Atlas FDA

2004

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

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RecordFirmDate
BAIR HUGGER TEMPERATURE MANAGEMENT SYSTEM (K041686)Arizant Healthcare, Inc.2004-06-30
IMPLANTOLOGY CONTRA ANGLES, ENDODONTIC CONTRA ANGLES, GENERAL DENTISTRY CONTRA ANGLES (K040674)Anthogyr2004-06-30
WEST NILE VIRUS IGM CAPTURE ELISA (K040854)Focus Technologies, Inc.2004-06-30
PRECISION RXI ANALOG X-RAY SYSTEM (K041605)General Medical Merate S.P.A2004-06-30
BMLS03-3 (K033174)Biomedical Life Systems, Inc.2004-06-30
LACTOSCREW SCREW ANCHOR (K033355)Biomet Orthopedics, Inc.2004-06-30
MODIFICATION TO CD HORIZON SPINAL SYSTEM (K041030)Medtronic Sofamor Danek2004-06-30
H-FLOW VALVE (K034043)Elcam Medical Acal2004-06-30
RAICHEM BUN RATE REAGENT (LIQUID) (K041051)Hemagen Diagnostics, Inc.2004-06-30
IMASK TM (K041309)Vital Signs, Inc.2004-06-30
RAICHEM GLUCOSE UV (LIQUID) (K041052)Hemagen Diagnostics, Inc.2004-06-30
TELENABLE EMS SYSTEM (K040663)Molex, Inc.2004-06-30
STRAUMANN DENTAL IMPLANT SYSTEM (K033984)Institut Straumann AG2004-06-30
PORTABLE SLEEP DATA RECORDER (PSDR) (K033402)Pro-Tech Services, Inc.2004-06-30
GUARDIAN NEONATE CPAP/HUMIDIFICATION SYSTEM (K040862)Caradyne, Ltd.2004-06-30
CONTACT DETACH (K041545)Unomedical A/S2004-06-30
MEDPOR CRANIOFACIAL IMPLANTS WITH EMBEDDED TITANIUM MESH (K040364)Porex Surgical, Inc.2004-06-30
CLEAR100 PHOTOTHERAPY SYSTEM, MODEL FGCM0002 (K041569)Curelight, Ltd.2004-06-30
HOSPIRA PHOENIX INFUSION SYSTEM WITH HOSPIRA MEDNET SOFTWARE (K041550)Abbott Laboratories2004-06-30
MODIFICATION TO: MONOJET PREFILL 0.9% SODIUM CHLORIDE FLUSH SYRINGE, MONOJET PREFILL HEPRIN LOCK FLUSH SYRINGE (K032438)Tyco Healthcare2004-06-30
G-BOND (K041471)GC America, Inc.2004-06-29
PRELUDE (K040952)Danville Materials, Inc.2004-06-29
NC SP02 ADAPTER CABLE (K041204)Masimo Corp.2004-06-29
IMAGERAYI (K041580)Henry Schein, Inc.2004-06-29
LIQUICHEK HEMATOLOGY CONTROL (A) (K041457)Bio-Rad2004-06-28
REMOTENURSE PATIENT MONITORING SYSTEM (K041308)Webvmc, LLC2004-06-28
CELLSEARCH EPITHELIAL CELL CONTROL KIT (K040898)Veridex, LLC2004-06-28
SCD EXPRESS PORTABLE COMPRESSION SYSTEM (K040511)Tyco Healthcare/Kendall2004-06-28
BIPRO MODEL SDS-CB200 (K033118)Medical Solutions International2004-06-28
AMBU BLUE SENSOR, MRX, ECG ELECTRODE PRODUCT #:MRX-00-S (K041026)Ambu, Inc.2004-06-28
GC FUSION (K041398)GC America, Inc.2004-06-25
MOBILEMOSFET WIRELESS DOSIMETRY SYSTEM, MODEL TN-RD-70-W (K041557)Thomson & Nielsen Electronics, Ltd.2004-06-25
ONEDOSE PATIENT DOSIMETRY SYSTEM (K040687)Sicel Technologies, Inc.2004-06-25
RAICHEM CALCIUM (OCPC) LIQUID REAGENT (K041009)Hemagen Diagnostics, Inc.2004-06-25
SPSMEDICAL AIRVIEW BOWIE DICK TEST PACK (K041017)Spsmedical Supply Corp.2004-06-25
OPUS MAGNUM ANCHOR WITH INSERTER (K041440)Opus Medical, Inc.2004-06-25
INSTEAD INTIMATE LUBRICANT (K033776)Instead, Inc.2004-06-25
QUANTA LITE GP210 ELISA (K040885)Inova Diagnostics, Inc.2004-06-25
PINNACLE3 RADIATION THERAPY PLANNING SYSTEM (K041577)Adac Laboratories2004-06-25
CELLERATION MIST THERAPY SYSTEM (DEN040004)Celleration2004-06-25
MEDIA CULTURE SYSTEM (K040530)<Genx> Intl., Inc.2004-06-25
TRIAGE PROFILER S.O.B. PANEL (K040437)Biosite Incorporated2004-06-25
ELASTIC SKIN LIQUID BANDAGE (K032948)Medpak, LLC2004-06-25
N-GENEOUS WIDE RANGE CRP REAGENT AND CALIBRATOR SET (K040241)Genzyme Corp.2004-06-25
COLLEAGUE VOLUMETRIC INFUSION PUMPS (K041191)Baxter Healthcare Corp2004-06-25
EBI DISTAL RADIUS PLATING SYSTEM (K040908)Ebi, L.P.2004-06-25
JOEY CLAMP OPENING TOOL (K041332)Maternus, Inc.2004-06-25
WILOSN-COOK BILIARY DILATION BALLOON (K040800)Wilson-Cook Medical, Inc.2004-06-25
CONSERVE PLUS REVISION SHELL AND CONSERVE PLUS THICK SHELL (K041425)Wrightmedicaltechnologyinc2004-06-25
IMALUX OCT PROBE GUIDE (K041077)Imalux Corporation2004-06-25
WAFER SYSTEM (K033303)Spine Wave, Inc.2004-06-24
TSY SHOULDER PLATE IMPLANT (K040850)Orthopedic Sciences, Inc.2004-06-24
BIO-EUROLIG INTERFERENCE SCREW (K031939)Fournitures Hospitalieres Industrie2004-06-24
LIFESTENT LP SDS BILIARY ENDOPROSTHESIS (K041370)Orbus Medical Technologies2004-06-24
TMS SNAPP SOFT NASAL ACCESSORY FOR POSITIVE PRESSURE, MODELS TMS-3020, TMS-3030 & TMS-3040 (K034053)Tiara Medical Systems, Inc.2004-06-24
INSPEKTOR PRO (K040063)Inspektor Dental Care BV2004-06-24
SMARTLITE PS PEN-STYLE LED CURING LIGHT (K041372)Dentsply International2004-06-24
POWDER FREE LATEX EXAMINATION GLOVES (K033533)Apl International Incorporated Limited2004-06-24
HUMAN SUBCUTANEOUS INJECTOR, MODEL HSI 500 (K041280)Felton International, Inc.2004-06-24
MONOCHROME LCD MONITOR, MODEL RADIFORCE G22 (K041597)Eizo Nanao Corporation2004-06-24
MODIFICATION TO VERTE-STACK SPINAL SYSTEM (K041452)Medtronic Sofamor Danek2004-06-24
CEDIA BUPRENORPHINE ASSAY (K040316)Microgenics Corp.2004-06-23
CAPSULE DELIVERY DEVICE, 160CM, MODEL 711143; CAPSULE DELIVERY DEVICE, 210CM, MODEL 711144 (K040494)United States Endoscopy Group, Inc.2004-06-23
DIGITAL FUNDUS CAMERA, MODEL CF-60DSI (K041546)Canon, Inc.2004-06-23
ACCUSOFT (K040474)Direx Systems Corp.2004-06-23
AUTODETECT SYRINGE (K041590)Indigo Orb, Inc.2004-06-23
AESKULISA ANA HEP-2 (K040953)Aesku, Inc.2004-06-23
VITALHEAT (K040911)Dynatherm Medical, Inc.2004-06-22
ISCIENCE SURGICAL OPHTHALMIC MICROCANNULA (K041108)Iscience Surgical Corporation2004-06-22
GE DISCOVERY ST (K041543)GE Healthcare2004-06-22
CODMAN DURAFORM DURAL GRAFT IMPLANT (K041518)Codman & Shurtleff, Inc.2004-06-22
POPSPEK DISPOSABLE ADJUSTABLE VAGINAL SPECULUM (K040817)Advanced Urological Developments2004-06-22
COMPACS, VERSION 1.0 (K041581)Intelligent Images Srl2004-06-22
VOLUME VIEWER PLUS (K041521)General Electric Medical Systems2004-06-22
QBTEST (K040894)Qbtech AB2004-06-22
SOFTSEAL HSG CATHETER (K040238)Modern Medical Equipment Mfg., Ltd.2004-06-22
NAVITRACK SYSTEM - S&N IMAGE FREE HIP, MODEL PRO-03017 (K041369)Orthosoft, Inc.2004-06-22
POWDERED LATEX SURGEON'S GLOVES (K031368)Cephas Medical Private , Ltd.2004-06-22
EDWARDS LIFESCIENCES RESEARCH MEDICAL PEDIATRIC VENOUS RETURN CANNULAE (K033464)Edwards Lifesciences, LLC2004-06-22
MEDICINAL LEECHES (K040187)Ricarimpex Sas2004-06-21
CONCENTRIC RETRIEVER X5, MODEL 90035; CONCENTRIC RETRIEVER X6, MODEL 90037 (K040700)Concentric Medical, Inc.2004-06-21
ALOCLAIR ORAL GEL (K040950)Sinclair Pharmaceuticals, Ltd.2004-06-21
CORDIS PALMAZ BLUE TRANSHEPATIC BILIARY STENT ON SLALOM .018 DELIVERY SYSTEM (K040413)Cordis Europa, N.V.2004-06-21
SYNTHES (USA) PATIENT SPECIFIC CRANIAL/CRANIOFACIAL IMPLANTS (K033868)Synthes (Usa)2004-06-21
PHOENIX PHOTOTHERAPY UNIT CFL, MODEL 101 (K040853)International Hospital Supply Co.2004-06-21
STARPACS ORTHOPEDICS SYSTEM (K041500)Infinitt Co., Ltd.2004-06-21
THERMAGE THERMACOOL SYSTEM (K040135)Thermage, Inc.2004-06-21
TAIDOC CHECK (K041107)Taidoc Technology Corporation2004-06-18
ANGIODYNAMICS, INC., PERCUTANEOUS INTRODUCER AND ELVS PROCEDURE KIT (K040728)AngioDynamics, Inc.2004-06-18
ESPRIT VENTILATOR WITH NICO-ESPRIT INTERFACE OPTION, MODEL V1000 (K041412)Respironics California, Inc.2004-06-18
RED, WHITE & BLUE (K040874)Allesee Orthodontic Appliances2004-06-18
MODIFICATION TO NICO WITH MARS, MODEL 7300 (K041450)Respironics Novametrix, Inc.2004-06-18
MODIFICATION TO HENSCHKE HDR CERVIX APPLICATOR AND HILARIS/NORI HDR CERVIX APPLICATOR (K040704)Mick Radio-Nuclear Instruments, Inc.2004-06-18
LCP RADIAL HEAD PLATING SYSTEM (K040777)Synthes (Usa)2004-06-18
CRYOCHECK CLOT C (K040987)Precision Biologic, Inc.2004-06-18
PTA, PTV, ATRIOSEPTOSTOMY, ANGIOGRAPHIC, SIZING CATHETERS (K040830)NuMED, Inc.2004-06-18
STABIL-O-GRAPH (K041313)I.E.M. GmbH2004-06-18
CHOLETECH LDX HIGH-SENSITIVITY C-REACTIVE PROTEIN (HS-CRP) (K040579)Cholestech Corp.2004-06-18
M3 MICROKERATOME (K032836)Moria SA2004-06-18
VASCULAR SOLUTIONS D-STAT CLAMP HEMOSTATIC CLAMP (K040730)Vascular Solutions, Inc.2004-06-18
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Every clearance here is in the API, with alerts when new ones post.