Atlas FDA

2006

3,217 FDA 510(k) clearances · Clearance year

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RecordFirmDate
AQUARIUSAPS SERVER (K061214)Terarecon,Inc.2006-05-15
AQUASOFT ALL-DAY & ALL-DAY T (HIOXIFILCON A) DAILY WEAR CONTACT LENS (K052290)Clearlab Pte , Ltd.2006-05-15
MORTARA SURVEYOR TELEMETRY CENTRAL STATION (K060135)Mortara Instrument, Inc.2006-05-15
ELLIPSE 12PL, MODEL 9ESL7228 (K060516)Danish Dermatologic Development A/S2006-05-15
MODIFICATION TO: CARDIMA ABLATION SYSTEM (K060715)Cardima, Inc.2006-05-15
SAUFLON NEW DAY (METHAFILCON A) SOFT (HYDROPHILIC) DAILY DISPOSABLE CONTACT LENSES (K052832)Sauflon Pharmaceuticals, Ltd.2006-05-15
TISSUEMEND SOFT TISSUE REPAIR MATRIX (K060989)Tei Biosciences, Inc.2006-05-15
TRILOGY RADIOTHERAPY DELIVERY SYSTEM (K061140)Varian Medical Systems2006-05-15
ADSCOPE 657BK ELECTRONIC STETHOSCOPE, MODEL 657BK (K060321)American Diagnostic Corp.2006-05-15
PYRENEES CERVICAL PLATE SYSTEM (K060442)K2m, LLC2006-05-15
DATEX-OHMEDA S/5 COMPACT ANESTHESIA MONITOR WITH L-CANE05A AND L-CANE05A SOFTWARE (K061185)GE Healthcare2006-05-15
CATHASSIST (K052952)Physician Technologies, Inc.2006-05-14
FLIGHT (K061186)Aero Innovative Research, Inc.2006-05-12
TSX-201A, AQUILION LB CT SCANNER WITH RESPIRATORY GATING (K061187)Toshiba America Medical Systems, In.C2006-05-12
ZIMMER M/L TAPER HIP PROSTHESIS (K060040)Zimmer, Inc.2006-05-12
POLYAX LOCKED PLATING SYSTEM (K060969)DePuy Orthopaedics, Inc.2006-05-12
DISCON DAILY (ETAFILCON A) ONE-DAY SOFT (HYDROPHILIC) CONTACT LENS (K053191)Innova Vision, Inc.2006-05-12
SURETEK REPROCESSED LAPAROSCOPIC INSTRUMENTS (K052690)Suretek Medical2006-05-12
ULTRAFLEX PRECISION COLONIC STENT, MODELS M00557330, MO00557360, M00557380 (K060323)Boston Scientific Corporation2006-05-12
PARA-PRO FC50 (K053257)Alpha-Tec Systems, Inc.2006-05-12
IVENA VASCULAR PATCH (K060396)Atrium Medical Corp.2006-05-12
MEDTOX OXYCODONE (K060351)Medtox Diagnostics, Inc.2006-05-12
MICRUS COURIER MICROCATHETERS (K060116)Micrus Endovascular Corporation2006-05-12
MODIFICATION TO BODYGUARD INFUSION PUMP SYSTEM (K060479)Caesarea Medical Electronics , Ltd.2006-05-12
BREATH ALCOHOL TEST SYSTEM, MODEL AL-6000 (K060343)Sentech Korea Corp.2006-05-11
LIFE SPINE CEMENT RESTRICTOR (K060247)Life Spine2006-05-11
KONICA MINOLTA PULSOX-300, 300I (K053419)Konica Minolta Sensing, Inc.2006-05-11
BD PHOENIX AUTOMATED MICROBIOLOGY SYSTEM CEPHALOTHIN - GN 1 - 64 UG/ML (K060558)Becton, Dickinson & CO2006-05-11
RS-1000 ZOOM SLITLAMP WITH OPTION (K060869)Rightmedical Products, LLC2006-05-11
MICROPOWER HAND PIECE : MEDIUM SPEED DRILL, SAGGITAL SAW, RECIPROCATING SAW, AND OSCILLATING SAW (K060198)Linvatec Corp.2006-05-11
BACSTOP (K053405)Elcam Medical Acal2006-05-11
ENZYME IMMUNOASSAY, VANCOMYCIN (K060586)Roche Diagnostics Corp.2006-05-11
IG4 IMAGE GUIDED SYSTEM (K060903)Veran Medical Technologies, Inc.2006-05-11
SURETEK MEDICAL REPROCESSED ELECTROSURGICAL ELECTRODES (K052692)Suretek Medical2006-05-10
SIGMA ALPHA VAPORIZER (K060331)Penlon Limited2006-05-10
SYNVITRO CUMULASE (HYALURONIDASE MEDIUM) (K060699)Medicult A/S2006-05-10
HIPSTAR FEMORAL STEM (K051223)Stryker Orthopaedics2006-05-10
ACTALYKE QC KIT, MODELS AQC-HP AND AQC-LP (K061014)Helena Laboratories2006-05-10
CRYOCHECK CLOT APCR (K060284)Precision Biologic, Inc.2006-05-10
LICOX IT2 COMPLETE BRAIN TUNNELING PROBE KIT (K053244)Integra Lifesciences Corp.2006-05-10
NEXA CARPO METACARPAL IMPLANT (K060386)Nexa Orthopedics, Inc.2006-05-10
IF TRUE SINE INTERFERENTIAL STIMULATOR / MODEL WL-2206A1 & WI-2206A2 (K060975)Theratech, Inc.2006-05-10
RHYTHMLINK DISC ELECTRODES (K061148)Rhythmlink International, LLC2006-05-10
MUCHECK V7.0 (K061152)Oncology Data Systems, Inc.2006-05-10
PROFEMUR TL HIP STEM (K060358)Wrightmedicaltechnologyinc2006-05-10
ORAMAGIC PLUS ORAL WOUND RINSE (K060340)Mpm Medical., Inc.2006-05-10
DIMENSION VISTA ALBUMIN, ALKALINE PHOSPHATASE, ASPARTATE AMINO TRANSFERASE, CARBAMAZEPINE & ALANINE AMINO TRANSFERASE (K061020)Dade Behring, Inc.2006-05-10
ARCHITECT ANTI-TG IMMUNOASSAY REAGENTS, CALIBRATORS, CONTROLS AND SYSTEM ASSAY CD-ROM (K052308)Fisher Diagnostics2006-05-10
SURETEK MEDICAL REPROCESSED ARTHROSCOPIC BLADES AND BURS (K052695)Suretek Medical2006-05-10
XPAND RADIOLUCENT CORPECTOMY SPACER (K060665)Globus Medical, Inc.2006-05-10
CEMENT-IT ALL PURPOSE, MODEL N97 (K060698)Pentron Clinical Technologies2006-05-10
ESTECH AORTIC EASY FLOW CANNULA (K060101)Endoscopic Technologies, Inc.2006-05-10
SYSMEX AUTOMATED HEMATOLOGY ANALYZER MODELS XS SERIES (K060656)Sysmex America, Inc.2006-05-10
ROBERTSITE STOPCOCK (K061143)Halkey-Roberts Corp.2006-05-10
EVOLUTION MECHANICAL DILATOR SHEATH SET MODELS-LR-EVN-7.0, LR-EVN-9.0 (K061000)Cook Vascular, Inc.2006-05-10
PLAYTEX SPORT PLASTIC, PLAYTEX SPORT PLASTIC MULTIPACK TAMPONS (K060981)Playtex Products, Inc.2006-05-09
SOLACE POST-OPERATIVE PAIN RELIEF INFUSION SYSTEM (K060933)Apex Medical Technologies, Inc.2006-05-09
ALPHASPHERE ORBITAL IMPLANT (K053298)Hydron Pty Limited2006-05-09
ACCUREX (K061126)Cybermed, Inc.2006-05-09
MICROMANIPULATION MEDIA SYSTEM, LG HYALURONIDASE AND LG PARAFFIN OIL (K053551)<Genx> Intl., Inc.2006-05-09
BIOBLANKET SURGICAL MESH (K061030)Kensey Nash Corporation2006-05-09
ACON AUTOMATIC BLOOD PRESSURE MONITOR KIT, MODEL OB11-111, W/AC ADAPTER, MODEL OB11-112 (K060925)ACON Laboratories, Inc.2006-05-09
AXIOM ARISTOS FX PLUS (K061054)Siemens Medical Solutions USA, Inc.2006-05-09
15.5FR DECATHLON COATED TWIN LUMEN CHRONIC HEMODIALYSIS CATHETER WITH SEPARATED TIPS (K060155)Spire Biomedical, Inc.2006-05-09
GIVEN DIAGNOSTIC SYSTEM (K053639)Given Imaging , Ltd.2006-05-08
CONDYLAFORM II NFC (K060565)Ivoclar Vivadent, Inc.2006-05-08
SYNTHETIC (YELLOW) VINYL PATIENT EXAMINATION GLOVE-POWDER FREE (K060786)Ever Light Plastic Products Co., Ltd.2006-05-08
S. AUREUS PNA FISH (K060099)Advandx, Inc.2006-05-08
ARCADIA MEDICAL SILICONE WIRE REINFORCED ENDOTRACHEAL TUBES (K060094)Arcadia Medical Corporation2006-05-08
OMI RETRACTABLE SAFETY SYRINGE (K060109)Vitalcare Group, Inc.2006-05-05
MODIFICATION TO BLUE SKY BIO DENTAL IMPLANT SYSTEM (K060957)Blue Sky Bio, LLC2006-05-05
ACRO BIOTECH LLC RAPID BENZOYLECGONINE URINE TEST; CATALOG# MET001000 (K053035)Acro Biotech, LLC2006-05-05
RELIENT NAVIGATION DEVICE (K060974)Acclarent, Inc.2006-05-05
GLUCOSE (K060383)Abbott Laboratories2006-05-05
NAVIGANT WORKSTATION WITH NIOBE MAGNETIC NAVIGATION SYSTEM, MODEL NWS05 (K051760)Stereotaxis, Inc.2006-05-05
NODECREST TRANSCRANICAL DOPPLER ULTRASOUND SYSTEM (K060112)Nodecrest, LLC2006-05-05
HOMMED CENTRAL STATION, VERSION 3.5 (K053453)Honeywell Hommed, LLC2006-05-05
ASCENSION PYROSPHERE CMC/TMT (K060560)Ascension Orthopedics, Inc.2006-05-05
INTRODUCER ASSEMBLY WITH ROTATOR LOCK (K060519)Teleflex Medical2006-05-05
OR HEAD COIL 1.5 T (K060758)Siemens Medical Solutions USA, Inc.2006-05-05
INFREX (K060246)Johari Digital Healthcare , Ltd.2006-05-05
BABYBEAT CORDLESS (K061091)The Newman Group, LLC2006-05-04
HOT DOG PATIENT WARMING SYSTEM (K052392)Augustine Biomedical & Design, LLC2006-05-04
IGS VAGINAL SPECULUM (K060129)Innovative Gynecological Solutions, LLC2006-05-04
DEPILITE EL-8B SERIES DERMO FLASH SYSTEMS (K052371)Hair International Systems USA, Inc.2006-05-04
INSURE II (K060930)Enterix, Inc.2006-05-04
KVUE IGRT TREATMENT TABLE TOP, RT-4551KV, KVUE INSERTS AND ACCESSORIES, VARIOUS (K060671)Wfr/Aquaplast Corp.2006-05-04
POWDERED VINYL PATIENT EXAMINATION GLOVES (K060886)Wei Fang Jiuzhou Gloves Co., Ltd.2006-05-04
RC LOOP /DUAL ORTHOCORD SUTURE,RC LOOP W/ETHIBOND SUTURE,RC LOOP W/PANACRYL SUTURE (K060553)Depuy Mitek, A Johnson & Johnson Company2006-05-04
SPIRALOK ANCHOR (K060271)Depuy Mitek, A Johnson & Johnson Company2006-05-04
CAPNOSTREAM20 TWO PARAMETER BEDSIDE MONITOR & CAPNOSTREAM10 ONE PARAMETER BEDSIDE MONITOR (K060065)Oridion Capnography, Inc.2006-05-04
PM-9000 EXPRESS PATIENT MONITOR (K053234)Shenzhen Mindray Bio-Medical Electronics Co., Ltd.2006-05-04
STA-CEPHASCREEN KIT (K053111)Diagnostica Stago, Inc.2006-05-04
STRATUS CS ACUTE CARE CARDIOPHASE HSCRP TEST PAK, CALPAK, DILPAK (K060369)Dade Behring, Inc.2006-05-04
SONICATOR 740, MODEL ME 740 (K053546)Mettler Electronics Corp.2006-05-04
G-SCAN-MODEL 9800020000, E-SCAN MODEL 9800010000 AND E-SCAN XQ-MODELS-9800010011/9800010005,9800010009/9800010004 (K060956)Esaote, S.p.A.2006-05-04
CARBON DIOXIDE (K060295)Abbott Laboratories2006-05-04
AUTOMOBILE LIGHTER POWER CORD (K060549)Pulmonetic Systems, Inc.2006-05-04
REPROCESSED BALOON INFLATION DEVICE (K053188)Sterilmed, Inc.2006-05-04
POWDER-FREE VINYL PATIENT EXAMINATION GLOVES (K060884)Wei Fang Jiuzhou Gloves Co., Ltd.2006-05-04
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Every clearance here is in the API, with alerts when new ones post.