118 results
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20ms
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Sources: EU EUDAMED, US FDA
Stent, Coronary
FDA Pre-Market Approval
FDA Class 3
·BESTENT 2 OVER-THE-WIRE (OTW)/RAPID EXCHANGE CORONARY STENT DELIVERY SYSTEM
Stent, Coronary
FDA Pre-Market Approval
FDA Class 3
·BESTENT(TM) 2 WITH DISCRETE TECHNOLOGY(TM) RAPID EXCHANGE CORONARY STENT SYSTEMS
Stent, Coronary
FDA Pre-Market Approval
FDA Class 3
·BESTENT 2 WITH DISCRETE TECHNOLOGY OTW/RAPID EXCHANGE CORONARY STENT DELIVERY SYSTEM
Stent, Coronary
FDA Pre-Market Approval
FDA Class 3
·BESTENT 2 WITH DISCRETE TECHNOLOGY OTW/RX CORONARY STENT DELIVERY SYSTEMS
Stent, Coronary
FDA Pre-Market Approval
FDA Class 3
·BESTENT 2 WITH DISCRETE TECHNOLOGY OTW/RAPID EXCHANGE CORONARY STENT DELIVERY SYSTEM
Stent, Coronary
FDA Pre-Market Approval
FDA Class 3
·BESTENT (TM) 2 WITH DISCRETE TECHNOLOGY OTW/RAPID EXCHANGE CORONARY STENT DELIVERY SYSTEM
Stent, Coronary
FDA Pre-Market Approval
FDA Class 3
·S670/S660/BESTENT(TM)2 WITH DISCRETE TECHNOLOGY RAPID EXCHANGE CORONARY STENT SYSTEM
Stent, Coronary
FDA Pre-Market Approval
FDA Class 3
·BESTENT 2 WITH DISCRETE TECHNOLOGY(TM) OVER-THE-WIRE AND RAPID EXCHANGE CORONARY STENT SYSTEMS
Stent, Coronary
FDA Pre-Market Approval
FDA Class 3
·S7/S670/S660/BESTENT 2/ WITH DISCRETE TECHNOLOGY RAPID EXCHANGE CORONARY STENT DELIVERY SYSTEM
N/A
FDA UDI
MEDTRONIC SOFAMOR DANEK, INC.·00613994989703·CALIPER 2000022
ACE
FDA UDI
ACE SURGICAL SUPPLY CO., INC.·00614950023578·RONGEUR CLEVELAND 4A 6-3/4" 17CM
SABLE Rotamax PRO KL
FDA UDI
Sable Industries Inc·00841359010049·Sable RotaMax Pro KL Interchangeable Fiber Opti...
Dermagold100
FDA UDI
MTS Medical AG·04260484571823·The OW100S is indicated to provide acoustic pre...
LIFEPAK 15, REF: 99577-001957, Part Number V15-5-000586 and V15-7-000022
FDA Recall
Open, Classified
·Physio-Control, Inc.·Product code MKJ·September 29, 2023
LIFEPAK 15, REF: 99577-001957, Part Number V15-5-000586 and V15-7-000022
FDA Enforcement
Class II
·Ongoing·Physio-Control, Inc.·November 22, 2023
AP417-01- MICROBORE YELLOW MARKED INFUSION SET WITH NON-VENTED SPIKE AND NEURAXI
FDA UDI
EITAN MEDICAL LTD·17290109153206·
AP206-01- INFUSION SET WITH NON-VENTED SPIKE, FX ADMINISTRATION CASSETTE
FDA UDI
EITAN MEDICAL LTD·17290109154623·
AP416-01 MICROBORE WITH 2 FEMALE LUER LOCKS AND A BACK CHECK VALVE
FDA UDI
EITAN MEDICAL LTD·17290109150465·
General Instrument
FDA UDI
ORTHOPEDIATRICS CORP.·00841132124918·Rod Cutter
Pin Guide, Right
FDA UDI
Treace Medical Concepts, Inc.·00810111221979·Pin Guide, Right