11 results
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21ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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BUBBLE SUCTION TUBING
FDA 510(k)
FDA Class 2
·General Hospital
Azur CX Detachable
FDA UDI
Microvention, Inc.·00810170018329·Azur
Azur CX Detachable
FDA UDI
Microvention, Inc.·00810170017513·Azur
Azur
FDA UDI
Microvention, Inc.·00842429119211·Azur CX Detachable
SPIRA Open Matrix LLIF
FDA 510(k)
FDA Class 2
·Orthopedic
GC OPB-100
FDA 510(k)
FDA Class 2
·Dental
ACRYSOF
FDA Adverse Event
Injury
·ALCON RESEARCH, LTD./HUNTINGTON·Product code HQL·April 22, 2014
OCTRODE
FDA Adverse Event
Injury
·ST. JUDE MEDICAL - NEUROMODULATION·Product code LGW·October 5, 2012
PARADIGM REAL-TIME REVEL INSULIN INFUSION PUMP
FDA Adverse Event
Malfunction
·MEDTRONIC PUERTO RICO OPERATIONS CO.·Product code OYC·May 19, 2015
Terumo AZUR CX Peripheral Coil System, Detachable 18, CX Coil, REF numbers 45-781032, 45-781238, 45-781434, 45-781639, 45-781836, 45-782040, 45-780202, 45-780204, 45-780304, 45-780308, 45-780413, 45-780516, 45-780620, 45-780724, 45-780828, 45-780928, MV-AX80202CL, MV-AX80204CL, MV-AX80304CL, MV-AX80308CL, MV-AX80413CL, MV-AX80516CL, MV-AX80620CL, MV-AX80724CL, MV-AX80828CL, MV-AX80928CL, MV-AX81032CL, MV-AX81238CL, MV-AX81434CL, MV-AX81639CL, and MV-AX82040CL, Sterile, Rx. The firm name on the label is MicroVention, Inc., Tustin, CA; Distributed By: Terumo Medical Corporation, Somerset, NJ; Made in Costa Rica.
FDA Recall
Terminated
·Microvention, Inc.·Product code KRD·November 24, 2019
Terumo AZUR CX Peripheral Coil System, Detachable 18, CX Coil, REF numbers 45-781032, 45-781238, 45-781434, 45-781639, 45-781836, 45-782040, 45-780202, 45-780204, 45-780304, 45-780308, 45-780413, 45-780516, 45-780620, 45-780724, 45-780828, 45-780928, MV-AX80202CL, MV-AX80204CL, MV-AX80304CL, MV-AX80308CL, MV-AX80413CL, MV-AX80516CL, MV-AX80620CL, MV-AX80724CL, MV-AX80828CL, MV-AX80928CL, MV-AX81032CL, MV-AX81238CL, MV-AX81434CL, MV-AX81639CL, and MV-AX82040CL, Sterile, Rx. The firm name on the label is MicroVention, Inc., Tustin, CA; Distributed By: Terumo Medical Corporation, Somerset, NJ; Made in Costa Rica.
FDA Enforcement
Class II
·Terminated·Microvention, Inc.·February 19, 2020