Atlas FDA

Cardiovascular

19,134 FDA 510(k) clearances · Medical specialty

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RecordFirmDate
IMPL. PROGRAMMABLE BIPOLAR CARD.GEN.#274 (K803197)Telectronics, Inc.1981-01-22
TERUMO HOLLOW FIBER OXYGENATOR (K802970)Terumo America, Inc.1981-01-22
INTERPULSE MEMBRANE OXYGENATION SYSTEM (K803003)Extracorporeal Medical Specialities, Inc.1981-01-22
CRITERION II RHYTHM PROFILE MONITOR (K803315)Dart Medical Equipment1981-01-22
SIRECUST 400 SYSTEM PATIENT MONITORING (K802113)Analogic Corp.1981-01-22
HP MODEL 4710A ECG TRANSMITTER (K802717)Hewlett-Packard Co.1981-01-22
PERM. ENDOCARDIAL UNIPOLAR WEDGE URETHAN (K802553)Daig Corp.1981-01-16
DISPOSABLE QUICK RELEASE PERFUSION ADAP (K802544)Texas Medical Products, Inc.1981-01-16
DISPOSABLE CONNECTORS (K802542)Texas Medical Products, Inc.1981-01-16
PERM. ENDOCARDIAL UNIPOLAR TINED/WEDGE (K802552)Daig Corp.1981-01-16
ENDOCARDIAL LEADS 414S & 515S (K802816)Siemens Elema AB1981-01-16
DISPOSABLE GAS LINE FILTER (K802539)Texas Medical Products, Inc.1981-01-16
DISPOSABLE PARALLEL Y CONNECTORS (K802541)Texas Medical Products, Inc.1981-01-16
PERMANENT & TEMP. PACEMAKER ELECTRODE (K802547)Daig Corp.1981-01-16
ALP-KII (K810008)Martin'S Maine Exchange1981-01-16
RIDGID VENA CAVA CANNULAE (K802543)Texas Medical Products, Inc.1981-01-16
SWAN-GANZ FLOW-DIRECTED MULTIPUR. CATH. (K803058)American Edwards Laboratories1981-01-16
CARDIOPLEGIC SETS (K802545)Texas Medical Products, Inc.1981-01-16
MARK III ULTRASONIC SCANNING SYSTEM (K802917)Advanced Technology Laboratories, Inc.1981-01-16
VITASTAT ECG-1/ECG-3 ELECTROCARDIOGRAPH (K803309)Advanced Technology Laboratories, Inc.1981-01-16
THB 6000 HARDSHELL BUBBLE OXYGENATOR (K803231)Travenol Laboratories, S.A.1981-01-16
4-CHANNEL ECG TELEMETRY MON. SYST. #3045 (K803229)Cambridge Instruments, Inc.1981-01-13
PERCOR DATASCOPE INTRA-AORTIC BALLOON (K802167)Datascope Corp.1981-01-13
ADVANCEMED HOLTER RECORDERS (K803224)American Edwards Laboratories1981-01-13
CRT DISPLAY #1310B (K803123)Hewlett-Packard Co.1981-01-13
DATASCOPE/AVCO CONNECTOR (K801601)Datascope Corp.1981-01-13
TYGON TUBING (K803277)Electromedics, Inc.1981-01-13
ADVANCEMED EXAMINER (K803225)American Edwards Laboratories1981-01-13
ADVANCMED ELIMINATOR (K803223)American Edwards Laboratories1981-01-13
FOGARTY BALLON ANGIOPLASTY CATHETERS (K803057)American Edwards Laboratories1981-01-13
ADVANCEMED CCU DOCUMENTOR (K803222)American Edwards Laboratories1981-01-13
NARCO TELECARE TRANSDUCER DOME #700-4000 (K803096)Narco Scientific1981-01-13
MODEL HEC-7 HEART EVALUATION COMPUTER (K802952)Kluwe Corp.1981-01-07
CC101 ECG MONITORING SYSTEM (K802312)Anthro-Metrics Corp.1981-01-07
ARTERIAL BLOOD FILTER BF-37 (K802755)Delta Medical Industries1981-01-07
CYBERLITH PROGRAMMER (K801338)Intermedics, Inc.1981-01-07
IMPLANT. ENDOCARDIAL DISH TIP ELECT. LDS (K802413)Telectronics, Inc.1981-01-02
ATRIAL/VENTRICULAR SEQENTIAL #080-20000 (K801799)Medical Testing System, Inc.1981-01-02
ELECTROMAGNETIC BLOOD & ARTERIAL GAUGE (K801802)Medical Testing System, Inc.1981-01-02
CREST ELECTRONIC WARMING BLANKET (K801253)Penlon, Inc.1981-01-02
DISPOSABLE DIAPHRAGM DONE (K803011)Sorensen Research1980-12-31
TRANSDUCER DOME, CAT.#SD-101 (K802961)Sorensen Research1980-12-31
INTERSEPT* VENOUS RESERVOIR BAG & HOLDER (K803059)Extracorporeal Medical Specialities, Inc.1980-12-22
MICRO THIN-PII, #0523 (K802353)Cardiac Pacemakers, Inc.1980-12-22
ELECATH FLUID-DRAIN ASSEMBLY (K803002)Electro-Catheter Corp.1980-12-22
SIEMENS-ELEMA ENDOCARDIAL LEAD 402S (K803042)Siemens Elema AB1980-12-22
MICROTHIN-PII BIPOLAR PULSE GEN. #0623 (K803034)Cardiac Pacemakers, Inc.1980-12-22
MICROTHIN-PII BIPOLAR PULSE GEN. #0621 (K803035)Cardiac Pacemakers, Inc.1980-12-22
ARTERIAL BUBBLE TRAP K-20 (K803102)Delta Medical Industries1980-12-22
PREBYPASS FILTER CAT.#K-5 (K803101)Delta Medical Industries1980-12-22
UNIPOLAR ENDOCARDIAL LASER DRILLED ELEC (K802968)Telectronics, Inc.1980-12-22
MICRO THIN-DII, #0521 (K802352)Cardiac Pacemakers, Inc.1980-12-22
BUCKBERG-SHILEY BLOOD CARDIOPLEGIC SPL. (K802879)Shiley, Inc.1980-12-19
PRESSURE MONITORING SET (K802945)Norton Performance Plastics Corp.1980-12-19
6-415 FILTER, ELEMENT, 170-C (K802925)Lifecare Services, Inc.1980-12-19
PFIZONIC 100 ULTRASOUND SCANNER (K802529)Pfizer Medical Systems, Inc.1980-12-18
WILLIAM HARVEY OXYGENATING GAS FILTER (K802906)C.R. Bard, Inc.1980-12-16
SPIRAFLO BLOOD OXYGENATORS MODEL BOS-5S (K802720)Bentley Laboratories, Inc.1980-12-16
BLOOD PRESSURE UNIT MODEL 410 (K802412)Js & A Group1980-12-16
SPIRAFLO BLOOD OXYGENATORS MODEL BOS-10S (K802719)Bentley Laboratories, Inc.1980-12-16
BLOOD PRESSURE UNIT MODEL 310 (K802411)Js & A Group1980-12-16
TECNOL TELEMETRY UNIT POUCH (K802849)Tecnol New Jersey Wound Care, Inc.1980-12-16
UNIFOCAL VP, MODELS 7501 AND 7502 (K800746)American Pacemaker Corp.1980-12-16
PUIG MASSANA-SHILEY ANNULOPLASTY RING (K801879)Shiley, Inc.1980-12-16
CARDIOPLEGIA COOLING SYST. CCAS-2 (K802848)Bentley Laboratories, Inc.1980-12-11
MILLAR MIKRO-TIP CATHETER PHONOTRANS (K802830)Millar Instruments, Inc.1980-12-10
SIEMENS-ELEMA PULSE GENERATOR 668 (K801324)Siemens Elema AB1980-12-01
INTERMEDICS' LIFELINE TLE ENDOCARDIAL (K801172)Intermedics, Inc.1980-12-01
LOW PROFILE LEAD CONNECTOR MODIFICATION (4002) (K801284)Medtronic Vascular1980-12-01
PDS THERMAL DILUTION CARDIAC MODULE(OUT) (K802316)General Electric Co.1980-11-26
CONTIUOUS WAVE DOPPLER ULTRASOUND (K802670)American Edwards Laboratories1980-11-26
MODEL 4700A ELECTROCARDIOGRAPH (K802718)Hewlett-Packard Co.1980-11-26
HP MODEL 8880A FILTER (K802686)Hewlett-Packard Co.1980-11-26
COBE/STOCKERT BATTERY MODULE (K802714)Cobe Laboratories, Inc.1980-11-26
BIOMETRIC ERG SYSTEM (K802472)Biometric Analysis Group, Inc.1980-11-26
NARCO AIR-SHEILDS SYS. 100 MONITOR SYS (K802800)Narco Air-Shields1980-11-24
RIGHT ATRIAL LINE KIT (K802287)Stanco Medical, Inc.1980-11-20
SWAN GANZ CATHETER PLACEMENT KIT (K802288)Stanco Medical, Inc.1980-11-20
SAVE MOR (K801945)Cardia Concepts Corp.1980-11-19
MAPPING PROBE MODEL #6540 (K802058)Cardiac Pacemakers, Inc.1980-11-19
THE CRITERION II PACING SYS. MONITOR (K802782)Dart Medical Equipment1980-11-19
CARDIACINDEX COMPUTER MODEL SP 1435 (K802476)Gould, Inc.1980-11-19
CPR TRAVELER (K801947)Cardia Concepts Corp.1980-11-19
CHRONOCOR IV MODEL 250 (K802221)Cordis Corp.1980-11-19
CPR HELPER (K801946)Cardia Concepts Corp.1980-11-19
MODEL 3003 UNIPOLAR DEMAND CARDIAC GEN. (K802588)Arco Medical Products Co.1980-11-19
LITHICRON 0520 P-SYNCHRONEOUS PULSE GEN. (K792609)Medcor, Inc.1980-11-19
MEDTRONIC MODEL 6958 (K800870)Medtronic Vascular1980-11-13
L-3 PURGE LINE (K802602)Delta Medical Industries1980-11-12
BENZALKONIUM-HEPARIN COATED GUIDEWIRES (K802473)Medrad, Inc.1980-11-12
EXTERNAL JUGULAR CVP CATHERIZATION KIT (K802576)Willson1980-11-12
CARDIOSCOPE J200 (K802179)Telectronics, Inc.1980-11-12
ATGM MODEL AT-80 (K802191)Herald of America, Inc.1980-11-12
MEDICAL MAGNETIC TAPE RECORDER (K802564)Medical Concepts, Inc.1980-11-12
AMP PORTABLE PATIENT PRESSURE MONITOR (K802600)American Medical Products, Inc.1980-11-12
POLYFLEX IMPLANTABLE PACING LEAD (K802293)Intermedics, Inc.1980-10-31
WISCONSIN HEART RATE MONITOR (K802182)Lunar Radiation Corp.1980-10-31
PACEPATH MODEL 810 (K801416)Pacesetter Systems1980-10-31
STERI-SLEEVE (K802629)Cordis Corp.1980-10-31
MICROTHIN-DI BIPOLAR PULSE GENERATOR (K802409)Cardiac Pacemakers, Inc.1980-10-31
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