18 results · 22ms · 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.

Arthrex NanoScope System

FDA 510(k)
FDA Class 2 ·Gastroenterology, Urology

MSI Precision Specialty Instruments

FDA UDI
Med Saver, Inc.·00194613017910·K-Wire, Double Ended, Trocar Point, Diameter Si...

MSI Precision Specialty Instruments

FDA UDI
Med Saver, Inc.·00194613017927·K-Wire, Double Ended, Trocar Point, Diameter 0....

Pre-Finisher

FDA UDI
TP ORTHODONTICS INC·00192029042434·Asian 4 Bicuspid Extraction

SCREW EXTRACTOR SIZE 4 - 9 MM

FDA Adverse Event
Injury ·ORTHOFIX SRL·Product code HSB·June 11, 2021

AFFINITY PIXIE OXYGENATION SYSTEM WITH CARMEDA BIOACTIVE SURFACE OR BALANCE BIOSURFACE

FDA 510(k)
FDA Class 2 ·Cardiovascular

BIO Z CARDIO PROFILE HEMODYNAMIC MONITOR

FDA 510(k)
FDA Class 2 ·Cardiovascular

SCREW EXTRACTOR SIZE 4 - 9 MM

FDA Adverse Event
Injury ·ORTHOFIX SRL·Product code HSB·February 23, 2021

VERSACARE

FDA Adverse Event
Malfunction ·HILL-ROM RITTER·Product code FNL·October 3, 2008

PRIME BIG WHEEL STRETCHER,30"

FDA Adverse Event
Malfunction ·STRYKER MEDICAL-KALAMAZOO·Product code FPO·June 26, 2013

6F ANGIO-SEAL VASCULAR CLOSURE DEVICE VIP

FDA Adverse Event
Injury ·ST. JUDE MEDICAL·Product code MGB·July 22, 2011

GALAXY G3 6MM X 20CM

FDA Adverse Event
Injury ·MEDOS INTERNATIONAL SARL·Product code KRD·June 14, 2022

GALAXY G3 XSFT 3MM X 4CM

FDA Adverse Event
Injury ·MEDOS INTERNATIONAL SARL·Product code KRD·June 14, 2022

GALAXY G3 8MM X 24CM

FDA Adverse Event
Injury ·MEDOS INTERNATIONAL SARL·Product code KRD·June 14, 2022

GALAXY G3 7MM X 15CM

FDA Adverse Event
Injury ·MEDOS INTERNATIONAL SARL·Product code KRD·June 14, 2022

GALAXY G3 6MM X 10CM

FDA Adverse Event
Injury ·MEDOS INTERNATIONAL SARL·Product code KRD·June 14, 2022

GALAXY G3 6MM X 15CM

FDA Adverse Event
Injury ·MEDOS INTERNATIONAL SARL·Product code KRD·June 14, 2022

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