13 results
·
22ms
·
Sources: EU EUDAMED, US FDA
SUPPLE PERI-GUARD PERICARDIUM
FDA 510(k)
FDA Class 2
·General, Plastic Surgery
P.F.C. SIGMA
FDA UDI
DEPUY ORTHOPAEDICS, INC.·10603295240181·P.F.C. SIGMA DISTAL AUGMENTATION TRIAL SZ 1.5 12mm
BD BACTEC Standard/10 Aerobic/F Culture Vials Soybean-Casein Digest Broth in a Plastic Vial
FDA 510(k)
FDA Class 1
·Microbiology
COUGAR WHEELCHAIR
FDA 510(k)
FDA Class 1
·Physical Medicine
BD MULTI-CHECK¿
FDA Adverse Event
Malfunction
·BECTON, DICKINSON AND COMPANY, BD BIOSCIENCES·Product code GKZ·May 5, 2023
BD MULTI-CHECK¿
FDA Adverse Event
Malfunction
·BECTON DICKINSON AND COMPANY BD BIOSCIENCES·Product code GKZ·May 22, 2023
BD MULTI-CHECK¿
FDA Adverse Event
Malfunction
·BECTON DICKINSON AND COMPANY BD BIOSCIENCES·Product code GKZ·May 22, 2023
MED-EL COMBI 40+ COCHLEAR IMPLANT SYSTEM
FDA Adverse Event
Injury
·MED-EL ELEKTROMEDIZINISCHE GERAETE, GMBH·Product code MCM·May 5, 2014
VITROS CHEMISTRY PRODUCTS PHBR SLIDES
FDA Adverse Event
Malfunction
·ORTHO-CLINICAL DIAGNOSTICS·Product code DLZ·February 14, 2013
LEVEEN NEEDLE ELECTRODE
FDA Adverse Event
Malfunction
·BOSTON SCIENTIFIC - SPENCER·Product code GEI·January 14, 2011
BD MULTI-CHECK¿
FDA Adverse Event
Malfunction
·BECTON, DICKINSON AND COMPANY, BD BIOSCIENCES·Product code GKZ·July 26, 2023
Medtronic INTREPID Spinal System SPACER, 32X23, 8 DEG, Size: 10MM, Part Number: REF 7961810; 12MM, REF 7961812; 14MM, REF 7961814; 16MM, REF 7961816; 18MM, REF 7961818; 20MM, REF 7961820; Rx only, STERILE R. The INTREPID Spinal System is indicated for use with autogenous bone graft in patients with degenerative disc disease.
FDA Recall
Terminated
·Medtronic Sofamor Danek USA Inc·Product code MAX·February 6, 2009
Vanguard XP Knee System Porous Femoral Component various sizes and orientation a total knee replacement system. prosthesis, knee, patella/femorotibial, semi-constrained, uncemented, porous, coated, polymer/metal/polymer
FDA Enforcement
Class II
·Terminated·Biomet, Inc.·April 6, 2016