Atlas FDA

Cardiovascular

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

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RecordFirmDate
MULTITRAK-PLUS (K930894)Zymed Medical Instrumentation1993-11-01
SWAN-GANZ CCO/SVO2 THERMODILUTION CATHETER (K924452)Baxter Healthcare Corp1993-10-29
BARD PTFE VASCULAR GRAFT (K933204)C.R. Bard, Inc.1993-10-27
AIRCAST VENAFLOW SYSTEM (K932900)Aircast, Inc.1993-10-25
SAFESET RESERVOIR (K932188)Abbott Laboratories1993-10-25
GORE-TEX CARDIOVASCULAR PATCH & SURGICAL MEMBRANE (K930950)W. L. Gore & Associates, Inc.1993-10-22
ANGEMED MODEL 4000 QC BIPOLAR TEMP PACING LEAD (K924388)Angemed, Inc.1993-10-21
MODEL EP-2 CLINICAL STIMULATOR (K933069)Ep Medical, Inc.1993-10-21
PHOENIX DISPOSABLE PRESSURE TRANSDUCER #73-600 (K925638)Baxter Healthcare Corp1993-10-18
AUTOMATIC PULL BACK DEVICE (K933517)Cardiovascular Imaging Systems, Inc.1993-10-15
MAXIMA FILTERED HARDSHELL RESERVIOR (K933496)Medtronic Vascular1993-10-15
INTHERM RADIALLY EXPANDING DILATING INTRODUCER (K931489)Innerdyne Medical, Inc.1993-10-15
ZOLL PD 5300 (K931787)Zoll Medical Corp1993-10-15
P/METER (K921377)Zertl Medical, Inc.1993-10-12
PD-1400 PACER/DEFIBRILLATOR (K932028)Zoll Medical Corp1993-10-08
5200 ADULT SOLID GEL MULTI-FUNCTION ELECTRODES (K931803)Zoll Medical Corp1993-10-08
ZOLL D 5400 ADULT SOLID GEL DEFIBRILLATION ELECTRO (K931804)Zoll Medical Corp1993-10-08
ZOLL PD 5200C ADULT SOLID GEL MULTI-FUNCTION ELECT (K931805)Zoll Medical Corp1993-10-08
D1400 DEFIBRILLATOR W/ DEFIBRILLATION ADVISORY OPT (K932931)Zoll Medical Corp1993-10-07
SCIMED TRANSEND EX STEERABLE GUIDE WIRE AND ACCESSORIES (K934122)Scimed Peripheral Interventions1993-10-07
SURELOCK(TM) SNAPLESS MONITORING ELECTRODE (K931903)Ludlow Technical Products1993-10-07
ELECTRONIC DIGITAL BLOOD PRESSURE MONITOR (K923344)Citizen Watch Co., Ltd.1993-10-07
POWRPAK REPLACEMENT BATTERIES FOR PHISIO-CONTROL LIFEPAK 5/10 (K934067)National Custom Ent., Inc.1993-10-07
SCIMED STRIKE STEERABLE GUIDE WIRE (K934359)Scimed Peripheral Interventions1993-10-07
MEADOX SURGIMED DISPOSABLE PRESSURE GUAGE FOR USE WITH THE OLBERT CATHETER SYSTEM (K933975)Meadox Medicals, Div. Boston Scientific Corp.1993-10-06
SOFTOUCH DIAGNOSTIC INTRAVASCULAR CATHETER (K931479)Mallinckrodt Medical1993-10-06
MULTI-PORT Y INTRODUCER SET (K931587)Thomas Medical Products, Inc.1993-10-06
USCI MACH 10 GUIDE WIRE WITH PRO/PEL COATING (K933466)C.R. Bard, Inc.1993-10-01
PACEART CARDIOPHONE (K931296)Paceart, Inc.1993-10-01
MEADOX SURGIMED BALLOON CATHETER (K923947)Meadox Medicals, Div. Boston Scientific Corp.1993-09-30
NIKKISO NK PUMP (K920077)International Medical Products, Inc.1993-09-29
USCI SUPER 6 6F PTCA GUIDING CATHETER (K933019)C.R. Bard, Inc.1993-09-28
MODIFIED LUER (K931833)Medi-Dyne, Inc.1993-09-28
VITAL-PORT MINI VASCULAR ACCESS SYSTEM (K931586)Med Institute, Inc.1993-09-27
MODIFICATION OF INTRA-AORTIC BALLOON CATHETERS (K925248)Kontron Instruments, Inc.1993-09-27
OPTI-PLAST 5F PTA CATHETERS (K933483)Vas-Cath, Inc.1993-09-24
MICROSNARE (K925439)Microvena Corp.1993-09-24
MEDTRONIC MODEL 4081,4581,4582 TARGET TIP PACING L (K931411)Medtronic Vascular1993-09-23
CARDIAC THERAPHY SYSTEM SCP 900 (K921666)Ppg Hellige B.V.1993-09-23
ON-LINE ANALYSIS SYSTEM (K930639)Softheart, Inc.1993-09-22
HEMOSTASIS VALVE AND TUBING SET (K930194)Opticon Medical, Inc.1993-09-22
INTROPEEL (K930801)Menlo Care, Inc.1993-09-22
INTROPEEL V (K931218)Menlo Care, Inc.1993-09-22
BIOSCOPE (K923406)Biotronik, GmbH & Co.1993-09-22
THE SAMUELS RETROGRAD VALVULOTOME (K932009)Vascutech, Inc.1993-09-21
OSCILLOMATE BLOOD PRESSURE MONITOR-MODEL 9300 (K925402)Cas Medical Systems, Inc.1993-09-17
AVE ALLIANCE DILATATION CATHETER (K931384)Applied Vascular Engineering, Inc.1993-09-17
MS DISPOSABLE RIGID DOPPLER PROBE (K930227)Meadox Medicals, Div. Boston Scientific Corp.1993-09-16
SCD(R) CONTROLLER (K933259)Kendall Healthcare Products Co. Div.Of Tyco Health1993-09-13
FREEDOM OXIMETER/EEG DIGITAL INTERFACE (K924752)Pro-Tech, Inc.1993-09-10
GUIDING CATHETER HEMOSTASIS VALVE CAP (K933033)Arrow Intl., Inc.1993-09-10
HRV 4000EM (K932929)All-Tronics Medical Systems1993-09-09
SCIMED VIPER (K933183)Scimed Life Systems, Inc.1993-09-09
SARNS 8000 DELPHIN II CENTRI PUMP MOD W/INTEGR BAT (K915547)3M Health Care, Sarns1993-09-09
SPACELABS MEDICAL PATIENT MONITOR (K930095)Spacelabs Medical, Inc.1993-09-03
EXPLORER/360-POLARIS-L.E./JACKMAN CORON SINUS ELEC (K924163)Boston Scientific Corp1993-09-03
CAPIOX SX HOLLOW FIBER OXYGENATOR (K922799)Terumo Medical Corp.1993-09-02
CARDIMA SEEKER AND STUBBIE GUIDEWIRES (K932801)Cardima, Inc.1993-09-01
CORDIS BIPAL 7 BIOPSY FORCEPS WITH A INLINE HANDLE (K932788)Cordis Corp.1993-09-01
3M RED DOT 2234 RADIOLUCENT MONITORING ELECTRODE (K930312)3M Health Care, Ltd.1993-09-01
LEAD INTRODUCER SET, VARIOUS MODELS AND SIZES (K931662)Pace Medical1993-08-31
9.5 FR SIDEWINDER DL INTRA-AORTIC BALLON CATHETER (K926000)Boston Scientific Corp1993-08-30
PERCUTANEOUS INTRODUCER FOR VENA CAVA FILTER SYST (K932921)B. Braun Vena-Tech1993-08-30
CARDIAC CATH OR ANGIOGRAPHIC TRAYS (K932218)Associated Medical Products Co.1993-08-27
CORDIS CATHETER SHEATH INTRODUCER (K932733)Cordis Corp.1993-08-26
DATASCOPE PERCOR STAT DL9.5 FR34CC INTRA-AORT BALL (K914802)Datascope Corp.1993-08-25
ANGEMED 5000 LEAD ADAPTER (K924390)Angemed, Inc.1993-08-25
VASCO TIP/VASCOFLANGE (K913831)Vascor Medical Corp.1993-08-25
PERCOR STAT DL 8.5 FR 40CC INTRA-AORTIC BALLOON (K911000)Datascope Corp.1993-08-25
MEDTRONIC ARTERIAL FILTER (K926413)Medtronic Vascular1993-08-24
TRANSSEPTAL INTRODUCER SET (K932619)Thomas Medical Products, Inc.1993-08-24
VASCOSCREW 6/60 AND VASCOSCREW 8/60 (K914121)Vascor Medical Corp.1993-08-24
ROTABLATOR, MODIFICATION (K933238)Heart Technology, Inc.1993-08-24
CARDIOMETRICS SMARTWIRE(TM)/FLOMAP(R) (K925524)Cardio Metrics, Inc.1993-08-23
INNERSENSE(TM) DISPOSABLE MICROTRANSDUCER (K924737)Becton Dickinson Vascular Access, Inc.1993-08-23
B-D ARTERIAL BLOOD CONTAINMENT DEVICE (K925947)Bd Becton Dickinson Vacutainer Systems Preanalytic1993-08-20
ARROW BLOOD CONTAINMENT DEVICE (K924558)Arrow Intl., Inc.1993-08-19
PIKOS 01-A AND PIKOS E01-A IMPLANTABLE PACEMAKER (K923026)Biotronik, GmbH & Co.1993-08-19
SCIMED 6 FR., 7 FR., AND 8 FR.,TRIGUIDE GUIDING (K932420)Scimed Life Systems, Inc.1993-08-17
ANGIOGRAPHIC CATHETER (K926243)Target Therapeutics1993-08-16
3M RED DOT 2330 RESTING EKG ELECTRODE (K932454)3M Health Care, Ltd.1993-08-16
NEW HYDROPHILIC COATING FOR WIRE GUIDES (K924385)Arrow Intl., Inc.1993-08-15
SCIMED 6F ANGIOGRAPHIC CATHETER (K932542)Scimed Life Systems, Inc.1993-08-11
DATASCOPE 6000 MONITOR (K926099)Datascope Corp.1993-08-06
ANGESTAT FLUORO-TIP HEMOSTASIS INTRODUCER SET (K930057)B.Braun Medical, Inc.1993-08-06
KENDALL T.E.D./SCD SEQUENTIAL COMPRESSION DEVICE (K932835)Kendall Healthcare Products Co. Div.Of Tyco Health1993-08-06
TC2000 POWER UNIT AND ACCESSORIES (K930345)Gaymar Industries, Inc.1993-08-06
ROTATOR;MALE-MALE, MALE-FEMALE (K932251)Merit Medical Systems, Inc.1993-08-05
MAXIMA FILTERED HARDSHELL RESERVOIR (K932254)Medtronic Vascular1993-08-03
PERCOR STAT DL 9.5 FR 40CC INTRA-AORTIC BALLOON (K920427)Datascope Corp.1993-08-03
MEDI-DYNE ANGIOGRAPHIC CATHETER (K930694)Medi-Dyne, Inc.1993-08-02
PEDIATRIC INTRA-AORTIC BALLOON CATHETERS (K905663)Datascope Corp.1993-08-02
TEMPA-KUFF SINGLE PAT PRE-GAGED BALANCED DISP CUFF (K925744)Pymah Corp.1993-07-30
CARDIAX (K924544)Fairlake Marketing Group, Inc.1993-07-29
USCI ANGIOGRAPHIC CATHETER (K932092)C.R. Bard, Inc.1993-07-29
SARNS 7850 CENTRIFUGAL PUMP (MODIFIED) (K915363)3M Health Care, Ltd.1993-07-28
SITERITE NEEDLE GUIDE (MODIFIED) (K931403)Dymax Corp1993-07-27
WRISTRECORDER PLUS CARDIAC EVENT RECORDING SYSTEM (K930888)Ralin Medical, Inc.1993-07-21
COWBOY III (K932215)Kinetic Concepts, Inc.1993-07-21
CVIS INSIGHT IMAGING GUIDE CATHETER (K930232)Cardiovascular Imaging Systems, Inc.1993-07-21
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