Atlas FDA

2007

2,987 FDA 510(k) clearances · Clearance year

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RecordFirmDate
ADVANCE STATURE FEMORAL COMPONENT (K063731)Wrightmedicaltechnologyinc2007-03-02
DEPUY KNEE PROSTHESIS SYSTEM UNIVERSAL STEM EXTENSIONS AND FEMORAL METAPHYSEAL SLEEVES (K063633)DePuy Orthopaedics, Inc.2007-03-02
APOZA LED CURING LIGHT, MODEL E-MORLIT, D-2000, TOP 3W, TOP 5W (K070373)Apoza Enterprise Co., Ltd.2007-03-02
MATRYX INTERFERENCE SCREW, 239038T5,231025T5,231033T5,231038T5,231125T5,231133T5,231138T5 (K063588)Conmed Linvatec Biomaterials2007-03-02
ABLE GLOVE LATEX POWDERED EXAMINATION GLOVES (K063776)Bright Element Sdn Bhd2007-03-02
DALL-MILES SYSTEM (K070170)Stryker Orthopaedics2007-03-02
FLEXILUX II CYSTOSCOPE AND HYSTEROSCOPE (K060899)Schoelly Imaging, Inc.2007-03-02
WILLSON ONE-FIT HEALTHCARE PARTICLE RESPIRATOR AND SURGICAL MASK, HC-NB095 (K070139)Survivair, Inc.2007-03-02
S4 SPINAL SYSTEM (K062085)Aesculap2007-03-02
RADIESSE LARYNGEAL IMPLANT (K070090)Bioform Medical, Inc.2007-03-01
DERMA YAG (K062762)El.En Electronic Engineering Spa2007-03-01
TRIAGE PROTEIN C CONTROLS AND CALIBRATION VERIFICATION CONTROLS (K062840)Biosite Incorporated2007-03-01
VELOCITYAIS (K070248)Velocity Medical Solutions, LLC2007-03-01
URINE CHEMISTRY ANALYZER UR-50 (K063390)Ind Diagnostic, Inc.2007-03-01
MAXHEALTH MECHANICAL WHEELCHAIR, K1 (K070176)Maxhealth Corp.2007-03-01
CREATION CP-ZI PORCELAIN (K070114)Jensen Industries, Inc.2007-03-01
SYNTHES TROCHANTERIC FIXATION NAIL (TFN) SYSTEM, ADDITIONAL HELICAL BLADES (K070294)Synthes (Usa)2007-03-01
ERCHONIA IOTO_240 (K062792)Erchonia Medical, Inc.2007-03-01
BRACHYSCIENCES STRANDPORT (K062214)Worldwide Medical Technologies, LLC2007-03-01
VARIAN ESOPHAGUS BOUGIE APPLICATOR (K063815)Varian Medical Systems2007-03-01
DELUXE NEBULIZER (K063449)Access Point Medical, LLC2007-03-01
TOP FINE INSULIN SYRINGE (K063348)Daejin Tech Medical Manufacturing Co., Ltd.2007-03-01
FUJINON ULTRASONIC ENDOSCOPE AND PROCESSOR, MODELS EG-530UR, EG-530UT AND SU-700 (K063847)Fujinon, Inc.2007-03-01
AMS SINGLE INCISION SLING SYSTEM (SIS-0) (K070065)American Medical Systems, Inc.2007-03-01
CHAMPION IONTOPHORETIC DRUG DELIVERY DEVICE (K063465)Iomed, Inc.2007-02-28
AMPLATZER RELIANT CATHETER DELIVERY SYSTEM (K070238)Aga Medical Corp.2007-02-28
CTLOGICS NAVIGATIONS SYSTEMS (K063408)Praxim Medivision, SA2007-02-28
LC THERAPY, MODEL LCT-1000 (K070400)Litecure, LLC2007-02-28
POWDERED VINYL PATIENT EXAMINATION GLOVES (K070145)Wuxi Shenzhou Plastic Products Co., Ltd.2007-02-28
SHIJIAZHUANG JUNFEI PLASTICS PRODUCTS CO., LTD. POWDER FREE (WHITE) VINYL PATIENT EXAMINATION GLOVES (K063471)Shijiazhuang Junfei Plastic Products Co., Ltd.2007-02-28
ATLANTIS ABUTMENT FOR 3I CERTAIN MICRO MINI; GEMINI AND GEMINI+ ABUTMENT (K062197)Atlantis Components, Inc.2007-02-28
D-STAT HANDLE, MODEL 8500-053 (K063871)Vascular Solutions, Inc.2007-02-28
ZOLL M SERIES WITH REAL CPR HELP (K062537)ZOLL Medical Corporation2007-02-28
CRITIVIEW, MODEL CRV3 (K062977)Critisense , Ltd.2007-02-28
PRECISION OXYGEN MONITOR (K063096)Precision Medical, Inc.2007-02-27
SYNTHES (USA) RAPID RESORBABLE FIXATION SYSTEM (K062789)Synthes (Usa)2007-02-27
SYNGO DYNAMICS, VERSION 6.0 (K070322)Siemens Medical Solutions USA, Inc.2007-02-27
COLLEAGUE VOLUMETRIC INFUSION PUMP MODEL# 2M8151,8153,8161,8163,9161,9163 (K063696)Baxterhealthcare, Inc.2007-02-27
PORTEX HYPODERMIC NEEDLE-PRO FIXED NEEDLE SYRINGE (K063755)Smiths Medical Asd, Inc.2007-02-27
PALOMAR LUX1540 HANDPIECE (K061652)Palomar Medical Products, Inc.2007-02-27
POWDER-FREE NITRILE PATIENT EXAMINATION GLOVE, WHITE (NON-COLORED) AND BLUE COLORED (K062764)Kossan Latex Industries(M)Sdn Bhd2007-02-27
ELECTRIC POWERED LIFT WHEELCHAIR, MODEL VISION (P13) (K063320)Imc-Heart Way LLC2007-02-27
BIOMET TIBIAL LOCKING NAIL SYSTEM (K063570)Biomet Manufacturing Corp2007-02-27
ELECTRIC POWERED WHEELCHAIR, MODEL - RUMBA SR (4R) (K063307)Imc-Heart Way LLC2007-02-27
ADAPTER PS RP-NP, 34551, ADAPTER PS WP-RP,34552, ABUTMENT SCREW PS RP-NP, 34553, ABUTMENT SCREW PS WP-RP, 34554 (K063592)Nobel Biocare AB2007-02-27
CAPTION APPLICATOR (K063535)Smith & Nephew, Inc.2007-02-26
GC FUJI IX GP EXTRA (K070319)GC America, Inc.2007-02-26
ATLAS SPINE VERTEBRAL BODY REPLACEMENT (K063205)Atlas Spine, LLC2007-02-26
GYNECARE PROSIMA PELVIC FLOOR REPAIR SYSTEMS (K063562)ETHICON, Inc.2007-02-26
SIMPLEX P SPEEDSET WITH TOBRAMYCIN BONE CEMENT (K063857)Howmedica Osteonics Corp.2007-02-26
CONTOUR CURVED CUTTER STAPLER AND RELOADS, MODELS CS40B, CS40G, CR40B AND CR40G (K062869)Ethicon Endo-Surgery, LLC2007-02-26
SURGINETICS ADVANTAGEBLADE (K062350)Surginetics2007-02-26
DIASORIN LIAISON VZV IGG (K061820)DiaSorin, Inc.2007-02-26
BALANCE REHABILITATION UNIT (BRU) (K070085)Medicaa (Uruguay) S.A.2007-02-26
ORIGEN DBM WITH BIOACTIVE GLASS (K062459)Nanotherapeutics2007-02-26
MEDELA DOMINANT 50 LIPO, MODEL 600-5706 (K063336)Medela AG2007-02-26
HF54 COMBINATION ULTRASOUND INTERFERENTIAL AND PREMODULATED STIMULATION SYSTEM (K062256)Hill Laboratories Co.2007-02-26
CERTAIN PREVAIL DENTAL IMPLANT (K061629)Implant Innovations, Inc.2007-02-23
ABLE GLOVE NITRILE BLUE POWDER FREE EXAMINATION GLOVE (K063777)Bright Element Sdn Bhd2007-02-23
STAR ST AND ARRHYTHMIA SOFTWARE, RELEASE H.0 (K070260)Philips Medical Systems2007-02-23
3M HEALTH CARE PARTICULATE RESPIRATOR AND SURGICAL MASK, MODEL 1870 (K063023)3M Company2007-02-23
DIMENSION VISTA APOA1 AND APOB FLEX REAGENT CARTRIDGES AND PROTEIN 1 CALIBRATOR AND CONTROL MEDIUM AND HIGH (K063608)Dade Behring, Inc.2007-02-23
SIGNATURE EDITION INFUSION SYSTEM, MODELS 710X, 720X (K070268)Cardinal Health 303,Inc.2007-02-23
ATLANTIS ANTERIOR CERVICAL PLATE SYSTEM, TRANSLATIONAL PLATE (K063100)Medtronic Sofamor Danek, Inc.2007-02-23
POWDER-FREE VINYL PATIENT EXAMINATION GLOVES (K070149)Wuxi Shenzhou Plastic Products Co., Ltd.2007-02-23
PARI HYDRATE G (K070107)Pari Innovative Manufacturers, Inc.2007-02-23
OMRON MICRO-AIR VIBRATING MESH NEBULIZER, MODEL NE-U22 (K062263)Omron Healthcare, Inc.2007-02-23
HEMOSIL ANTITHROMBIN (K070301)Instrumentation Laboratory CO2007-02-23
BALLOON EXPANDABLE TRANSSEPTAL INDRODUCER, MODELS BETI-1840 AND BETI-1870 (K062852)Onset Medical Corporation2007-02-23
EQUINOXE REVERSE SHOULDER SYSTEM (K063569)Exactech, Inc.2007-02-23
CPAP/VPAP MASKS, MODELS 1225, 1205 AND 1235 (K063268)Hsiner Co., Ltd.2007-02-23
ACUMEN LEAD DELIVERY SHEATH WITH STYLET, MODELS LDS-10-64-STY AND LDS-10-57-STY (K070197)Acumen Medical, Inc.2007-02-23
CARDIODAY, VERSION 2.0 (K070280)Getemed Medizin- Und Informationstechnik AG2007-02-23
WAKO L-TYPE CREATININE-M TEST, AND WAKO CREATININE CALIBRATOR (K061775)Wako Chemicals USA, Inc.2007-02-23
PLATELETWORKS ARACHIDONIC ACID, MODEL PW-ACA (K061991)Helena Laboratories2007-02-23
SYREX HEPARIN LOCK FLUSH SYRINGE, 1 UNIT/ML & 2 UNITS/ML (K061497)Excelsior Medical Corp.2007-02-23
RETIC-CHEX LINEARITY FOR BC (K070199)Streck2007-02-23
DIMENSION VISTA (TM) BHCG FLEX(R) REAGENT CARTRIDGE, AND BHCG CALIBRATOR, MODEL# K6430,KC632 (K063754)Dade Behring, Inc.2007-02-23
POWDERED VINYL PATIENT EXAMINATION GLOVES, YELLOW (K070042)Super Safe Plastic Products Co., Ltd.2007-02-23
ALEUTIAN SPACER SYSTEM (K063399)K2m, Inc.2007-02-23
HI-SLIP AND HI-SLIP PLUS SINGLE USE HYDROPHILIC URINARY CATHETERS AND KIT (K062444)Oasis Medikal Urunler Kimya Sanayi VE Tic A.S.2007-02-22
AMS SMART SLING SYSTEM (K063713)American Medical Systems, Inc.2007-02-22
NANOTITE DENTAL IMPLANTS (K062432)Implant Innovations, Inc.2007-02-22
BIPAP AUTOSV (K063540)Respironics, Inc.2007-02-22
POWDER FREE VINYL PATINET EXAMINATION GLOVES, CLEAR (NON-COLORED) (K070076)Jiangsu Cureguard Glove Co., Ltd.2007-02-22
AQUAMANTYS SS4.0 BIPOLAR SEALER, MODEL 23-121-1 (K063639)Tissuelink Medical, Inc.2007-02-22
560 HIGH DEFINITION CAMERA SYSTEM (K070266)Smith & Nephew, Inc.2007-02-22
ANESTHESIA INFORMATION AND DIGITAL-DRUG MANAGEMENT SYSTEM (K062388)Docusys2007-02-22
MAXO2 CU (K063488)Maxtec, Inc.2007-02-22
SERIES 3 LOTUS LAPAROSCOPIC ULTRASOUND SURGERY SYSTEM (K063531)Sra Developments, Ltd.2007-02-22
PERIOGLAS PUTTY-BIOACTIVE BONE GRAFT GEL (K063596)Novabone Products, LLC2007-02-22
C300 SERIES AIR NEBULIZER COMPRESSOR (K062952)Choice Smart Health Care Co. , Ltd.2007-02-21
ACCU-CHEK ULTRAFLEX INFUSION SET (K070189)Disetronic Medical Systems AG2007-02-21
SBI LATERAL RADIO CAPITELLUM (K070236)Small Bone Innovations, Inc.2007-02-21
PATHIAM IMAGING SOFTWARE FOR HER2/NEU (K062756)Bioimagene, Inc.2007-02-20
SOPRO 162 CAMERA (K070102)Sopro2007-02-20
BIPAP SYNCHRONY (K063533)Respironics, Inc.2007-02-20
BRITEWHITE TEETH WHITENING SYSTEM, MODEL BW1101 (K063704)Beks Incorporated2007-02-20
POWDER FREE VINYL PATIENT EXAMINATION GLOVE (K070037)Shijiazhuang Lianhe Shunda Plastic Products Co., L2007-02-20
STATUS DS NICOTINE, ACCUSIGN NICOTINE, BIOSIGN NICOTINE (K062565)Princeton BioMeditech Corp.2007-02-20
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Every clearance here is in the API, with alerts when new ones post.