15 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.

Zimmer Knee Joint Replacement Prostheses MR Labeling

FDA 510(k)
FDA Class 2 ·Orthopedic

STEM EXTENSION

FDA Adverse Event
Injury ·ZIMMER MANUFACTURING B.V.·Product code JWH·March 29, 2023

STEMMED NONAUGMENTABLE TIBIAL COMPONENT

FDA Adverse Event
Injury ·ZIMMER MANUFACTURING B.V.·Product code JWH·June 9, 2023

LCCK NEXGEN ARTICULAR SURFACE WITH LOCKING SCREW

FDA Adverse Event
Injury ·ZIMMER BIOMET, INC.·Product code JWH·February 9, 2022

CENTRONAIL TITANIUM HUMERAL NAILING SYSTEM

FDA UDI
ORTHOFIX SRL·18032568865684·SPACER NAIL 14 MM

PULSAR GENERATOR, MODEL PS100-100, AND PEAK PLASMABLADE TISSUE DISSECTION DEVICE, MODEL PS200-040

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

ASAHI ASTATO XS 20 PERIPHERAL GUIDE WIRE

FDA 510(k)
FDA Class 2 ·Cardiovascular

PRECISE PRO RX CAROTID STENT SYSTEM

FDA Adverse Event
Death ·CORDIS DE MEXICO·Product code NIM·July 23, 2011

PAINSMART IOD

FDA Adverse Event
Malfunction ·MOOG DEVICE GROUP·Product code FRN·May 30, 2013

GE OEC 9800

FDA Adverse Event
Malfunction ·GE OEC MEDICAL SYSTEMS INC.·Product code JAA·September 19, 2008

ASAHI CONFIANZA PRO 8-20

FDA Adverse Event
Malfunction ·ASAHI INTECC CO., LTD.·Product code DQX·August 23, 2016

PATIENT INFORMATION CENTER IX

FDA Adverse Event
Injury ·PHILIPS MEDICAL SYSTEMS·Product code MHX·December 4, 2023

ASAHI CONFIANZA PRO 8-20

FDA Adverse Event
Injury ·ASAHI INTECC CO., LTD.·Product code DQX·April 14, 2016

ASAHI CONFIANZA PRO 8-20

FDA Adverse Event
Injury ·ASAHI INTECC CO., LTD.·Product code DQX·June 6, 2016

Disposable Accessory Kit, 3-Arm (Box of 5) individually sealed in poly-Tyvek pouches / Rx Sterile / to used exclusively on the Intuitive Surgical Da Vinci Si Robotic system / Distributed by Intuitive Surgical Product Usage: Microtek Medical Equipment Drapes are intended to cover/wrap various surgical and/or nonsurgical instruments/equipment [e.g. robotic arms, microscopes, tables, x ray systems, light handles, etc]. They function as a physical barrier to prevent cross contamination between the instrument / equipment and medical staff and/or to allow the instrument/equipment to enter a hygienic area [e.g. sterile surgical field] in various clinical settings. They are typically made of flexible plastic and shaped to fit the type of instrument / equipment. They are a single use device [not to be reprocessed]

FDA Enforcement
Class II ·Terminated·Ecolab Inc·October 31, 2018