Atlas FDA

1987

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

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RecordFirmDate
DIGITAL FLUORICON CARDIAC/VASCULAR QUANTITATIVE (K863132)General Electric Co.1987-01-14
PALMER OBSTETRIC BRACE (K864194)Ad-Tech Medical Instrument Corp1987-01-14
BAYER HEALTHCARE RAPIDQC PLUS (K870036)Ciba Corning Diagnostics Corp.1987-01-14
THE IMAGE/R (K862294)Quantum Diagnostics, Ltd.1987-01-14
PANTEX FTE FREE TESTOSTERONE RADIOIMMUNOASSAY KIT (K862483)Pantex, Div. Bio-Analysis, Inc.1987-01-14
SYSTEM 90 TRANSPORT (K863219)Datascope Corp.1987-01-14
ERYPUR B (K864636)Organon Teknika Corp.1987-01-14
SERALYZER ARIS CARBAMAZEPINE STRIPS/MODU/CALI/CONT (K863842)Miles Laboratories, Inc.1987-01-14
MICROPOROUS MONITORING ELECTRODES & ADAPTER BLOCK (K864868)Hewlett-Packard Co.1987-01-14
MODIFIED LABELING TO MODEL 2000 AMBULATORY INFUSER (K863532)Parker Hannifin Corp.1987-01-14
LUXTEC, KILLIAN AND VIENNA NASAL SPECULUMS (K864383)Luxtec Corp.1987-01-14
FRAZIER SUCTION TUBE (K864382)Luxtec Corp.1987-01-14
CARDS(TM) - EARLY PREGNANCY TEST (K863341)Pacific Biotech, Inc.1987-01-14
E-Z HOLD - #4060 (K864190)John F. Greer Co., Inc.1987-01-14
SIRECUST 888/888R NON-INVASIVE BLOOD PRESS MONITOR (K863042)Siemens Medical Solutions USA, Inc.1987-01-14
LAD MODEL 535 LUMINOMETER (K864201)Los Alamos Diagnostics1987-01-13
FOUR TANK DISSOLUTION MODULE (K864635)National Medical Care, Medical Products Div., Inc.1987-01-13
CREATINE PHOSPHOKINASE (CK) (K864744)Tech-Co, Inc.1987-01-13
ALKALINE PHOSPHATASE (K864905)Tech-Co, Inc.1987-01-13
AST S.C.E. (GOT) (K863054)J. D. Assoc.1987-01-13
IMMPULSE COATED TUBE PHENYTOIN ASSAY REAGENTS (K865102)Sclavo, Inc.1987-01-13
AIR CARE AIR SANITIZER (K860132)Cooper-Hewitt Electric Co.1987-01-13
EES 10 ELECTRODELESS ELECTRICAL STIMULATOR (K863175)Cadwell Laboratories, Inc.1987-01-13
CHEMTROL(TM) (K862565)G.B.F. Industries, Inc.1987-01-13
LUXTEC LIGHT SOURCES (K864385)Luxtec Corp.1987-01-13
DYNALUME(TM) REMOVAWELL STRIPS (NO. 011-010-7403) (K864863)Dynatech Laboratories, Inc.1987-01-13
UREA NITROGEN(BUN), COLORIMETRIC METHOD (K864742)Tech-Co, Inc.1987-01-13
H-H SUBGALEAL TROCAR (K865075)Holter-Hausner Intl.1987-01-13
PEG 6,000 (K863103)J. D. Assoc.1987-01-13
REVEAL COLOUR STREP A ZL16 (K864206)Wellcome Diagnostics1987-01-13
BIURET (COLORIMETRIC), TOTAL PROTEIN (K864743)Tech-Co, Inc.1987-01-13
DART PHENOBARBITAL ASSAY SYSTEM (K864612)Coulter Electronics, Inc.1987-01-13
OHMEDA 5500 AIRWAY PRESSURE MONITOR (K864536)Ohmeda Medical1987-01-12
OHMEDA 6000 MULTI-GAS MONITOR (K863959)Ohmeda Medical1987-01-12
COVER, SHOE OPERATING ROOM (K865023)Ulti-Med Intl., Inc.1987-01-12
BREAST PROSTHESIS (NON & INFLATABLE) SKIN EXPANDER (K865033)Cox-Uphuff Intl.1987-01-12
BARD HARVARD MINI-INFUSER 950 PUMP (K864233)C.R. Bard, Inc.1987-01-12
ARKIVE (TM) (K862085)Diatek, Inc.1987-01-12
TISSUE-EQUIVALENT BREAST SIMULATOR (K865100)Computerized Imaging Reference Systems, Inc.1987-01-12
TEFLON-COATED HYPODERMIC NEEDLES/REGIONAL BLOCK (K864830)Professional Instruments Co.1987-01-12
PATIENT VALVE WITH AIR ENTRAINMENT (K863410)Pneupac , Ltd.1987-01-12
PROCON (K864218)Healthcare Management Systems1987-01-12
ARNOLD-KING PRESSURE DRESSING (K864688)Angiosystems, Inc.1987-01-12
BOARD, ARM (WITH COVER) (K864670)Anago, Inc.1987-01-12
BLOOD LANCET (K865016)Falcon Medical Industries, Inc.1987-01-12
PERSON TO PERSON VALVE-MASK & TRI-SEAL FACE MASK (K864472)Tagg Industries1987-01-12
ADDITIONAL MODEL TO CANON UNIVERSAL STAND (K870048)Canon USA, Inc.1987-01-12
EDP-20 PACEMAKER (K860036)Biotronik Sales, Inc.1987-01-12
TMM MODEL 3000 ANESTHESIA CIRCUIT EVALUATOR (K863801)Traverse Medical Monitors1987-01-12
HEATED JET HUMIDIFIER MODEL AMS-1020 (K863154)Acutronic Medical Systems AG1987-01-12
MODEL NS-3CC NEURO-STIM PERIPHERAL NERVE STIMULAT (K864829)Professional Instruments Co.1987-01-12
SCANLAN (TM) INSTRUMENT TRAY (K864920)Scanlan Intl., Inc.1987-01-12
SCANLAN (TM) VEIN/GRAFT HOLDER (K864919)Scanlan Intl., Inc.1987-01-12
MINGOGRAF 410 (K864009)Siemens Medical Solutions USA, Inc.1987-01-12
PEDIATRIC BELLOWS (K864431)Draeger Medical, Inc.1987-01-12
DALE VENIPUNCTURE TOURNIQUET, PRODUCT NO. 1335 (K864897)Dale Medical Products, Inc.1987-01-12
BIRD 6500 AIR COMPRESSOR (K864547)Bird Products Corp.1987-01-12
SURGICAL GARMENTS (K865022)Ulti-Med Intl., Inc.1987-01-12
ANKLE HOLDER W/ANKLE SUPPORT KIT FOR LEG HOLDER (K865024)American Container Technology, Inc.1987-01-12
SEP-PAK CARTRIDGES (LIQUID CHROMATOGRAPHY) (K864267)Millipore Corp.1987-01-09
GENERAL PURPOSE CENTRIFUGE (K864974)Norfolk Scientific, Inc.1987-01-09
LIQUICHEK IMMUNOLOGY CONTROL (HUMAN) LEVELS I & II (K865014)Bio-Rad1987-01-09
IC MICROASSAY (K864312)Diamedix Corp.1987-01-09
EASY-TEST ALCOHOL (ALC), ITEM NO. 67515/93 (K864894)Em Diagnostic Systems, Inc.1987-01-09
CYTOLOGY BRUSHES (K864323)Medical Packaging Corp.1987-01-09
TRU-LEVEL CONTROL IMMUNOASSAY CONTROLS (K861202)Nms Pharmaceuticals, Inc.1987-01-09
CRESOLPHTHALEIN COMPLEXONE, CALCIUM (K864741)Tech-Co, Inc.1987-01-09
ESTRONE ANALYSIS PRODUCTS RADIOIMMUNOASSAY ESTRONE (K864966)Diagnostics Biochem Canada, Inc.1987-01-09
SONOLAYER-L, SAL-77B (K863947)Toshiba Medical Systems1987-01-09
VIS-CUBE PREGNANCY HOME TEST,CAT. # JPL-042 (K863999)Leeco Diagnostics, Inc.1987-01-09
CLEARBLUE PREGNANCY TESTING KIT (MODIFICATION) (K864373)Unipath , Ltd.1987-01-09
MAXI-TAN DEVICE (K864546)National Biological Corp.1987-01-09
MOBIL 02 (K864680)Roman Laboratories, Inc.1987-01-09
SPECULUM, VAGINAL, METAL FIBEROPTIC (K864865)Luxtec Corp.1987-01-09
UNIMAX ITE & ULTRAMAX-CCR CUSTOM CANAL INSTRUMENTS (K864277)Unimax Hearing Instruments1987-01-09
WAKO(TM) AUTOKIT GPT (K864850)Wako Chemicals USA, Inc.1987-01-09
PACHYMETER SYSTEM V (K864336)CooperVision, Inc.1987-01-09
MODEL 10-C W/LP-10A/U & OS-10A/U FOR ORAL/ENT USE (K862866)Directed Energy, Inc.1987-01-09
TERUMO OVATION SPECTROPHOTOMETER (K864285)Terumo Medical Corp.1987-01-09
MODEL 10-C W/LP-10A/U & OB-10A/U FOR ORAL/ENT USE (K862865)Directed Energy, Inc.1987-01-09
AMOENA BREAST FORMS (K864785)Coloplast Corp.1987-01-08
MODEL FORCE 100 BIPOLAR ELECTROSURGICAL GENERATOR (K864851)Valleylab, Inc.1987-01-08
EASY-TEST QUINIDINE ITEM NO. 67---/95 (K864607)Em Diagnostic Systems, Inc.1987-01-08
PERSONALLY(TM), MODEL 241 SIZES 0-12,LEFT & RIGHT (K864786)Coloplast Corp.1987-01-08
MODEL FORCE 4B ELECTROSURGICAL GENERATOR (K864675)Valleylab, Inc.1987-01-08
EASY-TEST CARBAMAZEPINE ITEM NO. 67---/95 (K864553)Em Diagnostic Systems, Inc.1987-01-08
CK 5000 SERIES, ACE BANDAGE/ESMARK BANDAGE (K864816)Currie Medical Specialties, Inc.1987-01-08
REMBRANDT PORCELAIN TINTING KIT (K864346)Den-Mat Corp.1987-01-07
EZ-SCREEN: CANNABINOID (K862916)Environmental Diagnostics, Inc.1987-01-07
MINOLTA/MARQUEST PULSOX-7 OXYGEN SATURATION MONIT. (K863918)Marquest Medical Products, Inc.1987-01-07
VNA OPTICAL CORRELATOR (K861514)Vna Systems, Inc.1987-01-07
TSH MAIACLONE IMMUNORADIOMETRIC ASSAY KIT/MAG SEP (K864677)Serono Diagnostics, Inc.1987-01-07
EMDS TM PHENOBARBITAL(PHNO) TESTPACK, #67677/95 (K864926)Em Diagnostic Systems, Inc.1987-01-07
DUOCEPH (K864527)Gary E. Hall, Dds1987-01-07
THE OB-GYN CONCEPTS VAGINAL ASPIRATOR (K863610)Ob/Gyn Concepts, Ltd.1987-01-07
FYODOROV COLLAGEN CORNEAL SHIELD (K862315)Medical Technology Development Corp.1987-01-07
MICRO-VENT (K864321)Core-Vent Corp.1987-01-07
EASY-TEST PRIMIDONE ITEM NO. 67---/95 (K864554)Em Diagnostic Systems, Inc.1987-01-07
ARTHROPHONOMETER (K862286)Arthrotek, Inc.1987-01-07
EMDS TM PHENYTOIN (PTN) TESTPACK, ITEM #67676/95 (K864925)Em Diagnostic Systems, Inc.1987-01-07
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Every clearance here is in the API, with alerts when new ones post.