Atlas FDA

1987

4,160 FDA 510(k) clearances · Clearance year

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RecordFirmDate
MODEL CBC-1 COA COMP ANTI-STICKING BIPOLAR COAG. (K871077)Radionics, Inc.1987-06-12
SHARPLAN MEDILAS MODEL 40 N FOR UROLOGICAL USE (K871348)Sharplan Lasers, Inc.1987-06-12
DIGITAL SPHYGMOMANOMETER (K871371)Omron Tateisi Electronics Co.1987-06-12
QM300 C3 ANTIBODY PACK (K871939)Kallestad Diag, A Div. of Erbamont, Inc.1987-06-12
MVS 19 AND MVS 20 GAUGE SCLERAL PLUGS (K871604)Advanced Surgical Products, Inc.1987-06-12
SERIES TEN THOUSAND OCUTOME (K871871)CooperVision, Inc.1987-06-11
LIFESTYLES EXTRA STRENGTH CONDOMS W/NONOXYNOL-9 (K871304)Ansell, Inc.1987-06-11
QUIK-BRUSH (K870414)Intl. Medication Systems, Ltd.1987-06-11
MICROCHECK LH OVULATION TEST (K871602)Syntron Bioresearch, Inc.1987-06-11
IL MONARCH 1000 CLINICAL CHEMISTRY ANALYTICAL SYS. (K871973)Instrumentation Laboratory CO1987-06-11
PHENYTOIN FPIA CALIBRATORS (K871423)Sigma Diagnostics, Inc.1987-06-11
GAMMA GLUTAMYLTRANSFERASE REAGENT (K871979)Intersect Systems, Inc.1987-06-11
TDXR REA(TM) ETHANOL (K871645)Abbott Laboratories1987-06-11
ALLELIX PREGNANCY DETECTION KIT 48 TEST KIT (K871308)Allelix, Inc.1987-06-11
ENDOCATER (K863393)The Hygenic Corp.1987-06-11
4-9295 BARBITURATES TEST MIX (K871174)Supelco, Inc.1987-06-11
ULTRA MAXITHINS PADS (K871716)Tambrands, Inc.1987-06-11
MULTICHEM LDH-L REAGENT (K872010)Simmler, Inc.1987-06-11
ACCULATOR 287EP (K871396)Accu Science Corp.1987-06-11
VINYL POLYSILOXANE IMPRESSION SYSTEM (K871409)Crown Delta Corp.1987-06-11
SUMMIT OPTICS POST-MYDRIATIC SPECTACLES (K871800)Summit Optics, Inc.1987-06-11
RODENSTOCK SCANNING LASER OPHTHALMOSCOPE (K871268)G. Rodenstock Instrumente GmbH1987-06-10
SYNECTICS LIBERTY SYSTEM AMPLIFIER AND SOFTWARE (K871282)Synectics-Dantec1987-06-10
AMEDA AMECARE(R) NEONATAL INCUBATOR (K870222)Hollister, Inc.1987-06-10
SUBCUTANEOUSLY IMPLANTED DRUG DELIVERY DEPOT (K871192)Norfolk Medical Products, Inc.1987-06-10
DS-II DIGITAL SONOGRAPHY SYSTEM (K864278)Intl. Acoustics, Inc.1987-06-10
MINIATURE TEMP. CARDIAC PACEMAKERS EC4542 & EC4543 (K871915)Pace Medical1987-06-10
AMEDA AMELETTE(R) NEONATAL INCUBATOR (K870223)Hollister, Inc.1987-06-10
CONVEEN(R) LEG-BAG (600 ML) (K871643)Coloplast A/S1987-06-10
ORICULT-N CULTURE-PADDLE (K872058)Orion Corp.1987-06-10
THE BUDDY SYSTEM W/OPTIONAL ECG ELECTRODE (K871748)The Buddy Systems, Inc.1987-06-10
CONVEEN(R) NIGHT DRAINAGE BAG (2000 ML) (K871610)Coloplast A/S1987-06-10
URETERAL STENT (K871667)Penn Medical Devices, Inc.1987-06-10
RABBIT PLASMA FIBRINOGEN SUPPLEMENT SR 122 (K870945)Oxoid U.S.A., Inc.1987-06-10
BIODAN TYPE COMET ELECTRODE (K871668)National Medical Technology1987-06-10
Q.I.C. BLEEDING TIME DEVICE (K871318)Helena Laboratories1987-06-10
GRASPING FORCEP, 1.7MM (K871926)Arthropedics, Inc.1987-06-09
MULTI-FLEX TABLE -- MODEL 105 (K870714)Slenderizers Equipment Mfg., Inc.1987-06-09
MULTI-FLEX TABLE -- MODEL 106 (K870715)Slenderizers Equipment Mfg., Inc.1987-06-09
ORTHOMET AUSTIN-MOORE SYSTEM (K871656)Orthomet, Inc.1987-06-09
MULTI-FLEX TABLE -- MODEL 103 (K870712)Slenderizers Equipment Mfg., Inc.1987-06-09
UNIMED SURGEON'S GOWNS (K871906)Unimed Hospital Supply Corp.1987-06-09
MULTI-FLEX TABLE -- MODEL 104 (K870713)Slenderizers Equipment Mfg., Inc.1987-06-09
CUP BIOPSY FORCEP, 1.7MM (K871927)Arthropedics, Inc.1987-06-09
UROSCAN (K870855)Endotherapeutics1987-06-09
LYOSHEET SURGICAL SHEET FOR BURNS (K871740)Acme United Corp.1987-06-09
CYTOTECH ANTINUCLEAR ANTIBODY (ANA) IFA KIT (K871801)Cytotech, Inc.1987-06-09
ENFUSE ENTERNAL ADMINISTRATION SET & PUMP SET (K871019)Entech, Inc.1987-06-09
MULTI-FLEX TABLE -- MODEL 102 (K870711)Slenderizers Equipment Mfg., Inc.1987-06-09
MULTI-FLEX TABLE -- MODEL 101 (K870710)Slenderizers Equipment Mfg., Inc.1987-06-09
ACTRIL FOR KIDNEY MACHINE DISINFECTANT (K861730)Renal Systems, Inc.1987-06-09
TOURNIQUET PRESSURE REGULATOR (K871982)Avec Scientific Design Corp.1987-06-09
BUBBLE TRAP CAT. NO. B-180 (K870819)American Omni Medical, Inc.1987-06-08
DSL ESTRADIAL RADIOIMMUNOASSAY (DSL-4400) (K870405)Diagnostic Systems Laboratories, Inc.1987-06-08
OXIMETER (K871353)Radiometer America, Inc.1987-06-08
PREBYPASS FILTER (K871350)American Omni Medical, Inc.1987-06-08
OMEGA NASAL SEPTAL BUTTON (K871072)Omega Silicone, Inc.1987-06-08
BOWEN REUSEABLE/DISPOSABLE ELECTRODE (K871325)Bowen & Company, Inc.1987-06-08
COSMETIC SINGLE SPAN BRIDGE (K871439)Cosmetic Dental Technologies, Inc.1987-06-08
MODIFIED HEART*AID 97 AUTO. EXTERNAL DEFIBRILLATOR (K871569)Cardiac Resucitator Corp.1987-06-08
MODIFIED PERTRACH DISP. PEDIATRIC PERCUT. TRACHEO. (K871199)Frederic J. Toye, M.D.1987-06-08
RIBBED CUSHION MASK (K871851)Engineered Medical Systems1987-06-08
TMJ CANNULA SET (K871648)Aspen Laboratories, Inc.1987-06-08
ACCUDENT ACCUPROBE (K870280)Accudent, Inc.1987-06-08
MODIFIED COBAS FP REAGENTS FOR NAPA AND CALIBRATOR (K871680)Roche Diagnostic Systems, Inc.1987-06-08
BTE HEARING AID OTICON MODEL E30P (K872017)Oticon Corp.1987-06-08
VIP'S PROPHYLACTICS, NATURAL, ANATOMIC & FEMINA (K871300)Professional Pharmacy West, Inc.1987-06-08
TELSTAR MODEL FS HEARING AID (K871520)Telstar Electronics, Inc.1987-06-08
ESKA-HERRMANN TRACHEOSTOMY VALVE (K871885)C.R. Bard, Inc.1987-06-08
OHIO(R) CARE PLUS INCUBATOR (K871399)Ohmeda Medical1987-06-05
CDI(TM) EXTRACORPOREAL BLOOD GAS SYSTEM 300 (K871221)Cardiovascular Devices, Inc.1987-06-05
IMPLANTABLE PROGRAMMABLE CARDIAC PULSE GENERATORS (K871861)Telectronics, Inc.1987-06-05
IMPRESSION SYRINGE (K871937)Dentsply Intl.1987-06-05
DUCERAM-METAL-CERAMIC DENTAL PORCELAIN SYSTEM (K871808)Degussa Dental, Inc.1987-06-05
MASTER MEDICAL DEVICE IS I.V. STAT 2 (K871753)The Master Medical Corp.1987-06-05
THE KARL STORZ MODEL 28805 ARTHRO PUMP (K871621)KARL STORZ Endoscopy-America, Inc.1987-06-05
M-2 OXYGEN/TEMPERATURE MONITOR (K871337)Bio-Med Devices, Inc.1987-06-05
TELSTAR MODEL C HEARING AID (K871522)Telstar Electronics, Inc.1987-06-05
MODEL NUMBER 8200 RESPIRATION/HEART RATE MONITOR (K871551)Aequitron Medical, Inc.1987-06-05
UNIPOLAR ENDOCARDIAL SCREW-IN LEAD, MODEL 1007M (K871208)Pacesetter Systems1987-06-05
ELECTROTRACE DISP REST EKG ELECTRODE, CAT. ET1200 (K871626)Jason Marketing Co.1987-06-05
DOUBLE ANTIBODY CANNABINOIDS KTHD1 AND KTHD5 (K871695)Diagnostic Products Corp.1987-06-05
LIDO ACTIVE (K871793)Loredan Biomedical, Inc.1987-06-05
MULTICHEM TOTAL PROTEIN REAGENT #S0928 (K871975)Simmler, Inc.1987-06-05
COCAINE METABOLITE ENZYME IMMUNOASSAY KIT (K871305)General Diagnostics1987-06-05
HYPERTENSION RISK DETECTOR(TM) (K871482)Pearce Clinical Laboratories, Inc.1987-06-05
TRI-SERVICE OMV VAPORIZER (K864589)Bear Medical Systems, Inc.1987-06-05
AMERICAN LUBRICATING JELLY STERILE 2.7G & 5G (K870742)Span-America Medical Systems, Inc.1987-06-05
M-1 PRESSURE MONITOR (K871336)Bio-Med Devices, Inc.1987-06-05
MODIFIED MODEL UA-751 DIGITAL SPHYGMONOMETER (K871719)A&D Engineering, Inc.1987-06-05
BIRTHING ROOM WARMER (K871594)Air-Shields, Inc.1987-06-05
TELSTAR MODEL F3TS HEARING AID (K871518)Telstar Electronics, Inc.1987-06-05
D-23 DENTURE ADHESIVE (K871980)Solar Dental Co., Inc.1987-06-05
KARL STORZ MODEL 28184 PNEUMATIC SHUTTLE SHAVER (K871891)KARL STORZ Endoscopy-America, Inc.1987-06-05
FULL SHELL ITE HEARING AID (K871521)Telstar Electronics, Inc.1987-06-05
MODEL 420 SYSTEM MEASUREMENT, BLOOD PRESSURE (K871363)Quinton, Inc.1987-06-05
SURVIVAL KIT, INDIV TROP TACT AIR CREW/PLASTIC BAG (K871459)Frass Survival Systems, Inc.1987-06-05
BARD BIOPTY BIOPSY SYSTEM (K871390)C.R. Bard, Inc.1987-06-05
ACUSON PHYSIOLOGICAL CONTROL MODULE (K871239)Acuson Computed Sonography1987-06-05
DORROS(TM) SMALL VESSEL PTA CATHETER (K870460)C.R. Bard, Inc.1987-06-05
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Every clearance here is in the API, with alerts when new ones post.