Atlas FDA

2003

3,516 FDA 510(k) clearances · Clearance year

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RecordFirmDate
GLOBAL CAP RESURFACING REPLACEMENT SHOULDER (K031971)DePuy Orthopaedics, Inc.2003-09-24
RODEO MODEL, RD12, RD14, RD16, RADIO TRANSIT MODEL, RD12T, RD14T, RD16T, (K032402)Convaid Products, Inc.2003-09-24
GI SUPPLY BILIARY STENT (K031360)Gi Supply2003-09-24
KONICA LASER IMAGER, MODEL DRYPRO MODEL 771 (K032681)Konica Medical and Graphic Corporation2003-09-24
MODIFICATION TO: AURORA (K032678)Aurora Imaging Technology, Inc.2003-09-24
REPROCESSED ELECTROPHYSIOLOGY CATHETER (K030187)Alliance Medical, Inc.2003-09-24
WU'S 4-WHEELED NEO SCOOTER, WT-M4JR (K032489)Wu'S Tech Co., Ltd.2003-09-24
TELEMIS-MEDICAL SOLUTION (K032157)Telemis S.A.2003-09-24
JUSTWIN SCOOTER, MODEL JS-401 (K032277)Joy Ride Tech Co., Ltd.2003-09-24
HEMAPROMPT GASTRIC (K031356)Aerscher Diagnostics2003-09-24
DRYSTAR 5300 MEDICAL IMAGE PRINTER, MODEL 5300 (K032635)Agfa Corp.2003-09-24
CONTOUR SE MICROSPHERES (SYRINGE) (K032707)Boston Scientific Corp2003-09-23
PALACOS R (K030902)Heraeus Kulzer GmbH & Co. KG2003-09-23
VINYL EXAMINATION GLOVES, POWDER FREE AND PINK COLOR (K031944)Arista Latindo Industrial Ltd. P.T2003-09-23
F-11 FOLDING POWER CHAIR (K032440)Wheelchair & Scooter Express2003-09-23
OPTETRAK TOTAL KNEE SYSTEM ASYMMETRIC FEMORAL COMPONENTS SIZE 6 PSOTERIOR-STABILIZING, CEMENTED FEMORAL COMPONENTS (K032606)Exactech, Inc.2003-09-23
ROWENTA INC. BODYPARTNER VISION, MODEL BM 210 (2079565620) (K023429)Rowenta, Inc.2003-09-23
OSTEOPAL (K030903)Heraeus Kulzer GmbH & Co. KG2003-09-23
STERILE POWDER FREE SYNTHETIC SURGICAL GLOVE WITH POLYMER COATING (K031669)P.T. Saptindo Surgica2003-09-23
CYCLONE ANTERIOR CERVICAL PLATE SYSTEM (K031214)Encore Medical L.P.2003-09-23
TRUFILL DCS ORBIT DETACHABLE COIL AND TRUFILL DCS SYRINGE, ALSO KNOWN AS TRUFILL DCS ORBIT DETACHABLE COIL SYSTEM (K032553)Cordis Neurovascular, Inc.2003-09-23
MICROLIFE DIGITAL UNDERARM ELECTRONIC THERMOMETER, MODEL MT 18E1 (V932) (K032364)Microlife Intellectual Property GmbH2003-09-23
STERILE POWDER FREE LATEX SURGICAL GLOVE WITH POLYMER COATING (K031670)P.T. Saptindo Surgica2003-09-23
CONTOUR EMBOLI PVA AND FASTRACKER-325 INFUSION CATHETER (K030966)Boston Scientific Corp2003-09-23
KSEA OPSERVER LAP (K031895)KARL STORZ Endoscopy-America, Inc.2003-09-23
MEDRAD CONTINUUM MR INFUSION SYSTEM (K032771)Medrad, Inc.2003-09-23
PERSONNA PLUS SAFETY SCALPEL SYSTEM (K032242)Omi Manufacturing Pty., Ltd.2003-09-23
OLYMPUS ULTRASONIC SURGICAL SYSTEM (K031305)Olympus Optical Co., Ltd.2003-09-23
EYESOPEN TONOMETER (K032769)Eye-Deas, LLC2003-09-23
SUTURTEK FASTCLOSE STERNUM CLOSURE DEVICE (K032468)Suturtek Incorporated2003-09-23
PALAMED (K030904)Heraeus Medical GmbH Technology2003-09-23
MYOSYSTEM WITH CUSTOMIZING (K032833)Otto Bock Healthcare LP2003-09-23
PF-2 BATTERY OPERATED ELECTRIC FOUR WHEEL POWER SCOOTER (K031897)Imc-Heart Way LLC2003-09-23
S&T MICROSURGICAL SUTURE (K031531)S & T AG2003-09-23
DIAMOND D HIGH IMPACT DENTURE ACRYLIC (K032773)Mycone Dental Supply Co., Inc.2003-09-23
MODULAR PLUS HIP STEM (K032709)Plus Orthopedics2003-09-23
BEELINE SYSTEM (K032642)Mckinley, Inc.2003-09-23
MODIFICATION TO THE TRABECULAR METAL GLENOID - BIGLIANI/FLATOW THE COMPLETE SHOULDER SOLUTION (K031449)Implex Corp.2003-09-23
GLYCOMARK (K031604)Tomen America, Inc.2003-09-22
LARGE VOLUME FLUID RESERVOIR (K032778)Belmont Instrument Corp.2003-09-22
ACON QUIK-CHECK II MIDSTREAM HOME PREGNANCY TEST (K032510)ACON Laboratories, Inc.2003-09-22
MEDLINE BAND BAGS AND EQUIPMENT COVERS (K032065)Medline Industries, Inc.2003-09-22
ANTHREX TITANIUM OPENING WEDGE OSTEOTOMY SYSTEM (K032187)Arthrex, Inc.2003-09-22
ALEXIS WOUND RETRACTOR (K031889)Applied Medical Resources Corp.2003-09-22
BD PHOENIX AUTOMATED MICROBIOLOGY SYSTEM,-AMPICILLIN 0.5.-32 UG/ML (K032299)Becton, Dickinson & CO2003-09-22
ULTRA-DRIVE 3 (K031280)Biomet, Inc.2003-09-22
ARTHREX TRIMIT SCREW, MODEL AR-4161B (K031945)Arthrex, Inc.2003-09-22
HALM ZIELKE INSTRUMENTATION SYSTEM (K024125)Micomed Ortho GmbH2003-09-22
MODIFICATION TO HIGHGATE CURVED ROD SYSTEM (K023983)Highgate Orthopaedics2003-09-22
PROCLASS PRESS FIT HIP STEM (K032110)Stelkast Company2003-09-22
MACROPORE SURGI-WRAP MAST BIORESORBABLE SHEET (K031955)Macropore Biosurgery, Inc.2003-09-22
ESKA MODULAR HIP SYSTEM CEMENTED (K030867)Eska Implants GmbH2003-09-22
WAGNER CONE PROSTHESIS (K032380)Centerpulse Orthopedics, Inc.2003-09-22
CARBON FIBER COMPOSITE CIRCULAR FIXATION (CIRFIX) DEVICE (HALF RING) (K032169)Cyberorthology, Inc.2003-09-22
LYPHOCHEK COAGULATION CONTROL, LEVEL 4, MODEL 743 (K032611)Bio-Rad2003-09-17
SYNTHES (USA) 3.5/4.5MM LCP MEDIAL PROXIMAL TIBIA PLATES (K032269)Synthes (Usa)2003-09-17
SIMUPLAN TREATMENT PLANNING SYSTEM, MODEL V. 7.5 (K030821)Simuplan S.L.2003-09-17
APAX PACS SYSTEM (K032760)Tis, Inc.2003-09-17
FLEX-NECK PD CATHETER, INFANT (K031351)Medigroup, Inc.2003-09-17
D-STAT-DRY HEMOSTATIC BANDAGE; D-STAT RADIAL HEMOSTATIC BANDAGE (K030836)Vascular Solutions, Inc.2003-09-17
PRECISE RX NITINOL STENT TRANSHEPATIC BILIARY SYSTEM (K032137)Cordis Corp.2003-09-17
TSRH SPINAL SYSTEM (K032578)Medtronic Sofamor Danek, Inc.2003-09-17
SPINAL CONCEPTS, INC. INSIGHT PEDICLE SCREW SYSTEM (K031855)Spinal Concepts, Inc.2003-09-17
BLUE LINE ULTRA SUCTIONAID TRACHEOSTOMY TUBE (K030570)Portex , Ltd.2003-09-17
UNITY NETWORK PATIENT DATA SERVER (K032582)Ge Medical Systems Information Technologies2003-09-17
CRESCENT TINNITUS RETAINING SOUND GENERATOR (K030180)Starkey Laboratories, Inc.2003-09-17
TSRH SPINAL SYSTEM (K031967)Medtronic Sofamor Danek, Inc.2003-09-17
AKERS LABORATORIES INC. BLOOD CELL SEPARATOR (K030815)Akers Laboratories, Inc.2003-09-17
GALIX WINTER (K030145)Galix Biomedical Instrumentation, Inc.2003-09-17
RUBICOR ENCAPSULE BREAST BIOPSY DEVICE, MODEL 30629 (K032584)Rubicor Medical, Inc.2003-09-17
PRIMOSPLINT SYSTEM (K030832)Cosmedent, Inc.2003-09-17
SORB+HISORB+CARTRIDGE (K031099)Renal Solutions, Inc.2003-09-17
CONDUCTIVITY STANDARD SOLUTION-METERCARE (K032075)Ibp Instruments GmbH2003-09-17
R&D DESIGNATION AP-052-5 (K032267)Jensen Industries, Inc.2003-09-17
BECKER TRANSNASAL LACRIMAL (INTUBATION SETS) (K023758)Fci Ophthalmics, Inc.2003-09-17
BD PHOENIX AUTOMATED MICROBIOLOGY SYSTEM-CEFOXITIN-GRAM NEGATIVE (K032567)Becton, Dickinson & CO2003-09-17
ONLINE TDM CARBAMAZEPINE (K031902)Roche Diagnostics Corp.2003-09-17
FETAL SPIRAL ELECTRODE, MODEL FSE07000 (K030691)Clinical Innovations, Inc.2003-09-17
THE LIFECORE STAGE-1 ANGLED ABUTMENT SYSTEM (K032495)Lifecore Biomedical, Inc.2003-09-17
PROCEED TRILAMINATE SURGICAL MESH (K031925)ETHICON, Inc.2003-09-17
VINTAGE AL (K032165)Shofu Dental Corp.2003-09-16
PERIPATCH SHEET, MODELS 1.5P8, 4P4, 4P6, 6P8, 10P16, 1.5P16 (K031948)Pm Devices, Inc.2003-09-16
CANDELA SMOOTHBEAM LASER SYSTEM (K030846)Candela Corp.2003-09-16
SOPRO 61D (K031593)Sopro2003-09-16
MODIFICATION TO CONTOUR SE MICROSPHERES (K032542)Boston Scientific Corp2003-09-16
HYDROCISION ARTHROJET SYSTEM WITH CAUTERY, TURBOBURR AND CURETTE, MODELS 51300, 51310 (K032529)Hydrocision, Inc.2003-09-16
AKONYA ELIMINATOR MECHANICAL THROMBECTOMY DEVICE, MODEL EL 10060060 (K030504)Idev Technologies, Inc.2003-09-16
SHORT INTRODUCER SHEATH (K032569)Rex Medical2003-09-16
BELMONT FLUID MANAGEMENT SYSTEM, MODEL FMS2000 (K032674)Belmont Instrument Corp.2003-09-16
ASAHI PTCA CATHETER GUIDE WIRES, MODELS AGH147000 AND AGH147300 (K032615)Asahi Intecc Co., Ltd.2003-09-16
BEDSIDE MONITOR, MODEL OPV-1500 (K032749)Nihon Kohden America, Inc.2003-09-16
OSSEOTITE IOL IMPLANTS AND OSSEOTITE CERTAIN IOL IMPLANTS (K031632)Implant Innovations, Inc.2003-09-16
MEDLINE REUSABLE SURGICAL GOWNS (100X) (K031933)Medline Industries, Inc.2003-09-16
DIOBEAM 830 (K031499)Soft-Core Texas, Inc.2003-09-16
PENTACAM SCHEIMPFLUG CAMERA (K030719)Oculus Optikgerate GmbH2003-09-16
PRISMA M60/M100 SETS (K032431)Gambro, Inc.2003-09-15
NATURAL COMFORT BATTERY/ELECTRIC BREAST PUMP (K032566)The First Years, Inc.2003-09-15
ACUMEN SURGICAL NAVIGATION SYSTEM (K031337)Biomet, Inc.2003-09-15
3I DENTAL IMPLANTS (K030614)Implant Innovations, Inc.2003-09-15
LIFESIGN HOME DRUG TEST (ECSTASY/MET), STATUS STIK MET & MDMA, ACCUSIGN STIK MET & MDMA, ACCUSTIK MET & MDMA (K023837)Princeton BioMeditech Corp.2003-09-15
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Every clearance here is in the API, with alerts when new ones post.