15 results · 21ms · Sources: EU EUDAMED, US FDA

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FRAXEL III SR LASER SYSTEM AND ACCESSORIES

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

SOLIDEA

FDA UDI
CALZIFICIO PINELLI SRL·08300496071051·MISS RELAX 70 SHEER, SIZE XL, SABBIA, GRADUATED...

NA

FDA UDI
KEY SURGICAL, INC.·00849771052296·K-Wire and Steinmann Pin Dispensers, No Dispen...

ANNULOFLO SYSTEM, MITRAL MODEL AR700

FDA 510(k)
FDA Class 2 ·Cardiovascular

RX EVEREST

FDA 510(k)
FDA Class 2 ·Dental

SPECTRA WAVEWRITER

FDA Adverse Event
Injury ·BOSTON SCIENTIFIC NEUROMODULATION·Product code LGW·October 8, 2021

INFUSE BONE GRAFT

FDA Adverse Event
Injury ·MEDTRONIC SOFAMOR DANEK USA, INC·Product code NEK·April 22, 2013

EXPRESS LD ILIAC/BILIARY PREMOUNTED STENT SYSTEM

FDA Adverse Event
Malfunction ·BOSTON SCIENTIFIC - GALWAY·Product code NIO·April 27, 2011

2800

FDA Adverse Event
Malfunction ·GE OEC MEDICAL SYSTEMS, INC.·Product code JAA·July 10, 2008

LEGION PS OXIN FEM SZ5 LT

FDA Adverse Event
Injury ·SMITH & NEPHEW, INC.·Product code JWH·February 5, 2018

GII OVAL RESURFACING PAT 32MM

FDA Adverse Event
Injury ·SMITH & NEPHEW, INC.·Product code JWH·December 18, 2015

STEMMED TIBIAL COMPONENT

FDA Adverse Event
Injury ·ZIMMER BIOMET, INC.·Product code JWH·January 2, 2019

Stryker MA204 Bed Model (FL25E) Beds are intended for medical purposes in both general patient care as well as critical care environments. Each uses built-in electric motors and controls which can be operated by the patient, or caregiver, to adjust the height and/or surface contour of the bed.The devices listed above also include movable and latchable side rails which can be lowered or raised to help prevent patient fall and subsequent injury. The Beds include an optional Scale (Models: FL20E, FL25E, FL28C, FL28EX) as well as an optional Bed Exit (1 Zone) or Chaperone

FDA Enforcement
Class II ·Terminated·Stryker Medical Division of Stryker Corporation·July 4, 2012

PM 1250 and PM 2250 ZENEX; PM1282 and PM2282 ZENEX MRI These low voltage (LV) devices are implantable pacemaker pulse generators, intended to be permanently implanted in the body, that have a power supply and electronic circuits that produce a periodic electrical pulse to stimulate the heart. These devices are used as a substitute for the heart's intrinsic pacing system to correct both intermittent and continuous cardiac rhythm disorders.

FDA Enforcement
Class II ·Terminated·St Jude Medical Inc.·October 25, 2017

PM 1260 ASSURITY + These low voltage (LV) devices are implantable pacemaker pulse generators, intended to be permanently implanted in the body, that have a power supply and electronic circuits that produce a periodic electrical pulse to stimulate the heart. These devices are used as a substitute for the heart's intrinsic pacing system to correct both intermittent and continuous cardiac rhythm disorders.

FDA Enforcement
Class II ·Terminated·St Jude Medical Inc.·October 25, 2017