX SRL·18032568861679·OSTEOTITE BONE SCREW 110/50 MM SHAFT D 6 MM TH...
Guided Tissue Punch
FDA UDI
BICON, LLC·00813110026606·6.0mm Guided Tissue Punch
ESTECH AORTIC EASY FLOW CANNULA
FDA 510(k)
FDA Class 2
·Cardiovascular
SinuBand
FDA 510(k)
FDA Class 1
·Ear, Nose, Throat
PFC*SIGMA/OV/DOME PAT 3PEG,35
FDA Adverse Event
Malfunction
·DEPUY ORTHOPAEDICS INC US·Product code JWH·July 2, 2020
PFC*SIGMA/OV/DOME PAT 3PEG,35
FDA Adverse Event
Malfunction
·DEPUY ORTHOPAEDICS, INC. 1818910·Product code JWH·December 21, 2018
PFC*SIGMA/OV/DOME PAT 3PEG,35
FDA Adverse Event
Malfunction
·DEPUY ORTHOPAEDICS INC US·Product code JWH·November 13, 2023
PFC*SIGMA/OV/DOME PAT 3PEG,35
FDA Adverse Event
Injury
·DEPUY ORTHOPAEDICS INC US·Product code JWH·March 11, 2024
ACCESS® 2 IMMUNOASSAY SYSTEM
FDA Adverse Event
Malfunction
·BECKMAN COULTER·Product code MMI·February 13, 2013
CENTRA BED
FDA Adverse Event
Malfunction
·HILL-ROM, INC.·Product code FNL·December 17, 2010
ACRYSOF IQ TORIC
FDA Adverse Event
Injury
·ALCON MANUFACTURING, LTD. HUNTINGTON·Product code HQL·July 17, 2014
COBALT HV BONE CEMENT 40G
FDA Adverse Event
Injury
·ZIMMER BIOMET, INC.·Product code LOD·April 26, 2021
Ortho Minor Pack, part number AMS3710(A
FDA Enforcement
Class II
·Terminated·Windstone Medical Packaging, Inc.·March 8, 2017
PFC*SIGMA/OV/DOME PAT 3PEG,35
FDA Adverse Event
Malfunction
·DEPUY ORTHOPAEDICS INC US·Product code JWH·December 5, 2019
SIGMA STAB GVF INS 2.5 10MM
FDA Adverse Event
Injury
·DEPUY ORTHOPAEDICS INC US·Product code JWH·September 14, 2020