Atlas FDA

2004

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

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RecordFirmDate
NOBELRONDO DENTAL CERAMIC-ALUMINA (K041312)Nobel Biocare Uas, Inc.2004-07-23
PIONEER SURGICAL TECHNOLOGY QUANTUM SPINAL SYSTEM (K041167)Pioneer Surgical Technology2004-07-23
GE LOGIQ 7 ULTRASOUND BT04 (K041813)Ge Medical Systems Ultrasound and Primary Care Dia2004-07-23
SMITH & NEPHEW TUMESCENT CATHETER INVERSION SYSTEM, MODEL 7210023 (K041453)Smith & Nephew, Inc.2004-07-22
ACE CONNECT INTERNAL CONNECTION (K041759)Ace Surgical Supply Co., Inc.2004-07-22
GOODKNIGHT 425, MODELM-114500-00 (K041819)Mallinckrodt Developpement France2004-07-22
THERMOTEK Q5 (K041646)Saat , Ltd.2004-07-22
SAS INFLUENZA A TEST (K041441)Sa Scientific, Inc.2004-07-22
SAS INFLUENZA B TEST (K041439)Sa Scientific, Inc.2004-07-22
COOK SIDEARM CORE TISSUE BIOPSY DEVICE (K041544)Urological, Inc.2004-07-22
PHYSICIAN INDUSTRIES RADIOFREQUENCY ABLATION NEEDLE (K040565)Physician Industries, Inc.2004-07-22
MAXIMUS OS (OVERDENTURE SYSTEM) (K041938)BioHorizons Implant Systems, Inc.2004-07-22
MICROSCAN SYNERGIES PLUS GRAM-NEGATIVE MIC/COMBO PANELS (K041150)Dade Behring, Inc.2004-07-22
3DSCOPE (K041213)Direx Systems Corp.2004-07-22
AMBU DISPOSABLE PRESSURE MANOMETER (K040991)Ambu, Inc.2004-07-22
PTFE FELTS AND PLEDGETS (K041716)Boston Scientific Corp2004-07-22
LUMINESCENT IMMUNOASSAY KIT FOR THE DETECTION OF PROGESTERONE IN SALIVA (K040923)Ibl GmbH2004-07-22
IMAGENMD (K041671)Cardiovascular Imaging Technologies, LLC2004-07-22
PEEK CEMENT RESTRICTOR X-BOX (K041583)Innovasis, Inc.2004-07-22
TANITA SCALE PLUS BODY FAT MONITOR WITH BODY WATER PERCENTAGE (K040978)Tanita Corp. of America2004-07-22
OPTISOURCE, MODEL 1032P (K040766)International Brachytherapy S.A.2004-07-22
KERBEROS OCCLUDING GUIDE CATHETER AND ACCESSORIES (K041151)Kerberos Proximal Solutions, Inc.2004-07-22
AFGA CR25.0 COMPUTED RADIOGRAPHY SYSTEM (K041701)Agfa Corp.2004-07-22
LPS (LIMB PRESERVATION SYSTEM) LOWER EXTREMITY DOVETAIL INTERCALARY (K041085)Depuy, Inc.2004-07-22
ONCENTRA-VISIR (K041719)Nucletron Corp.2004-07-22
PATXFER RT (K040931)Brainlab AG2004-07-22
PROTECTIV JELCO SAFETY I.V. CATHETER, MODEL 3600 SERIES (K041345)Medix, Inc.2004-07-22
SUPER REVO HERCULINE SUTURE ANCHOR (K041713)Linvatec Corp.2004-07-22
LUNG CAR 1.1 (K041807)Medicsight2004-07-22
GETTIG UNIVERSAL VIAL ACCESS PIN (K041232)Gettig Pharmaceutical Instrument Co.2004-07-22
EOCD (K041568)Respironics, Inc.2004-07-21
M3290A INTELLIVUE INFORMATION CENTER SOFTWARE RELEASE F.0 AND M4840A PHILIPS TELEMETRY SYSTEM II INCLUDING M4841A PATIEN (K041741)Philips Medical Systems, Inc.2004-07-21
ARCHITECT STAT CK-MB IMMUNOASSAY (K041596)Fisher Diagnostics2004-07-21
MICROLIFE UPPER ARM BLOOD PRESSURE MONITOR, MODEL BP-3BTO-AP (K041411)Microlife Corp.2004-07-21
MAXCEM (K041474)Sybron Dental Specialties, Inc.2004-07-21
VIABIL BILIARY ENDOPROSTHESIS (K041423)W. L. Gore & Associates, Inc.2004-07-21
DYNACAD V1.0 (K041286)Mri Devices Corp.2004-07-21
MAGNETOM ESPREE SYSTEM (K041112)Siemens Medical Solutions USA, Inc.2004-07-21
MED2000 SPA NEBULIZER ANDYFLOW, MODEL A1/C WITH ACCESSORIES (K041327)Med2000 S.R.L.2004-07-20
PRO WALKER PL-200 POWER WHEELCHAIR (K041336)Pro Walker, Inc.2004-07-20
MYO-TRODE SG DISPOSABLE ELECTRODE (K040400)Myotronics-Noromed, Inc.2004-07-20
ZIMMER ANATOMIC II HIP PROSTHESIS (K041109)Zimmer, Inc.2004-07-20
FERTELL MALE FERTILITY TEST (K041039)Genosis , Ltd.2004-07-20
LATIT FLOW (K040465)Ab Ardent2004-07-20
DOVER ROB-NEL CATHETER (K040897)Tyco Healthcare2004-07-20
FS SERIES WHEELCHAIR (K041814)Foshan Dongfang Medical Equipment Manufactory(Ltd)2004-07-20
DIMENSION NT-PROBNP FLEX REAGENT CARTRIDGE METHOD, DIMENSION PBNP CALIBRATOR, MODELS RF423, RC423 (K041417)Dade Behring, Inc.2004-07-20
C1 SERIES PATIENT MONITOR, MODELS 863051, 863052, 863053, 863054; OPTIONAL PRINTER FOR CI, MODEL M3925A (K041376)Analogic Corp.2004-07-20
EXPEDIUM SPINE SYSTEM (K041119)Depuy Spine, Inc.2004-07-19
MEDTRONIC MINIMED PARADIGM MODEL 511 INSULIN PUMP (K041318)Medtronic Minimed2004-07-19
CELIKEY TTG (HUMAN, RECOMBINANT) IGA ANTIBODIES MODEL #18148/18196 (K041174)Sweden Diagnostics (Germany) GmbH2004-07-19
C-TEK C-THRU ANTERIOR CERVICAL PLATE SYSTEM (K041794)Interpore Cross Intl.2004-07-19
RTX3320PSTN WIRELESS TELEHEALTH GATEWAY (K041816)Rtx Healthcare A/S2004-07-19
CALMATRIX CALCIUM SULFATE BONE GRAFT BINDER (K041324)Lifecore Biomedical, Inc.2004-07-19
MODEL BBC-127 BIOPSY BREAST COIL (K041481)Mri Devices Corp.2004-07-19
MODIFICATION TO MEDTRONIC MINIMED PARADIGM MODEL 512 INSULIN PUMP (K041317)Medtronic Minimed2004-07-19
MEDTRONIC OCTOPUS TE STABILIZER & ACCESSORIES (K041338)Medtronic Vascular2004-07-19
GENESIS MEDICAL INTERVENTIONAL F.A.S.T. (FACILITATED ASPIRATION/SUCTION THROMBECTOMY) SYSTEMS (K040010)Genesis Medical Interventional, Inc.2004-07-19
THE M3810A PHILIPS TELEMONITORING SYSTEM WITH M3814A SPO2 UNIT (K041674)Philips Medical Systems2004-07-19
MEDICYL-E-LITE PORTABLE OXYGEN DELIVERY SYSTEM (K033897)Aga-Linde Health Care2004-07-19
FENZIAN TREATMENT SYSTEM (K041575)Eumedic Limited2004-07-16
PTCA STEERABLE HYDROPHILIC GUIDEWIRE (K041624)Lake Region Mfg., Inc.2004-07-16
SPLIT SEPTUM INJECTION SITES (K041042)Fresenius Medical Care North America2004-07-16
OPEN BORE SYRINGE (K041344)Isotis NV2004-07-16
ACTIGRAPH, MODEL AM7164-2.2 AND ACTIGRAPH WITH EXTENDED MEMORY, MODEL AM71256 (K040554)Manufacturing Technology, Inc.2004-07-16
Q-CAP NEEDLE-FREE RECONSTITUTION 13MM VIAL ADAPTER, MODEL 6100-01 (K041564)Bioject Medical Technologies, Inc.2004-07-16
BINDAZYME HUMAN ANTI TISSUE TRANSGLUTAMINASE IGA AND IGG EIA DIAGNOSTIC TEST KITS (K040466)The Binding Site2004-07-16
NEURA WRAP NERVE PROTECTOR (K041620)Integra Lifesciences Corp.2004-07-16
VARELISA GLIADIN IGA ANTIBODIES MODEL #19848/19896 (K041354)Sweden Diagnostics (Germany) GmbH2004-07-16
MEDPOR ATTRACTOR MAGNETIC COUPLING SYSTEM (K040851)Porex Surgical, Inc.2004-07-16
MAGNETOM C! MR SYSTEM (K041111)Siemens Medical Solutions USA, Inc.2004-07-16
MERLIN RESUSCITATOR (K031395)Merlin Medical Limited2004-07-16
EMPOWER TRANSFER SET, (CAT. NO. 7725) (K041178)E-Z-Em, Inc.2004-07-16
SAPPHIRE NXT DETACHABLE COIL SYSTEM (K041649)Micro Therapeutics, Inc.2004-07-16
QUINTON Q-TE; RMS (K041607)Quinton Cardiology, Inc.2004-07-16
OLYMPUS UNSATURATED IRON BINDING CAPCITY REAGENT, OSR6124/0SR6524 (K041793)Olympus America, Inc.2004-07-16
EZ-PAK (EZ-PAK IS A TRADEMARK OF IBT S.A.) (K041702)Ibt SA2004-07-16
MODIFICATION TO ENCOMPASS (K040896)Heartlab, Inc.2004-07-16
RESMED HOSPITAL FULL FACE MASK (K041362)Resmed, Ltd.2004-07-15
CLIP-ON SPACER 20%; 40%; 50% (K041084)Serono, Inc.2004-07-15
NONINVASIVE BLOOD PRESSURE MONITOR, MODELS MD-880B AND MD-900T (K041789)Meditec Co., Ltd.2004-07-15
VAR-PLUS (VORTRAN AUTOMATIC RESUSCITATOR), MODEL PCM (K041473)Vortran Medical Technology 1, Inc.2004-07-15
KENDALL SCD EXPRESS KAMBIA THIGH LENGTH TEARAWAY SLEEVE (K040649)Tyco Healthcare2004-07-15
SYNTHETIC (YELLOW) VINYL PATIENT EXAMINATION GLOVES-POWERED (K041225)Grand Work Plastic Products Co., Ltd.2004-07-15
OXYGEN MEDICELS, CITICELS (K041773)City Technology Limited2004-07-15
POCONE INFRARED SPECTROPHOTOMETER (K041148)Otsuka Pharmaceutical Co., Ltd.2004-07-15
VINYL EXAMINATION GLOVES, POWDER FREE, GREEN COLOR (K041745)Arista Latindo Industrial Ltd. P.T2004-07-15
ALLOMATRIX C PUTTY, ALLOMATRIX CUSTOM PUTTY, ALLOMATRIX DR PUTTY, IGNITE SCAFFOLD, MODELS 860C, 86XC, 86DR, 860D, 860T (K040980)Wrightmedicaltechnologyinc2004-07-14
TSH-CTK-3 IRMA (K041014)DiaSorin, Inc.2004-07-14
AESKULISA ENA 6 S (K041753)Aesku Diagnostics2004-07-14
EUSURE BLOOD GLUCOSE MONITORING SYSTEM (K040678)Eumed Biotechnology Co., Ltd.2004-07-14
THE TRABECULAR METAL RECONSTRUCTION SYSTEM, MODEL 10-340-XXXXX (K040756)Implex Corp.2004-07-14
N-VIVO CALCIUM SCORE ON IA CHASSIS RELEASE, MODEL RELEASE X.XX (K040782)Image Analysis, Inc.2004-07-13
CAPTIA HSV 2 IGG TYPE SPECIFIC ELISA KIT (K033106)Trinity Biotech USA2004-07-13
PORTEX ULTRAPERC PERCUTANEOUS DILATION TRACHEOSTOMY KIT_WITH SERIAL DILATORS OR SINGLE STAGE DILATOR, BLUE LINE ULTRA (K041348)Smiths Medical2004-07-13
SHIMADZU MOBILE X-RAY SYSTEM MUX-100D SERIES (K041763)Shimadzu Corp.2004-07-13
CAPTIA HSV 1 IGG TYPE SPECIFIC ELISA KIT (K033105)Trinity Biotech USA2004-07-13
RAPIDIACOLON (K041761)Infinitt Co., Ltd.2004-07-13
BAWMED RESCUE MASK (K031431)Bawmed UK2004-07-13
INTELIPORT OCCLUDING DEVICE (K040231)Alcon, Inc.2004-07-13
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Every clearance here is in the API, with alerts when new ones post.