12 results
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21ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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WALLFLEX BILIARY RX STENT SYSTEM
FDA 510(k)
FDA Class 2
·Gastroenterology, Urology
General Instruments
FDA UDI
ALPHATEC SPINE, INC.·00840180521748·Stopped Awl, Short, 1/4-Sq, 30mm
RZ Medizintechnik GmbH
FDA UDI
RZ-Medizintechnik GmbH·04049197383127·SCHNIDT-SAWTELL Tonsil Seizing Forceps
185mm,...
MECHANICAL WALKER, ROLLATOR
FDA Adverse Event
KENSTONE METAL·Product code ITJ·July 20, 2012
REMINGTON I-LIGHT HAIR REMOVAL SYSTEM
FDA Adverse Event
Injury
·SHASER INC·Product code ONF·May 21, 2021
TRABECULAR METAL FEMORAL CONE AUGMENTS, MODEL 03-125-ZZZZ
FDA 510(k)
FDA Class 2
·Orthopedic
G-FORCE PEEK SUTURE ANCHOR SYSTEM
FDA 510(k)
FDA Class 2
·Orthopedic
MECTALIF ANTERIOR STAND-ALONE SCREW DIAM.5.5X35 (DOUBLE PACKAGING)
FDA Adverse Event
Injury
·MEDACTA INTERNATIONAL SA·Product code OVD·March 16, 2018
INTERSTIM II
FDA Adverse Event
Injury
·MEDTRONIC MED REL MEDTRONIC PUERTO RICO·Product code EZW·May 31, 2013
HEARTSTART MRX - EMS DEFBRILLATOR
FDA Adverse Event
Malfunction
·PHILIPS HEALTHCARE·Product code MKJ·June 16, 2011
RESTORE
FDA Adverse Event
Malfunction
·MEDTRONIC NEUROMODULATION·Product code LGW·August 28, 2008
Lifesaver Single Patient Use Manual Resuscitator Product Usage: The Hudson RCI Lifesaver Single Patient Use manual resuscitator with pressure monitoring port is a disposable medical device intended for use on patients requiring temporary augmentation of ventilation with or without supplemental oxygen delivery during episodes of acute ventilatory failure or insufficiency.
FDA Enforcement
Class I
·Terminated·Teleflex Medical·July 1, 2015