Atlas FDA

2002

3,685 FDA 510(k) clearances · Clearance year

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RecordFirmDate
LACTOSORB MINI INTERFERENCE SCREW (K021254)Biomet Orthopedics, Inc.2002-07-17
DIGITAL CLINICAL THERMOMETER, MODEL KD-193 (K021851)K-Jump Health Co., Ltd.2002-07-17
PHILIPS COMPONENT COMPACT MONITOR, RELEASE A.04, MODEL #M1275B (K021778)Philips Medical Systems2002-07-17
INION HEXALON BIODEGRADABLE ACL/PCL SCREW (K021280)Inion , Ltd.2002-07-17
ZEODYNE TOOTHBRUSH WITH AGION ANTIMICROBIAL (K021383)Agion Technologies, LLC2002-07-17
INSEMINATION CATHETER, MODEL 320301 (K021438)Labotect Labor-Technik Gottingen2002-07-16
INFANT FEEDING TUBES (K020005)Promedic, Inc.2002-07-16
LUNGCARE CT SOFTWARE PACKAGE (K022013)Siemens Medical Solutions USA, Inc.2002-07-16
BICAP COAG BIPOLAR LAPAROSCOPY PROBE, MODEL 006908-910 (K012018)Acmi Corporation2002-07-16
ONLINE DAT II METHADONE II (K021505)Roche Diagnostics Corp.2002-07-16
EASYSTAT PH, PCO2, PO2, HCT, NA+, K+, CA++ ANALYZER (K021515)Medica Corp.2002-07-16
LYPHOCHEK WHOLE BLOOD CONTROL, MODELS 561, 562, 563 (K022041)Bio-Rad Laboratories, Inc.2002-07-16
HEARTWAVE ALTERNANS PROCESSING SYSTEM, MODEL APS (K022152)Cambridge Heart, Inc.2002-07-16
AUTOSET SPIRIT CPAP SYSTEM (K013843)Resmed Corp2002-07-16
AART SILICONE CARVING BLOCK (K021820)Aesthetic and Reconstructive Technologies, Inc.2002-07-16
AART GLUTEAL IMPLANT (K021839)Aesthetic and Reconstructive Technologies, Inc.2002-07-16
DEVILBISS SLEEP RECORDER MODEL # RM60 (K012437)Sunrise Medical Hhg, Inc.2002-07-16
THE DIVACUP MENSTRUAL SOLUTION (K021356)Diva International, Inc.2002-07-16
HUMAN IGG SUBCLASS KIT FOR USE ON THE BECKMAN IMMAGE ANALYSER (K022083)The Binding Site, Ltd.2002-07-16
BARD VENTRALEX HERNIA PATCH, MODELS 0010302, 0010301 (K021736)C.R. Bard, Inc.2002-07-16
CARDIAC DIAGNOSTIC SYSTEM, MODEL CH2000 (K022149)Cambridge Heart, Inc.2002-07-16
COBAS INTEGRA ONLINE DAT II METHADONE II (K021512)Roche Diagnostics Corp.2002-07-16
AVID-NIT NERVE STIMULATION NEEDLES (K014246)Avid N.I.T., Inc.2002-07-16
TAGG DISPOSABLE VAGINAL SPECULUM (K021849)Tagg Industries2002-07-16
EMT-CPAP (K021520)Emergency Medical Techology2002-07-15
VISION SCIENCES ENDOSHEATH SYSTEM (K012543)Vision-Sciences, Inc.2002-07-15
PHFW-10 (K021592)Pihsiang Machinery Mfg. Co., Ltd.2002-07-15
LIVESURE HCG URINARY PREGNANCY TEST STRIP AND TEST CARD (K020968)Pan Probe Biotech, Inc.2002-07-15
ARM AUTOMATIC REPROCESSING MACHINE (K013713)Alcavis International Incorporated2002-07-15
SPI ONETIME DENTAL IMPLANT (K022038)Paxmed International2002-07-15
ZIP OPEN FORCEPS WITH ELECTROSURGICAL CUT (K020585)Gyrus Medical, Inc.2002-07-13
BACTEC MGIT 960 PZA KIT (K021582)Becton, Dickinson & CO2002-07-13
AMMONIA ASSAY FOR THE ADVIA INTEGRATED MODULAR SYSTEM (K021151)Bayer Diagnostics Corp.2002-07-13
ULTRAQUIET (K021202)Sound Technique System, LLC2002-07-13
SYNTHETIC ABSORBABLE SEEDING SPACERS MADE OF POLYDIOXANONE MATERIAL (K021311)Cp Medical2002-07-13
ROCHE ONLINE GENTAMICIN (K020704)Roche Diagnostics Corp.2002-07-12
HEMADERM COTAINING HEMADEX CLOTTING BEADS (K021678)Medafor, Inc.2002-07-12
GLUCOSE CONTROL SOLUTION FOR BD LATITUDE (K021697)Bionostics, Inc.2002-07-12
PRIMECHAIR (K021199)Dalton Medical Corp.2002-07-12
EIZO, MODEL FC-2091 (K022109)Eizo Nanao Corporation2002-07-12
RNA GL4 GLUCOSE CALIBRATION VERIFICATION CONTROL, MODEL RNA CVC GL4 (K021624)Bionostics, Inc.2002-07-12
AUTOALIGN (K021191)Cortechs Labs, Inc.2002-07-12
MEDX 1000 SERIES (K020017)Medx Electronics, Inc.2002-07-12
ATAC PAK BUN REAGENT (K021385)Elan Diagnostics2002-07-12
HEMOSORB (K021581)On Site Gas Systems, Inc.2002-07-12
HORIZONS CYTOLOGY BRUSH (K021998)Horizons Intl. Corp.2002-07-12
CYPRESS MEDICAL PRODUCTS, LP DISPOSABLE VAGINAL SPECULUM, NON-METAL (K021676)Cypress Medical Products, Ltd.2002-07-12
QAB2A IGM ELISA KIT HRP (K021610)Cheshire Diagnostics , Ltd.2002-07-12
MEDICAL ADMINISTRATOR (K020073)Barco N.V.2002-07-12
MECHANICAL DAILY USE WHEELCHAIR (K021075)First World Services, Inc.2002-07-12
MPOWER, MODEL 712 SERIES (K022001)Positron Corp.2002-07-12
EXTENSION SET, MODELS 1911-512 (K020926)Epimed International, Inc.2002-07-12
QAB2A IGG ELISA KIT HRP (K021611)Cheshire Diagnostics , Ltd.2002-07-12
HYDRAGEL 7 LIPOPROTEIN(E), PN 4114 & HYDRAGEL LIPOPROTEIN(E) 15/30 PN 4134 (K022053)Sebia2002-07-12
SOF-PACH REUSABLE NEUROSTIMULATION ELECTRODES (K020735)Cathay International, Ltd.2002-07-12
TOPCUT (K021525)H.S. Hospital Service S.R.L.2002-07-12
PLATELET CONCENTRATE SEPARATION KIT FOR CELSEP CENTRIFUGE SYSTEM (K021927)Biomet, Inc.2002-07-12
3D KNEE (K020114)Encore Orthopedics, Inc.2002-07-12
THE TRABECULAR METAL MONOBLOCK CUP, MODELS 00-7259-0XX-28 (ZIMMER CAT. #) AND 02-293-28XX1 (IMPLEX PART #) (K021970)Implex Corp.2002-07-12
ENDOCERVICAL BLOCK NEEDLE (K021224)Wallach Surgical Devices, Inc.2002-07-12
NERVUS MONITOR (K021185)Taugagreining HF2002-07-12
ABBOTT Q2 PLUS S02/CONTINUOUS CARDIAC OUTPUT COMPUTER, LIST NUMBER 56711 (K021874)Abbott Laboratories2002-07-12
DISPOSABLE POWDER FREE VINYL SYNTHETIC EXAM GLOVES WITH ALOE VERA, GREEN COLOR (K022087)Shanghai PT Plastics Enterprise Company, Ltd.2002-07-11
CRPEX-HS CRP CALIBRATOR SET, CATALOG NO: 1510 (K021882)Good Biotech Corp.2002-07-11
FT101 FOREHEAD THERMOMETER; FT101 INFRARED DIGITAL THERMOMETER (K020433)Idt Technology Limited2002-07-11
AMC ANTIMICROBIAL PIN/WIRE SLEEVE (K012193)Smith & Nephew, Inc.2002-07-11
AARON A950 HIGH FREQUENCY ELECTROSURGICAL GENERATOR, AARON A950 ELECTROSURGICAL GENERATOR, 240V (K021817)Aaron Medical Industries2002-07-11
MONARCH SPINE SYSTEM (K021335)Depuyacromed2002-07-11
SALICYLATE ASSAY FOR THE ADVIA INTEGRATED MODULAR SYSTEM (K020794)Bayer Diagnostics Corp.2002-07-11
NT MEDITENS PLUS, TYPE 290 (K014020)Bio-Medical Research, Ltd.2002-07-11
LUTZ NEEDLE (K013892)Ballard Medical Products2002-07-11
NO-POKES NEEDLE SAFETY DEVICE (K020921)Bemis Mfg. Co.2002-07-11
NEUROTECH MEDISTIM PLUS, TYPE 291 (K014019)Bio-Medical Research, Ltd.2002-07-11
DOLPHIN MEDICAL STAND-ALONE PULSE OXIMETER, MODEL 2100 (K021959)Dolphin Medical, Inc.2002-07-11
DELIGHT DENTAL ER: YAG LASER SYSTEM (K021616)Continuum Electro-Optics, Inc.2002-07-11
COBRA CARDIAC ELECTROSURGICAL SYSTEM (K013873)Boston Scientific Corp2002-07-11
ACETAMINOPHEN ASSAY FOR THE ADVIA INTEGRATED MODULAR SYSTEM (K020792)Bayer Diagnostics Corp.2002-07-11
ILT TORQUER, MODEL 114TR1 (K021243)Intra Luminal Therapeutics, Inc.2002-07-11
ALOKA SSD-1000 DIAGNOSTIC ULTRASOUND SYSTEM, MODELS ASU-1003, UST-9121, UST-9124 (K020668)Aloka Co., Ltd.2002-07-10
MICHEALTH ET 1100/ET 1200 INFARED EAR THERMOMETER (K021601)Duteck Industrial Co., Ltd.2002-07-10
CONCENTRIC BALLOON GUIDE CATHETER, MODEL 90072 (K021899)Concentric Medical, Inc.2002-07-10
KODAK X-OMAT CASSETTE/LEADLESS FOR DENTAL USE (K021903)Eastman Kodak Company2002-07-10
BIOTEQUE 3 IN 1 HEMODIALYSIS BLOOD TUBING PACK (K013634)Bioteque Corp.2002-07-09
TSRH SPINAL SYSTEM (K021170)Medtronic Sofamor Danek USA, Inc.2002-07-09
AURORA DS (K021149)Syneron Medical, Ltd.2002-07-09
AM-BIO EXTENDED RANGE SERIES DIALYZER, MODELS WET AND DRY (K013418)Asahi Medical Co., Ltd.2002-07-09
ENDOVIVE INITIAL PLACEMENT GASTROSTOMY KIT; ENDOVIVE LOW PROFILE BUTTON REPLACEMENT GASTROSTOMY TUBE; SECURI-T INITIAL P (K014297)Boston Scientific Corp2002-07-09
PROVEN MODULAR POSTERIOR STABILIZED FEMORAL (K021908)Stelkast Company2002-07-09
CGS-31A MULTISLICE UPGRADE KIT FOR AQUILION CT SCANNER. TSX-101A (AQUILION ADVANCE MULTI) (K022050)Toshiba America Medical Systems, In.C2002-07-09
HORIZON PHACOEMULSIFICATION SYSTEM, MODEL HZN-2030 (K020527)American Optisurgical, Inc.2002-07-09
BAIR HUGGER TEMPERATURE MANAGEMENT SYSTEM (K021473)Augustine Medical, Inc.2002-07-09
WALLGRAFT TRACHEOBRONCHIAL ENDOPROTHESIS WITH UNISTEP PLUS DELIVERY SYSTEM (K021901)Boston Scientific Scimed, Inc.2002-07-09
VP-2000/1000 (K013434)Colin Corp.2002-07-09
MICROPLEX COIL SYSTEMS (MCS) (K021914)MicroVention, Inc.2002-07-09
CYPRESS ULTRASOUND SYSTEM (K021497)Acuson Corp.2002-07-09
EASI 12 LEAD ALGORITHM (K020456)Philips Medical Systems2002-07-09
DIAMEDIX IS-RHEUMATOID FACTOR TEST SYSTEM (K021394)Diamedix Corp.2002-07-09
STARLIGHT (K021207)Orthomerica Products, Inc.2002-07-09
SURECAN SAFETY HUBER NEEDLE INFUSION SETS (K021488)B.Braun Medical, Inc.2002-07-08
S7 ELITE CP AP SYSTEM (K013909)Resmed Corp2002-07-08
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Every clearance here is in the API, with alerts when new ones post.