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

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NANOFUSE DBM

FDA 510(k)
FDA Class 2 ·Orthopedic

Preat

FDA UDI
Preat Corporation·00842092138892·Equator Abutment For MegaGen AnyRidge x 5mm

LACTOSORB* 2.0MM SYSTEM TEMPLATE

FDA UDI
BIOMET MICROFIXATION, INC·00841036078089·

SINGLEY TUTTLE FORCEPS

FDA UDI
SONTEC INSTRUMENTS, INC.·00192896076587·SINGLEY TUTTLE FORCEPS SERRATED TIP

GE VIVID P3 DIAGNOSTIC ULTRASOUND IMAGING SYSTEM

FDA 510(k)
FDA Class 2 ·Radiology

AMERICAN BANTEX, MODEL MS 3

FDA 510(k)
FDA Class 2 ·Physical Medicine

PARADIGM REAL-TIME INSULIN INFUSION PUMP

FDA Adverse Event
Malfunction ·MEDTRONIC MINIMED·Product code OYC·October 4, 2014

RUSCH FOLEY CATHETERS, 2-WAY PEDIATRIC, 8FR

FDA Adverse Event
Malfunction ·TELEFLEX MEDICAL·Product code KOD·May 26, 2011

OT ULTRALINK METER

FDA Adverse Event
Malfunction ·LIFESCAN EUROPE, A DIVISION OF CILAG GMBH INTL·Product code NBW·June 3, 2013

C-FLEX MULTI-LENGTH URETERAL STENT SET

FDA Adverse Event
Malfunction ·COOK INC·Product code FAD·January 24, 2020

Philips Upgrade to MR 7700 with MR Elastography (MRE). 1. Model Number (REF): 782130.

FDA Enforcement
Class II ·Ongoing·Philips North America·May 6, 2026

MAGNETOM Aera magnetic resonance diagnostic devices Model # 10432914

FDA Enforcement
Class II ·Terminated·Siemens Medical Solutions USA, Inc·August 28, 2019

Allegiance Laminated Wood Crutches, item 74151-050, Child - 28'' - 36''; 1 pair individually shrink wrapped, 10 pairs per case; Distributed by Cardinal Health, McGaw Park, IL 60085-6787 USA, Made in China

FDA Recall
Terminated ·Duro-Med Industries, Inc.·Product code IPR·August 4, 2004

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