Atlas FDA

2005

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

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RecordFirmDate
CARDIOCOM COMMANDER III (K053303)Cardiocom, LLC2005-12-30
AMPLATZER SIZING BALLOON II (K053440)Aga Medical Corp.2005-12-30
PHILIPS AVALON FETAL MONITOR, MODELS FM20 AND FM30 (K052795)Philips Medizin Systeme Boeblingen GmbH2005-12-30
CAAS (K052988)Pie Medical Imaging BV2005-12-30
WAKO DIRECT BILIRUBIN V, MODELS 996-23591, 412-22901, 992-23691, 998-23791 (K053132)Wako Chemicals USA, Inc.2005-12-30
ENCORE CLP OFFSET TOTAL HIP SYSTEM (K052320)Encore Medical Corporation2005-12-30
COMMANDER III NON-INVASIVE BLOOD PRESSURE SYSTEM (K053304)Cardiocom, LLC2005-12-30
TNL-ULTRA ASSAY FOR THE ADVIA CENTAUR SYSTEM (K053020)Bayer Healthcare, LLC2005-12-30
WIRELESS PHYSIOLOGIC MONITORING SYSTEM (K053016)Edwards Lifesciences, LLC2005-12-30
EKOS MICRO-INFUSION SYSTEM (K053432)Ekos Corp.2005-12-30
STRYKER INJECTABLE CEMENT (K051603)Stryker Leibinger Micro Implants2005-12-30
FULL BREATH SLEEP APPLIANCE - AB (ANTERIOR BITE) (K052862)Bryan Keropian Dds2005-12-30
WAKO TOTAL BILIRUBIN V, MODELS 410-22701, 998-23291, 416-22801, 990-23191 (K053131)Wako Chemicals USA, Inc.2005-12-30
FIRST CHECK MULTI DRUG CUP 12 FOR MARIJUANA (THC), COCAINE (COC), AMPHETAMINE (AMP), METHAMPHETAMINE (MET), ECSTASY (K052115)First Check Diagnostics, LLC2005-12-29
DATEX-OHMEDA NETWORK AND ICENTRAL '05, SALES REVISION 4.3 (K052972)GE Healthcare2005-12-29
ABX MICROS CRP 200, OPTION IM (K053308)Horiba Abx2005-12-29
MYOTRAC INFINITI (K053266)Thought Technology , Ltd.2005-12-29
PROTECTOR NEEDLE SHEATH PROP (K052725)Certol International, LLC2005-12-28
ZIMMER COMPUTER ASSISTED SOLUTIONS-ELECTROMAGNETIC AND IMAGELESS KNEE INSTRUMENTATION (K052425)Zimmer, Inc.2005-12-28
VAX-D GENESIS SYSTEM (THERAPEUTIC TABLE) (K053503)Vax-D Medical Technologies USA, L.C.2005-12-28
ALLOCRAFT DBM (K052735)Lifecell Corp.2005-12-28
A-200 POWERED WHEELCHAIR (K052706)Otto Bock Healthcare LP2005-12-27
FETALGARD LITE-NIBP, MODEL FGL-NIBP (K051903)Analogic Corporation2005-12-27
IST PEDICLE SCREW SYSTEM (K053276)Innovative Spinal Technologies, Inc.2005-12-27
TAMPAX PEARL PLASTIC APPLICATOR TAMPONS, ULTRA ABSORBENCY (UNSCENTED AND SCENTED) (K051290)Procter & Gamble Co.2005-12-27
ACUMATCH 12/14 C-SERIES CEMENTED FEMORAL STEMS (SIZE 1-6), ACUMATCH 12/14 L-SERIES CEMENTED FEMORAL STEMS (SIZE 1-5) (K052787)Exactech, Inc.2005-12-27
21.3INCH MONOCHROME LCD MONITOR (K052942)Nec-Mitsubishi Electric Visual Systems Corp.2005-12-27
SMITH & NEPHEW COMPETITOR DUO KNEE FEMORAL (K052265)Smith & Nephew, Inc.2005-12-27
ARTHROCARE PERC-D SPINEWAND (K053447)Arthrocare Corp.2005-12-27
MENTOR NOVASILK MESH (K053414)Mentor Corp.2005-12-27
PROSTIM REUSABLE NEUROSTIMULATION ELECTRODES (K052875)Summit Manufacturing, LLC2005-12-27
TANGORS POLYAXIAL SYSTEM (K052385)Ulrich GmbH & Co. KG2005-12-27
STRYKER COMPARTMENTAL KNEE SYSTEM (K052917)Howmedica Osteonics Corp.2005-12-27
BIOPHEN PROTEIN C5, C2.5, MODELS 221205, 221202 (K050365)Hyphen Biomed2005-12-27
SPECTRA HAIR REMOVAL LASER (K052848)Spectragenics, Inc.2005-12-27
SUPERSTITCH GW, MODELS 06-15-04-GW, 08-15-04-GW (K053482)Sutura, Inc.2005-12-27
AQ-830 SLIM BODY, BODY FAT MONITOR (K052678)Limax Electronics Co., Ltd.2005-12-27
3D ACCU-I-TOMO XYZ SLICE VIEW TOMOGRAPH, MODEL MCT-1 EXF (K052587)J. Morita USA, Inc.2005-12-27
E-Z-EM ENDOSCOPIC CO2 REGULATOR (K053008)E-Z-Em, Inc.2005-12-27
DIMENSION CARDIOPHASE HIGH SENSITIVITY C-REACTIVE PROTEIN CALIBRATOR (K053104)Dade Behring, Inc.2005-12-23
VENTLINK SYSTEM (K052751)Mediserve Information Systems, Inc.2005-12-23
AMBU MARK IV RESUSCITATOR (K053140)Ambu A/S2005-12-23
QMS QUINIDINE. QMS QUINIDINE CALIBRATORS (K052826)Seradyn, Inc.2005-12-23
HEART STG SYSTEM AND SOFTWARE (K052283)Stethographics, Inc.2005-12-23
ZYGOMA 17 ABUTMENT MULTI-UNIT RP 2MM, MODEL 29314; ZYGOMA 17 ABUTMENT MULTI-UNIT RP 3MM, MODEL 29315 (K052885)Nobel Biocare USA, LLC2005-12-23
VITROS CHEMISTRY PRODUCTS DTIBC REAGENT (K052867)Ortho-Clinical Diagnostics, Inc.2005-12-23
VITROS CHEMISTRY PRODUCTS AAT REAGENT, CALIBRATOR KIT 99 AND AAT PERFORMANCE VERIFIERS I, II AND III (K052819)Ortho-Clinical Diagnostics, Inc.2005-12-23
ECLIPSE (CABINET NAME), TEOAE25, EP15, OR THE COMBINATION OF SYSTEMS. (K052562)Interacoustics AS2005-12-23
HDC SPIDER SCREW (K052471)Hdc S.R.L.2005-12-23
COAG-A-MATE MTX III (K051030)bioMerieux, Inc.2005-12-23
BIOPHEN LMWH CONTROL, LMWH CONTROL LOW, UFH CONTROL, HEPARIN CALIBRATOR & UFH CALIBRATOR (K051472)Hyphen Biomed2005-12-23
DIMENSION CARDIOPHASE HIGH SENSITIVITY CRP FLEX REAGENT CARTRIDGE (K053109)Dade Behring, Inc.2005-12-23
AVANT DIGITAL PULSE OXIMETRY SYSTEM, MODEL 4000, 4100 (K052669)Nonin Medical, Inc.2005-12-23
K-ASSAY FERRITIN (2) & FERRITIN CALIBRATOR SET (K050944)Kamiya Biomedical Co.2005-12-23
SMARTSITE VENTED VIAL ACCESS DEVICE, MODEL TBD (K052790)Cardinal Health, Alaris Products2005-12-23
INSULIN PUMP (K051041)Abbott Diabetes Care, Inc.2005-12-23
BP PRO BLOOD PRESSURE MONITOR (K053395)Card Guard Scientific Survival , Ltd.2005-12-23
WEB1000 (K053458)Agfa Corp.2005-12-22
CALM CURVE, VERSION 01.00 (K052715)Lms Medical Systems (Canada), Ltd.2005-12-22
VANGUARD REPROCESSED EXTERNAL FIXATION DEVICES (K053051)Vanguard Medical Concepts, Inc.2005-12-22
ZAN LUNG-FUNCTION LAB (K052328)Zan Messgerate GmbH2005-12-22
TYRX SURGICAL MESH, MODEL SMPC-0501 (K052864)Tyrx Pharma, Inc.2005-12-22
CHEMPAQ XBC ANALYZER (K050758)Chempaq A/S2005-12-22
NEXA BONE PLATE AND SCREW SYSTEM (K053408)Nexa Orthopedics, Inc.2005-12-22
TEWA CJ-TYPE, PJ-TYPE, CB-TYPE AND PB-TYPE ACUPUNCTURE NEEDLES FOR SINGLE USE (K052846)Maanshan Medical Instruments Co., Ltd.2005-12-22
CAREO SAFETY SYRINGE (3CC/ML, 5CC/ML, 10CC/ML) (K052397)Life-Shield Products, Inc.2005-12-22
DYNAREX CPR SHIELD WITH ONE WAY VALVE AND BARRIER FILTER, MODEL 4921 (K052743)Dynarex Corp.2005-12-22
HOSPIRA CATH LAB CONVENIENCE KITS (K052865)Icu Medical, Inc.2005-12-22
NITOM LOCKING FACEBOW (K052553)Russell Samuels Orthodontic Design2005-12-22
AXXENT ELECTRONIC BRACHYTHERAPY SYSTEM (K050843)Xoft, Inc.2005-12-22
ALMITECH INC. DENTAL IMPLANT SYSTEM (K052733)Almitech, Inc.2005-12-22
LIFEPAK, MODEL 1000 (K042404)Medtronic Emergency Response Systems, Inc.2005-12-22
MEDILOG DARWIN HOLTER ANALYSIS (K053369)Huntleigh Healthcare2005-12-22
BD PHOENIX AUTOMATED MICROBIOLOGY SYSTEM - CEFOXITIN GP 1-32 G/ML (K053241)Becton, Dickinson & CO2005-12-22
DRG LARYNGEAL AUGMENTATION IMPLANT DEVICE (K051487)Doctor'S Research Group, Inc.2005-12-22
ADULT CEREBRAL OXIMETER, MODEL 2040 (K051257)Cas Medical Systems, Inc.2005-12-22
UROVANTAGE (K053279)Pck Electronic Industry & Trade Co., Ltd.2005-12-22
ORTHODONTIC POLYMER COMPOSITE BRACKET (K053055)Gestenco International AB2005-12-22
MODIFICATION TO: NXSTAGE PUREFLOW-B SOLUTION (K053286)Nxstage Medical, Inc.2005-12-22
SEASPINE VBR SYSTEM (K052170)Seaspine, Inc.2005-12-21
HSINER JET NEBULIZER, MODEL HS-31100 (K052811)Hsiner Co., Ltd.2005-12-21
CLICKZIP NEEDLE RETRACTABLE SAFETY SYRINGE (K051694)Medical Device Manufacturer (Thailand) , Ltd.2005-12-21
NITRILE BLUE POWDER FREE EXAMINATION GLOVE (K052956)Great Glove Sdn Bhd2005-12-21
LIFESTENT FLEXSTART BILIARY STENT SYSTEM (K053404)Edwards Lifesciences, LLC2005-12-21
MASIMO SET RAD-8 PULSE OXIMETER (K053269)Masimo Corporation2005-12-21
VAPORMAX II (K053457)Trimedyne, Inc.2005-12-21
DENTAPLAST HOT, MODEL 16-XXX (K052780)Bredent-Products For the Dental Technician Laborat2005-12-21
NOVOFINE 32G TIP (K053470)Novo Nordisk, Inc.2005-12-21
GREAT GLOVE POWDER FREE VINYL EXAMINATION GLOVES (K052923)Great Glove (China), Inc.2005-12-21
FEMTEST ENDOMETRIAL SUCTION CURETTE, MODEL FT-1 (K051294)Femspec LLC2005-12-21
MAGSTIM RAPID2, MAGSTIM SUPER RAPID2, MODELS 3004-000, 3005-00 (K051864)The Magstim Company , Ltd.2005-12-21
VITALOGIK (K052288)Mennen Medical , Ltd.2005-12-20
GREAT GLOVE POWDERED VINYL EXAMINATION GLOVES (K052922)Great Glove (China), Inc.2005-12-20
BRAIN VIEWRX VIEWER, VERSION 1.0 (K052467)Kyron Clinical Imaging, Inc.2005-12-20
PANA-SPRAY (K052700)Nsk America Corp.2005-12-20
BRECOMP (K052779)Bredent-Products For the Dental Technician Laborat2005-12-20
MYNEB NEBULIZER, MODEL RDD100 (K053203)Respironics New Jersey, Inc.2005-12-20
ASCENT PIT & FISSURE SEALANT (K053089)CAO Group, Inc.2005-12-20
BARRIERPLUS GOLD ORTHO POWDER-FREE SYNTHETIC POLYISOPRENE ORTHOPEDIC SURGICAL GLOVES (K052772)Barriermed Glove Co.2005-12-20
CYBERSONICS CYBERWAND DUAL PROBE LITHOTRIPTER (K052135)Cybersonics, Inc.2005-12-20
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Every clearance here is in the API, with alerts when new ones post.