Atlas FDA

2005

3,156 FDA 510(k) clearances · Clearance year

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RecordFirmDate
LIBERTY GLUCOSE CONTROL, MODEL 2120031 (K052980)Liberty Healthcare Group, Inc.2005-11-30
MEDCOMP SPLIT CATH II (K051280)Medcomp2005-11-30
SYNTHALON PC PLUS POWDER-FREE POLYCHLOROPRENE EXAMINATION GLOVES, MODELS 1372-11 TO 1272-55 (K052892)Barriermed Glove Co.2005-11-30
BINAXNOW INFLUENZA A & B TEST (K053126)Binax, Inc.2005-11-30
LUMINA 1600, 3300 AND 6600 SYSTEMS (K052814)Usa Laser Biotech, Inc.2005-11-30
MEDTRONIC MINIMED LEAPFROG II INFUSION SET, MODELS MMT-801S1, MMT-801L1, MMT-801S2, MMT-801L2, MMT-803S1 (K052431)Medtronic Minimed2005-11-29
ARTHREX FINGERSHIELD FINGER GUARD, MODEL AR-7199-XX (K052387)Arthrex, Inc.2005-11-29
MEDTRONIC MINIMED PARADIGM LEAPFROG II INFUSION SET, MODELS MMT-802S1, MMT-802L1, MMT-802S2, MMT-802L2 (K052432)Medtronic Minimed2005-11-29
CARESTART CARDIAC 3-IN-1 TROPONIN 1/CK-MB/MYOGLOBIN (K051925)Access Bio Incorporate2005-11-29
GYNECARE TVT SECUR SYSTEM (K052401)ETHICON, Inc.2005-11-28
BD VIPER SYSTEM (K052481)Becton, Dickinson & CO2005-11-28
OPTIUM DBM GEL AND PUTTY (K053098)Lifenet2005-11-28
QUILL NONABSORBABLE NYLON BARBED SUTURE (K052900)Quill Medical, Inc.2005-11-28
ROCHE DIAGNOSTICS ELECSYS PROLACTIN II CALCHECK (K053059)Roche Diagnostics2005-11-28
ESTEEM STRETCHY VINYL GLOVE WITH COATING (K052568)Cardinalhealth2005-11-28
SENTINEL AMMONIA ULTRA DIAGNOSTIC ASSAY (K051114)Sentinel Ch. Srl2005-11-25
BARD G2 FILTER SYSTEM - JUGULAR/SUBCLAVIAN DELIVERY KIT, MODEL RF-320J (K052578)Bard Peripheral Vascular, Inc.2005-11-25
INION S-1 BIODEGRADABLE ANTERIOR CERVICAL FUSION SYSTEM (K051821)Inion , Ltd.2005-11-25
ARTSANA PISTON AND INSULIN SYRINGES (K052667)Artsana S.P.A2005-11-25
OMNIPICC PI (K051102)Rita Medical Systems, Inc.2005-11-23
IMPRESSIX (K052455)Cavex Holland BV2005-11-23
POWERPICC (K051672)Bard Access Systems, Inc.2005-11-23
GE HEALTHCARE INSTA TRAK 3500PLUS/ FLUORO TRAK 9800 PLUS SYSTEM WITH AXCESS BONE PIN, MODEL PART # 1006955 (K051734)Ge Healthcare Technologies2005-11-23
NIKI T34 AND BODYGUARD T34 SYRINGE DRIVERS (K050800)Caesarea Medical Electronics , Ltd.2005-11-23
VASCULAR SOLUTIONS TWIN-PASS DUAL ACCESS CATHETER (K052257)Vascular Solutions, Inc.2005-11-23
ANALGESIA GAS MACHINE, MODEL DIGITAL ULTRA (K052335)Accutron, Inc.2005-11-23
BE-CERTAIN PREGNANCY TEST (K051963)Natureplex, LLC2005-11-23
VIMPLANT (K053155)Cybermed, Inc.2005-11-23
VISION (WITH OFF-LINE REVIEW) (K052391)Varian Medical Systems2005-11-23
GRAFTON PLUS DBM PASTE (K043048)Osteotech, Inc.2005-11-23
ARCOMXL POLYETHYLENE RX90 ACETABULAR LINERS (K052255)Biomet, Inc.2005-11-23
WIESLAB CAP MPO-ANCA (K051455)Eurodiagnostica2005-11-23
THROMBIX 3X3 HEMOSTATIC PAD (K053054)Vascular Solutions, Inc.2005-11-23
MREYE EMBOLIZATION COIL (K052834)Cook, Inc.2005-11-23
SMITH & NEPHEW CONTROL DIGITAL OPERATING ROOM SYSTEM (K050209)Smith & Nephew, Inc.2005-11-23
ASSISTO ARM SYSTEMS (K052745)Geomed Medizin-Technik GmbH & Co.2005-11-23
SUPER PORCELAIN EX-3 PRESS (K052304)Noritake Co., Inc.2005-11-23
TERUMO MICRO TAPERED PEN NEEDLE (K052561)Kofu Factory of Terumo Corp.2005-11-23
SONOLINE G60 S ULTRASOUND SYSTEM (K052894)Siemens Medical Solutions USA, Inc.2005-11-23
IDOC UPPER ARM ATTACHED BLOOD PRESSURE AND PULSE RATE MONITOR, MODEL ID-42A/ID-43A (K052872)Taidoc Technology Corporation2005-11-23
CRONO FIVE AND CRONO PCA 50 (K052218)Cane S.R.L.2005-11-23
IGD DIAGNOSTIC TEST KITS (K051299)The Binding Site, Ltd.2005-11-23
QUANTA LITE CCP3 IGG ELISA (K052264)Inova Diagnostics, Inc.2005-11-23
DISPOSABLE POWDER FREE VINYL EXAM GLOVES WITH VITAMIN COMPLEX, NOPAL AND LANOLIN BLUE COLOR (K052612)Shanghai Antares Industries, Inc.2005-11-22
WIESLAB CAP PR-3 ANCA (K051458)Eurodiagnostica2005-11-22
BIO-MEDICUS MULTI-STAGE VENOUS FEMORAL PERCUTANEOUS KIT (K052524)Medtronic Perfusion Systems2005-11-22
DEPUY CMW 1 GENTAMICIN BONE CEMENT (K053002)DePuy Orthopaedics, Inc.2005-11-22
DEVICE CONNECTIVITY SOFTWARE DEVELOPERS KIT (SDK), MODEL 4500-900 (K052784)Welch Allyn, Inc.2005-11-22
NEXGEN COMPLETE KNEE SOLUTION MIS MODULAR TIBIAL PLATES AND KEELS (K052879)Zimmer, Inc.2005-11-22
DATEX-OHMEDA S/5 CARDIAC OUTPUT AND SVO2 MODULE, E-COPSV AND ACCESSORIES (K052977)GE Healthcare2005-11-22
IUI CATHETER, MODEL 9057 (K052059)Inntec, Inc.2005-11-22
RPS ADENO DETECTOR (K052092)Rapid Pathogen Screening2005-11-22
RAPID PROGEAMMER 3.0 (K052374)Advanced Neuromodulation Systems2005-11-22
DEPUY CMW 1, 2 AND 3 BONE CEMENTS (K053003)DePuy Orthopaedics, Inc.2005-11-22
VILEX X-FIX (K052196)Vilex, Inc.2005-11-22
URYXXON 200 URINE ANALYZER (K051034)Macherey-Nagel GmbH & Co. KG2005-11-22
VSM VITAL SIGNS MONITOR, MODEL 53000 (VSM 300) (K053027)Welch Allyn, Inc.2005-11-22
SOPRANO HAIR REMOVAL DIODE LASER (K052874)Msq (M2) , Ltd.2005-11-22
VISTADENT AT COMPLETE, MODEL 3.1 (K053010)Dentsply Intl., Inc.2005-11-22
HOFFMANN II COMPACT MRI EXTERNAL FIXATION SYSTEM (K053038)Howmedica Osteonics Corp.2005-11-22
QUEST DIAGNOSTICS HAIRCHECK-DT (AMPHETAMINES) (K051161)Quest Diagnostics, Inc.2005-11-22
MISONIX INC. FS-1000-RF BIPOLAR FORCEPS ACCESSORY (K052702)Misonix, Inc.2005-11-21
MODIFICATION TO: MAYFIELD RADIOLUCENT SKULL PINS, MODEL 4-0-A-2020 (K053045)Integra LifeSciences Corporation2005-11-21
HAEMONETICS CARDIOVASCULAR PERIOPERATIVE AUTOTRANSFUSION SYSTEM (CARDIOPAT) (K053000)Haemonetics Corp.2005-11-21
SKELITE RESORBABLE CEMENT RESTRICTOR (K051836)Millenium Biologix, Inc.2005-11-21
SENSIFLEX PLUS POLYMER COATED LATEX POWDER-FREE SURGICAL GLOVE WITH ALOE VERA (K052837)Terang Nusa Sdn Bhd2005-11-21
GUARDIAN HEMOSTASIS VALVE WITH GUIDEWIRE INTRODUCER (K052381)Zerusa Limited2005-11-21
NASOPORE NASAL DRESSING, MODEL NDOX-YYY/ZZ (K052099)Polyganics B.V.,2005-11-21
TRICOS T (K051722)Baxter Healthcare Corp2005-11-18
IMMUNALYSIS COCAINE/COCAINE METABOLITE ELISA FOR ORAL FLUIDS (K051578)Immunalysis Corporation2005-11-18
ACETYLCHOLINE RECEPTOR AB (ARAB)RRA (K051144)Ibl-Hamburg GmbH2005-11-18
MODIFICATION TO COULTER LH 750 HEMATOLOGY ANALYZER (K052905)Beckman Coulter, Inc.2005-11-18
MATRIX DIGITAL REVERSE OSMOSIS WATER TREATMENT SYSTEM, MODEL EQRMD SERIES (K051620)Better Water, Inc.2005-11-18
MEDITECH MODEL ABPM-04 (K051149)Meditech Kft.2005-11-18
UVBIOTEK MODELS 3200B AND 4000B (K051330)Medtek Lighting Corporation2005-11-18
EXACTECH ZIRAMIC ZIRCONIA 12/14 FEMORAL HEADS (K050398)Exactech, Inc.2005-11-18
QMS ZONISAMIDE REAGENTS, CALIBRATORS AND CONTROLS (K051211)Seradyn, Inc.2005-11-18
JBAIDS ANTHRAC DETECTION SYSTEM (K051713)Idaho Technology, Inc.2005-11-18
THE PHILIPS MP20, MP30, MP40, MP50, MP60, MP70, AND MP90 INTELLIVUE PATIENT MONITORS, WITH 802.11 WIRELESS LAN (K052961)Philips Medical Systems2005-11-18
NON-STERILE, POWDER-FREE NITRILE BLUE & WHITE EXAMINATION GLOVES (K052502)Yty Industry (Manjung) Sdn Bhd2005-11-18
ENCOMPASS SOFTWARE PACKAGE (K053043)Toshiba America Medical Systems, In.C2005-11-18
VINTAGE ZR (K052033)Shofu Dental Corp.2005-11-18
RUBICOR MAGIC BREAST BIOPSY DEVICE (K053151)Rubicor Medical, Inc.2005-11-18
BETACONE HIP PROSTHESIS SYSTEM (K051826)Waldemar Link GmbH & Co. KG2005-11-18
SEEDNET, SEEDNET GOLD, CRYOHIT, CRYOTHERA (K052530)Galil Medical , Ltd.2005-11-18
VOYAGER LINUX WITH TACTILE GUIDANCE SYSTEM (TGS) (K052851)Mako Surgical Corp.2005-11-18
CLINIQA LIQUID QC BILIRUBIN CONTROLS LEVELS 1, 2 & 3; CLINIQA LINICAL BILIRUBIN CALIBRATION VERIFIERS LEVELS A-E (K052679)Cliniqa Corporation2005-11-18
KOKO LEGEND (K051572)Pulmonary Data Services, Inc.2005-11-17
TIGECYCLINE 15UG BBL SENSI-DISC (K052853)Becton, Dickinson & CO2005-11-17
GE 0.35T SIGNA OVATION WITH EXCITE MR SYSTEM (K053009)GE Medical Systems2005-11-17
PHILIPS DISPOSABLE SPO2 SENSORS MII32A AND M1133A. (K052377)Philips Medizin Systeme Boeblingen GmbH2005-11-17
MEDRAD 1.5T PELVIC IMAGING SYSTEM INTERFACE DEVICE (K053042)Medrad, Inc.2005-11-17
ATS SIMULUS ANNULOPLASTY BAND, MODEL 700FC (K052899)Genesee Biomedical, Inc.2005-11-17
AIRLIFE NASAL CONTINUOUS POSITIVE AIRWAY PRESSURE (NCPAP) SYTEM DRIVER (K051226)Cardinalhealth2005-11-17
IMAGECAST PACS (K052618)Idx Systems Corp.2005-11-17
FLEXI-LITE, MODEL FL-V1.2 (K051759)Performance Hyperbarics2005-11-17
TUNA SYSTEM, MODELS 8909, 8929, 8930, 8934 (K052413)Medtronic Vascular2005-11-17
ATS SIMULUS ANNULOPLASTY RING, MODEL 700FF (K052565)Genesee Biomedical, Inc.2005-11-17
GIARDIA/CRYPTOSPORIDIUM CHEK (K051929)Techlab, Inc.2005-11-17
SENTINEL UIBC LIQUID (K051111)Sentinel Ch. Srl2005-11-17
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Every clearance here is in the API, with alerts when new ones post.