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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