Atlas FDA

2000

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

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RecordFirmDate
DIMENSION TRNF FLEX REAGENT CARTRIDGE (K994294)Dade Behring, Inc.2000-02-04
ARTHROCARE CONTROLLER, ARTHROCARE CABLE, FOOTSWITCH, POWERCORD, PLASMA SCALPEL GS, TURBOVAC GS (K000074)Arthrocare Corp.2000-02-04
ENTEC REFLEX WAND 55, MODEL E4055-00 (K000036)Arthrocare Corp.2000-02-04
POLYESTER (K994000)Trading Consultants and Distributors Intl., Inc.2000-02-04
BILICHEK NON-INVASIVE BILIRUBIN ANALYZER (K994438)Spectrx, Inc.2000-02-04
ILM ENDOTRACHEAL TUBE (K991580)The Laryngeal Mask Co., Ltd.2000-02-04
CP PERIPHERAL ANGIO ARRAY COIL/ MAGNETOM SYMPHONY SYSTEM (K994315)Siemens Medical Solutions USA, Inc.2000-02-04
NYLON (K993998)Trading Consultants and Distributors Intl., Inc.2000-02-04
DOGBONE ACFS (K994383)Theken Surgical2000-02-04
MALLORY/HEAD SMOOTH FEMORAL COMPONENT (K994007)Biomet, Inc.2000-02-04
COALESCENT SURGICAL SUTURED-CLIP (K994160)Coalescent Surgical2000-02-04
INTURIS SUITE (K994210)Philips Medical Systems, Inc.2000-02-04
NIKOPAD ELECTROSURGICAL GROUNDING PAD, MODEL 4777M (K000079)Nikomed U.S.A., Inc.2000-02-04
MODIFICATION TO ISOBAR SPINAL SYSTEM (K000020)Encore Orthopedics, Inc.2000-02-03
GLORY (K994127)Pillar Technology, Inc.2000-02-03
ADVANTAGE HCG TEST (URINE/SERUM) (K994227)Advantage Diagnostics Corp.2000-02-03
SUCTION IRRIGATION TRUMPET VALVE SET, MODEL Q65-823 (K994256)A & A Medical, Inc.2000-02-03
POWDER-FREE NON-STERILE VINYL EXAMINATION GLOVES (K994136)Shanghai Champion Plastic Products Co., Ltd.2000-02-03
E-2000 POWER ELEVATING SEAT SYSTEM, MODELS ARD-ESTORM, ARD-EP320, ARD-ELANCER (K992828)Accelerated Rehab Designs, Inc.2000-02-03
HP VIRIDIA MULTI-MEASUREMENT SERVER/COMPACT PORTABLE PATIENT MONITOR MODELS M3000A, M3046A, M3015A, REL.B (K993383)Hewlett-Packard GmbH2000-02-03
AVOCET ACUSURE (FOR PATIENT SELF-TESTING) AND AVOCET ACUSURE PRO (FOR PROFESSIONAL USE) (K994006)Avocet Medical, Inc.2000-02-03
SYNCHRON LX SYSTEMS PREALBUMIN CALIBRATOR (K994168)Beckman Coulter, Inc.2000-02-03
SYNCHRON CX SYSTEMS PREALBUMIN CALIBRATOR (K994169)Beckman Coulter, Inc.2000-02-03
MARATHON CROSS-LINKED POLYETHYLENE ACETABULAR CUP LINERS (K994415)DePuy Orthopaedics, Inc.2000-02-03
T-2000-POWER TILT SEATING SYSTEM, MODELS ARD-TSTORM, ARD-TP-320, ARD-TG424, ARD-TS525, ARD-TJAZZY, ARD-TLANCER (K992804)Accelerated Rehab Designs, Inc.2000-02-03
TED 200T7 OXYGEN MONITOR (K990403)Teledyne Electronic Technologies2000-02-03
AUTOSTAT II RHEUMATOID FACTOR IGM ELISA (K994338)Cogent Diagnotics , Ltd.2000-02-03
SYNTHES 4.0 AND 5.0 MM LOCKING SCREWS (K000089)Synthes (Usa)2000-02-03
EXTENDED STRAIGHT ATTACHMENT (K994024)Team Technologies, Inc.2000-02-03
K-DEFIB/PACE ADULT ELECTRODE, MODEL KDP-80 (K993745)Katecho, Inc.2000-02-03
ARABESK TOP (K994268)Voco GmbH2000-02-03
VERSALET 7700 CARE CENTER, MODEL # 7700 (K993051)Hill-Rom Air-Shields2000-02-03
PRO-TORQ (K000120)Micro Motors, Inc.2000-02-03
POLYMER COATED POWDER FREE NITRILE EXAMINATION GLOVES, BLUE (K994416)Flexitech Sdn. Bhd.2000-02-03
EBI XFIX DFS RAIL SYSTEM (K000083)Ebi, L.P.2000-02-03
SD-730 IF-SDS, PERFECT PULSE IF-SDS (K992652)Skylark Device & Systems Co., Ltd.2000-02-03
DEPUY CONTOUR UNICOMPARTMENTAL KNEE PROSTHESIS (K000172)DePuy Orthopaedics, Inc.2000-02-03
CD HORIZON SPINAL SYSTEM (K993810)Danek Medical, Inc.2000-02-03
SIMPLEX CONDOMS, LATEX CONDOMS-SILICON LUBRICATED (K993781)P.T. Vonix Latexindo Condom (Rubber) Mfg.2000-02-02
PROSOLV ECHOVIEWER, PROSOLV ECHOVIEWER SE, PROSOLV ECHOANALYZER, PROSOLV ECHOSERV, PROSOLV ECHO (K993750)Problem Solving Concepts, Inc.2000-02-02
SNAP MODEL 5 (K992322)Snap Laboratories, LLC2000-02-02
SPECIALTY 55 (METHAFILCON A) SOFT (HYDROPHILIC) CONTACT LENSES FOR DAILY WEAR (K993580)Specialty Ultravision, Inc.2000-02-02
RUSCH ORAL/NASAL (SAFETY CLEAR PLUS) TRACHEAL TUBE CUFFED, MAGILL/MURPHY (K993786)Rusch Intl.2000-02-02
ULTRATEMP TEMPORARY POLYCARBOXYLATE CEMENT (K994261)Ultradent Products, Inc.2000-02-02
SIMPLEX CONDOMS, LATEX CONDOMS-FLAVORED AND LUBRICATED (K993779)P.T. Vonix Latexindo Condom (Rubber) Mfg.2000-02-02
SUPER TISSUE (K993742)I.Z.I. Corp.2000-02-02
QUINN'S SPERM WASHING MEDIUM (K991379)Advanced Reproductive Technologies2000-02-02
TOKUYAMA ONE-UP-BOND F (K993917)Tokuyama America, Inc.2000-02-02
COROMETRICS MODEL 173 FETAL MONITOR (K993751)Ge Medical Systems Information Technologies2000-02-02
HYALURONIDASE, 80 U/ML (K991393)Sage Biopharma2000-02-02
EPICON (CARBOSILFOCON A) RIGID GAS PERMEABLE CONTACT LENS DAILY WEAR (K992787)Specialty Ultravision, Inc.2000-02-02
SIMPLEX CONDOMS, LATEX CONDOMS-WITH SPERMICIDAL LUBRICANT (NONOXYNOL-9) (K993782)P.T. Vonix Latexindo Condom (Rubber) Mfg.2000-02-02
SYVA EMIT II PLUS ETHYL ALCOHOL ASSAY, MODELS 9K309UL/9K409UL (K993980)Syva Co.2000-02-01
JE 2000 (K993878)Jack'S Electrodes2000-02-01
BECKMAN COULTER IMMAGE IMMUNOCHEMISTRY SYSTEM LOW CONCENTRATION IMMUNOGLOBULIN A (IGALC) REAGENT, BECKMAN COULTER CEREBR (K993549)Beckman Coulter, Inc.2000-02-01
TAC' PIN (K993910)New Deal, S.A.2000-02-01
IONTOPATCH (K992708)Birch Point Medical, Inc.2000-02-01
HARDYDISK CEFACLOR 30MCG (K994046)Hardy Diagnostics2000-02-01
AUTOSTAT II ANTI-CARDIOLIPIN SCREEN ELISA (K993085)Cogent Diagnotics , Ltd.2000-02-01
BECKMAN COULTER IMMAGE IMMUNOCHEMISTRY SYSTEM LOW CONCENTRATION IMMUNOGLOBULIN M (IGMLC) REAGENT, BECKMAN COULTER CEREB (K993547)Beckman Coulter, Inc.2000-02-01
SYVA EMIT II PLUS PROPOXYPHENE ASSAY, MODELS 9G029UL/9G129UL (K993981)Syva Co.2000-02-01
ARTHROCARE CONTROLLER, ARTHROCARE CABLE, FOOTSWITCH, POWERCORD, ARTHROWANDS AND SPINEWANDS (K000044)Arthrocare Corp.2000-02-01
IMMUNODIP URINARY ALBUMIN SCREEN, MODEL 790-01, 790-15 (K994035)Diagnostic Chemicals , Ltd.2000-02-01
GTI-FVIII INHIBITOR ASSAY (K993553)Genetic Testing Institute2000-02-01
HSV-2 ELISA IGG, MODEL EL0920G (K993724)Mrl Diagnostics2000-02-01
3I MODEL(S)7426 AND 7427 CELSEP CENTRIFUGE SYSTEM (K994148)Implant Innovations, Inc.2000-02-01
INTRASTENT DOUBLESTRUT LD (K993904)Intratherapeutics, Inc.2000-02-01
CERALAS D10 810NM DIODE LASER (K993828)Ceram Optec, Inc.2000-02-01
CERALAS D DIODE LASER SYSTEM, MODEL D15, D25,D50 (K993911)Ceram Optec, Inc.2000-02-01
ABL 77 PH, BLOOD GAS AND ELECTROLYTE ANALYSIS SYSTEM (K994346)Sendx Medical, Inc.2000-02-01
ROTARY MASTER (K992648)J. Morita USA, Inc.2000-01-31
KERLIX MD ANTIMICROBIAL GAUZE DRESSING (K990530)The Kendall Company, L.P.2000-01-31
SHARP 9000 PHASED ARRAY BRAIN COIL (K994042)Usa Instruments, Inc.2000-01-31
BARD UROFORCE BALLOON DILATION CATHETER (K993840)C.R. Bard, Inc.2000-01-31
SEALOUETTE FIBRIN SEALANT EXTENDED DROPLET APPLICATOR, MODEL TE-1 (K000048)Biosurgical Corp.2000-01-31
OMNI GRACE NITRILE, BLUE, EXAMINATION GLOVE, POWDER-FREE, POLYMER COATED (K994246)Omnigrace , Ltd.2000-01-31
NANMA NON-ADJUSTABLE CONSTRICTION RING (K993906)Nanma Mfg Co., Ltd.2000-01-31
THE ORIGINAL PERRY, STYLE 42 WHITE LATEX POWDERED SURGICAL GLOVES WITH PROTEIN CONTENT LABELING CLAIM (60 MICROGRAMS OR (K993857)Ansell Perry2000-01-31
ULTRASHAPER KERATOME (K990227)Lasersight Technologies, Inc.2000-01-31
POLYMER COATED, POWDER FREE, LATEX EXAMINATION GLOVES WITH PROTEIN CONTENT LABELING CLAIM (50 MICROGRAMS OR LESS) (K994354)Flexitech Sdn. Bhd.2000-01-31
NANMA AJUSTABLE CONSTRICTION RING (K993908)Nanma Mfg Co., Ltd.2000-01-31
PRIME-DENT CHEMICAL CURE COMPOSITE RESTORATIVE MATERIAL (K994224)Prime Dental Manufacturing, Inc.2000-01-31
RIM-FIX, ACETABULAR CUP (K993713)Surgical Implants, Inc.2000-01-28
BIOLOX ALUMINA CERAMIC FEMORAL HEAD (K991162)Smith & Nephew, Inc.2000-01-28
ADVANCED D-DIMER (K992957)Dade Behring, Inc.2000-01-28
HP VIRIDIA MULTI-MEASUREMENT SERVER/COMPACT PORTABLE PATIENT MONITOR M3000A/M3046A/M3016A,REL B (K992273)Hewlett-Packard GmbH2000-01-28
HENRY SCHEIN SURGICAL MASK (K992604)Mitsui Textile Corp.2000-01-28
ARTHREX PLA TISSUETAK, MODEL # AR-1940 BU (K990340)Arthrex, Inc.2000-01-28
NOBEL BIOCARE'S MODIFIED SURFACE IMPLANT (INTENDED FOR IMMEDIATE LOADING UPON PLACEMENT) (K993595)Nobel Biocare Uas, Inc.2000-01-28
SULZER VASCUTEK SEALPTFE VASCULAR PROSTHESIS (K993667)Sulzermedica2000-01-28
TOTAL IRON BINDING CAPACITY (IBCT) FLEX REAGENT CARTRIDGE (K994115)Dade Behring, Inc.2000-01-28
BLUE NITRILE EXAMINATION GLOVES - POWDER FREE (K994064)Glove Source, Inc.2000-01-28
IMPREGUM PENTA M MONOSOFT (K994192)Espe Dental AG2000-01-28
COAGULATION ELECTRODE, MODEL 2000; RADIOFREQUENCY GENERATOR, MODEL 20-115 (K993900)Broncus Technologies, Inc.2000-01-28
MAGNA ABUTMENT (K984297)Factor, Ii, Inc.2000-01-28
POWDERED LATEX EXAMINATION GLOVES (PROTEIN LABEL CLAIM) (50 MICROGRAM OR LESS) (K994082)Besglove Medicare Sdn. Bhd.2000-01-28
CAMLOG CYLINDER IMPLANT SYSTEM (K000065)Altatec Biotechnologies2000-01-28
IMMULITE TURBO HCG, MODELS LSKCG1, LSKCG5 (K994085)Diagnostic Products Corp.2000-01-28
SENSI-PRO, DISPOSABLE PRE-POWDERED SYNTHETIC VINYL PATIENT EXAMINATION GLOVES WITH BEIGE PIGMENT ADDITIVES (K994248)Shinemound Enterprise, Inc.2000-01-28
IMPREGUM PENTA DUOSOFT (K994193)Espe Dental AG2000-01-28
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Every clearance here is in the API, with alerts when new ones post.