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