12 results
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19ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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BRANNON ARTERIO-VENOUS PORTSYRINGE
FDA 510(k)
FDA Class 2
·General Hospital
Nexxis OR
FDA UDI
Barco NV·05415334034877·NEXXIS SYSTEM X620 CM V4
MEGA PLUS MIS SPINE SYSTEM
FDA UDI
BK MEDITECH CO.,LTD.·08809665583284·MIS Cannulated Screw, Ø5.0 x 35mm, Ø6.0mm Rod
Eye Shield
FDA UDI
KATENA PRODUCTS, INC.·00841668111154·FOX EYE SHIELD GARTER ASST COLOR PK/50
BOSS Instruments
FDA UDI
BOSS INSTRUMENTS, LTD., INC.·00888515251656·Brown Diss Sci, str, overall 5-3/4"
CARDIOFAX-V ECG-8240A
FDA 510(k)
FDA Class 2
·Cardiovascular
SURGEON'S GLOVE
FDA 510(k)
FDA Class 1
·General, Plastic Surgery
XMAX MOTOR
FDA Adverse Event
Malfunction
·DEPUY SYNTHES POWER TOOLS·Product code ERL·March 31, 2015
SENSIA
FDA Adverse Event
Malfunction
·MEDTRONIC MED REL MEDTRONIC PUERTO RICO·Product code NVZ·February 15, 2013
PRECISION TEST STRIPS
FDA Adverse Event
Malfunction
·ABBOTT DIABETES CARE, INC. USA·Product code NBW·January 20, 2011
INTERSTIM II
FDA Adverse Event
Injury
·MEDTRONIC PUERTO RICO OPERATIONS CO.·Product code EZW·July 29, 2014
OPTETRAK Comprehensive Knee System including OPTETRAK All-polyethylene UNI Tibial Components, Product Lines, 252-12-XX, 252-13-XX, 252-22-XX, 252-23-XX. NOTE: Information reflects Exactech recall expansion initiated on 02/07/2022.
FDA Enforcement
Class II
·Ongoing·Exactech, Inc.·October 13, 2021