13 results · 22ms · Sources: EU EUDAMED, US FDA

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TUMARK PROFESSIONAL, MODEL 271560, MR-TUMARK PROFESSIONAL, MODEL 601560

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

De Soutter Medical

FDA UDI
DE SOUTTER MEDICAL LIMITED·05051471130463·K-WIRE - DOUBLE TROCAR WITH GUIDE 0.6mm DIA x 1...

TINA-QUANT SOLUBLE TRANSFERRIN RECEPTOR TEST SYSTEM, HITACHI CATALOG # 2148315; INTEGRA CATALOG # 2148323

FDA 510(k)
FDA Class 2 ·Immunology

HEMOCLEAN

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

COPPERHEAD CERVICAL INTERBODY CAGE

FDA Adverse Event
Injury ·EMINENT SPINE·Product code ODP·January 8, 2016

VELA VENTILATOR

FDA Adverse Event
Malfunction ·CAREFUSION·Product code CBK·July 21, 2015

GRAFTYS BCP (510K NUMBER: K073064)

FDA Adverse Event
Injury ·GRAFTYS·Product code MQV·July 11, 2013

VELA VENTILATOR

FDA Adverse Event
Malfunction ·CAREFUSION·Product code CBK·February 19, 2015

OT VERIO IQ METER

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

OMNIPOD INSULIN PUMP

FDA Adverse Event
Malfunction ·INSULET CORPORATION·Product code LZG·September 10, 2014

UNKNOWN BUR

FDA Adverse Event
Malfunction ·STRYKER IRELAND LTD.·Product code EQJ·April 15, 2011

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

TRULIANT Knee System including TRULIANT Tibial Inserts, also labeled as the following: a. TRULIANT CR Tibial Inserts; b. TRULIANT CR Slope + Tibial Inserts; c. TRULIANT CR Slope ++ Tibial Inserts; d. TRULIANT CRC Tibial Inserts; e. TRULIANT PS Tibial Inserts; f. TRULIANT PSC Tibial Inserts. NOTE: Information reflects Exactech recall expansion initiated on 02/07/2022.

FDA Enforcement
Class II ·Ongoing·Exactech, Inc.·October 13, 2021