8 results
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18ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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SPONGER CABLE SYSTEM, MODIFICATION
FDA 510(k)
FDA Class 2
·Orthopedic
NORTHGATE TECHNOLOGIES MODEL 7201 INSUFFLATOR
FDA 510(k)
FDA Class 2
·Obstetrics/Gynecology
B-D ULTRA-VUE PROCEDURE NEEDLE W/ CHIBA TYPE POINT
FDA 510(k)
FDA Class 2
·Cardiovascular
LARGE MOD HEAD ADAPT 12/14 +5
FDA Adverse Event
Injury
·DEPUY INTERNATIONAL LTD - 8010379·Product code KWA·July 23, 2015
ONE TOUCH PING GLUCOSE MANAGEMENT SYSTEM
FDA Adverse Event
Malfunction
·ANIMAS CORP.·Product code LZG·December 14, 2010
SPECTRUM INFUSION PUMP
FDA Adverse Event
Malfunction
·BAXTER HEALTHCARE CORPORATION·Product code FRN·February 3, 2014
TI Single Vector Distractor Proximal Foot/Left; Catalog ID 487.975 The Titanium Single Vector Distractor and Proximal Foot Plates are intended for mandibular bone lengthening where gradual bone distraction is required, including conditions such as congenital mandibular deficiencies or post-traumatic defects.
FDA Enforcement
Class II
·Terminated·Synthes (USA) Products LLC·August 24, 2016
ev3 Pipeline Flex Embolization Device with Shield Technology. Sold OUS. For neurological endovascular use.
FDA Enforcement
Class I
·Terminated·Micro Therapeutics Inc, Dba Ev3 Neurovascular·April 1, 2020