Atlas FDA

1987

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

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RecordFirmDate
COMPANION 2800 PORTABLE VOLUME VENTILATOR (K870275)Puritan Bennett Corp.1987-03-09
BONE MINERAL DENSITOMETRY OPTION B7918AA (K863618)General Electric Co.1987-03-09
ACROMED WALLIE-HEINIG DISECTOR/ELEVATORS (K870781)Buckman Co., Inc.1987-03-09
WARSAW ORTHOPEDIC I BONE PLATE (K870727)Warsaw Orthopedic, Inc.1987-03-09
ACROMED WALLIE-HEINIG OSTEOTOMES (K870780)Buckman Co., Inc.1987-03-09
HAWKINS BREAST LOCALIZATION NEEDLE (K870523)N-S Medical Products1987-03-09
LIFEWATCH PLUS (K870661)The Perkin-Elmer Corp.1987-03-09
WAKO(TM) AUTOKIT LDH (K870401)Wako Chemicals USA, Inc.1987-03-06
DRV DISP RESUSCIT 3000/BAG ADAPT 3010 & 3011 (K870382)Nova-Ventrx1987-03-06
SUPER URINE ANALYZER SYSTEM (K870526)Kyoto Daiichi Kagaku Co., Ltd.1987-03-06
ROTAX-II BI-PLANE CIRCULAR ARM (K870205)B C Medical , Ltd.1987-03-06
EASY-TEST CREATINE KINASE (CK) NUMBER: 16614 (K870461)Em Diagnostic Systems, Inc.1987-03-06
MICROBOND COMPOSITE KIT FOR CERAMIC BONDING SYSTEM (K870628)Chem-E-Dent1987-03-06
L.A.P. SPIROMETER (K864836)Timeter Instrument Corp.1987-03-06
CIBA CORNING MODEL 278 PH/BLOOD GAS SYSTEM (K865036)Ciba Corning Diagnostics Corp.1987-03-06
RESPIGRAPH-RESPISOMNOGRAPH-RESPICENTRAL (K864886)Nims/Respitrace Corp.1987-03-06
ALANINE AMINOTRANSFERASE (ALT)/(GPT) (K870086)Catachem, Inc.1987-03-06
ASPARTATE AMINOTRANSFERASE (AST)/(GOT) (K870077)Catachem, Inc.1987-03-06
SELVERSTONE CLAMP SALIBI CLAMP (K870399)Codman & Shurtleff, Inc.1987-03-06
INSPIRON(R) BREATH FOR LIFE EMERG. RESUSCITATOR (K870253)Intertech Resources, Inc.1987-03-06
OTOLOGICAL METRIC SCALE/GAUGE (K870757)Treace Medical, Inc.1987-03-06
V-PACE(TM) TRANSLUMINAL VENTRICULAR/ MODEL SP5540 (K864507)Spectramed, Inc.1987-03-06
P.C.A. MODULAR KNEE SYSTEM (K864632)Howmedica Corp.1987-03-06
1160 SIMPLE ISOLATION VALVE & 1161 FILTERED VALVE (K870138)Hudson Oxygen Therapy Sales Co.1987-03-06
BUNN MODEL 530 ASPIRATOR (K870094)The John Bunn Co.1987-03-06
EASY-TEST CALCIUM (CA), ITEM NO. 67528/93 (K870170)Em Diagnostic Systems, Inc.1987-03-06
GLUCOSE OXIDASE REAGENT (K870616)Intersect Systems, Inc.1987-03-06
EASY-TEST MAGNESIUM (MG) ITEM NO. 16XXX (K870553)Em Diagnostic Systems, Inc.1987-03-06
EAZY COVERS (K863853)Superior Medical Products1987-03-06
EAR APPLICATOR, CATALOG NO. 2229 (K870762)Treace Medical, Inc.1987-03-06
MAJOR QUALITY GLUCOSE AND KETONES URINE TEST (K870500)American Diagnostic Corp.1987-03-06
OMNI-TRAK (K864889)Invivo Research Labs, Inc.1987-03-06
AZTREONAM 30 MCG SENSITIVITY DISKS (K870347)Difco Laboratories, Inc.1987-03-05
CO2 LASER MICROMANIPULATOR (K864378)Transamerican Technologies Intl.1987-03-05
COSMEDTECH GENERAL ASPIRATOR (K870574)Cosmedtech, Inc.1987-03-05
DOUBLE PUNCTURE CO2 LASER LAPAROSCOPY SET (K870046)Tti Medical1987-03-05
RCT-1, RCT-2, RCT-3 ARTHROGRAM TRAY (K870417)North Coast Medi-Tek1987-03-05
KIDNEY PERFUSION MACHINE (K864140)Advanced Equipment Development, Inc.1987-03-05
PERSONAL/DERBY CONDOMS (K862401)Razi Corp.1987-03-04
'EXMOOR' ATKINS NASAL SPLINT (K864930)Exmoor Plastics , Ltd.1987-03-04
EASY-TEST TRIGLYCERIDE (TRIG) NUMBER 16608 (K870408)Em Diagnostic Systems, Inc.1987-03-04
D. FARINAE ALLERGEN DISC (K870597)Incstar Corp.1987-03-04
CHIRO-STIM (K865070)Diversified Chiropractic Systems1987-03-04
SUPER PETAL SOFT PLASTIC APPLICATOR TAMPAX TAMPONS (K864859)Tambrands, Inc.1987-03-04
THE EQUALIZER AIRWAY DEVICE (K870501)Sleep Renewal, Inc.1987-03-04
LACEY PRESS-FIT CONDYLAR TOTAL KNEE (K864518)Dow Corning Wright1987-03-04
EMDS UREA NITROGEN (BUN) TESTPACKS ITEM #67654/95 (K870571)Em Diagnostic Systems, Inc.1987-03-04
TEFLON UTERINE SOUND (K870550)Cook Ob/Gyn1987-03-04
SUPER TAMPONS (K864651)Tambrands, Inc.1987-03-04
VISTA INTERFACE SYSTEM (K864852)Vacumetrics, Inc.1987-03-04
YSI MODEL 801 (K865012)Yellow Springs Instrument Co., Inc.1987-03-04
SERIES 620 RECTAL PROBE COVER (K864222)General Electric Co.1987-03-04
HUNTLEIGH BETA II HM85 (K870681)Huntleigh Technology, Inc.1987-03-04
'EXMOOR' SHAH & MACKAY NASAL SPLINTS (K864933)Exmoor Plastics , Ltd.1987-03-04
SLENDER REGULAR TAMPONS (K864650)Tambrands, Inc.1987-03-04
MODEL 6110 IONTOPHORETIC APPLICATOR (K863166)Life-Tech Intl., Inc.1987-03-04
SUPER PLUS PETAL SOFT PLASTIC APPLICATOR TAMPONS (K864648)Tambrands, Inc.1987-03-04
COSMEDTECH CANNULA (K870560)Cosmedtech, Inc.1987-03-04
'EXMOOR' CAWOOD NASAL SPLINTS (K864932)Exmoor Plastics , Ltd.1987-03-04
GDC 1824 (K865049)Deringer-Ney, Inc.1987-03-04
SMALL MASTOID RETRACTOR (K870758)Treace Medical, Inc.1987-03-04
502 OXYGEN SATURATION MONITOR (K864613)Criticare Systems, Inc.1987-03-04
REGULAR PETAL SOFT PLASTIC APPLICATOR TAMPONS (K864649)Tambrands, Inc.1987-03-04
SUPER PLUS TAMPONS (K864652)Tambrands, Inc.1987-03-04
EASY-TEST CHOLESTEROL(CHOL) NUMBER 16607 (K870407)Em Diagnostic Systems, Inc.1987-03-04
MICRO-EAR FULL-CONCHA IN-THE-EAR HEARING AID (K870080)Micro-Ear Hearing Center, Inc.1987-03-03
MODEL PY...U UNIPOLAR & BIPOLAR PACING LEAD (K870034)Oscor Medical Corp.1987-03-03
HYDROPHOBIC #6194418/HYDRAPHILIC #6104418 FILTERS (K870394)Clinical Connections, Inc.1987-03-03
ETP 180A NON-INVASIVE EXTERNAL PACEMAKER (K864989)Medac, Inc.1987-03-03
MICRO-EAR LOW-PROFILE IN-THE-EAR HEARING AID (K870081)Micro-Ear Hearing Center, Inc.1987-03-03
ETP 300 NON-INVASIVE EXTERNAL PACEMAKER (K864986)Medac, Inc.1987-03-03
BIOCHEM MICROSPAN 1040 OXIMETER (K870163)Biochem International, Inc.1987-03-03
MICRO-EAR CANAL IN-THE-EAR HEARING AID (K870079)Micro-Ear Hearing Center, Inc.1987-03-03
ASPIRATING NEEDLE, CATALOG CODE #12006 (K865079)Dlp, Inc.1987-03-03
DAIG PACEMAKER LEAD ADAPTOR (K870562)Daig Corp.1987-03-03
EAR LOOP (K870761)Treace Medical, Inc.1987-03-03
MODEL EV4543 MINIATURE TEMPORARY CARDIAC PACEMAKER (K870323)Pace Medical1987-03-03
DUAL PHOTON BONE DENSITOMETER (K861233)Medical and Scientific Enterprises, Inc.1987-03-03
DISPOS GEL EXTERNAL PACING ELECTRODE/HI IMPEDANCE (K864987)Medac, Inc.1987-03-03
VEIN GRAFT EAR SCISSORS (K870756)Treace Medical, Inc.1987-03-03
AMICI XENON REBREATHING SYSTEM* (K865084)Amici, Inc.1987-03-03
ETP 180E NON-INVASIVE EXTERNAL PACEMAKER (K864988)Medac, Inc.1987-03-03
HZI CEEG/EP SYSTEM SOFTWARE (CEEG-SCAN)TM (K863783)Hzi Research Center1987-03-03
SOFTIP CORONARY SINUS CARDIOPLEGIA CATHETER (K863342)Angiomedics, Inc.1987-03-03
PLURIMUS CARDIAC EVALUATION SYSTEM (K864401)Vivix Corp.1987-03-03
FRESENIUS ULTRAFLUX AV400, AV600 (K864587)Seratronics, Inc.1987-03-03
ALPHA-DENT PIT AND FISSURE SEALANT (K870579)Wallace A. Erickson & Co.1987-03-02
INTRAUTERINE INSEMINATION CATHETER (K870551)Cook Ob/Gyn1987-03-02
THERMAPAD (K864158)Avail-Southwest Division1987-03-02
S.C.T. MULTI PORT, INJECTION SITE (K864296)Salt Creek Medical Technologies1987-03-02
OMNIPLUS PHOTOSURGICAL LASER SYSTEM FOR OB-GYN (K863221)Laserscope1987-03-02
IMZ INTRAMOBILE CYLINDER IMPLANT SYSTEM COMPONENTS (K870331)Interpore Intl.1987-03-02
SOLUSET CALCIUM DEMINERALIZING SOLUTION (K864976)Endo Technic Corp.1987-02-27
POREX(TM) EYE SPHERE IMPLANT (K863943)Porex Medical1987-02-27
KONTRON SIGMA 1SC DIGITAL ECHOCARDIOGRAPHY SYSTEM (K862686)Kontron Instruments, Inc.1987-02-27
A+MED DISPOSABLE NEEDLE (K870193)Can-Am Surgical Corp.1987-02-27
INFUMIX MIXING CONTAINER (K870052)Biodynamics Corp.1987-02-27
MEDTRAC VP VOLUMETRIC INFUSION PUMP (K864997)American Edwards Laboratories1987-02-27
STRYKER MODEL 977 BIRTHING BED (K870745)Stryker Corp.1987-02-27
PROFESSIONAL DISINFECTION SYSTEM (PDS) (K863346)Ciba Vision Care1987-02-27
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