48 results · 22ms · Sources: EU EUDAMED, 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