Atlas FDA

1978

1,975 FDA 510(k) clearances · Clearance year

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RecordFirmDate
STOCKINETTE (K781944)Kimberly-Clark Corp.1978-12-29
BETA-TEC (K781794)Wampole Laboratories1978-12-29
MEDTRONIC MODEL 546 (K782108)Medtronic Vascular1978-12-29
LIGHT, INSIDE (K781878)Midwest1978-12-29
HT-110 MICROMINI (K782076)Health Tech1978-12-29
LASER, PHOTOCOAGULATION (K782065)Cavitron Corp.1978-12-28
GOLD, 24 KARAT CASTING (K781788)Williams Gold Refining Co., Inc.1978-12-28
MODULAT DENTAL SYSTEMS (K781882)Vacudent Sales Corp.1978-12-28
IMPLANT DRIVERS AND TIPS (K781974)Miter, Inc.1978-12-28
TABLE, EXAMINING-TWO EIGHTY (K782064)Amsco Co.1978-12-28
SPONGE SYSTEM, ROSERING CONTAIN-COUNT (K782120)Medline Industries, Inc.1978-12-27
PACEMAKER, MODEL DDP ELECTRONIC CIRCUIT (K782146)Arco Medical Products Co.1978-12-27
VALVE, AMBU PEEP (K782152)Narco Air-Shields1978-12-26
MONITOR, SENSOMATIII OXYGEN (K781910)Biochem International, Inc.1978-12-26
MICROLITH A MODEL 703 (K782022)Cardiac Pacemakers, Inc.1978-12-22
ELECTRODE LEAD MODEL 030-198 (K782097)Telectronics, Inc.1978-12-22
MAXI CAMERA 400T (K782029)General Electric Co.1978-12-22
LITHICRON F PROGRAMMABLE PULSE GEN (K780430)Medcor, Inc.1978-12-22
MICROLITH A MODEL 803 (K782023)Cardiac Pacemakers, Inc.1978-12-22
TRANSMITTER, TR-1 ECG (K782059)Burdick Corp.1978-12-21
VENTILATOR, INFANT MODEL 100 (K781926)Healthdyne, Inc.1978-12-21
PACING LEAD MODEL BUS 860, BUS 890 (K781624)R.E. Brown Co., Inc.1978-12-21
PULSTRON MODEL 100 (K781835)Micro-Rel1978-12-21
VENTILATOR, MODEL AVA-1, ADULT (K782074)Rule Medical Instruments, Inc.1978-12-21
CORTRAL I (K780527)Hospal Medical Corp.1978-12-20
ANALYZER, AUTOMED CENTRIFUGAL (K781900)Autogenic Systems1978-12-20
LINER, CAVITY CALCIUM HYDROXIDE (K781688)Kerr Corporation (Danbury)1978-12-20
CONTROL, PROTEIN ELECTROPHORESIS (K781893)Sigma Chemical Co.1978-12-20
EXTUBE (K781728)Analytichem International, Inc.1978-12-20
CLEARING SOLUTION #ECA01976 (K781898)Electrophoresis Corp. of America1978-12-20
BLOOD GROUP SUBSTANCE A (K781862)North American Biologicals, Inc.1978-12-20
DETECTOR, MODEL 79875A, VARIABLE (K781771)Hewlett-Packard Co.1978-12-20
CLAMP, DISPOSABLE (K782090)Concord Laboratories, Inc.1978-12-20
WASHER SYSTEM, MICROELISA (K781802)Metrix Teknika, Inc.1978-12-20
API ZYM (K781567)Analytical Products, Inc.1978-12-20
RUBINDEX*DIRECT SYSTEM (K781638)Ortho Diagnostics, Inc.1978-12-20
SURGAIRTOME TWO (K781979)American Sterilizer Co.1978-12-20
HYSTERECTOMY T DRAIN (K782027)Davol, Inc.1978-12-20
PROCESSING SYSTEM, A2 IMAGE (K782047)Medtronic Vascular1978-12-20
UROTRON (K781632)Boehringer Mannheim Corp.1978-12-20
SERUM, CREATININE DETERMINATIONS (K781884)Fisher Scientific Co., LLC1978-12-20
SERUM, BLOOD UREA NITIOGEN (K781885)Fisher Scientific Co., LLC1978-12-20
HEMODIALYZER, MODEL RP610, RP AN 69 (K781464)Hospal Medical Corp.1978-12-20
COLUMN TEST, HEMOGLOBIN A (K781948)Bio-Rad1978-12-20
COMPRESSION HIP SCREW SYSTEM (K781762)Howmedica Corp.1978-12-20
STAIN KIT FOR CELL CULTURES (30-100-00) (K781875)Flow Laboratories, Inc.1978-12-20
MYCOPLASMA ARGININI FITC (30-403-41) (K781874)Flow Laboratories, Inc.1978-12-20
CATHETER, DIGITAL POSITRAL II (K782082)C.R. Bard, Inc.1978-12-20
DIJI-DENT (K781962)J&J Technologies, Inc.1978-12-20
RADIATION ONCOLOGY SYSTEM (K782005)Adac Laboratories1978-12-20
ROUND SILICONE DRAIN (K782028)Davol, Inc.1978-12-20
MULTIFORMAT FILM CASSETTE TRANSPORT (K782060)Mediscan, Inc.1978-12-20
BLOOD GROUP SUBSTANCE B (K781895)North American Biologicals, Inc.1978-12-20
HUMIDIFIERS, MODEL:LS-420 AND LS-460 (K781760)Bourns Medical Systems, Inc.1978-12-20
HUMAN II LENS (K781927)Spectra-Shield, Inc.1978-12-20
RIA KIT, PREG-STAT (K781733)Serono Laboratories, Inc.1978-12-20
ABRASIVE WHEELS (K781777)Dentsply Intl.1978-12-20
BLOOD GROUP SUBSTANCE A,B (K781896)North American Biologicals, Inc.1978-12-20
NU-GLAZE (K781935)Deringer-Ney, Inc.1978-12-20
SURGICAL GOWNS & DRAPES (K781682)Kimberly-Clark Corp.1978-12-20
APPLICATOR, LEE IMPRESSION (K781977)Lee Pharmaceuticals1978-12-20
ISOPLAST (K781787)Vivadent (Usa), Inc.1978-12-20
UREA NITROGEN TEST (K781899)Wako Intl., Inc.1978-12-20
CHEMSTRIP CONTROL (K781691)Boehringer Mannheim Corp.1978-12-20
ELECTROSURGICAL UNIT 3001-3009 (K781810)Neomed Corp.1978-12-20
ADAPTER KIT (K781864)Daig Corp.1978-12-19
ELECTRODES, OFFSET AND DX (K781963)Graphic Controls Corp.1978-12-19
ALARM UNIT, BATTERY OPERATED (K781158)Thompson Respiration Products, Inc.1978-12-18
SUPER-SORBER (K780938)Home Healthcare Products, Inc.1978-12-15
UNDERPADS, HIGH ABSORBANT POLYMER (K781877)Bridgewater Mfg. Corp.1978-12-15
HEARING AID, POST-AURICULAR (K782053)Hc Electronics1978-12-15
DIALYZER, PARALLEL FLOW DISPOSABLE (K781795)Medical, Inc.1978-12-15
TUBE, LEATHERMAN/IMBRUCE (K781665)National Catheter Co. Div. Mallinckrodt1978-12-15
CATHETER, USCI GRUNTZIG/BALLOON (K782071)C.R. Bard, Inc.1978-12-15
LEAD, TIMED PACING, IMPLANTABLE (K782004)Daig Corp.1978-12-15
TRACH-COLLAR (K782002)Kinetic Concepts, Inc.1978-12-15
AQUA-GEL (K781032)Murray, Salk, Inc.1978-12-15
CARDIAC CARE Q/C TEST KIT (K782033)Instrumentation Laboratory CO1978-12-15
SPIROMETER, INCENTIVE CATALOG # 1750 (K781831)Hudson Oxygen Therapy Sales Co.1978-12-15
MEDGENERAL SINGLE-USE BULLDOG (K782006)Med General1978-12-15
OMNIPREP (K781989)Weaver & Co.1978-12-15
AIRFLOMETER (K780894)Glaxo Australia Ply. , Ltd.1978-12-14
STIMULATOR, MODEL 7727 (K782075)Medtronic Vascular1978-12-14
VENTILATOR, MINILUNG (K781160)Thompson Respiration Products, Inc.1978-12-13
TRANSMITTER, MODEL 9406 AND 9401 (K781986)Medtronic Vascular1978-12-13
SPIROCARE 108-B (K782016)Marion Laboratories, Inc.1978-12-13
SUCTION APPARATUS, POWERED BY COMP. AIR (K781988)Farley, W.T.1978-12-12
MODEL IV 1500 STANDARD BURETTE (K781637)Valleylab, Inc.1978-12-12
ADAPTER, CATHETER SHEATH (K781846)Arrow Intl., Inc.1978-12-12
9100 DAYSTAR AND 9110 ORBITER PACKAGE (K781887)Castle Co.1978-12-12
VENTILATOR, PRESSURE (K781159)Thompson Respiration Products, Inc.1978-12-12
PUNCTURE KIT, DISPOSALBE VEIN (K781978)Arrow Intl., Inc.1978-12-12
IRRIGATION TRAY (K781748)Intermed, Inc.1978-12-12
DEFIBRILLATOR, MARK II (K781678)Ipco Corp.1978-12-12
MONITOR/MINI SCOPE (K781679)Ipco Corp.1978-12-12
ADAPTER, C/D SUCTION (K781713)Novametrix Medical Systems, Inc.1978-12-12
FLAT SILICONE DRAIN (K782026)Davol, Inc.1978-12-12
COMPRESSION DEVICES, LIMB (K781964)Alba-Waldensian, Inc.1978-12-12
PULSE GENERATOR, MODEL 240, EXTERNAL (K781327)Intermedics, Inc.1978-12-11
RESPIRATOR, BANTAM MODEL (K781161)Thompson Respiration Products, Inc.1978-12-11
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Track 1978 automatically

Every clearance here is in the API, with alerts when new ones post.