10 results
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21ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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AccelFix Lumbar Plate System
FDA 510(k)
FDA Class 2
·Orthopedic
AUTOSURE VOICE 3 BLOOD GLUCOSE MONITORING SYSTEM AND TEST STRIP
FDA 510(k)
FDA Class 2
·Clinical Chemistry
HEMODIALYSIS CARBON EXCHANGE, DUAL BED DEIONIZER EXCHANGE, MIXED BED DEIONIZER EXCHANGE, MODEL .60MAW,1.2MAW,3.6MAW, 1.2
FDA 510(k)
FDA Class 2
·Gastroenterology, Urology
SUMMIT POR TAPER SZ6 HI OFF
FDA Adverse Event
Injury
·DEPUY ORTHOPAEDICS, INC.·Product code LPH·October 22, 2014
PELVICOL ACELLULAR COLLAGEN MATRIX 4X7CM
FDA Adverse Event
Injury
·COVIDIEN, FORMERLY TISSUE·Product code FTL·May 15, 2013
TIBIAL RESECTION GUIDE RT
FDA Adverse Event
Malfunction
·HOWMEDICA OSTEONICS MAHWAH·Product code LXH·June 30, 2011
CRITICOOL
FDA Adverse Event
Malfunction
·BELMONT MEDICAL TECHNOLOGIES·Product code DWJ·February 14, 2020
CRITICOOL
FDA Adverse Event
Malfunction
·BELMONT MEDICAL TECHNOLOGIES·Product code DWJ·February 15, 2020
CRITICOOL
FDA Adverse Event
Malfunction
·BELMONT MEDICAL TECHNOLOGIES·Product code DWJ·February 15, 2020
Boston Scientific Fetch 2 Aspiration Catheter, Catalog No. 109400-001. Product The Fetch 2 Aspiration Catheter is indicated for the removal of fresh, soft emboli and thrombi from vessels in the peripheral and coronary vasculature.
FDA Enforcement
Class I
·Terminated·Boston Scientific Corporation·April 27, 2016