Atlas FDA

2000

3,453 FDA 510(k) clearances · Clearance year

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RecordFirmDate
PARAPOST FIBER WHITE (K000311)Coltene/Whaledent, Inc.2000-03-14
BARCOMED 5MP2 (K000016)Barco N.V.2000-03-14
BITEM LOCK, MODELS SW006, SW012 (K994357)Thermoelastic Technologies, Inc.2000-03-14
BARCOMED 5MP1H (K000014)Barco N.V.2000-03-14
ORTHORALIX 9200, ORTHORALIX 9200 PLUS, ORTHORALIX 9200 CEPH, ORTHORALIX 9200 PLUS CEPH (K994285)Dentsply Intl.2000-03-14
PROSTEC 125I BRACHYTHERAPY SEEDS (K993280)Prostec, LLC2000-03-14
SURGI-VISION ESOPHAGEAL STYLET COIL (K994436)Surgi-Vision, Inc.2000-03-14
INTERACOUSTICS AT235 IMPEDANCE AUDIOMETER (K994254)International Distributors of Electronics For Medi2000-03-14
DATASCOPE'S 8FR. POLYMIDE 25CC,34CC AND 40CC IAB AND ACCESSORIES, MODELS 0684-00-0327, 06844-00-0328, 0684-00-0329 (K994157)Datascope Corp.2000-03-13
CBYON SURGICAL OPERATING SYSTEM (SOS) (K000171)Cbyon, Inc.2000-03-13
CODMAN ETHISORB DURA PATCH (K991413)Johnson & Johnson Professionals, Inc.2000-03-13
CELSITE IMPLANTABLE PORT WITH VALVED CATHETER (K993024)B. Braun of America, Inc.2000-03-13
HYLASINE (K993362)Biomatrix, Inc.2000-03-13
MODIFICATION TO ARTHROCARE CONTROLLER, ARTHROCARE CABLE, FOOTSWITCH, POWERCORD, ARTHROWANDS AND SPINE WANDS (K000511)Arthrocare Corp.2000-03-13
COHERENT LASERLINK Z-1000 SLIT LAMP LASER DELIVERY ADAPTER (K000498)Lumenis, Inc.2000-03-13
BLASTOCYST FREEZE MEDIUM, BLASTOCYST THAW MEDIUM (K000309)Irvine Scientific Sales Co., Inc.2000-03-13
COMPUMEDICS E-SERIES EEG SYSTEM (K000068)Compumedics Neuro Science Pty , Ltd.2000-03-13
FERTILOSCOPY KIT FH 1.29/FTO 1.40 (K992655)Soprane S.A.2000-03-13
WALLACE OOCYTE RETRIEVAL SET-16G, MODEL MEONS1633; WALLACE OOCYTE RETRIEVAL SET-17G, MODEL MEONS1733 (K000628)Sims Portex , Ltd.2000-03-13
MACHIDA FLEXIBLE NEURO-ENDOSCOPE, MODELS NEU-4, NEU-4L (K993568)Machida Endoscope Co., Ltd.2000-03-13
HOWMEDICA OSTEONICS MODULAR ROTATING HINGE KNEE (K994207)Howmedica Osteonics Corp.2000-03-13
CYNOSURE PHOTOGENICA VLS-STAR (K000490)Cynosure, Inc.2000-03-13
FOAM CALCIUM ALGINATE TOPICAL WOUND DRESSING WITH COLLAGEN (K000054)Adri2000-03-13
DYONICS ELECTROBLADE (K994365)Smith & Nephew, Inc.2000-03-13
DURACON SYMMETRIC METAL-BACKED PATELLAR COMPONENT (K000091)Howmedica Osteonics Corp.2000-03-10
SPIRAL RADIUS RODDING SYSTEM (K000009)United States Surgical, A Division of Tyco Healthc2000-03-10
NONLINEAR TAPER LAG SCREW (K994382)Theken Surgical2000-03-10
SYNTHETIC POWDER-FREE VINYL PATIENT EXAMINATION GLOVES (K992821)Shijiazhuang Hongxiang Plastics Products Co., Ltd.2000-03-10
NEXT STEP POWDER FREE LATEX EXAMINATION GLOVES CONTAINS 50 MCGM OR LESS OF TOTAL WATER EXTRACTABLE PROTEIN PER GRAM (K000165)Ansell Perry2000-03-10
NITRI-CARE NITRILE POWDER-FREE STERILE MEDICAL EXAMINATION GLOVES (BLUE, CHERRY FLAVORED) (K993805)Best Manufacturing Company2000-03-10
AEQUALIS SHOULDER FRACTURE SYSTEM (K994392)Tornier2000-03-10
MODIFICATION TO SYNTHES USS (K000450)Synthes Spine2000-03-10
MODIFICATION TO CD SPINAL SYSTEM (K000476)Medtronic Sofamor Danek, Inc.2000-03-10
MAGELLAN TIBIAL INTRAMEDULLARY NAIL (K992850)Orthomatrix, Inc.2000-03-10
BROTHERS POWDER-FREE VINYL EXAMINATION GLOVES (K000058)Kaohsiung Brothers Products Corp.2000-03-10
INTER-OP DURASUL ACETABULAR INSERTS/COCR FEMORAL HEADS (K993259)Sulzer Orthopedics, Inc.2000-03-10
MAGELLAN HUMERAL INTRAMEDULLARY NAIL (K992856)Orthomatrix, Inc.2000-03-10
GLOBAL ADVANTAGE EXTENDED HUMERAL HEAD (K000575)DePuy Orthopaedics, Inc.2000-03-10
MODIFICATION TO CD SPINAL SYSTEM (K000453)Medtronic Sofamor Danek, Inc.2000-03-10
ZMR HIP SYSTEM-POROUS REVISION (K994286)Zimmer, Inc.2000-03-10
ROD TO ROD CROSS BRACES (K000634)Corin USA2000-03-10
BRACHYVISION 6.0 (K992762)Varian Assoc., Inc.2000-03-09
EMBRYON GIFT TRANSFER CATHETERS/SETS (K000656)Rocket Medical Plc2000-03-09
BOUCHER DEGROOT HEAD POSITIONING GLASSES, MODEL 8080 (K000544)Labtician Ophthalmics, Inc.2000-03-09
ULTRASOUND SCANNER TYPE 2102 (K000567)B & K Medical A/S2000-03-09
PEGASYS ULTRA (K993946)Adac Laboratories2000-03-09
MODOFICATION TO VITRO IMMUNODIAGNOSTIC PRODUCTS PSA REAGENT PACK, VITRO IMMUNODIAGNOSTIC PRODUCTS PSA CALIBRATORS (K000566)Ortho-Clinical Diagnostics, Inc.2000-03-09
INSTATRAK 3000 SYSTEM WITH FLUOROTRAK MODULE, MODEL IT3000 (K994270)Visualization Technology, Inc.2000-03-09
SUPERGUARD SAFETY SYRINGE (K990831)U.S. Safety Syringes Co., Inc.2000-03-08
KAWASUMI LABORATORIES PHILEBOTOMY SET (K994323)Kawasumi Laboratories Co., Ltd.2000-03-08
OOCYTE ASPIRATION NEEDLE (K991271)Casmed UK2000-03-08
CARDIAC PATHWAYS REFERENCE CATHETER AND REFERENCE CATHETER WITH TRACKING, CARDIAC PATHWAYS RADII CATHETER AND RADII CATH (K992912)Cardiac Pathways Corp.2000-03-08
LIFECORE SINGLE TOOTH ABUTMENT SYSTEM (K993894)Lifecore Biomedical, Inc.2000-03-08
VOYAGER/VIPER WHEELCHAIR (K000497)Otto Bock Orthopedic Industry, Inc.2000-03-08
LUER ACCESS UNIVERSAL VIAL ADAPTER (K000657)Baxter Healthcare Corp2000-03-08
ARROWG +ARD BLUE PLUS ANTIMICROBIAL MULTI-LUMEN CENTRAL VENOUS CATHETER (K993691)Arrow Intl., Inc.2000-03-08
ORION SERIES SURGICAL LASER SYSTEM (SL SERIESQ-SWITCHED ND:YAG CONFIGURATION) (K990718)Laserscope2000-03-08
HORIZON LIGHT (K994375)B.Braun Medical, Inc.2000-03-08
BD PREEFILE NORMAL SALINE FLUSH SYRINGE FLUSH SYRINGE (K982558)Bd/Preefil2000-03-08
LEMAITRE IRRIGATION CATHETER (K992933)Vascutech, Inc.2000-03-08
SPEEDBAND SUPERVIEW MULTIPLE BAND LIGATOR, MODELS 4225, 4228; INJECTION SPEEDBAND SUPERVIEW MULTIPLE BAND LIGATOR, MODEL (K000397)Boston Scientific Corp2000-03-07
MALLINCKRODT, GOODKNIGHT 418A, GOODKNIGHT 418P, SILVERLINING 2 (K993584)Nellcor Puritan Bennett France Dvpt.2000-03-07
STARION CAUTERY HOOK (K000296)Starion Instruments2000-03-07
SAS STREP A TEST (K993456)Sa Scientific, Inc.2000-03-07
MEDI-CULT ACIDIFIED TYRODES SOLUTION- MEDIUM; INTERNAL CATALOG NUMBERS (1060) (K991470)Medicult A/S2000-03-07
ALLON 2000 (K992386)Mtre Advanced Technology , Ltd.2000-03-07
MODIFICATION TO EBI SPINELINK ANTERIOR CERVICAL SPINAL SYSTEM (K000513)Ebi, L.P.2000-03-07
QUICKSCREEN METHAMPHETAMINE TEST, MODELS 9045, 9046, QUICKSCREEN PRO MULTI DRUG SCREENING TEST, MODEL 9225 (K000447)Phamatech2000-03-07
ELECSYS CORTISOL TEST SYSTEM (K000270)Roche Diagnostics Corp.2000-03-07
E7512 PREMIE REM POLYHESIVE II PATIENT RETURN ELECTRODE (K994428)Valleylab, Inc.2000-03-07
SUCTION VASCULAR STAPLER AND IMPLANTABLE STAPLE SYSTEM (K000608)Std Mfg., Inc.2000-03-07
CODE AC: ATTENUATION CORRECTION SYSTEM FOR DUAL-HEAD VARIABLE-ANGLE GAMMA CAMERA WITH COINCIDENCE OPTION (CODE) (K994167)Ge Medical Systems F.I. Haifa2000-03-07
AIRIS II (K994378)Hitachi Medical Systems America, Inc.2000-03-07
CAUTERY FORCEPS WITH FOOTSWITCH (K000250)Starion Instruments2000-03-07
ISOBAR SPINAL SYSTEM (K000425)Encore Orthopedics, Inc.2000-03-07
ART-M3 25K, MODEL M3-1-ART2-A1; ART-M3 30K, MODEL M3-1-ART3-A1 (K994203)Bonart Co., Ltd.2000-03-06
ART-P3, MODEL P3-1-ART-A1 (K994299)Bonart Co., Ltd.2000-03-06
FREQUENCY 55, FREQUENCY 55 ASPHERIC, ENCORE, ENCORE TORIC, ONEVIEW, COOPERFLEX (K000384)CooperVision, Inc.2000-03-06
ACME MEDICAL AESTHETIC ND:YAG LASER (K991798)Altus Medical2000-03-06
GRASS TS3201/6401 EEG AMPLIFIER SYSTEM (K994142)Grass Instrument Co.2000-03-06
INSTRUMENTS FOR MINIMALLY INVASIVE SPINAL SURGERY (MISS) (K994363)Richard Wolf Medical Instruments Corp.2000-03-06
THE LIGAMENT ANCHOR SOFT SCREW (K994152)Corin USA2000-03-06
SCORPIO TOTAL STABLIZER (TS) TOTAL KNEE SYSTEM (K994128)Howmedica Osteonics Corp.2000-03-06
Q-TEL TELEMETRY SYSTEM V. 6.0 (ST) (K992908)Quinton, Inc.2000-03-06
MODIFICATION TO AUTOJECT MINI (K000482)Owen Mumford, Ltd.2000-03-06
CORTEK CYSTOSCOPE (K000197)Cortek Endoscopy, Inc.2000-03-03
SLENDAIR 4000 COMPRESSION SYSTEM (K994057)Medical Compression Systems (Dbn) , Ltd.2000-03-03
IO-DRIVE (K993081)Selectivemed Components, Inc.2000-03-03
ENDOSCOPIC ANTI FOG DEVICE (K993604)Mectra Labs, Inc.2000-03-03
SOAKER CATHETER (K994374)I-Flow Corp.2000-03-03
FIBRINOGEN CALIBRATOR KIT (K994341)Dade Behring, Inc.2000-03-03
BAUSCH & LOMB 2-WEEK (HILAFILCON B) VISIBILITY TINTED CONTACT LENSES (K994125)Bausch & Lomb, Inc.2000-03-03
IMMULITE PHENOBARBITAL, MODELS LKPB1, LKPB5 (K000012)Diagnostic Products Corp.2000-03-03
KSEA SCB-RUI (K994348)KARL STORZ Endoscopy-America, Inc.2000-03-03
PROTEGE WHEELCHAIR (K000602)Otto Bock Orthopedic Industry, Inc.2000-03-03
VENUSA, LTD. EXTENSION SET WITH FILTER (K994429)Venusa , Ltd.2000-03-03
DAKO MONOCLONAL MOUSE ANTI-HUMAN ESTROGEN RECEPTOR (K993957)Dako Corp.2000-03-03
IMMULITE VALPROIC ACID, IMMULITE 2000 VALPROIC ACID, CATALOG # LKVA1, LKVA5 & L2KVA2, L2KVA6 (K000005)Diagnostic Products Corp.2000-03-03
CORTEK URETHEROSCOPE (K000200)Cortek Endoscopy, Inc.2000-03-03
AUTOSTAT II RHEUMATOID FACTOR IGA ELISA (K993557)Cogent Diagnotics , Ltd.2000-03-03
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Every clearance here is in the API, with alerts when new ones post.