12 results · 30ms · Sources: EU EUDAMED, US FDA

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PICOSURE WORKSTATION

FDA 510(k)
FDA Class 2 ·General, Plastic Surgery

Merit Medical®

FDA UDI
Merit Medical Systems, Inc.·00884450394717·

GC ORAL MOISTURIZING GEL

FDA 510(k)
FDA Unclassified ·Unknown

STEM HIP REPLACEMENT SYSTEM, MODEL PHA002XX

FDA 510(k)
FDA Class 2 ·Orthopedic

COAGUCHEK ® XS SYSTEM

FDA Adverse Event
Malfunction ·ROCHE DIAGNOSTICS·Product code GJS·March 31, 2017

OT VERIO IQ METER

FDA Adverse Event
Malfunction ·LIFESCAN EUROPE, A DIVISION OF CILAG GMBH INTL·Product code NBW·May 20, 2013

FIRST PICC PERIPHERALLY INSERTED CENTRAL CATHETER

FDA Adverse Event
Other ·BECTON DICKINSON INFUSION THERAPY SYSTEMS·Product code LJS·August 11, 2008

ASR XL TAP SLV ADAP 12/14+5

FDA Adverse Event
Injury ·DEPUY INTERNATIONAL LTD. 8010379·Product code KWA·June 1, 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

XIA TITANIUM 4.5 BLOCKER

FDA Adverse Event
Malfunction ·STRYKER SPINE-US·Product code NKB·September 3, 2020

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 Recall
Open, Classified ·Merit Medical Systems, Inc.·Product code DTL·March 1, 2022

EMBLEM S-ICD Model A209

FDA Enforcement
Class I ·Terminated·Boston Scientific Corporation·February 17, 2021