Atlas FDA

2004

3,373 FDA 510(k) clearances · Clearance year

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RecordFirmDate
KLS MARTIN DRILL-FREE MMF SCREW (K042573)KLS-Martin L.P.2004-10-18
TECNO REUSABLE BIPOLAR CABLES, MODEL 190-100 AND 190-110 (K042608)Tecno Instruments (Pvt.) , Ltd.2004-10-18
MAXAIR SURGICAL HELMET SYSTEM (K040485)Bio-Medical Devices, Inc.2004-10-18
DYRACT CEM PLUS CEMENT (K041272)Dentsply Intl.2004-10-18
LIFECARE PCA INFUSION SYSTEM WITH HOSPIRA MEDNET SOFTWARE (K042800)Hospira, Inc.2004-10-18
HEPARINASE HR ACT CONTROL, MODEL 550-12 (K042175)Medtronic Vascular2004-10-18
JEJE TEETHER (K034017)Vibe 20002004-10-18
DRG SOFTRELEASE (K041018)Doctor'S Research Group, Inc.2004-10-18
EAR THERMOMETER MODELS ST61, ST62, ST63, ST64, AND ST65 (K042627)Mesure Technology Co., Ltd.2004-10-18
VALIDATE LIPOPROTEIN CALIBRATION VERIFICATION TEST SET, MODEL 501 (K041975)Maine Standards Co.2004-10-15
EXCELSIOR 1018 AND SL-10 MICROCATHETERS (K042568)Boston Scientific Corp2004-10-15
PHILIPS SP02 DISPOSABLE SENSOR, MODEL M1131A (K042306)Philips Medizin Systeme Boeblingen GmbH2004-10-15
ACUSON ACUNAV 8F ULTRASOUND CATHETER (K042593)Siemens Medical Solutions USA, Inc.2004-10-15
ENSITE SYSTEM, MODEL EE3000 (K042493)Endocardial Solutions, Inc.2004-10-15
CAP-ONE, MODEL TG-920P (K040875)Nihon Kohden America, Inc.2004-10-15
INTRAVASCULAR ACCESS INTRODUCER SHEATH (K041506)Applied Medical Resources Corp.2004-10-15
KELES FACEMASK (K041718)Great Lakes Orthodontics, Ltd.2004-10-15
TAMPER EVIDENT ULTRASAFE PASSIVE DELIVERY SYSTEM (K042712)Safety Syringes, Inc.2004-10-15
MODIFICATION TO URETERAL STENT (K040760)Applied Medical Resources Corp.2004-10-15
SILICONE COATED GUIDEWIRE (K041740)Arrow International, Inc.2004-10-15
LIQUI-HEME GLYCO A1C ASSAY (K031296)Biodiagnostic Intl2004-10-15
3M LITTMANN ELECTRONIC STETHOSCOPE, MODEL 3000 (K041934)3M Company2004-10-15
GE DATEX-OHMEDA S/5 NETWORK AND ICENTRAL '03, SALES REVISION 3.3 (K042771)Datex-Ohmeda2004-10-15
INTEGRATED PATIENT MONITORING SYSTEM (K041918)Invivo Research, Inc.2004-10-15
ERBE BICLAMP OPEN AND LAPAROSCOPIC INSTRUMENTS (K033421)Erbe USA, Inc.2004-10-14
WIDE RANGE C-REACTIVE PROTEIN (WR CRP) ASSAY (K041155)Stanbio Laboratory2004-10-14
APNEA RISK EVALUATION SYSTEM (ARES) (K041662)Advanced Brain Monitoring, Inc.2004-10-14
3 SERIES PHOTOTHERAPY CABINET (K042502)Daavlin Distributing Co.2004-10-14
METER TRAX TRILEVEL, LOW LEVEL, MID LEVEL, HIGH LEVEL TRILEVEL MINIPAK (K042336)Bio-Rad Laboratories, Inc.2004-10-14
PINNACLE TPN MANAGEMENT SYSTEM TRANSFER SET (K041222)B.Braun Medical, Inc.2004-10-14
TRANSDERM IONTO SYSTEM, MK 2 (K042590)Mattioli Engineering Corp.2004-10-14
SEEDNET GOLD WITH RENAL KIT, MODEL FPRPR 3021, (RENAL KIT), FPRCH 2024 (SEEDNETGOLD) (K042667)Galil Medical , Ltd.2004-10-14
XTRAC XL, MODEL AL8000 (K041943)Photo Medex, Inc.2004-10-14
PAINPUMP1; PAINPUMP2 (K042405)Stryker Corp.2004-10-14
PRESS TACK NEEDLE (K042063)Asia-Med GmbH & Co. Kg. - Werk Suhl2004-10-14
NYLON THREADED NEEDLE (K042367)Aros Surgical Instruments Corp.2004-10-14
AESKULISA DS DNA G (K041628)Aesku Diagnostics2004-10-14
HEMOVAC BLOOD REINFUSION SYSTEM (K041525)Zimmer, Inc.2004-10-14
EXCALIBUR LIGHT THERAPY SYSTEM, MODEL SGIEX-04-001 (K041530)Stargate International, Inc.2004-10-14
FOUNDATION (K040783)Terumo Corp.2004-10-13
CDX DIGITAL X-RAY IMAGING SYSTEM (K042736)Cnc Imaging, Inc.2004-10-13
NEXGEN COMPLETE KNEE SOLUTION LPS-FLEX PROLONG HIGHLY CROSSLINKED POLYETHYLENE ARTICULAR SURFACES (K042271)Zimmer, Inc.2004-10-13
HEIDELBERG RETINA TOMOGRAPH II / ROSTOCK CORNEA MODULE (HRT II / RCM) (K042742)Heidelberg Engineering2004-10-13
MB 105 MILLENNIUM BLADES (K041110)Millennium Biomedical, Inc.2004-10-13
AMLUCK, YA HORNG (K042581)Ya Horng Electronic Co., Ltd.2004-10-13
INSPIRATION ELITE NEBULIZER COMPRESSOR, WITH NEBULIZER, MODEL HS456 (K042655)Respironics New Jersey, Inc.2004-10-13
BIOMEDIX PADNET LAB (K042616)Biomedix, Inc.2004-10-12
COULTER A T 5DIFF CAP PIERCE (CP) (K042173)Beckman Coulter, Inc.2004-10-12
MODIFICATION TO POLARCATH PERIPHERAL DILATATION SYSTEM (K042541)Cryo Vascular Systems, Inc.2004-10-12
CYBIRD LED CURING LIGHT (K042703)Dxm Co., Ltd.2004-10-12
VERICHIP HEALTH INFORMATION MICROTRANSPONDER AND POCKET READER (DEN040007)Digital Angel Corporation2004-10-12
ETG-4000 OPTICAL TOPOGRAPHY SYSTEM (K042501)Hitachi Medical Corp.2004-10-12
KLIMAMED THERMAL BLANKETS, INCLUDING ARM SHOULDER WEST THERMAL BLANKET AND LEG WARMER THERMAL BLANKET (K031728)Klimamed Technologie Medizingerate GmbH2004-10-12
TWINHEADS TH-103 EXTRACORPOREAL SHOCK WAVE LITHOTRIPTER (K042561)Fmd, LLC2004-10-12
LS FAMILY OF CO2 LASERS INCLUDING: LS-15 LASER SYSTEM (15 WATT) AND LS-25 LASER SYSTEM (25 WATT) (K040563)Sandstone Medical Technologies, LLC2004-10-08
BAXJECT II (K042410)Baxter Healthcare Corp2004-10-08
T2 PROXIMAL HUMERAL NAIL (K042396)Howmedica Osteonics Corp.2004-10-08
FURLONG H-AC TOTAL HIP REPLACEMENT SYSTEM (K041353)Jri Manufacturing, Ltd.2004-10-08
IQQA-CHEST SOFTWARE PACKAGE (K042408)Edda Technology, Inc.2004-10-08
MODIFICATION TO VERTEX RECONSTRUCTION SYSTEM (K042524)Medtronic Sofamor Danek2004-10-08
ACU-STRAP MOTION SICKNESS BAND (K041877)Health Ent., Inc.2004-10-08
COLONGRAPHY SOFTWARE PACKAGE WITH EXTENDED FUNCTIONALITY (K042605)Siemens AG Medical Solutions2004-10-08
ATHENA MULTI-LYTE ANA-II TEST SYSTEM (K042416)Zeus Scientific, Inc.2004-10-08
MEDLINE STRIDER MIDI 4 (K042764)Medline Industries, Inc.2004-10-08
WIDE 1MP LCD MONITOR SYSTEM (K042634)Wide Corporation2004-10-08
BIOSORB FX AND BIOSORB PDX 1.5 AND 2.0 SCREWS (K042517)Linvatec Biomaterials, Ltd.2004-10-08
FABIUS GS/FABIUS TIRO ANESTHESIA SYSTEM (K042419)Draeger Medical, Inc.2004-10-08
MIRAGE SWIFT (K042403)Resmed, Ltd.2004-10-08
THE FUGO BLADE FOR GLAUCOMA (K041019)Medisurg , Ltd.2004-10-08
DORSAL INTRAMEDULLARY PLATE (K042437)Deo Volente Orthopaedics, LLC2004-10-08
AUTO THERM 390, MODEL ME 390 (K042554)Mettler Electronics Corp.2004-10-08
ABL800 FLEX (K041874)Radiometer Medical Aps2004-10-08
ORION ANTERIOR CERVICAL PLATING SYSTEM (K042499)Medtronic Sofamor Danek2004-10-07
IIIZAROV PULLEY SYSTEM (K042436)Smith & Nephew, Inc.2004-10-07
MODIFICATION TO EQUATION FIXATION SYSTEM (K042453)Medtronic Sofamor Danek, Inc.2004-10-07
VERTEX RECONSTRUCTION SYSTEM (K042498)Medtronic Sofamor Danek2004-10-07
EXCELLA-M SPINAL SYSTEM (K042143)Innovasis, Inc.2004-10-07
LOCON VLS DISTAL RADIUS PLATE SYSTEM (K042358)Wrightmedicaltechnologyinc2004-10-07
TITANIUM TELEGRAPH HUMERAL NAIL (K042332)Fournitures Hospitalieres Industrie2004-10-07
SYNTHES (USA) ELASTIC INTRAMEDULLARY NAIL (EIN) SYSTEM (LINE EXTENSION) (K042135)Synthes (Usa)2004-10-07
SYNTHES LOW PROFILE RECONSTRUCTION PLATES (K042377)Synthes (Usa)2004-10-07
NOVEL VBR SPINAL SYSTEM (K042201)Alphatec/Nexmed2004-10-07
DIAZYME SODIUM ENZYMATIC ASSAY (K042189)Diazyme Laboratories2004-10-07
MAESTRO TOTAL WRIST (K042032)Biomet, Inc.2004-10-07
MODIFICATION TO MEDLINE STRIDER MIDI 3 (K042763)Medline Industries, Inc.2004-10-07
SYNTHES 1.0/1.2 MM PLUSDRIVE SCREWS (K042356)Synthes (Usa)2004-10-07
PASCO MIC AND MIC/ID PANELS (K042331)Pasco Laboratories, Inc.2004-10-07
A.M. SURGICAL CPF DISTAL RADIAL EXTERNAL CROSS PIN FIXATION SYSTEM (K042458)A.M. Surgical, Inc.2004-10-07
SUMIT OCT SPINAL SYSTEM AND MOUNTAINEER OCT SPINAL SYSTEM (K042508)Depuy Spine, Inc.2004-10-07
ALPHATEC FEMORAL TROCHANTERIC NAIL (FTN) SYSTEM (K042440)Alphatec/Nexmed2004-10-07
CLARITY FUSION (K042692)Shared P.E.T. Imaging, LLC2004-10-07
MODIFICATION TO BLACKSTONE MODULAR PEDICLE SCREW SYSTEM (K042514)Blackstone Medical, Inc.2004-10-07
AZURYT MODEL CLT 1401, CO2 SURGICAL LASER SYSTEM (K042439)Diamond Age Systems, Inc.2004-10-07
GAMBRO PRISMAFLEX AND GAMBRO PRISMAFLEX M60 & M100 SETS (K041005)Gambro Renal Products2004-10-07
LYPHOCHEK ELEVATED IMMUNOSUPPRESSANT CONTROL, LEVEL 4, 5 (K042324)Bio-Rad2004-10-07
IUR RECIPROCATING MORCELLATOR MODEL # 7210517 (K041774)Smith & Nephew, Inc.2004-10-07
BLEASE SIRIUS ANESTHESIA SYSTEM, MODELS 3000 AND 2000 (K041430)Blease Medical Equipment , Ltd.2004-10-07
EXAM-PACS (K042647)Coactiv, LLC2004-10-07
CLEO 90 INFUSION SET (K042172)Smiths Medical MD, Inc.2004-10-07
PANORAMIC 200A (K042001)Optos Plc.2004-10-07
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Every clearance here is in the API, with alerts when new ones post.