48 results
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22ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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VERTE-STACK K030736, K041197
FDA Adverse Event
Death
·MEDTRONIC SOFAMOR DANEK USA, INC.·Product code MQP·January 4, 2019
MODIFICATION TO VERTE-STACK SPINAL SYSTEM
FDA 510(k)
FDA Class 2
·Orthopedic
CORNERSTONE-SR CAGE SYSTEM
FDA Adverse Event
Death
·MSD DEGGENDORF MFG·Product code ODP·February 17, 2012
Merit Medical®
FDA UDI
Merit Medical Systems, Inc.·00884450329207·
DERMACLEAR UV-B PHOTOTHERAPY SYSTEM
FDA 510(k)
FDA Class 2
·General, Plastic Surgery
COCAINE METABOLITE INTERCEPT MICRO-PLATE EIA
FDA 510(k)
FDA Class 2
·Clinical Toxicology
COLLEAGUE
FDA Adverse Event
Malfunction
·BAXTER HEALTHCARE - SINGAPORE·Product code FRN·September 29, 2011
FLEXTEND
FDA Adverse Event
Malfunction
·CPI - DEL CARIBE·Product code NVN·April 8, 2013
ACCU-CHEK COMPACT TEST DRUM
FDA Adverse Event
Malfunction
·OROCHE DIAGNOSTICS·Product code LFR·May 9, 2008
EASYTRAK 2
FDA Adverse Event
Injury
·CPI - DEL CARIBE·Product code OJX·April 6, 2011
AccessPLUS Large Bore Hemostasis Valves, Catalog Code: 580758001, 580774001, IN8152/C, K04-01197, K05T-01863, K09-09102B, K09-10388A, K09-12917, K09-13501AP, K10-05457AP, K10-05635, K10-05868P, K10-05872P, K12-08303, K12-10346, K12-10375, K12-10724AP, K12-10962, K12-11413, MAP150/F, MAP152/B, MAP152/F, K12-01551, K12-YP064A, K12-YP114, K12-YP115, K12-YS047A, IN8152, K12-01551
FDA Enforcement
Class II
·Ongoing·Merit Medical Systems, Inc.·April 20, 2022
OT ULTRA TEST STRIPS
FDA Adverse Event
Injury
·LIFESCAN, INC.·Product code NBW·October 6, 2010
COLLEAGUE PRE P1.7
FDA Adverse Event
Malfunction
·BAXTER HEALTHCARE - SINGAPORE·Product code FRN·August 12, 2011
COLLEAGUE PRE P1.7
FDA Adverse Event
Malfunction
·BAXTER HEALTHCARE - SINGAPORE·Product code FRN·August 2, 2011
COLLEAGUE
FDA Adverse Event
Malfunction
·BAXTER HEALTHCARE - SINGAPORE·Product code FRN·October 25, 2011
COLLEAGUE
FDA Adverse Event
Malfunction
·BAXTER HEALTHCARE - SINGAPORE·Product code FRN·November 10, 2011
OT ULTRA TEST STRIPS
FDA Adverse Event
Injury
·LIFESCAN, INC.·Product code NBW·September 27, 2010
OT ULTRA TEST STRIPS
FDA Adverse Event
Injury
·LIFESCAN INC.·Product code NBW·April 5, 2012
COLLEAGUE PRE P1.7
FDA Adverse Event
Malfunction
·BAXTER HEALTHCARE - SINGAPORE·Product code FRN·August 11, 2011
COLLEAGUE
FDA Adverse Event
Malfunction
·BAXTER HEALTHCARE - SINGAPORE·Product code FRN·October 11, 2011