20 results · 26ms · Sources: EU EUDAMED, 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