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

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NavLock Trackers, Robotic Reference Frame

FDA 510(k)
FDA Class 2 ·Neurology

BOSS Instruments

FDA UDI
BOSS INSTRUMENTS, LTD., INC.·00888515026742·Doyen Retr, 2 1/4"x 3 1/2 8 1/2"

Ophthalmic Retractor

FDA UDI
KATENA PRODUCTS, INC.·00841668100967·DESMARRES LID RETRACTOR #1

GE VIVID P3 DIAGNOSTIC ULTRASOUND IMAGING SYSTEM

FDA 510(k)
FDA Class 2 ·Radiology

GE LIGHTSPEED RT16 / LIGHTSPEED XTRA V2 CT SYSTEM (AKA GE LIGHTSPEED RT16 / LIGHTSPEED XTRA CT SYSTEM

FDA 510(k)
FDA Class 2 ·Radiology

UNKN SUSPENSORY FIXATION DEV

FDA Adverse Event
Injury ·SMITH & NEPHEW, INC.·Product code GAT·September 13, 2021

UNKNOWN MESH PRODUCT (EWHU)

FDA Adverse Event
Injury ·ETHICON·Product code FTL·June 3, 2011

ABBOTT AXSYM SYSTEM

FDA Adverse Event
Malfunction ·ABBOTT MANUFACTURING, INC.·Product code JJE·October 2, 2008

7.2CM ADJUSTABLE DRILL GUIDE

FDA Adverse Event
Malfunction ·DEPUY SYNTHES POWER TOOLS·Product code HBC·June 21, 2013

IOWA METH DES MOINES IA 1

FDA Adverse Event
Malfunction ·SORIN GROUP USA, INC.·Product code DTZ·June 23, 2011

UNKN SUSPENSORY FIXATION DEV

FDA Adverse Event
Injury ·SMITH & NEPHEW, INC.·Product code GAT·September 13, 2021

UNKN SUSPENSORY FIXATION DEV

FDA Adverse Event
Injury ·SMITH & NEPHEW, INC.·Product code GAT·September 13, 2021

UNKN SUSPENSORY FIXATION DEV

FDA Adverse Event
Injury ·SMITH & NEPHEW, INC.·Product code GAT·September 13, 2021

UNKN SUSPENSORY FIXATION DEV

FDA Adverse Event
Injury ·SMITH & NEPHEW, INC.·Product code GAT·September 13, 2021

UNKN SUSPENSORY FIXATION DEV

FDA Adverse Event
Injury ·SMITH & NEPHEW, INC.·Product code GAT·September 13, 2021

UNKN NON-ABSORBABLE SUTURE AND TAPE

FDA Adverse Event
Injury ·SMITH & NEPHEW, INC.·Product code MBI·September 13, 2021

C-FLEX MULTI-LENGTH URETERAL STENT SET

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

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