Atlas FDA

1987

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

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RecordFirmDate
MODEL 28200C MICRO-ARTHROPLASTY SYSTEM (K871717)KARL STORZ Endoscopy-America, Inc.1987-06-05
MULTICHEM GLUCOSE HEXOKINASE REAGENT #S0919 (K871976)Simmler, Inc.1987-06-05
DRM 2300 PLETHYSMOGRAPHIC CARDIOTACHOMETER (K871149)Iontec Corp.1987-06-05
DOUBLE ANTIBODY AMPHETAMINE KAPD1 AND KAPD5 (K871696)Diagnostic Products Corp.1987-06-05
CONSULTANT BODY COMPOSITION ANALYZER (K871040)Body Composition Analog, Inc.1987-06-05
ULTRAVIOLET ASPARTATE AMINO-TRANS (UV-AST/UV-GOT) (K871780)Biochemical Trade, Inc.1987-06-04
IMED(R) MODEL 960A VOLUMETRIC INFUSION PUMP (K870991)Imed Corp.1987-06-04
FIRST AID KIT, VARIOUS SIZES (K871376)Fraass Survival Systems, Inc.1987-06-04
HERPES SIMPLEX ANTIBODY TEST FOR DECT. OF HSV 1&2 (K870814)Microscan Div. Baxter Healthcare Corp.1987-06-04
IMED(R) MODEL 965A VOLUMETRIC INFUSION PUMP (K870992)Imed Corp.1987-06-04
ADENOLEX (R) LATEX AGGLUTINATION TEST (K864645)Orion Diagnostica, Inc.1987-06-04
PROSTHETIC - FEMORAL HIP COMPONENT (K871462)Louis A. Serafin, Jr., M.D.1987-06-04
ENTROSET-SW (K871003)White River (Tm)1987-06-04
KODNER ANAL PERIONEAL RETRACTOR (K870897)Sur-Med Instruments, Inc.1987-06-04
TITANODONT SUBCORTICAL IMPLANT WITH POROCOAT (K871219)Depuy, Inc.1987-06-04
BILIRUBIN TESTER (K870095)Wako Chemicals USA, Inc.1987-06-03
MULTIPLE SPECTACLE LENS (K871961)Korea Asahi Optical Co., Ltd.1987-06-03
ANALYZER: NOVA STAT PROFILE 3 ANALYZER (K871397)Nova Biomedical Corp.1987-06-03
FREEDOM SET II WITH TRIFLEX VALVE (K870626)Delmed, Inc.1987-06-03
D.A.T. (TM) AMYLASE REAGENT (K871943)Behring Diagnostics, Inc.1987-06-03
THE URIC ACID REAGENT SET (K871902)Macomb Biotechnology, Inc.1987-06-03
T P C (TONOMETER PROBE COVER) (K871935)Krb Ent.1987-06-03
TANDEM(R) ICON(R) QSR(TM) HCG IMMUNO. ASSAY KIT (K871235)Hybritech, Inc.1987-06-03
25MM PEYMAN WIDE FIELD YAG LASER LENS (K871450)Ocular Instruments, Inc.1987-06-03
ULTRAVIOLET LACTATE DEHYDROGENASE REAGENT SET (K871781)Biochemical Trade, Inc.1987-06-03
HEMODIALYSIS CONCENTRATES & RELATED PRODUCTS (K870979)Inventory Supply Corp.1987-06-03
SITE PHACOEMULSIFICATION SYSTEM/OPHTHALMIC USE (K871485)Site Microsurgical Systems, Inc.1987-06-03
KRONNER COLLES-FOREARM EXTERNAL FIXATION (K871248)Kronner Medical1987-06-03
VOROSCOPE(TM) (K871735)Australian Biomedical Corporation , Ltd.1987-06-03
KINEMATIC III POST CRUCIATE TOTAL CONDYLAR KNEE SY (K871772)Howmedica Corp.1987-06-03
HEALTH CONCEPTS CONDUCTIVE MEMBRANE (K871292)Health Concepts, Inc.1987-06-02
OMNIFIT(R) TOTAL KNEE SYSTEM (MODIFICATION) (K871769)Osteonics Corp.1987-06-02
CENTRAL VEIN CATHERIZATION KIT W/WITHOUT MEDICA. (K870411)Medical Surgical Concepts, Inc.1987-06-02
MUCATE AGAR, SLANTS AND MUCATE BROTH (K872020)Bd Becton Dickinson Vacutainer Systems Preanalytic1987-06-02
INTRAUTERINE HEMOSTASIS BALLOON STENT (K863439)Mentor Corp.1987-06-02
POET OXIMETER (K864745)Criticare Systems, Inc.1987-06-02
ELECTRO-NERVE STIMULATOR TENS MODEL C & B11, B11C (K871126)Biomedical Life Systems, Inc.1987-06-02
KIT, FIRST AID, GENERAL PURPOSE, RIGID CASE (K871501)Fraass Survival Systems, Inc.1987-06-02
ELECTRO-NERVE STIMULATOR TENS MODEL B5/SKN (K871125)Biomedical Life Systems, Inc.1987-06-02
ELECTROCONVULSIVE THERAPY DEVICE, MODEL MF-1000 (K863815)Elcot, Inc.1987-06-02
STERILIZATION TRAY, TMJ INSTRUMENT SET (K871924)Arthropedics, Inc.1987-06-01
PERCUTANEOUS SHEATH W/WO MEDI. (5,6,7,8,8.5FR) (K870413)Medical Surgical Concepts, Inc.1987-06-01
MICRO SCISSOR, 1.7MM (K871923)Arthropedics, Inc.1987-06-01
STANBIO ALPHA-AMYLASE TEST SET, CATALOG 0180-715 (K870746)Stanbio Laboratory1987-06-01
STERILIZATION INDICATOR FOR FLASH STERILIZATION (K871672)Propper Mfg. Co., Inc.1987-06-01
TRACHEOSTOMY & NASAL SUCTIONING KIT, 3C-TNS-1 (K871692)Automatic Liquid Packaging, Inc.1987-06-01
ALKALINE PHOSPHATASE INDOLYL BLUE REAGENT (K870890)Helena Laboratories1987-06-01
SURGITEK DISPOSABLE BIPOLAR CORD (K871910)Dermacare Products, Inc.1987-06-01
AXIAL COMPRESSION SCREW (K870786)Straub Clinic and Hospital1987-06-01
PDA699/PDA700 PROTAMINE DOSE ASSAY FOR HEP. NEUTRA (K870831)International Technidyne Corp.1987-06-01
FETALERT ADR FETAL MONITOR (K871383)Advanced Technology Laboratories, Inc.1987-06-01
KDI QUIK TEST(TM) MARIJUANA SCREEN (K870197)Keystone Diagnostics, Inc.1987-06-01
ULTRAFLOW (K871901)Custom Industries, Inc.1987-06-01
THEOPHYLLINE FPIA CALIBRATORS (K871394)Sigma Diagnostics, Inc.1987-06-01
STRAIGHT CUP CURRETTE, 1.7MM (K871925)Arthropedics, Inc.1987-06-01
LASE SYSTEM II (K871334)Lase, Inc.1987-06-01
NOVAPATH C. TRACHOMATIS DIRECT SPEC COLLECTION KIT (K871860)Bio-Rad1987-05-29
FLASHPAK CONTAINER SYSTEM (K871202)Performance Instruments Corp.1987-05-29
SECOND NATURE(TM) (K871387)Advanced Clinical Products, Inc.1987-05-29
VASOTRAIN 447 (K871107)Henley Intl.1987-05-29
BREATHING CIRCUIT (K871386)Dryden Corp.1987-05-29
SPECTACLE FRAME - LORRAINE (K871689)Roseburg SA1987-05-29
SPECTACLE FRAME - DANIELLE (K871688)Roseburg SA1987-05-29
ADAPTALITE* PORCELAIN VENEER CEMENTATION SYSTEM (K871295)Johnson & Johnson Professionals, Inc.1987-05-29
MICROLAB AT (K871945)Hamilton Co.1987-05-29
MODIFIED HERCON ANTISEPTIC TRANSPARENT DRESSING (K871255)Hercon Laboratories Corp.1987-05-29
TANTONE MULTI-DAY #633 TENS ELECTRODE (K871222)Uni-Patch, Inc.1987-05-29
CHECK-MATE AND CHECK-MATE [+] (K871359)Veritech, Inc.1987-05-29
THE F SPOON HAND HELD FLUOROSCOPIC COMPRESSION (K871911)F. Spoon Co.1987-05-29
SIBIS REMOTE ACTUATOR (K871158)Human Technologies, Inc.1987-05-29
SOLA UV GARD(TM) SUNGLASSES (K870997)Sola-Syntex Ophthalmics1987-05-29
CLASSIC 70 LENS (K871649)Korea Asahi Optical Co., Ltd.1987-05-29
FIRST AID KIT, EYE DRESSING (K871457)Fraass Survival Systems, Inc.1987-05-29
PERFORM DENTURE BASE RESIN (K871270)Ipco Corp.1987-05-29
OMNIFIT II HIP PROSTHESES: CEMENT FIXATION (K870235)Osteonics Corp.1987-05-29
INDWELLING BLOOD CARBONDIOXIDE PARTIAL PRES. ANALY (K870911)American Bentley1987-05-29
BKS-1000 REFRACTIVE SET USE IN KERATOREFRACTIVE (K870807)Allergan, Inc.1987-05-29
DIGISPOT IMAGER (K871778)Siemens Gammasonics, Inc.1987-05-29
HOLLOW FIBER DIALYZER FOCUS 70,90,120,90H,120H (K871236)National Medical Care, Medical Products Div., Inc.1987-05-29
PPG BIOMEDICAL VENTILATOR MODEL AV 400 (K871433)Ppg Industries, Inc.1987-05-29
DISPOSABLE LASER PROTECTIVE DRAPE FOR CO2 LASER (K871068)Lifestream Int'L, Inc.1987-05-28
IMS-2000S STRESS MONITOR (K871659)Integrated Medical Systems, Inc.1987-05-28
TRU-SOUND ULTRASOUND THERAPY UNIT (K871633)Tru-Trac Therapy Products, Inc.1987-05-28
LITHIUM INTERNAL STANDARD 1 MEQ/L #60085 (K871185)In Vitro Diagnostics, Inc.1987-05-28
FLAME PHOTOMETER STANDARD #60081 120 NA/2K (K871182)In Vitro Diagnostics, Inc.1987-05-28
CIBA CORNING MODEL 664/FAST 4 SYSTEM (K871028)Ciba Corning Diagnostics Corp.1987-05-28
OMRON DIGITAL BLOOD PRESSURE MONITOR HEM-401C (K871207)Omron Electronics, Inc.1987-05-28
LITHIUM INTERNAL STANDARD 3000 MEQ/L #60084 (K871187)In Vitro Diagnostics, Inc.1987-05-28
FLAME PHOTOMETER STANDARD #60082 140 NA/5K (K871183)In Vitro Diagnostics, Inc.1987-05-28
LITHIUM INTERNAL STANDARD 1500 MEQ/L #60086 (K871188)In Vitro Diagnostics, Inc.1987-05-28
LD PRESUMPTO QUAD (K871907)Bd Becton Dickinson Vacutainer Systems Preanalytic1987-05-28
CESIUM DILUENT 1.5 MMOL CS/L #60087 (K871186)In Vitro Diagnostics, Inc.1987-05-28
AFFINITY (TM) HCG IMMUNIT (TM) (K870627)Bd Becton Dickinson Vacutainer Systems Preanalytic1987-05-28
FLAME PHOTOMETER STANDARD #60083 160 NA/8K (K871184)In Vitro Diagnostics, Inc.1987-05-28
SYPHILIS SEROLOGICAL REAGENTS (K871226)New Horizons Diagnostics Co.1987-05-28
COBAS FP REAGENTS FOR THEOPHYLLINE & CALIBRATORS (K871484)Roche Diagnostic Systems, Inc.1987-05-28
ARTERIAL BLOOD GASSING MONITORING SYSTEM (ABG) (K870016)Migada, Ltd.1987-05-28
CAMINO COMPARTMENTAL PRESS MONITOR CATH/110-4D (K863969)Camino Laboratories, Inc.1987-05-27
MODEL 840 TRANSCUTAN. OXYGEN/CARBON DIOX. MONITOR (K870805)Novametrix Medical Systems, Inc.1987-05-27
SCHULTZ PHALANGEAL COMP RASP/METACARPAL COMP RASP (K870842)Warsaw Orthopedic, Inc.1987-05-27
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Track 1987 automatically

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