16 results · 20ms · Sources: EU EUDAMED, US FDA

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Westmed Gas Sampling Cannula with O2 delivery

FDA 510(k)
FDA Class 2 ·Anesthesiology

Truline

FDA UDI
Arbill Industries, Inc.·00850052602420·Made in Malaysia. Black disposable nitrile. Si...

Truline

FDA UDI
Arbill Industries, Inc.·10850052602144·

Bi-Metric® Revision Hip System

FDA UDI
Biomet Orthopedics, LLC·00887868261329·

BI-METRIC REVISION HIP SYSTEM

FDA UDI
Biomet Orthopedics, LLC·00880304006997·

BI-METRIC(R) HEAD/NECK PROVISIONAL

FDA UDI
Biomet Orthopedics, LLC·00880304307353·

EMERGE MEDICAL CANNULATED SCREW FIXATION SYSTEM

FDA 510(k)
FDA Class 2 ·Orthopedic

GRANDIO FLOW TRY-IN

FDA 510(k)
FDA Class 2 ·Dental

DEXCOM G7 CONTINUOUS GLUCOSE MONITORING SYSTEM

FDA Adverse Event
Malfunction ·DEXCOM, INC.·Product code QBJ·June 24, 2025

RESURFACING FEMORAL HEAD 54MM

FDA Adverse Event
Injury ·SMITH & NEPHEW ORTHOPAEDICS LTD·Product code KXA·September 28, 2017

COBAS 6000 CORE

FDA Adverse Event
Malfunction ·ROCHE DIAGNOSTICS·Product code CEM·November 8, 2011

HOMECHOICE PRO

FDA Adverse Event
Malfunction ·BAXTER HEALTHCARE - SINGAPORE·Product code FKX·June 11, 2013

COLLEAGUE PRE P1.7

FDA Adverse Event
Malfunction ·BAXTER HEALTHCARE - SINGAPORE·Product code FRN·July 14, 2011

ONE TOUCH ULTRALINK METER

FDA Adverse Event
Malfunction ·LIFESCAN, INC.·Product code NBW·September 9, 2008

Applied Medicals Epix¿ and Direct Drive Laparoscopic Graspers, Model Numbers C4130 and C4140. Used for grasping and manipulating tissue during general or laparoscopic surgery.

FDA Enforcement
Class II ·Terminated·Applied Medical Resources Corp·June 19, 2013

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