Atlas FDA

1997

4,309 FDA 510(k) clearances · Clearance year

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RecordFirmDate
O.B. APPLICATOR TAMPONS (K970954)Personal Products Co.1997-06-10
SCAR HEAL (K971468)Specialty Systems, Inc.1997-06-10
WHITE RIVER AUTOMATIC BREAST PUMP (K964679)White River Concepts1997-06-10
MILLEX - MP FILTER UNIT (SLMPO25SS/SLMPL25SS) (K963717)Millipore Corp.1997-06-10
MEDLINE Y-TYPE TUR/BLADDER IRRIGATION SET (K970946)Medline Industries, Inc.1997-06-10
SYNERGETICS SYNERLIGHT FIBER OPTIC LIGHTSOURCE (K964005)Synergetics, Inc.1997-06-09
OPPORTUNITY INC. GENERAL PURPOSE TRAY (K971062)Opportunity, Inc.1997-06-09
MITEK 3.5 MM PANALOK WEDGE ABSORBABLE SUTURE ANCHOR SYSTEM (K970896)ETHICON, Inc.1997-06-09
BIO-ANCHOR (K964805)Linvatec Corp.1997-06-09
BAYERS BIMANUAL I/A HANDPIECES (K971064)Visioncare Devices, Inc.1997-06-09
DEPUY LOW PROFILE BONE SCREW (K970929)Depuy, Inc.1997-06-09
ALEXANDER MANUFACTURING CO. RECHARGEABLE BATTERY PART NUMBER M006 (K971240)Alexander Mfg. Co.1997-06-06
PHILIPS S1694, S1695 (K971804)Philips Hearing Instruments Co.1997-06-06
WIDEX SENSO DIGITAL (MINI CANAL) (K971535)Widex Hearing Aid Co., Inc.1997-06-06
INSTEAD, SOFTCUP (K971303)Ultrafem, Inc.1997-06-06
MODEL HNC NEUROVASCULAR ARRAY COIL (K970868)Mri Devices Corp.1997-06-06
GSI SA60 DPOAE SYSTEM (K970324)Grason-Stadler, Inc.1997-06-06
PTCA GUIDEWIRE (K970376)Lake Region Mfg., Inc.1997-06-06
MRP-7000/AIRIS QD C-SPINE COIL (P/N MR-QCSC-42,MR-QCSC-52) (K971016)Hitachi Medical Systems America, Inc.1997-06-06
AQ OPIATES (MORPHINE) TEST (K971361)Bionike Laboratories, Inc.1997-06-06
RIONET HB-79P (K971693)Authorized Hearing Systems, Inc.1997-06-06
BIO-PLEXUS DROP-IT NEEDLE HOLDER (K963748)Bio-Plexus, Inc.1997-06-06
VISTA V-38 CIC (K970939)Vista Labs1997-06-06
STERRADD STERILIZATION SYSTEM (K954142)Advanced Sterilization Products1997-06-06
DOUBLE UP BREAST PUMP (K964396)The Natural Choice Co., Inc.1997-06-06
POWER D, TRU 5, PERSONA, PERSONA CHOICE, MERIDIAN (K970880)Micro-Ear Technology, Inc.1997-06-06
PRONE BREAST POSITIONING BOARD, MODEL #37-018 (K971382)Victoreen, Inc.1997-06-06
PROVOX 2 VOICE PROSTHESIS SYSTEM (K971244)Atos Medical AB1997-06-06
SCIENTIFIC PLASTICS MODEL SP (K971299)Scientific Plastics, Inc.1997-06-06
BOEHRINGER MANNHEIM DIRECT HDL-CHOLESTEROL (K970735)Randox Laboratories, Ltd.1997-06-06
NEURO PULSE II,III (K971143)Aaron Medical Industries1997-06-06
CONTINU-FLO SOLUTION SET (K971701)Baxter Healthcare Corp1997-06-06
EXTRESAFE PHLEBOTOMY (K964042)Specialized Health Products, Inc.1997-06-06
MAICO MA52 (K971080)Bernafon-Maico, Inc.1997-06-06
ANOKRYO (K964634)Mk Conquest Intl., Inc.1997-06-06
22.2/+4MM CO CR & ZIRCONIA FEMORAL HEAD (K970846)Landos, Inc.1997-06-05
STRAIGHTFIRE REUSABLE OPTICAL FIBERS (400,600,800,1000) (K965180)Myriad Lase, Inc.1997-06-05
ANO-RECTAL MANOMETRY OPTION, MODEL NUMBER UDS-ARM (K963064)Laborie Medical Tech Corp.1997-06-05
INTERGARD WOVEN COLLAGEN COATED VASCULAR PROSTHESES (K970843)Intervascular, Inc.1997-06-05
LAMIN-2 HYDRATING GEL (K970153)Procyte Corp.1997-06-05
MAGNETOM PROJECT 024 SYSTEM (NUMARIS 3.5 SOFTWARE) (K970852)Siemens Medical Solutions USA, Inc.1997-06-05
MAGELLAN INTRAMEDULLARY FEMORAL NAIL SYSTEM (K971135)Wrightmedicaltechnologyinc1997-06-05
ALEXANDER MANUFACTURING CO. RECHARGEABLE BATTERY PART NUMBER GL625-W (K971235)Alexander Mfg. Co.1997-06-05
TRAUMA-FIX EXTERNAL FIXATOR (K971272)Trend Medical, Inc.1997-06-05
ALEXANDER MANUFACTURING CO. RECHARGEABLE BATTERY PART NUMBER STR5 (K971107)Alexander Mfg. Co.1997-06-05
GLARE WARE (K970816)Ergovision, Inc.1997-06-05
ALEXANDER MANUFACTURING CO. RECHARGEABLE BATTERY PART NUMBER MS5169 (K971099)Alexander Mfg. Co.1997-06-05
GORE IRRIGATION SET (K964067)W. L. Gore & Associates, Inc.1997-06-05
RADIONICS BURR HOLE VALVE (K970578)Radionics, Inc.1997-06-04
ISG FAMILY OF VIEWING WANDS (K970865)I.S.G. Technologies, Inc.1997-06-04
TAMARYN I.V. FLOW REGULATOR EXTENSION SET (K971066)Tamaryn Medical Systems, Inc.1997-06-04
NATIONAL MEDICAL HALTHCARE CUSTOM OPHTHALMIC KITS OR TRAYS (K971465)National Healthcare Mfg. Corp.1997-06-04
ACS ESTADIOL-6 II (K970386)Chiron Diagnostics Corp.1997-06-04
PARAMAX CHOLESTEROL REAGENT (K964660)Dade Intl., Inc.1997-06-04
HILUX 200,250,275,300,350,500 DENTAL CURING LIGHT (K970506)Benlioglu Dental Ithalat, Inc.1997-06-04
BENCHMARK-IV (K971575)J.F. Jelenko & Co., Inc.1997-06-04
BIO-RAD SERUM PROTEINS BY CAPILLARY ELECTROPHORESIS (K963018)Bio-Rad1997-06-04
TRI AUTO ZX (K970339)J. Morita USA, Inc.1997-06-04
STERILE SUREFLEX FILES AND INSTRUMENTS (K971603)Dentsply Intl.1997-06-04
PACE 101H (K970497)Sulzer Oscor, Inc.1997-06-04
SERIES XE, SERIES SE, SERIES TE (K971350)Micro-Mega Societe Anonyme1997-06-04
SIEMENS SC9000/SC9015 MULTIGAS AND MULTIGAS+ MODULES (K965062)Siemens Medical Solutions USA, Inc.1997-06-04
FOGARTY VALVULOTOME MODEL 700091 (K965137)Baxter Edwards1997-06-04
GREINER VACUETTE BLOOD COLLECTION TUBE (K971220)Greiner America, Inc.1997-06-04
DUQIAO (K971551)Duqiao Glasses (Group) Co. , Ltd.1997-06-04
DERMACLEAN X-AM (PROTEIN LABELING CLAIM) EXAMINATION GLOVES (K971424)Ansell Perry1997-06-04
SYNCHRON CX SYSTEMS LIPASE (LIPA) REAGENT (K970905)Beckman Instruments, Inc.1997-06-04
AUTO SUTURE* ILM** KIT (K971201)United States Surgical, A Division of Tyco Healthc1997-06-03
BIOACCESS MARROW HARVEST SYSTEM (K971114)Bioaccess, Inc.1997-06-03
SYNCHRON SYSTEMS RHEUMATOID FACTOR (RF) REAGENT, SYNCHRON CX SYSTEMS RF CALIBRATOR (K971788)Beckman Instruments, Inc.1997-06-03
HEMAGEN ANTI CARDIOLIPIN SCREEN (K971039)Hemagen Diagnostics, Inc.1997-06-03
DISPOSABLE SILICONE EPISTAXIS CATHETER V-27030/DISPOSABLE SILICONE EPISTAXIS CATHETER KIT V-27030K (K971411)Bentec Medical, Inc.1997-06-03
SOLO (K970523)Ranger All Season Corp.1997-06-03
CYNOSURE DLS-10-810 DIODE LASER GENERAL PHOTOCOAGULATOR (K970243)Cynosure, Inc.1997-06-03
NOVATIP FAMILY OF LASER HANDPIECE TIPS (K971539)Xanova Corp.1997-06-03
STERILE FLEXOFILE FILES AND INSTRUMENTS (K971606)Dentsply Intl.1997-06-03
OPTIMA PLUS E DENTAL CHAIR; A DENTAL CHAIR; EXCEL CHAIR (K971063)King Dental Corp.1997-06-03
COMPOGLASS F (K971513)Ivoclar North America, Inc.1997-06-03
OPALDAM (K971284)Ultradent Products, Inc.1997-06-03
SYNCHRON SYSTEMS CAL 5 PLUS (K971283)Beckman Instruments, Inc.1997-06-03
ODONTIT AUTOGENOUS BONE COLLECTION DEVICE (K971036)Interpore Intl.1997-06-03
SYNCHRON SYSTEMS ALCOHOL (ALC) REAGENT, SYNCHRON SYSTEMS ALCOHOL CALIBRATOR (K971506)Beckman Instruments, Inc.1997-06-03
ALOKA UST-5258-5 DIAGNOSTIC ULTRASOUND TRANSDUCER (K964549)Aloka Co., Ltd.1997-06-03
SCIMED 8 FRENCH WISEGUIDE GUIDE CATHETER (K970823)Scimed Life Systems, Inc.1997-06-03
TRU-PULSE CO2 SURGICAL LASER (K970804)Tissue Technologies, Inc.1997-06-03
TEMPO CEM (MULTIPLE) (K970775)Foremost Dental Mfg., Inc.1997-06-03
EASY ROD (K970950)Acromed Corp.1997-06-03
AVANTA ORTHOPAEDICS TRAPEZIUM IMPLANT (K965204)Avanta Orthopaedics, Inc.1997-06-03
TEMPOCEM NE (MULTIPLE) (K970774)Foremost Dental Mfg., Inc.1997-06-03
LUMAX CYSTOMETRY ADMINISTRATION TUBE SET (K971911)Medamicus, Inc.1997-06-03
INNERWEAR/EXTRAWEAR/JIMMY-O RAINCOAT/ZEUS/GENTLEMEN'S CHOICE/JASMINE/DRINK/NAUGHTY (K970791)Custom Services Intl., Inc.1997-06-03
OSTEONICS RESTORATION ACETABULAR RING (K970957)Osteonics Corp.1997-06-03
ELECSYS FERRITIN (K971833)Boehringer Mannheim Corp.1997-06-02
VYGON MULTI-DOSE VIAL ADAPTER & BIONECTOR (K963571)Vygon Corp.1997-06-02
PERIPHERALLY INSERTED CENTRAL CATHETER (K964929)B.Braun Medical, Inc.1997-06-02
QUANTA LITE IGA GLIADIN ELISA (K964986)Inova Diagnostics, Inc.1997-06-02
SOFT TIP MULTI-LUMEN CENTRAL VENOUS CATHETER (K971085)B.Braun Medical, Inc.1997-06-02
INNERWEAR/EXTRAWEAR/JIMMY-O RAINCOAT/ZEUS/GENTLEMEN'S CHOICE (K970792)Titan Condoms1997-06-02
OPTICAL TRACKING SYSTEM (OTS) (K964801)Radionics Software Applications, Inc.1997-06-02
MODEL 1320, NEUROLINK II NEUROMONITORING SYSTEM (K970942)Physiometrix, Inc.1997-06-02
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Every clearance here is in the API, with alerts when new ones post.