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Cardiovascular

28,927 FDA 510(k) clearances · PMA advisory committee

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RecordFirmDate
DARDIK BIOGRAFT (P780002/S002)Synovis Surgical Innovations1981-12-01
DARDIK BIOGRAFT (P780002/S004)Synovis Surgical Innovations1981-11-30
MINI-BALLOON DETACHABLE BALLOON SYSTEM (P780011/S001)Bd Becton Dickinson Vacutainer Systems Preanalytic1981-11-27
MINI BALLOON (P780011/S005)Bd Becton Dickinson Vacutainer Systems Preanalytic1981-11-27
MINI BALLOON (P780011/S003)Bd Becton Dickinson Vacutainer Systems Preanalytic1981-11-20
CYBERLITH IV UNIPOLAR PULSE GENERATOR (P800019/S002)Boston Scientific1981-10-26
USCI GRUNTZIG DILACA CATHETER (P790017/S002)Medtronic, Ireland1981-09-30
USCI GRUNTZIG DILACA CATHETER (P790017/S003)Medtronic, Ireland1981-09-30
N.C.G.T. GRAFT (P800058)St. Jude Medical, Inc.1981-09-08
HANCOCK MODIFIED ORIFICE VALVED CONDUIT (P790007/S004)Medtronic Heart Valves1981-09-01
HANCOCK MODIFIED ORIFICE BIOPROSTHESIS (P790007/S005)Medtronic Heart Valves1981-09-01
BYREL PROGRAMABLE PACEMAKER (P780009/S001)Medtronic Cardiac Rhythm Disease Management1981-07-21
DARDIK BIOGRAFT FOR USE IN PERIPHERAL VASCULAR SUR (P780002/S001)Synovis Surgical Innovations1981-07-10
CYBERLITH IV UNIPOLAR PULSE GENERATOR (P800019/S001)Boston Scientific1981-06-12
CYBERLITH IV UNIPOLAR PULSE GENERATOR (P800019)Boston Scientific1981-03-06
USCI GRUNTZIG DILACA CORNARY BALLOON DILATATION CA (P790017/S001)Medtronic, Ireland1981-02-17
MINI BALLOON (P780011)Bd Becton Dickinson Vacutainer Systems Preanalytic1980-05-15
USCI DILATATION CATHETER (P790017)Medtronic, Ireland1980-03-24
HANCOCK MODIFIED ORIFICE AORTIC BIOPROSTHESIS (P790007/S003)Medtronic Heart Valves1980-03-06
HANCOCK MODIFIED ORIFICE BIOPROSTHESIS (P790007/S001)Medtronic Heart Valves1980-03-06
HANCOCK MODIFIED ORIFICE BIOPROSTHESIS (P790007/S002)Medtronic Heart Valves1980-01-30
HANCOCK MODIFIED ORIFICE BIOPROSTHESIS (P790007)Medtronic Heart Valves1979-11-15
SURGIKOS ARTIGRAFT (N16837/S001)LeMaitre Vascular, Inc.1979-08-01
ARTEGRAFT{TM} AND REINFORCED ARTEGRAFT{TM} (N16837)LeMaitre Vascular, Inc.1979-08-01
BYREL PROGRAMABLE PACEMAKER (P780009)Medtronic Cardiac Rhythm Disease Management1979-03-27
DARDIK BIOGRAFT (P780002)Synovis Surgical Innovations1979-01-17
HUNTER-SESSIONS VENA-CAVA OCCLUDER (P770005)Concept, Inc.1977-12-19
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