13 results
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21ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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ARTASSIST AND VENASSIST
FDA 510(k)
FDA Class 2
·Cardiovascular
PENNIG DYNAMIC WRIST FIXATOR
FDA UDI
ORTHOFIX SRL·18053504365693·Component. Not for sale. Used for reporting Dir...
NEWPORT HT70 VENTILATOR
FDA 510(k)
FDA Class 2
·Anesthesiology
WATER BOTTLE CAP SYSTEM
FDA 510(k)
FDA Class 2
·Gastroenterology, Urology
HT70 PLUS VENTILATOR
FDA Adverse Event
Malfunction
·NEWPORT MEDICAL INSTRUMENTS INC.·Product code CBK·June 2, 2017
DIGITAL RADIOGRAPHY CXDI
FDA Adverse Event
Malfunction
·CANON, INC.·Product code MQB·December 22, 2019
DIGITAL RADIOGRAPHY CXDI
FDA Adverse Event
Malfunction
·CANON, INC.·Product code MQB·December 22, 2019
DIGITAL RADIOGRAPHY CXDI
FDA Adverse Event
Malfunction
·CANON, INC.·Product code MQB·December 22, 2019
MEDLINE SURGICAL WRAP
FDA Adverse Event
Malfunction
·MEDLINE INDUSTRIES INC·Product code LRP·May 22, 2013
CAPSURE VDD-2
FDA Adverse Event
Malfunction
·MEDTRONIC PUERTO RICO, INC.·Product code DTB·June 16, 2011
DRILL GUIDE - OVERDRILL Ø2.7MM & Ø3.5MM FOR 2.7 & 3.5 SCREWS
FDA Adverse Event
Malfunction
·STRYKER TRAUMA SELZACH·Product code LXH·October 1, 2014
POLYMETHYLMETHACRYLATE BONE CEMENT
FDA Adverse Event
Injury
·SYNTHES SELZACH·Product code NDN·August 16, 2016
cobas 6000 Modular Series system; Part Numbers: 1. 04745914001 cobas c 501 module; 2. 05036453001 cobas 6000 UL c 501 + Core Fix configuration; 3. 05036453692 - cobas 6000 UL + CORE CU; and 4. 05860636001 cobas 6000 c 501 (UL) V
FDA Enforcement
Class II
·Terminated·Roche Diagnostics Corporation·March 14, 2018