Atlas FDA

2009

3,008 FDA 510(k) clearances · Clearance year

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RecordFirmDate
ALATUS VAGINAL BALLOON PACKING SYSTEM (K092534)Radiadyne2009-12-07
WATERLASE MD, MODEL 7100102 (K091746)Biolase Technology, Inc.2009-12-07
STARLIGHT PRO AND SILIVERLIGHT DENTAL CURING LIGHTS (K092951)Mectron S.P.A.2009-12-07
INJECTOR LUER, MODEL N34, INJECTOR LUER LOCK, MODEL N35, INJECTOR LUER LOCK, N35C, CONNECTOR LUER LOCK, MODEL C35, (K092782)Carmel Pharma Ab.2009-12-07
FULLY AUTOMATIC ELECTRONIC BLOOD PRESSURE MONITOR MODEL KD-5963, KD-7963 (K093528)Andon Health Co, Ltd.2009-12-04
POWDER FREE VINYL PATIENT EXAMINATION GLOVES, CLEAR (NON-COLORED) (K092956)Shandong Aobo Medical Co, Ltd.2009-12-04
3M COMPLY BOWIE- DICK TYPE LEAD FREE TEST PACK (K093199)3M Company2009-12-04
GTX GUIDEWIRE, MODELS TBD-GTX 1, 3,6,9,12, 15 (K091582)Medtronic Vascular2009-12-04
OBP SELF SEALING ENDOSCOPIC SEAL WITH LUER LOCK (K091838)Obp Medical2009-12-04
POWDER FREE VINYL PATIENT EXAMINATION GLOVES, LIGHT YELLOW COLOR (K093570)Jiangsu Jaysun Glove Co., Ltd.2009-12-04
SYNCHRON SYSTEMS ENZYMATIC CREATININE (CR-E) REAGENT, MODEL A60298 (K093458)Beckman Coulter, Inc.2009-12-04
D3 FASTPOINT L-DFA RSV/MVP IDENTIFICATION KIT (K093233)Diagnostic Hybrids, Inc.2009-12-04
MD300C318 FINGERTIP PULSE OXIMETER (K092620)Beijing Choice Electronic Technololgy Co., Ltd.2009-12-04
ARTHROCARE SYSTEM 15000 CONTROLLER, ARTHROWANDS (K093165)Arthrocare Corp.2009-12-04
RAYNER SMALL INCISION SINGLE USE SOFT TIPPED INJECTOR, MODEL R-INJ-04/18 (K091507)Rayner Intraocular Lenses , Ltd.2009-12-04
INTEGRA MOZAIK AND OS MOLDABLE MORSELS (K091302)Integra LifeSciences Corporation2009-12-04
TISSU TRANS FILTRON, MODELS 3-TT-FILTRON 2000-500 (K092482)Shippert Medical Technologies Corp.2009-12-04
COBAS INTEGRA GLUCOSE HK GEN 3 ASSAY (K092603)Roche Diagnostics2009-12-04
DISPOSABLE GROUNDING PAD SERIES AND ELECTRODE SERIES (K091672)Shuyou Electric Medical Science Co., Ltd.2009-12-04
DIDGET BLOOD GLUCOSE METER, MODEL 6181; CONTOUR BLOOD GLUCOSE TEST STRIPS, MODEL 7080 (K090628)Bayer Healthcare, LLC2009-12-04
SOUNDSTAR 3D DIAGNOSTIC CATHETER, MODEL M-5723-05 (K091352)Biosense Webster, Inc.2009-12-04
VIAMO SSA-640A VERSION 1.2 (K093171)Toshiba America Medical Systems, In.C2009-12-04
AMIGO ESCORT 7.5, MODEL 760001 PHS (K092936)Amigo Mobility Intl., Inc.2009-12-04
OMNISTIM CONTINENCE+ PELVIC FLOOR STIMULATION SYSTEM (K093600)Accelerated Care Plus2009-12-04
UPPERARM DIGITAL BLOOD PRESSURE MONITOR, MODEL: MB-300 SERIES (K092514)Hangzhou Hua'An Medical & Health Instruments Co.,2009-12-04
EMSI GARMENT ELECTRODES (K090889)Emsi2009-12-04
CARTO 3 VERSION 1.05 EP NAVIGATION SYSTEM AND ACCESSORIES (K093455)Biosense Webster, Inc.2009-12-04
MAS AND MINI-TROL PTH CONTROL (K092749)Microgenics Corporation2009-12-03
SLIT LAMP, MODELS HS-5000, HS-5500 AND HS-7500 (K093639)Huvitz Co., Ltd.2009-12-03
XIA 4.5 SPINAL SYSTEM (K092605)Stryker Spine2009-12-03
INSTRUMED FORCEPS OBSTETRICAL/GYNAECOLOGICAL (K092840)Instrumed International, Inc.2009-12-03
VITA VMK MASTER (K093446)Vita Zahnfabrik H. Rauter GmbH & Co. Kg.2009-12-03
STIMPOD MODEL NMS-400 NERVE STIMULATOR (K093591)Xavant Technology (Pty), Ltd.2009-12-03
ZOLL E SERIES WITH SPCO/SPMET OPTION (K092598)Zoll Medical Corporation, World Wide Headquarters2009-12-03
SIROLASER ADVANCE (K092660)Sirona Dental Systems GmbH2009-12-03
SILS PORT MODEL SILSPT15 (K093372)Covidien Lp, Formerly Registered AS Tyco Healthcar2009-12-03
H100B PULSE OXIMETER (K092727)Edan Instruments, Inc.2009-12-03
POWDER-FREE VINYL PATIENT EXAMINATION GLOVES (K092820)Shijiazhuang Fuhao Plastic Products Co., Ltd.2009-12-03
X-SMART EASY (K092614)Dentsply Interntional2009-12-02
INNOVA VISION, MODEL S18751VN, INNOVA TRACKVISION, MODEL S18751VT, INNOVA EPVISION, MODEL S18751EP (K092639)GE Medical Systems SCS2009-12-02
MEDICAL IMAGE PROCESSING UNIT, MODEL EZSENSOR (K090526)E-Woo Technology2009-12-02
TSO3 OZONE STERILIZER, MODEL 125L (K090636)Tso3, Inc.2009-12-02
MEDSYNAPSE PACS SOFTWARE (K093247)Medsynaptic Private, Ltd.2009-12-02
IG4 ENDOBRONCHIAL, MODEL SYS-0200, NAVIGATION GUIDEWIRE (ACCESSORY TO IG4 ENDOBRONCHIAL), MODEL INS-0300 (K091934)Veran Medical Technologies, Inc.2009-12-02
VERTEX RECONSTRUCTION SYSTEM AND VERTEX SELECT RECONSTRUCTION SYSTEM (K093434)Medtronic Sofamor Danek2009-12-02
PENTAX ED-3490TK, VIDEO DUODENOSCOPE (K092710)Pentax Medical Company2009-12-02
AVITA SCANEO IR THERMOMETER, MODELS TS2X & TS3X SERIES (K092958)Avita Corporation2009-12-02
RTC METERED DOSE INHALER ADAPTERS-SINGLE PATIENT USE, MODEL RTC 24-V, RTC MDI ADAPTER KIT-SINGLE PATIENT USE, MODEL RTC (K091111)Instrumentation Industries, Inc.2009-12-02
INSERTEASE (K092829)Christcot Medical Company2009-12-02
LIFT CHAIR, MODEL T3 (K091578)Pride Mobility Products Corp.2009-12-02
KS-CARE POWDER FREE POLYMER COATED LATEX EXAMINATION GLOVE WITH PROTEIN CONTENT LABELING CLAIM (50UG OR LESS) (K093375)Koon Seng Sdn Bhd2009-12-02
SYNERGY (K093313)Topcon Medical Systems, Inc.2009-12-02
DYNA LOCKING IM NAIL (K092771)U&I Corp.2009-12-02
DUOWEDGE SYNTHETIC BONE SUBSTITUTE (K073214)Kasios2009-12-01
LIPIDPRO SYSTEM (K090405)Infopia Co, Ltd.2009-12-01
OBS DISPOSABLE ELECTROSURGICAL PENCILS, MODELS: OBS-DB, OBS-DR, OBS-DF (K092634)Jiangmen City Xinhui Baisheng Medical Equipment CO2009-12-01
JETSTREAM G3 SYSTEM (K093456)Pathway Medical Technologies, Inc.2009-12-01
ACUSON MODEL X300 DIAGNOSTIC ULTRASOUND SYSTEM (K093531)Siemens Medi Cal Solutions, Inc.2009-12-01
PIVOTEC LUMBAR INTERBODY FUSION DEVICE (LIFD) (K092017)Captiva Spine, Inc.2009-12-01
BIOMET VISION FOOTRING SYSTEM (K093057)Ebi, L.P.2009-12-01
BORA UP 2080, BORA UP 2080 OP AND BORA UP 2080 MOUNTING (K092903)Maquet GmbH and Co. KG2009-12-01
POWDER-FREE VINYL PATIENT EXAMINATION GLOVES (K093277)Tangshan Green Healthcare Co., Ltd.2009-11-30
MODIFICATION TO COMPUTED ORAL RADIOLOGY SYSTEM (K093453)Schick Technologies, Inc.2009-11-30
MAXEMS, MODELS 1000 AND 2000 (K091248)Bio Protech, Inc.2009-11-30
LOW PROFILE ABUTMENTS - INTERNAL AND EXTERNAL CONNECTION (K092341)Biomet 3i, Inc.2009-11-30
CANON DIGITAL FLUOROSCOPY AND RADIOGRAPHY, MODEL CXDI-50RF (K092439)Virtual Imaging, Inc.2009-11-30
TRILOGY MX (K092871)Varian Medical Systems, Inc.2009-11-30
ERBELIFT HAND PUMP AND FLEXIBLE PROBE (K092090)Byrne Medical, Inc.2009-11-30
POWDER-FREE VINYL PATIENT EXAMINATION GLOVES (K093272)Tangshan Huamei Healthcare Co., Ltd.2009-11-30
IG4 IMAGE GUIDED SYSTEM, MODEL: SYS-0200 (K093146)Veran Medical Technologies, Inc.2009-11-30
ETHICON ENDO-SURGERY ROTATING ENDOSCOPIC SCISSORS, MODEL IN2507 (K091824)Ethicon Endo-Surgery, Inc.2009-11-27
POWDERFREE NITRILE (DARK BLUE) EXAMINATION GLOVES (K092160)Comfort Rubber Gloves Ind. Sdn. Bhd.2009-11-27
1103 DIGITAL BLOOD PRESSURE MONITOR, MODEL LD 1103, 1133 DIGITAL BLOOD PRESSURE MONITOR, MODEL LD 1133 (K093359)Shanghai Little Doctor Co. Limited2009-11-27
CERNER CAREAWARE IBUS (K093134)Cerner Corp.2009-11-27
AVITA RADAR THERMO IR THERMOMETER, MODEL NT 152 (K092959)Avita Corporation2009-11-27
FULLY AUTOMATIC ELECTRONIC BLOOD PRESSURE MONITOR MODEL KD-5961, KD-5962, KD-5902 (K093387)Andon Health Co, Ltd.2009-11-27
VIRAMED BIOTECH AG BORRELIA B31 IGG VIRASTRIPE, MODEL V-BBSGUS (K092693)Viramed Biotech AG2009-11-25
RET CAM II, RETCAM 3 AND RETCAM SHUTTLE AND PORTABLE OPHTHALMIC IMAGING SYSTEMS (K090326)Clarity Medical Systems2009-11-25
3.0T 16 CHANNEL HEAD NECK SPINE COIL (K093348)Ge Healthcare Coils (Usa Instruments, Inc.)2009-11-25
MODIFICATION TO UNIGRAFT (K092567)Unicare Biomedical, Inc.2009-11-25
PROPENCIL ESU PENCIL (K092732)Bio Protech, Inc.2009-11-25
EXILIS, MODEL 5000 (K092191)Btl Industries, Ltd.2009-11-25
SVED WOUND TREATMENT SYSTEM (K093564)Innovative Therapies, Inc.2009-11-25
MULTI-BITE HOT BIOPSY FORCEPS (K090796)Endo-Therapeutics, Inc.2009-11-25
EXPEDIUM SPINE SYSTEM (K092473)Depuy Spine, Inc.2009-11-25
GDXPRO (K093521)Carl Zeiss Meditec, Inc.2009-11-25
MONA - ORTHOPEDIC MRI SYSTEM, MODEL TMS-200ORTH-01 (K092230)Time Medical Limited2009-11-25
CEMEX GENTA, GENTA SYSTEM AND GENTA SYSTEM FAST (K092773)Tecres S.P.A.2009-11-24
PRO-LINE CT (BASIC TRAY) MODEL MR28036101 (K093309)Medcomp ( Medical Components)2009-11-24
HG III FIXTURE SYSTEM (K093352)Hiossen, Inc.2009-11-24
PROPLATE, MODELS 9641C, 9641F, P9641C, P9641F, 9642C, 9642F AND P9642C (K092761)Bio Protech, Inc.2009-11-24
POWDER FREE NITRILE EXAMINATION GLOVES BLACK; BLUE, GRAPE SCENTED (K091965)Platinum Glove Industries Sdn. Bhd.2009-11-24
REVLON RVSP3501 SPA MOISTURESTAY PARAFFIN BATH (TYPE SPB3752EA) (K093100)Shenzhen Comfort Technology Co., Ltd.2009-11-24
GEBDI TRIBOS 501 (K092231)Gebdi Dental-Products GmbH2009-11-24
INTRABEAM SYSTEM WITH BALLOON APPLICATOR AND CBG SETS (K090584)Carl Zeiss Surgical GmbH2009-11-24
PNEUMOTHERML, MODEL: 5800 (K092685)Salter Labs2009-11-24
ELANCE VITAL SIGNS MONITOR AND ELANCE CENTRAL STATION (K093501)Spacelabs Medical, Inc.2009-11-24
NBP CUFF (K092999)Draeger Medical AG & Co. KG2009-11-24
NMI PICC II (K093366)Navilyst Medical, Inc.2009-11-24
AXS-590 SERIES (K091650)Swr International, Ltd.2009-11-24
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