Atlas FDA

1987

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

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RecordFirmDate
TEMPORARY BRIDGE HEAD (K871953)Implant Innovations International, Inc.1987-07-31
SOLOS EYESITE SPONGES (K872612)Solos Ophthalmology1987-07-31
THEATRE GOWNS (K872758)Smith & Nephew, Inc.1987-07-31
PROBRIGHT TOOTH POLISHER (K871929)Lap Investments, Inc.1987-07-31
DRILL, HAND, BONE, SMEDBERG (K871834)Military Engineering, Inc.1987-07-31
BEHIND-THE-EAR HEARING AID OTICON E40 (K872372)Oticon Corp.1987-07-31
RESPIRATORY SYNCYTIAL VIRUS CONTROL SLIDE (K872082)Medical Diagnostic Technologies, Inc.1987-07-31
ANCHOR IIA/2 STAGE OSSEO. TIT. 6/4 ALLOY IMPLANT (K871887)Anchor Implants , Ltd.1987-07-31
WATERS M600E MULTI-SOLVENT DELIVERY SYSTEM (K872792)Millipore Corp.1987-07-31
CREMEEN ALVEOLAR BONE CALIPER (K872098)Bowen & Company, Inc.1987-07-31
MICROMEDIC COMBOSTAT LH/FSH KIT (K872309)Micromedic Systems1987-07-31
GUSTILO/RAND TOTAL KNEE SYSTEM (GENESIS) (K871146)Richards Medical Co., Inc.1987-07-31
TSH SEROZYME IMMUNOENZYMETRIC KIT, MAG. SOLID PHA. (K872897)Serono Diagnostics, Inc.1987-07-31
TEMPORARY SCREW (K871955)Implant Innovations International, Inc.1987-07-31
SOLOS EYESITE CANNULAS (K872610)Solos Ophthalmology1987-07-31
IMACK-MB(TM) (K872592)Intl. Immunoassay Laboratories, Inc.1987-07-31
ASPEN ESMARK BANDAGE (K872868)Aspen Laboratories, Inc.1987-07-31
WIDEX HEARING AID MODEL ES1 (K872374)Widex Hearing Aid Co., Inc.1987-07-31
AQUEOUS BLOOD GAS/ELECTROLYTE CONTR LEV I,II & III (K872196)American Dade1987-07-31
HEARING AID (K872348)Assured Sound Laboratories, Inc.1987-07-31
ABUTMENT HEAD POST (K871954)Implant Innovations International, Inc.1987-07-31
CAPTIA(R) TOXO-M: AN ENZYME IMMUNOASSAY (K871746)Mercia Diagnostics , Ltd.1987-07-31
THROMBOSCREEN JOSHUA HEMOGLOBIN S SCREENING KIT (K872217)Pacific Hemostasis1987-07-31
SOLOS EYESITE DRAPES (K872620)Solos Ophthalmology1987-07-31
BIRDIE BRACKET (K872028)William W. Wilkerson & Gregory A. Knutson1987-07-31
CIBA CORNING MODEL 580 ALLIANCE I.S.E. MODULE (K872716)Ciba Corning Diagnostics Corp.1987-07-31
SCALP VEIN SET (K870995)Mac Lee Medical Products1987-07-31
SEAMED MODEL 3200 (K872551)Seamed Corp.1987-07-31
CURRETTES, ALVEOLAR (MOLT AND MILLER) (K872091)Military Engineering, Inc.1987-07-31
CORTICAL BONE SCREWS (K872738)Military Engineering, Inc.1987-07-30
RAPID DIAGNOSTIC SYSTEM FOR MYCOBACTERIUM TUBER. (K871795)Gen-Probe, Inc.1987-07-30
TOXOPLASMA GONDII IGG ELISA (K871905)Electro-Nucleonics Laboratories, Inc.1987-07-30
SAFE-SEAT, LOW-PROFILE WHEELCHAIR CUSHION (K872739)D.A. Schulman, Inc.1987-07-30
MEDIPORT II MODEL MP-DL VASCULAR ACCESS PORT (K870817)C.R. Bard, Inc.1987-07-30
TB KINYOUN CARBOLFUCHSIN (K872187)Remel Co.1987-07-29
VITALNET(TM) SYSTEM (DINAMAP(TM), MODEL 2200) (K871418)Critikon Company, LLC1987-07-29
VITEL III, ECG TRANSMITTER (K872229)Equimed Corp.1987-07-29
MODIFIED DIGITAL BLOOD PRESSURE/PULSE METER (K872144)Vestra-Subco, Inc.1987-07-29
T.E.N.S. DEVICE MODEL SPL 2000 (K872398)Spartan Laboratories, Inc.1987-07-29
MODIFIED SPHYGMOMED NON-INVASIVE BLOOD PRES. MONIT (K871886)Draeger Medical, Inc.1987-07-29
TB METHYLENE BLUE (K872184)Remel Co.1987-07-29
MODIFIED MODEL UA-731 DIGITAL SPHYGMOMANOMETER (K871720)A&D Engineering, Inc.1987-07-29
INTRASITE INTERACTIVE HYDROCOLLOID WOUND DRESSING (K872624)Smith & Nephew, Inc.1987-07-29
METHANOL, ABSOLUTE (K872189)Remel Co.1987-07-29
LIGHT GREEN (K872185)Remel Co.1987-07-29
SULFURIC ACID 10% (K872186)Remel Co.1987-07-29
POST-AURICULAR HEARING AID MODEL PE 805CD2 (K872473)Phonic Ear, Inc.1987-07-28
FOCUS-GHB (K871679)Awareness Technology, Inc.1987-07-28
LPM-1 (LASER POWER METER) (K871619)Bio-Tek Instruments, Inc.1987-07-28
FINE NEEDLE ASPIRATION BIOPSY SYSTEM-PROSTATE (K872597)Dianon Systems, Inc.1987-07-28
SOFSWAB (K871879)Plastic Engineered Products Co.1987-07-28
REM500 THREE WHEELED ELEC. CART. (K872518)Royal Enterprises Manufacturing, Inc.1987-07-28
WIDEX HEARING AID MODEL ES6 (K872375)Widex Hearing Aid Co., Inc.1987-07-28
POST-AURICULAR HEARING AID MODEL PE 805 SCD2 (K872474)Phonic Ear, Inc.1987-07-28
OPSITE SPECIALITY DRAPES (K872757)Smith & Nephew, Inc.1987-07-28
EASY-TEST GAMMA-GLUTAMYL TRANSFERASE (GGT) 16616 (K872320)Em Diagnostic Systems, Inc.1987-07-27
PANOSOL 2000 624-616 (K872706)National Biological Corp.1987-07-27
OVUQUICK SELF-TEST (OVUQUICK; RAMP LH ASSAY) (K871726)Monoclonal Antibodies, Inc.1987-07-27
MELANITE I (K872506)Aura Lens Products1987-07-27
FRIGITRONICS ACC-1000 CAPSULE CUTTER (K872362)Frigitronics of Connecticut, Inc.1987-07-27
TAPELESS EYE SHIELD (K872659)Precision Therapeutics, Inc.1987-07-27
FH LEN (K872503)Fu Heng First Industrial Co., Ltd.1987-07-27
INFUSION PUMP ENCLOSURE (K872821)Pharmacia Deltec, Inc.1987-07-27
PANOSOL 2000 624-414 (K872651)National Biological Corp.1987-07-27
T.E.N.S. DEVICE MODEL SPL 2000S (K872399)Spartan Laboratories, Inc.1987-07-27
FORTEC MI-306, MI-327 DIGITAL THERMOMETER (K872584)Nam Tai , Ltd.1987-07-27
MODIFIED LIFECARE(R) 4100 PCA INFUSER (K871728)Abbott Laboratories1987-07-27
AMPICILLIN/SULBACTAM 20 MCG SENSI-DISC (K872783)Bd Becton Dickinson Vacutainer Systems Preanalytic1987-07-27
IV ADMINISTRATION SET (K871908)Travenol Laboratories, S.A.1987-07-27
DIABETES RISK DETECTOR (K864544)Pearce Clinical Laboratories, Inc.1987-07-27
PANOSOL 2000 624-404 (K872707)National Biological Corp.1987-07-27
HAND/FOOT UVA/UVB 624-224 (K872649)National Biological Corp.1987-07-27
EMDS GAMMA-GLUTAMYL TRANSFERASE (GGT) 67680/95 (K872322)Em Diagnostic Systems, Inc.1987-07-27
PANOSOL 2000 624-604 (K872650)National Biological Corp.1987-07-27
IN-LINE OPHTHALMIC IRRIGATING SOLUTION FILTERS (K871854)CooperVision, Inc.1987-07-27
VESTIBULAR AUTOROTATION TEST (K871466)Western Systems Research, Inc.1987-07-24
SSD-650 LINEAR, CONVEX SECTOR, ULTRASOUND SCANNING (K871400)Ge Medical Systems Information Technologies1987-07-24
CART, EMERGENCY, CARDIOPULMONARY (K872558)Nico Metal Products Corp.1987-07-24
AEROCHAMBER (K872037)Monaghan Medical Corp.1987-07-24
DEXTRANOMER (K872117)Interworld, Inc.1987-07-24
CUTINOVA(R) PLUS FOAM GELFILM (K864913)Beiersdorf, Inc.1987-07-24
DIDECO-SHILEY BLOOD SEPARATION WASH BOWL (K872160)Shiley, Inc.1987-07-24
HAND/FOOT UVA 624-218 (K872605)National Biological Corp.1987-07-24
HAND/FOOT 624-208 (K872604)National Biological Corp.1987-07-24
HOLDING ROD, SURGICAL FORCEPS, WEINSTEIN,12X2 3/4 (K872595)Grimm & Norton1987-07-23
1.1 SCREWDRIVERS (K872490)Micro-Aire Surgical Instruments, Inc.1987-07-23
NAIL SET (K872388)Med-Tool, Inc.1987-07-23
FLUORTRAN - C(TM) (K872751)Para Scientific Co.1987-07-23
ADDITIONS TO WSL NITROSPRAY CRYOSURGICAL UNITS (K872796)Tower Mfg. Co., Inc.1987-07-23
EASY-TEST HEMOGLOBIN (HGB) ITEM #16685 (K872653)Em Diagnostic Systems, Inc.1987-07-23
VIA-GUARD (K871950)Surgimark, Inc.1987-07-23
OMRON DIGITAL FEVER THERMOMETER MODEL MC-12B (K872527)Omron Electronics, Inc.1987-07-23
INFUSION STAND (K872729)Camtec1987-07-23
AN3000 MAHONEY DRAIN (K872460)H.W. Andersen Products, Inc.1987-07-23
TENSAGAIN (K872574)Ferris Mfg. Corp.1987-07-23
M.W.P. WRIST PROSTHESIS (K872502)Protek, Inc.1987-07-23
QM300 C4 ANTIBODY PACK (K872599)Kallestad Diag, A Div. of Erbamont, Inc.1987-07-23
CYTOTECH C1-INHIBITOR ENZYME IMMUNOASSAY (K872426)Cytotech, Inc.1987-07-23
SONOPULS 463, ULTRASOUND THERAPY EQUIPMENT (K872393)Henley Intl.1987-07-23
SONOLAYER - V, SSA-100A. (K863269)Toshiba Medical Systems1987-07-22
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Track 1987 automatically

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