Atlas FDA

1999

3,554 FDA 510(k) clearances · Clearance year

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RecordFirmDate
BIO-RAD HOMOCYSTEINE BY HPLC (K993107)Bio-Rad1999-12-21
EMIT CALIBRATER/CONTROL LEVEL 0, LEVEL 1, LEVEL 2, LEVEL 3, LEVEL 4, LEVEL 5 (K993755)Syva Co.1999-12-21
THE SOUNDVASER DISSECTION SYSTEM (K993868)Sound Surgical Technologies, LLC1999-12-21
IGM MININEPH ANTISERUM (K981784)The Binding Site, Ltd.1999-12-21
RAPTOR TREATMENT PLANNING SYSTEM (K993359)Nomos Corp.1999-12-21
PRIMUS LIQUID CALIBRATOR FOR GHB/A1C LEVEL 1 AND LEVEL 2 (K994045)Primus Corp.1999-12-21
DIGITEC TWO STAGE COMPRESSION KIT (K993681)Digitec Medical Service Corp.1999-12-21
MICRO-FRANCE ELECTROSURGICAL INSTRUMENTS, VARIOUS (K993655)Xomed, Inc.1999-12-21
BINDAZYME ANTI-DSDNA EIA KIT (K993727)The Binding Site, Ltd.1999-12-21
E. HISTOLYTICA II (K994101)Techlab, Inc.1999-12-21
KOORDINANT ANGIOGRAPHIC AND OPERATING ROOM MODEL X-RAY TABLE FAMILY (K993947)Siemens Corp.1999-12-21
DURATION IV STERILIZATION PROCESS (ACETABULAR INSERTS) (K990849)Howmedica Osteonics Corp.1999-12-20
POLLER CALIBRANTS (K991439)European Concerted Action on Anticoagulation1999-12-20
EIS THREADED SCREW FRACTURE FIXATION (K991964)Groupe Lepine1999-12-20
HANG UPS POWER II (K991835)Stl Intl., Inc.1999-12-20
TURBIDIMETRIC/NEPHELOMETRIC HUMAN COMPLEMEMT REFERENCE PREPARATION (K981915)The Binding Site, Ltd.1999-12-20
PEPPER GREEN MINT POWDERED LATEX EXAMINATION GLOVES (K993605)Top Glove Sdn. Bhd.1999-12-20
PRIVALINK SOFTWARE ACCESSORY TO THE LIFESTREAM CHOLESTEROL MONITOR (K993096)Lifestream Technologies, Inc.1999-12-20
SMITH & NEPHEW COMPRESSION HIP SCREW SYSTEM, INTRAMEDULLARY HIP SCREW SYSTEM (K993289)Smith & Nephew, Inc.1999-12-20
MODIFICATION OF: PHYSIOLOGICAL SIGNAL TRANSMITTER AND RECEIVER, MODEL 3810A (K993169)Hewlett-Packard Co.1999-12-20
TITANIUM PEDIATRIC FEMORAL NAIL (K993956)Biomet, Inc.1999-12-20
EMBOLIZATION COIL SYSTEM (K992121)Cook, Inc.1999-12-20
SADDLE SHAPED PATELLA (K993371)Wrightmedicaltechnologyinc1999-12-20
ABSOLUTE ABSORBABLE INTERFERENCE SCREW (K993975)Innovasive Devices, Inc.1999-12-20
BIRD V.I.P. GOLD/STERLING (K993449)Bird Products Corp.1999-12-20
ROSSMAX AUTOMATIC WRISTWATCH BLOOD PRESSURE MONITOR, MODEL Z46 (K993432)Rossmax International , Ltd.1999-12-20
ULTEGRA SYSTEM ANALYZER, ULTEGRA SYSTEM RPFA-TRAP TEST CARTIDGES, ULTEGRA SYSTEM RPFA-TRAP LEVEL ONE QC, ULTEGRA SYSTEM (K992531)Accumetrics, Inc.1999-12-20
STRYKER T4 POWER PACK, STRYKER T4 EIGHT STATION BATTERY CHARGER, STRYKER T4 CHARGER MODULE (K994053)Stryker Instruments1999-12-20
LAERDAL SUCTION UNIT,(4000) MODEL 78 00 20 (K993668)Laerdal Medical A/S1999-12-20
ROCHE DIAGNOSTICS INFLUENZA A/B RAPID TEST (K993048)Roche Diagnostics Corp.1999-12-20
CDS LTX CONTROL LATEX PARTICLE SUSPENSION AND PRIMER (K993375)Clinical Diagnostic Solutions, Inc.1999-12-20
LATEX EXAMINATION POWDERED GLOVES (K993386)Great Glove Sdn Bhd1999-12-20
LACTOSORB TRAUMA PLATING SYSTEM (K992355)Biomet, Inc.1999-12-20
GREEN POWDERED LATEX EXAMINATION GLOVES (K993452)Top Glove Sdn. Bhd.1999-12-20
INTERFACE MODULE IDDD (K992635)Stoeckert Instrumente1999-12-20
C4 MININEPH ANTISERUM (K981785)The Binding Site, Ltd.1999-12-20
OPUS SPINAL SYSTEM (K993402)Howmedica Osteonics Corp.1999-12-20
A & D MEDICALLIFESOURCE US-779PC & UA-779T DIGITAL BLOOD PRESSURE MONITORS (K993888)A&D Engineering, Inc.1999-12-20
PRE-POWDERED VINYL EXAM GLOVE, NON STERILE (K994036)Shanghai Champion Plastic Products Co., Ltd.1999-12-20
C3 MININEPH ANTISERUM (K981783)The Binding Site, Ltd.1999-12-20
ALATECH LATEX CONDOM (K993887)Alatech Healthcare, LLC1999-12-20
SONOHEART HAND-CARRIED ECHOCARDIOGRAPHY SYSTEM (K994096)Sonosite,Inc.1999-12-20
IGG AND IGG SUBCLASS NEPHELOMETRIC DIAGNOSTIC TEST KITS (K982100)The Binding Site, Ltd.1999-12-20
MULTITAK SS (K993115)Bonutti Research, Inc.1999-12-17
INNOVAQUARTZ GENERAL SHAPE LASER FIBER (K994010)Innovaquartz1999-12-17
QK-WIDE BAND SPECTRUM THERAPEUTIC APPARATUS, MODELS CO1A, CO1B, CO1C, CO1D, CO2A, CO2B (K993123)United Pacific Co., Ltd.1999-12-17
EIM-107 PREP-CHECK (K993202)General Devices1999-12-17
ULTRA-GARMENT ELECTRODE (K993130)Newwave Medical, LLC1999-12-17
OMNIAXIAL CONNECTOR (K993926)Ortho Tec, LLC1999-12-17
YP 45/15-BP; YP 53/15-BP; YP 60/15-BP (K993139)Biotronik, Inc.1999-12-17
HEM-O-LOK SMX POLYMER CLIPS, MODEL 544220, HEM-0-LOK MLX POLYMER CLIPS, MODEL 544240 (K993157)Weck Closure Systems1999-12-17
INTRALASE 600C LASER KERATOME (K993153)Intra Lase Corp.1999-12-17
BIOTEQUE A.V. FISTULA NEEDLE SET (K993118)Bioteque Corp.1999-12-17
ORATEC SPINECATH INTRADISCAL CATHETER, MODEL 920002 (K993967)Oratec Interventions, Inc.1999-12-17
RTD ARM ASSISTIVE ROBOTIC DEVICE (K993443)Rehabilitation Technologies Division1999-12-17
FRUCTOSAMINE, MODEL FR 106-01 (K991246)A.P. Total Care, Inc.1999-12-16
COPALIS TREPONEMAL ANTIGEN TOTAL ANTIBODY ASSAY (K992552)DiaSorin, Inc.1999-12-16
SURE-WAY REUSABLE SHARPS CONTAINER (K992626)Sure-Way Systems, Inc.1999-12-16
ADDITIONAL IMS ASSAYS FOR THE BAYER ADVIA IMS SYSTEM (INVITRO DIAGNOSTIC SYSTEM WITH 5 ADDITIONAL ASSAYS) (K993711)Bayer Corp.1999-12-16
INTRAY GC (K993033)Biomed Diagnostics, Inc.1999-12-16
AT WORK DRUG TEST, MODEL 9145-25C; MODEL 9177-25C (K994093)Phamatech1999-12-16
PATIENT LATEX EXAMINATION POWDER-FREE POLYMER COATED GLOVES (K992676)Wear Safe Malaysia Sdn. Bhd.1999-12-16
MEDIPACK SEE-THROUGH SEAL STERILIZATION POUCH (K993764)Medipack Medical Packaging Mfg. Co.1999-12-16
PALL SUPOR AEF FILTER (K993379)Pall Corp.1999-12-16
PARAPOST SYSTEM STERILIZABLE ORGANIZER (K993835)Coltene/Whaledent, Inc.1999-12-16
CLEARPLAN EASY II HOME PREGNANCY TEST (K993333)Unipath , Ltd.1999-12-16
IMMULITE 2000 CMV IGG, MODEL L2KCV2, L2KCV6 (K993952)Diagnostic Products Corp.1999-12-16
VERDICT -II OPIATES 2000 (K992111)Medtox Diagnostics, Inc.1999-12-16
WAKO L-TYPE GOT TEST (K993468)Wako Chemicals USA, Inc.1999-12-16
AVL OPTI CRITICAL CARE ANALYZER (K993837)Avl Scientific Corp.1999-12-16
BAYER DIAGNOSTICS ACS:180 VB12, BAYER DIAGNOSTICS ADVIA CENTAUE VB12 (K993571)Bayer Corp.1999-12-16
PATIENT LATEX EXAMINATION GLOVE POWDERED & POWDER FREE, STERILE (K992681)Wear Safe Malaysia Sdn. Bhd.1999-12-16
TALON ANCHOR SNAP-PAK (K993327)Mitek Products1999-12-16
DDS, DS3000, RS3000, CS5000, OT3000, IS3000, RS5000, CD3000, US3000, (AMONGST OTHER NAMES) (K993532)Impax Technology, Inc.1999-12-15
TRIP TONOMETRY CATHETER, 14F (K993296)Datex-Ohmeda, Inc.1999-12-15
BREMER HALO SYSTEM TITANIUM SKULL PIN (K993099)Depuyacromed1999-12-15
CONFORMAX MMLC VR1 (K993594)Radionics, Inc.1999-12-15
AED CYSTOSCOPE (K993689)National Advanced Endoscopy Devices, Inc.1999-12-15
PRE-VISION FILL (K993602)Heraeus Kulzer, Inc.1999-12-15
QMS MAPPING SYSTEM,MODEL 2000 (K990058)Cathdata, Inc.1999-12-15
PLLL, TELERADPRO, MODEL 12714/12715, VXR-12 PLUS, MODEL 8619/9617 (K993597)Vidar Systems Corp.1999-12-15
ATR 3000, ATR 2000, IMPLANT-PRO (K991401)Advanced Technology Research (A.T.R.) S.R.P.1999-12-15
SYSTEM 2100 (K993530)Math Solutions, LLC1999-12-15
ACUNAV DIAGNOSTIC ULTRASOUND CATHETER (K992631)Acuson Corp.1999-12-15
STORM SERIES, POWER 9000 SERIES AND POWER TIGER WITH GYROSCOPE CONTROL (K993413)Invacare Corp.1999-12-15
ATLANTIS ANTERIOR CERVICAL PLATE SYSTEM (K993855)Danek Medical, Inc.1999-12-15
DCI ENDOSCOPE (K993539)KARL STORZ Endoscopy-America, Inc.1999-12-15
BACT/ALERT SA (K993423)Organon Teknika Corp.1999-12-15
OMNISONICS ULTRASONIC PROBES (K993628)Omnisonics Medical Technologies1999-12-15
EBI XFIX VISION FIXATION SYSTEM (K993886)Ebi, L.P.1999-12-14
BACT/ALERT SN (K993421)Organon Teknika Corp.1999-12-14
BACT/ALERT MP PROCESS BOTTLE (K993576)Organon Teknika Corp.1999-12-14
SIMPLIFY D-DIMER, MODEL DCGK1 (K993276)Agen Biomedical , Ltd.1999-12-14
PULPDENT UNO-DUO (K993683)Pulpdent Corp.1999-12-13
TETRIC FLOW (K993783)Ivoclar North America, Inc.1999-12-13
CERADIUM V NON-PRECIOUS CERAMIC ALLOY (K993572)Matech, Inc.1999-12-13
MENTOR EVACARE VAGINAL PESSARIES (K993308)Mentor Corp.1999-12-13
SYNTHETIC VINYL MEDICAL EXAMINATION POWDER FREE GLOVE (K993680)Top Glove Sdn. Bhd.1999-12-13
INVASIVE BLOOD PRESSURE (IBP) FUNCTION, MODEL 9500 MULTIGAS MONITOR (K983250)Magnetic Resonance Equipment Corp.1999-12-12
PREMIER TOXINS A&B, MODEL 616096 (K993914)Meridian Diagnostics, Inc.1999-12-10
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