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

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EVOLUTION MP CS/CR POROUS FEMUR/EVOLUTION ADAPTIVE CS AND PS INSERTS

FDA 510(k)
FDA Class 2 ·Orthopedic

ForPro

FDA UDI
Tng Worldwide, Inc.·00672047000239·Vinyl Exam Gloves Size Large 100ct

SSW CARBIDE

FDA UDI
Ss White Burs, Inc.·D6901407352·FG SL CARBIDE 703 - 5 PACK

Cancellous Screw, Cannulated

FDA UDI
I.T.S. GmbH·09120034307874·Cancellous Screw, Cannulated, D=4.0mm, L=35m

OsteoMed

FDA UDI
OSTEOMED LLC·00845694046312·PrimaLIF LLIF PEEK Implant, 7mm X 26mm X 35mm, ...

SYRINGE 0.5ML 29GA 1/2IN BLS 100BX AU

FDA Adverse Event
Malfunction ·BD MEDICAL - DIABETES CARE·Product code FMF·March 12, 2020

ALM X'TEN (X10) SURGICAL LIGHT SYSTEM

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

POWDER FREE VINYL PATIENT EXAMINATION GLOVES, CLEAR (NON-COLORED)

FDA 510(k)
FDA Class 1 ·General Hospital

COBAS 6000 C (501) MODULE

FDA Adverse Event
Malfunction ·ROCHE DIAGNOSTICS·Product code JJE·November 18, 2016

ACS HI-TORQUE BALANCE MIDDLEWEIGHT GUIDE WIRE

FDA Adverse Event
Malfunction ·AV-TEMECULA-CT·Product code DQX·May 31, 2013

CORE IMPACTION DRILL

FDA Adverse Event
Malfunction ·STRYKER INSTRUMENTS KALAMAZOO·Product code DZJ·June 15, 2011

BREEZE2

FDA Adverse Event
Injury ·BAYER HEALTHCARE LLC·Product code NBW·October 3, 2014

UNID ROD

FDA Adverse Event
Malfunction ·MEDICREA INTERNATIONAL SA·Product code MNI·July 29, 2024

UNID ROD

FDA Adverse Event
Malfunction ·MEDICREA INTERNATIONAL SA·Product code MNI·July 29, 2024

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

C-Series High Energy Linear Accelerator - Models: Novalis Tx, Trilogy, Trilogy Tx, Clinac iX, Clinac 2100 C/D, Clinac 2300C/D, Clinac 21EX, Clinac 23EX with versions 7, 8, 9 and 6 MV configuration and maximum dose rate of at least 6000 MU/min only. Varian High Energy Linear Accelerator is intended to provide sterotactic radiosurgery and precision radio-therapy for lesions, tumors and conditions anywhere in the body when radiation treatment is indicated.

FDA Enforcement
Class II ·Terminated·Varian Medical Systems, Inc.·September 24, 2014