15 results · 23ms · Sources: EU EUDAMED, US FDA

Get notified when this changes

We'll email you when new records match this search — new devices, new clearances, certificate changes, or withdrawals.

INTERVERTEBRAL FUSION DEVICE WITH BONE GRAFT, LUMBAR

FDA Adverse Event
Injury ·MSD DEGGENDORF MFG·Product code OVD·December 18, 2019

CLYDESDALE PTC SPINAL SYSTEM

FDA Adverse Event
Injury ·MSD DEGGENDORF MFG·Product code MAX·October 17, 2019

CAPSTONE PTC SPINAL SYSTEM, CLYDESDALE PTC SPINAL SYSTEM

FDA 510(k)
FDA Class 2 ·Orthopedic

CD HORIZON SPINAL SYSTEM

FDA Adverse Event
Injury ·WARSAW ORTHOPEDICS·Product code NKB·April 19, 2019

Oticon

FDA UDI
Oticon A/S·05707131260505·RIA PRO, RITE 312 WL CNB

MANOA BREAST BIOPSY SYSTEM

FDA 510(k)
FDA Class 2 ·General, Plastic Surgery

BRIDGEPOINT SPINOUS PROCESS CAMP- POSTERIOR FIXATION SYSTEM

FDA 510(k)
FDA Class 2 ·Orthopedic

AC-POWERED ADJUSTABLE HOSPITAL BED, INCLUDING RAILS

FDA Adverse Event
Malfunction ·INVACARE FLORIDA OPERATIONS·Product code FNL·May 29, 2013

X8000 LIGHTSOURCE

FDA Adverse Event
Malfunction ·STRYKER ENDOSCOPY SAN JOSE·Product code FCW·May 9, 2011

PATIENT RETURN GROUNDING PAD

FDA Adverse Event
Injury ·BOSTON SCIENTIFIC CORPORATION·Product code ODR·August 22, 2008

SCREW AND PLATE HOLDING FORCEPS

FDA Adverse Event
Malfunction ·WRIGHTS LANE SYNTHES USA PRODUCTS LLC·Product code HTD·May 10, 2019

SCREW AND PLATE HOLDING FORCEPS

FDA Adverse Event
Malfunction ·SYNTHES TUTTLINGEN·Product code HTD·April 27, 2017

Depuy P.F.C. Modular Knee System, curved tibial insert (CVD); polyethylene tibial insert, Sz 1, 10.0 mm; Ref 98-4031.

FDA Recall
Terminated ·Depuy Orthopaedics, Inc.·Product code JWH·May 26, 2005

Stryker T2 Arthrodesis Nailing System. Manufacturer: Stryker Trauma GmbH, Professor-Kuntscher-Str. 1-5, 24232 Schonkirchen Germany. Distributed in the USA by Stryker Orthopaedics, 325 Corporate Drive, Mahwah, NJ 07430. The T2 Arthrodesis Nail is intended for the treatment of Knee Arthrodesis. The design of the T2 Arthrodesis Nail features a unique curvature which incorporates both femur ante curvature and knee valgus bend. Indications: Aseptic failed total knee arthro-plasty with or without bone loss; Failed external fixation, non unions and malunions; Periarticular fractures where repair is not possible; Pathologic fractures and tumor resections; Pseudoarthrosis and correct osteotomy; Ipsilateral femur fractures; and Open and closed femoral fractures.

FDA Enforcement
Class II ·Terminated·Stryker Howmedica Osteonics Corp.·July 25, 2012

Achieva 1.5T

FDA Enforcement
Class II ·Ongoing·Philips North America Llc·November 29, 2023