Atlas FDA

2005

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

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RecordFirmDate
BRIX WHEELCHAIR (K050941)Meyra, Inc.2005-05-05
SKIPPER AND SKIPPER RACE GUIDEWIRE (K050756)Invatec Innovative Technologies, S.R.L.2005-05-05
COMPRESSION ANASTOMOSIS RING (CAR) (K050356)Niti Medical Technologies , Ltd.2005-05-05
GUNTHER TULIP VENA CAVA FILTER SET (K043509)Cook, Inc.2005-05-05
HEMONIR TM (K050014)Nir Diagnostics, Inc.2005-05-05
ACCUCHANGER (K043409)Direx Systems Corp.2005-05-05
ALDAHOL III HIGH-LEVEL DISINFECTANT (K041360)Healthpoint, Ltd.2005-05-05
O-ARM IMAGING SYSTEM (K050996)Breakaway Imaging, LLC2005-05-05
DOPPLER-BOX (K051085)Compumedics Germany Gmgh2005-05-05
DISPOSABLE CONCENTRIC PROBE, DISPOSABLE BIPOLAR PROBE, DISPOSABLE MONOPOLAR PROBE (K050325)Technomed Europe2005-05-05
90XL INSTRUMENTATION SYSTEM (K050812)Mesa Laboratories, Inc.2005-05-05
NEUROLAC NERVE GUIDE (K050573)Polyganics B.V.,2005-05-04
IT NASAL MASK (K050171)Innomed Technologies2005-05-04
THE GUIDED SURGERY CONCEPT (K050393)Nobel Biocare AB2005-05-04
HA COATED LAG SCREW (K050849)Smith & Nephew, Inc.2005-05-04
RET-HE PARAMETER ON THE SYSMEX MODEL XE-2100 AUTOMATED HEMATOLOGY ANALYZER (K050589)Sysmex America, Inc.2005-05-04
BASIS SPINAL SYSTEM (K050484)Medtronic Sofamor Danek, Inc.2005-05-04
WINDSURFER (K050561)Medcon , Ltd.2005-05-04
ABC 2 SCREW (K050813)Aesculap, Inc.2005-05-04
SPIRO'AIR (K042595)Morgan Scientific, Inc.2005-05-04
PROCOTYL-E ACETABULAR SYSTEM (K043073)Wrightmedicaltechnologyinc2005-05-04
LIGHTSPEED CORDLESS ENDODONTIC HANDPIECE (K050612)Lightspeed Technology, Inc.2005-05-04
ORION DIAGNOSTICA UNIQ PINP RIA (K043125)Orion Diagnostica, OY2005-05-04
VITALCARE POWDER FREE SYNTHETIC VINYL EXAMINATION GLOVE (K040916)Vitalcare Group, Inc.2005-05-04
ATA HCM MONOPLACE HYPERBARIC SYSTEM (K040145)Ata Hyperbaric Chamber Manufacturing2005-05-04
LAGUNA PEDICLE SCREW SYSTEM (K050060)Allez Spine, LLC2005-05-04
PMP4 SPIROPRO (K050853)Card Guard Scientific Survival , Ltd.2005-05-04
KNEE FUSION NAIL (K050938)Smith & Nephew, Inc.2005-05-04
CARDIOVIT AT-10PLUS (K050686)Schiller AG2005-05-04
THE LF-P CERAMIC SYSTEM (K050838)Jensen Industries, Inc.2005-05-04
SPACELABS MEDICAL MULTIPARAMETER MODULE 91496 (K050605)Spacelabs Medical, Inc.2005-05-03
MODIFICATION TO MBCP (K043005)Biomatlante2005-05-03
E-TYPE STRAIGHT HANDPIECE, MODEL AHP-101 (K051077)Aseptico, Inc.2005-05-03
NTI TENSION SUPPRESSION SYSTEM, WITH A SNOREHOOK APPLICATION (K041184)Nti-Tss, Inc.2005-05-03
MICROCYN WOUND CARE DRESSING (K041161)Oculus Innovative Sciences, Inc.2005-05-03
REMREST HEATED HUMIDIFIER (K050990)Medical Industries America, Inc.2005-05-02
N ANTISERA TO HUMAN COMPLEMENT FACTORS (C3C, C4) (K050665)Dade Behring, Inc.2005-05-02
ACCU-CHEK INTEGRA SYSTEM (K050872)Roche Diagnostics Corp.2005-05-02
ERCHONIA EVRL LASER (K050672)Erchonia Medical, Inc.2005-05-02
AMSINO I.V. START KIT (K050654)Amsino International, Inc.2005-05-02
EASYSPRAY AND SPRAY SET FOR TISSEEL (FIBER SEALANT) (K050495)Baxter Healthcare Corp., Bioscience2005-05-02
HEMOSIL FACTOR II DEFICIENT PLASMA (K050661)Instrumentation Laboratory CO2005-05-02
EMBRYO TRANSFER CATHETER WITH ACCESSORY STYLET, MODELS 9018, 9023, 9018-S, 9023-S (K050521)Inntec, Inc.2005-05-02
SECURALLOY, SEPTALLOY NG 50 AND SEPTALLOY NG 70 (K051010)Septodont2005-05-02
PREMERE DELIVERY SHEATH, MODEL PDS (K043084)Velocimed, Inc.2005-05-02
AMSINO SUTURE REMOVAL KIT (K050656)Amsino International, Inc.2005-05-02
BD PHOENIX AUTOMATED MICROBIOLOGY SYSTEM, LEVOFLOXACIN (STREP) 0.25-16 UG/ML (K050747)Becton, Dickinson & CO2005-04-29
ELECTRODE JUNCTION BOX, MODEL JE-921A (K050833)Nihon Kohden America, Inc.2005-04-29
DRAEGER MEDICAL INFORMATION BUS (MIB, MIB II, MIB DUO) PROTOCOL CONVERTERS (K050974)Draeger Medical Systems, Inc.2005-04-29
THE NOTAL VISION PREVIEW PREFERENTIAL HYPERACUITY PERIMETER (PREVIEW PHP) (K050350)Notal Vision, Inc.2005-04-29
REM440 (K050496)Interacoustics A/S, Assens2005-04-29
LIFESHIRT REAL-TIME WITH VIVOMONITOR SOFTWARE (K043604)Vivometrics, Inc.2005-04-29
DBX DEMINERALIZED BONE MATRIX PUTTY, PASTE AND MIX (K040501)Musculoskeletal Transplant Foundation2005-04-29
DIASORIN LIAISON EBNA IGG, LIAISON VCA IGG, LIAISON VCA IGM ASSAYS (K040120)DiaSorin, Inc.2005-04-29
EPS EASY PAIN SUPREME SELF MONITORING BLOOD GLUCOSE SYSTEM (K043245)Eps Bio Technology Corp.2005-04-29
INTUITIVE SURGICAL DA VINCI SURGICAL SYSTEM, MODEL IS2000 (K050369)Intuitive Surgical, Inc.2005-04-29
VISION-SCIENCES ENT-3000 SCOPE (K050972)Vision-Sciences, Inc.2005-04-29
ATHENA MULTI-LYTE EBV IGG TEST SYSTEM (K042118)Zeus Scientific, Inc.2005-04-29
UCP RAPID DRUG SCREENING TESTS (K050540)Ucp Biosciences, Inc.2005-04-29
DIODENT II DENTAL LASER SYSTEM (K050274)Hoya Photonics, Inc.2005-04-29
MODELS CRYSTAL 512, RECORD 618, OPTIMA 518 PHOTO EPILATION SYSTEMS (K050950)Active Optical Systems, Ltd./Efraim Bidas2005-04-29
LIQUICHEK URINE TOXICOLOGY CONTROL (LEVEL C1) (K050682)Bio-Rad Laboratories, Inc.2005-04-29
BD PHOENIX AUTOMATED MICROBIOLOGY SYSTEM, VANCOMYCIN (STREP) 0.0625 -32 UG/ML (K050745)Becton, Dickinson & CO2005-04-29
NITI-S STENT & INTRODUCER, MODEL EOXXXX (K041648)Taewoong Medical Co., Ltd.2005-04-28
D-CARIE, MODEL N121-M1 (K043156)Neks Technologies, Inc.2005-04-28
COMPEL SURGICAL GOWNS (K041539)Standard Textile Co., Inc.2005-04-28
ANGIOJET DVX RHEOLYTIC THROMBECTOMY CATHETER (K050794)Possis Medical, Inc.2005-04-28
ZILOS-TK, VERSION 3, ZILOS-TK, VERSION 4 (K050768)Hamilton Thorne Biosciences2005-04-28
RX90 LOW PROFILE ACETABULAR SYSTEM (K042989)Biomet, Inc.2005-04-28
CERAMAGE (K050401)Shofu Dental Corp.2005-04-28
AIP INTENSE PULSED LIGHT SYSTEM (K041554)Aesthera Corporation2005-04-27
SPINEMED S200B/S200C (K051013)Cert Health Sciences, LLC2005-04-27
REUSABLE TEMPERATURE PROBES (M1024254 SKIN TEMPERATURE PROBE, REUSABLE; M1024247, GP TEMPERATURE PROBE, ADULT, RESUABLE (K050837)GE Healthcare2005-04-27
ACCU-CHEK AVIVA SYSTEM (K043474)Roche Diagnostics Corp.2005-04-27
LIQUICHEK CARDIAC MARKERS PLUS CONTROL, LIQUICHEK CARDIAC MARKERS PLUS CONTROL LT, LIQUICHEK CARDIAC MARKERS PLUS (K050537)Bio-Rad2005-04-27
MICROMEDICS SPHENOID SINUS STENT (K050340)Micromedics, Inc.2005-04-27
AESCULAP ORTHOPILOT 2 THA V 2.0 (K050752)Aesculap, Inc.2005-04-27
INFPUMP INFILTRATION PUMP (K050324)Carolina Medical, Inc.2005-04-27
SYNTHES (USA) 3.5MM CONICAL SCREWS (K050683)Synthes (Usa)2005-04-27
EPIGUARD (K050188)Episafe Medical Devices, Ltd.2005-04-27
DIGITAL RADIOGRAPHY MODEL CXDI-40EG (K050987)Canon, Inc.2005-04-27
COLACTIVE COLLAGEN WOUND DRESSING (K050177)Covalontechnologies, Inc.2005-04-27
HVO, INC., DISPOSABLE NON-STERILE SURGICAL DRAPES (K050508)Haywood Vocational Opportunities2005-04-27
EKOS ULTRASOUND INFUSION SYSTEM (K041826)Ekos Corp.2005-04-27
CENTRION 500 C-ARM SYSTEM (K050866)Osteosys Co.,Ltd2005-04-27
DATAPRO CLINICAL CHELISTRY ANALYZER (K042767)Thermo Electron Corporation2005-04-27
NEXUS DETACHABLE COIL SYSTEM (K050543)Micro Therapeutics, Inc.2005-04-27
QUANTIA LA(A) (K050487)Biokit, S.A.2005-04-26
APPLE MEDICAL/OB MOBIUS ELASTIC RETRACTOR (K050256)Apple Medical Corp.2005-04-26
VARELISA RECOMBI ANA PROFILE, MODEL 18496 (K050625)Sweden Diagnostics (Germany) GmbH2005-04-26
DISTAL VOLAR RADIUS ANATOMICAL PLATE SYSTEM (K050932)Hand Innovations, Inc.2005-04-26
SYNTHES (USA) 3.5/4.5MM LCP MEDIAL PROXIMAL TIBIA PLATES (K050646)Synthes (Usa)2005-04-26
MAXSIGHT (POLYMACON) SPORT-TINTED CONTACT LENS (K050157)Bausch & Lomb, Inc.2005-04-26
HEMOSIL D-DIMER HS (K050544)Instrumentation Laboratory CO2005-04-26
ABX PENTRA DX 120: OPTION SPS EVOLUTION (K050719)Horiba Abx2005-04-26
LERADO, AVANTICARE MECHANICAL WHEELCHAIR, MR-9000 (K050708)Lerado Oversea Ltd. Twn Branch (Bvi)2005-04-26
AXON SYSTEMS SUBDERMAL NEEDLE ELECTRODES (K050194)Axon Systems, Inc.2005-04-26
20.8-INCH (53CM) COLOR LCD MONITOR, MODELS CDL2112A, CCL350I & DV3MC-HB (K050619)Totoku Electric Co., Ltd.2005-04-26
XACT.CARDIAC & XPRESS.CARDIAC (K050815)Ultraspect , Ltd.2005-04-26
ECLIPSE LATEX POWDER FREE STERILE SURGEON'S GLOVE (K050533)Regent Medical Americas, LLC2005-04-26
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Every clearance here is in the API, with alerts when new ones post.