20 results
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26ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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CLEANER ROTATIONAL THROMBECTOMY SYSTEM
FDA 510(k)
FDA Class 2
·Cardiovascular
3M™ Unitek™
FDA UDI
3M UNITEK CORPORATION·00652221037787·Unitek(TM) Bicuspid Band General Purpose Narrow...
STALIF TT
FDA 510(k)
FDA Class 2
·Orthopedic
FLEXITIME XTREME 2 HEAVY TRAY CARTRIDGE REFILL, FEXITIME XTREME 2 LIGHT TRAY CARTRIDGE REFILL
FDA 510(k)
FDA Class 2
·Dental
AESCULAP SURGICAL INSTRUMENTS
FDA Adverse Event
Injury
·CHRISTOPH MIETHKE GMBH & CO. KG·Product code JXG·November 27, 2019
AESCULAP SURGICAL INSTRUMENTS
FDA Adverse Event
Injury
·CHRISTOPH MIETHKE GMBH & CO. KG·Product code JXG·November 27, 2019
Zavation
FDA UDI
Zavation LLC·00842166122901·Cage - 14x16mm, 17-25mm, 10°
Matrixx System
FDA UDI
NEXXT SPINE, LLC·00889929063835·Cervical 14Dx16Wx17H
Zavation
FDA UDI
Zavation LLC·00842166122888·Cage - 14x16mm, 17-25mm, 0°
Zavation
FDA UDI
Zavation LLC·00842166122895·Cage - 14x16mm, 17-25mm, 5°
Zavation
FDA UDI
Zavation LLC·00842166122918·Cage - 14x16mm, 17-25mm, 15°
Matrixx System
FDA UDI
NEXXT SPINE, LLC·00889929064214·Solid 14Dx16Wx17H
Matrixx System
FDA UDI
NEXXT SPINE, LLC·00889929034675·Corpectomy, 14Dx16Wx17H 6°
Matrixx System
FDA UDI
NEXXT SPINE, LLC·00889929065129·Corpectomy, 14Dx16Wx17H 0°
BD PEGASUS¿ SAFETY CLOSED IV CATHETER SYSTEM
FDA Adverse Event
Malfunction
·BD (SUZHOU)·Product code FOZ·January 7, 2020
PARADIGM REAL-TIME INSULIN INFUSION PUMP
FDA Adverse Event
Malfunction
·MEDTRONIC PUERTO RICO OPERATIONS CO.·Product code OYC·October 4, 2014
OT VERIO IQ METER
FDA Adverse Event
Malfunction
·LIFESCAN EUROPE, A DIVISION OF CILAG GMBH INTL·Product code NBW·June 3, 2013
RELIANCE 777 WASHER
FDA Adverse Event
Malfunction
·STERIS CANADA CORPORATION·Product code LDS·June 27, 2011
OXF ANAT BRG RT MD SIZE 4 PMA
FDA Adverse Event
Injury
·BIOMET UK LTD.·Product code NRA·July 20, 2021
OPTETRAK Comprehensive Knee System including OPTETRAK RBK PS Tibial Components. NOTE: Information reflects Exactech recall expansion initiated on 02/07/2022.
FDA Enforcement
Class II
·Ongoing·Exactech, Inc.·October 13, 2021