Atlas FDA

1985

4,483 FDA 510(k) clearances · Clearance year

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RecordFirmDate
TAN MODEL I (K853046)Philip Munsterman Tan, Inc.1985-08-07
SHARPLAN 1040 CO/2 SURGICAL LASER (K850628)Laser Industries , Ltd.1985-08-07
STILLE ANGULAR RONGEUR, 8-3/4 SS 410 (K853016)The Huxley Instrument Corp.1985-08-07
SPARROW MOTORIZED SCOOTER (K852380)Venturego, Inc.1985-08-07
MEDUS GMBH (K853153)Corkes Medical Co.1985-08-07
SIMPLASTIC SUPRA PUBIC CATHETER (K852200)Franklin Medical USA, Inc.1985-08-07
OPTIMATE DIGOXIN TEST (K853021)Miles Laboratories, Inc.1985-08-07
RESPIR GARD-II FACE MASK CORRUGATED TUBING (K853056)Marquest Medical Products, Inc.1985-08-07
DIASCAN BLOOD GLUCOSE SELF-MONITOR TEST STRIPS (K851618)Home Diagnostics, Inc.1985-08-06
MEDI-COMP NEONATAL OXYGEN HOOD (K851666)Medicomp, Inc.1985-08-06
CCS IMPLANTABLE MAESTRO SERIES 100 CARDIAC PACEMA (K852435)Cardiac Control Systems, Inc.1985-08-06
MEDTRONIC MODEL 5561 (K852356)Medtronic Vascular1985-08-06
LITEGUARD 9 (K851924)Temtech , Ltd.1985-08-06
DR. HESSEL'S VACUUM EXTRACTOR (K853037)Medic Group of Scandinavia, Inc.1985-08-06
AIRLIFE ELECTRONIC INCENTIVE SPIROMETER (K851334)American Pharmaseal Div. Ahsc1985-08-06
MCKNIFE (K853103)Medical Dimensions1985-08-06
ROTALOK WRIST STRAP, ROTALOK SKIN RETRACTOR (K853114)Australian Biomedical Corporation , Ltd.1985-08-06
APM DISPOS. BLOOD PRESSURE TRANSDUCER (K851888)Honeywell, Inc.1985-08-06
SARACAP RESPIRATORY MONITOR (K852062)Alleghany Intl. Medical Technology1985-08-06
RESPIR THER HUMID CONTAIN STERILE WATER FOR USP (K853146)Automatic Liquid Packaging, Inc.1985-08-06
BEAVER MULTIPURPOSE SAPPHIRE KNIFE (K853129)Rudolph Beaver, Inc.1985-08-06
HI CHEM DIAGNOSTICS CLEANING NEUTRALIZER SOL#88193 (K853003)Hi Chem, Inc.1985-08-06
STERILE NASOPHARYNGEAL AIRWAY (K853162)Inmed Corp.1985-08-06
DEFI 2 (K851931)S & W Medico Teknik1985-08-05
SILENT GUARD CAT. NO. SG-30 (K851465)American Omni Medical, Inc.1985-08-05
PHAKOSYSTEMS MODEL CES 4100 (K851674)Phakosystems, Inc.1985-08-05
BARD CRITICAL CARE THERMODILUTIN CATHETER W/INFUSI (K850952)C.R. Bard, Inc.1985-08-05
AJDJUSTABLE SUCTION CONTROL VALVE (K851406)American Omni Medical, Inc.1985-08-05
B-D DIGITAL FEVER THERMOMETER (K852954)Bd Becton Dickinson Vacutainer Systems Preanalytic1985-08-05
ELECTRICALLY HEATED STERILIZER STEAM STERILIZER (K844649)Takizawa Medical Instruments Manufacturer1985-08-05
TDX CORTISOL (K852927)Abbott Laboratories1985-08-05
OCCLUSION & OCCLUSION-IRRIGATION (K844918)Clincal Instruments Corp.1985-08-05
EQUITEST (K851744)Neurocom International, Inc.1985-08-05
ADVANCED CARDIOVASCULAR SYS LOW PROFILE PTA BALLOO (K851854)Advanced Cardiovascular Systems, Inc.1985-08-05
1208 BETACORD AND 1208 BETCORD M (K852434)Lkb Instruments, Inc.1985-08-02
MEDICON MODEL 8200 AMS(APNEA MONITOR SYSTEM) (K853084)Aequitron Medical, Inc.1985-08-02
ALBUMIN REAGENT FOR ASTRA 8 AUTO STAT/ROUT ANALYZE (K853049)Simmler, Inc.1985-08-02
SLEEP STAGER (K850541)Oxford Medilog, Inc.1985-08-02
PRESSURE REGULATOR/Y CONNECTOR (K852649)C.R. Bard, Inc.1985-08-02
STAT GAS MODULE (K851451)Vulcan Laboratories, Inc.1985-08-02
UREASE & GLUTAMATE DEHYDROGENASE, UREA NITROGEN (K853102)Diagnostic Chemicals, Ltd. (Usa)1985-08-02
CALCIUM REAGENT FOR ASTRA 8 AUTOM STAT/ROUT/ANALYZ (K853050)Simmler, Inc.1985-08-02
CORTISOL SYSTEM BY EIA (K852939)American Bioclinical, Inc.1985-08-02
SOPHEIA DHEA-SO4 EIA KIT (K852847)Diagnostic Products Corp.1985-08-02
ACA GENTAMICIN TEST PACK (K852672)E.I. Dupont DE Nemours & Co., Inc.1985-08-02
BIOVATION MAX DATA MANAGEMENT SYSTEM (K853026)Biovation, Inc.1985-08-02
URETERAL STONE DISLODGER (K851922)Inter-Med Corp.1985-08-02
DC LIQUITROL LEVEL 1 & 2 (K852753)Diagnostic Chemicals, Ltd. (Usa)1985-08-02
REPLACEMENT REAGENTS FOR SMAC II SYSTEMS (K852306)Methodist Hospital of Memphis1985-08-02
TITANIUM PROBES (K852415)L.A.S.E.R., Inc.1985-08-02
THORATEC MULTILUMEN CENTRAL VENOUS CATH-TRAY (K851495)Thoratec Laboratories Corp.1985-08-01
ACCU-CHEK II (K851456)Boehringer Mannheim Corp.1985-08-01
MYCOPLASMA SPP SEROLOGICAL REAGENTS (K852933)Microbix Biosystems, Inc.1985-08-01
EMERGENCY ROOM & MINOR OFFICE PROCEDURE CUSTOM KIT (K844596)Xanmed Corp.1985-08-01
ENZYME ANTINUCLEAR ANTIBODY SCREENING TEST (K852840)Modern Diagnostics, Inc.1985-08-01
INFUSION CANNULAM (K852758)Precision Medical Instruments, Inc.1985-08-01
RF CARD TEST (K853054)Preco, Inc.1985-08-01
CULTURETTE BRAND 10-MINUTE GROUP A STREP I.D. (K853073)Marion Laboratories, Inc.1985-08-01
PERMALID PAK (K842781)CooperVision, Inc.1985-08-01
PERMALID LINER PAK (K842814)CooperVision, Inc.1985-08-01
CARIOLINE(ELECTROCARDIOGRAPH) (K852770)Remco Italia S.P.A.1985-08-01
MDS 83 OPHTHALMIC DYE LASER SYSTEM (K852234)Meditec, Inc.1985-08-01
TROPHY COMPACT - DENTAL UNIT (K851136)Trophy Radiologie1985-07-31
INTERPLAK (K852476)Dental Research Corp.1985-07-31
SIGHT SAVER ALL PURPOSE LENS CARRYING CASE (K852384)Bausch & Lomb, Inc.1985-07-31
SATLEC PROPHY UNIT PU 3055 (K852521)Spelna, Inc.1985-07-31
ULTRATHIN/SP LENS (K843957)Optical Systems Intl., Inc.1985-07-31
SITE INFUSION CONTACT LENS W/ILLUMINATOR (K852187)Microsurgical Systems, Inc.1985-07-31
A-COMPANY ESPREE SAFETY HEADGEAR (K852670)A Company, Inc.1985-07-31
A-COMPANY SEPARATING ELASTICS (K852598)A Company, Inc.1985-07-31
COLLIN BODY PLETHYSMOGRAPH PLUS SYSTEM (K852102)Warren E. Collins, Inc.1985-07-31
HEARING AID, UNITRON MODEL UM60-H (K852690)Unitron Industries, Inc.1985-07-31
A-COMPANY ELASTIC LIGATURE RINGS (K852596)A Company, Inc.1985-07-31
CUPRIDENT (K851073)Bio Systems, Inc.1985-07-31
A-COMPANY SELF-LIGATING APPLIANCE (K852800)A Company, Inc.1985-07-31
ATL 225 MW TRAIL LENS SET (K852548)Ascon Medical Instruments, Ltd.1985-07-31
TELEDYNE GETZ BARRIER-DENTIN SEALER (K852756)Scientific Pharmaceuticals, Inc.1985-07-31
ANNE MARIE PERRIS SUNGLASSES AND FRAMES (K851698)Perlinea Co.1985-07-31
TUBULITEC PRIMER (K851052)Dental Therapeutics AB1985-07-31
DURACLEAN DENTURE CLEANER (K852906)Astron Dental Corp.1985-07-31
SATALEC SERVOTORQUE S2 SX2 (K852524)Spelna, Inc.1985-07-31
A-COMPANY ELASTOMERIC TUBING (K852599)A Company, Inc.1985-07-31
PORCELAIN VENEER SYSTEM LABORATORY KIT (K852743)The S. S. White Co.1985-07-31
RESTORE* (K851929)Johnson & Johnson Professionals, Inc.1985-07-31
OHMEDA 5120 OXYGEN MONITOR (K853082)Ohmeda Medical1985-07-31
DENTAL CASTING ALLOY GDC 1686 (K852347)Deringer-Ney, Inc.1985-07-31
GLOSSY POLISHING PASTE (K852814)Scientific Pharmaceuticals, Inc.1985-07-31
OMRON DIGITAL BP MONITOR HEM-400C (K851707)Omron Tateisi Electronics Co.1985-07-31
A-COMPANY ELASTIC ROTATION WEDGES (K852597)A Company, Inc.1985-07-31
A-COMPANY ELASTOMERIC CHAIN DISPENSER (K852600)A Company, Inc.1985-07-31
THERMIX INC. NASOTHERM II PERSONAL STEAM MACHINE (K852283)Thermix, Inc.1985-07-30
PATHFINDER DETECTION & COLLECTION KITS-HERPES SIMP (K852125)Kallestad Laboratories, Inc.1985-07-30
ELECTRODE FOR NEUROLOGICAL SURGERY 2111 (K845035)Progress Mankind Technology1985-07-30
POROCOAT SCHATZKER II ACETABULUM (K852193)Depuy, Inc.1985-07-30
NORMALIZED HS3N PROPORTIONAL SERIES HIP STEMS (K844818)Osteonics Corp.1985-07-30
WYLER SUBDURAL STRIP ELECTRODE (K850342)Ad-Tech Medical Instrument Corp1985-07-30
HOWMEDICA FEMORAL COMPONENT HIP SYS 6259 (K851566)Howmedica Corp.1985-07-30
LIFESCOPE 8 DEC-8108A AND DEC-8204A (K852270)Nihon Kohden America, Inc.1985-07-30
BACTEC NR-730 BACTERIAL DETECTION SYSTEM (K853011)Bd Becton Dickinson Vacutainer Systems Preanalytic1985-07-30
SYSTEM 1085 BODY PLETHYSMOGRAPH (K852088)Medical Graphics Corp.1985-07-30
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Every clearance here is in the API, with alerts when new ones post.