Atlas FDA

2005

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

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RecordFirmDate
USCOM 1A (K043139)Uscom, Ltd.2005-02-15
ALLUX (K050203)Wieland Dental + Technik GmbH & Co. KG2005-02-14
CALFORMA CALCIUM SULFATE BONE GRAFT BARRIER, MODEL 0.5G/1.0G (K042730)Lifecorebiomedical2005-02-14
VISCUCAM C DIGITAL CAMERA (K043222)Carl Zeiss Meditec, AG2005-02-14
MEDISISS REPROCESSED NON-ELECTRIC GI BIOPSY FORCEPS (K042659)Medisiss2005-02-14
BIOTEQ PIGTAIL DRAINAGE CATHETER SET (ONE STEP TYPE) WITH OR WITHOUT SAFETY STRING LOCK (K033862)Bioteque Corp.2005-02-14
MICROSCAN DRIED GRAM-POSITIVE MIC/COMBO PANELS - ERTAPENEM (K043589)Dade Microscan, Inc.2005-02-14
WU'S POWERED WHEELCHAIR, MAMBO 36X (K050010)Wu'S Tech Co., Ltd.2005-02-11
VANGUARD SSK KNEE SYSTEM (K042757)Biomet, Inc.2005-02-11
MODIFICATION TO AMPHIRION DEEP 0.014 OTW PTA BALLOON CATHETER (K050073)Invatec Innovative Technologies, S.R.L.2005-02-11
HOWMEDICA OSTEONICS ZIRCONIA-TOUGHENED-ALUMINA (BIOLOX DELTA) CERAMIC FEMORAL HEADS (K041940)Howmedica Osteonics Corp.2005-02-11
MILLENNIUM M10 OXYGEN CONCENTRATOR, MODEL M10600; WITH OPI, MODEL M10605 (K043006)Respironics, Inc.2005-02-11
MONARCH NASAL IMPLANT (K041690)Hanson Medical, Inc.2005-02-11
EXPA-SYL (K050180)Produits Dentaires Pierre Rolland2005-02-11
STEALTH PRODUCTS SEATING SYSTEM (K050264)Stealth Products2005-02-11
DEVILBISS AUTOADJUST, MODEL 9054 SERIES (K043282)Sunrise Medical2005-02-11
INF 4160, MODEL D-FJ27F (K043407)Fuji Dynamics Limited2005-02-11
QUICKIE INTERCHANGE FWD W/LIFT POWER WHEELCHAIR (K043435)Sunrise Medical2005-02-11
THE PHILIPS MP20, MP30, MP40, MP50, MP60, MP70 AND MP90 INTELLIVUE PATIENT MONITORS (K050141)Philips Medizin Systeme Boeblingen GmbH2005-02-11
WU'S POWERED WHEELCHAIR, MAMBO F 120 (K050011)Wu'S Tech Co., Ltd.2005-02-11
MICROMEDICS FIBRIJET AIR ASSISTED ENDOSCOPIC APPLICATOR (K042834)Micromedics, Inc.2005-02-11
ENVITEC REUSABLE MULTI-SITE Y SPO2 SENSORS (K043463)Envitec-Wismar GmbH2005-02-11
E-Z FRAME EXTERNAL SURGICAL SUPPORT BOOT (K043289)Signal Medical Corp.2005-02-11
INTERV BRAND SNARELOK BONE MARROW BIOPSY NEEDLE (K043523)Medical Device Technologies, Inc.2005-02-11
ACUPUNCTURE NEEDLES (K043506)Marknew Products2005-02-11
STRYKER SPINE AVS TL PEEK SPACER (K042571)Stryker Spine2005-02-11
EASYSPINE SYSTEM (K043094)Ldr Spine USA2005-02-11
CORAIL AMT HIP PROSTHESIS (K042992)DePuy Orthopaedics, Inc.2005-02-11
ASIAN INTRAMEDULLARY HIP SCREW NAILS (K050226)Smith & Nephew, Inc.2005-02-11
HARVARD 2 SYRINGE PUMP, MODEL 2001-001 (K050107)Harvard Clinical Technology2005-02-11
TRILLIUM BIOPUMP PLUS, MODEL BPX80T (K050109)Medtronic Perfusion Systems2005-02-11
ZOOMCAM LD-10 INTRAORAL CAMERA AND ACCESSORIES (K043325)Rolence Enteprise, Inc.2005-02-11
LUCION (K050033)Mevisys Co., Ltd.2005-02-11
COULTER LH 750 HEMATOLOGY ANALYZER (K050057)Beckman Coulter, Inc.2005-02-10
GEMIFLOXACIN, 5UG BBL SENSI-DISC (K050062)Becton, Dickinson & CO2005-02-10
POTASSIUM TEST KIT AND ELECTROLYTE CAL 1 AND 2 (K043267)Randox Laboratories, Ltd.2005-02-10
TRIDENT ACETABULAR SYSTEM (K033716)Howmedica Osteonics Corp.2005-02-10
EVIS EXERA BRONCHOVIDEOSCOPE, OLYMPUS XBF-160Y3AC, XBF-1T160Y3AC,XBF-Q160Y2AC (K050220)Olympus Medical Systems Corporation2005-02-10
APEX MODULAR HA HIP STEM (K043123)Apex Surgical, LLC2005-02-10
OSTEOFIL, OPTEFIL, REGENAFIL, RTI ALLOGRAFT PASTE (K043420)Regeneration Technologies, Inc.2005-02-10
CD HORIZON SPINAL SYSTEM (K050079)Medtronic Sofamor Danek USA, Inc.2005-02-10
OSTEOMED PEDIATRIC INTRAORAL MANDIBULAR DISTRACTION SYSTEM (K043434)Osteomed LP2005-02-10
MONOCHROME LCD MONITOR, RADIFORCE G51 (K042755)Eizo Nanao Corporation2005-02-10
VECTORVISION OSTEOTOMY (K042513)Brainlab AG2005-02-10
PATHWAY URETERAL ACCESS SHEATH, PATHWAY EXPANDABLE URETERAL ACCESS SHEATH (K043254)Onset Medical Corporation2005-02-10
ELECTROSURGICAL PENCILS (K040780)Hangzhou Shuyou Medical Instrument Company, Ltd.2005-02-10
HEMOCHRON SIGNATURE ELITE (K050016)International Technidyne Corp.2005-02-10
BONE SOURCE HAC RAPID SETTING CEMENT (K043334)Stryker Instruments2005-02-09
CATHETER INTRODUCER (K043525)Galt Medical Corp.2005-02-09
SMD 21500 OR DSB-2103-D-5MP-5M PIXEL GRAYSCALE FLAT PANEL DISPLAY (K043122)Siemens AG2005-02-09
PROSTATE-63 CANCER DIAGNOSTIC TEST (K050063)Asymmetrx2005-02-09
MULTIDIAGNOST ELEVA (K050151)Philips Medical Systems North America, Inc.2005-02-09
HL 188 & HL 189 BODY FAT METER (K043414)Health & Life Co., Ltd.2005-02-09
ALCOHAWK PRECISION (K043188)Q3 Innovations, LLC2005-02-09
DIAMOND MEDISTIM (K041390)Diamond Systems USA, Inc.2005-02-09
RETRACTOFOAM (K050013)Coltene/Whaledent AG2005-02-09
OXYTEC, MODEL 900 (K043615)Oxytec Medical Corporation2005-02-09
SCORPIO NRG KNEE SYSTEM (K042343)Howmedica Osteonics Corp.2005-02-09
HEMOSIL FACTOR XII DEFICIENT PLASMA (K043459)Instrumentation Laboratory CO2005-02-09
CORTISOL AND CORTISOL CALIBRATORS ON THE ACCESS IMMUNOASSAY SYSTEMS (K050202)Beckman Coulter, Inc.2005-02-09
DISCOVERY-MOSAIC TOTAL HUMERUS SYSTEM (K043505)Biomet, Inc.2005-02-09
ORTHOPANTOMOGRAPH OP200, OP200D, AND ORTHOCEPH OC200, OC200D (K043612)Instrumentarium Corp. Imaging Division2005-02-09
LNOPV AD-L AND PD-L OXIMETRY SENSORS (K050068)Masimo Corporation2005-02-09
SONALIS, MODEL 2000 (K043189)3g Ultrasound, Inc.2005-02-09
CANDELA FAMILY OF PULSED DYE LASER SYSTEMS, MODELS VBEAM, CBEAM, SPTL-1B (K043251)Candela Corp.2005-02-09
C&G ACUPUNCTURE NEEDLE (K043277)Helio Medical Supplies, Inc.2005-02-08
SELECT 3D ARTERIAL CANNULA (K043179)Medtronic Perfusion Systems2005-02-08
QUANTIX/OR BLOOD FLOW MONITOR; FLEXIBLE PROBE WITH OPTIONAL VESSEL STABILIZER (K050088)Neoprobe Corp.2005-02-08
LIQUICHEK BNP CONTROL (K043584)Bio-Rad Laboratories, Inc.2005-02-08
EASY CORE BIOPSY SYSTEM II (K050120)Boston Scientific Corp2005-02-08
ADVIA IMS VALPROIC ACID METHOD (K042807)Bayer Healthcare, LLC2005-02-08
CHISON 600M WITH C60 CONVEX PROBE, L700 LINEAR PROBE (K050167)Chison Medical Imaging Co., Ltd.2005-02-08
CALM PATTERNS, VERSION 01.00.00 (K040788)Lms Medical Systems , Ltd.2005-02-08
TINA-QUANT IGG GEN.2 (K050113)Roche Diagnostics Corp.2005-02-08
ADVIA IMS CARBAMAZEPINE METHOD (K042808)Bayer Healthcare, LLC2005-02-08
STEREOTAXIS ENDOVASCULAR GUIDE WIRE (K042854)Stereotaxis, Inc.2005-02-08
QUICKSCREEN OXYCODONE TEST, MODELS 9120, 9120T, 9120X AND 9121 (K043051)Phamatech, Inc.2005-02-07
RABEA SPINAL IMPLANT (K043316)Signus Medizintechnik GmbH2005-02-07
STEALTH FUSION SYSTEM, MODEL RR 1000 (K043174)R&R Medical, Inc.2005-02-07
OLSEN MEDICAL ANTERIOR CERVICAL VERTEBRAE PLATE SYSTEM (K042073)Olsen Medical2005-02-07
KATANA ZIRCONIA (K050160)Noritake Co., Inc.2005-02-07
ONLINE DAT BENZODIAZEPINES PLUS (K043327)Roche Diagnostics Corp.2005-02-07
MEDTRONIC CLIP GUN KIT (K050044)Medtronic Neurosurgery2005-02-07
NAVIGUS NEXDRIVE, MODEL MI-3000 (K043091)Image-Guided Neurologics, Inc.2005-02-07
GEL MARK V (K050090)Senorx, Inc.2005-02-07
ATALIA TITANIUM SURGICAL MESH (K041798)Us Spinal Technologies, LLC2005-02-07
PALM PRO PREMIUM, MODEL 6PF1 & PALM PRO, MODEL 6PF2, LATEX EXAM GLOVE (K050152)Dipped Products (Thailand), Ltd.2005-02-07
LIN/LIOU ORTHODONTIC MINI ANCHOR SYSTEM (LOMAS) (STERILE) (K050257)Mondeal Medical Systems GmbH2005-02-07
VITROS CHEMISTRY PRODUCTS VANC REAGENT, CALIBRATOR KIT 11 AND TDM PERFORMANCE VERIFIERS I, II AND III (K043386)Ortho-Clinical Diagnostics, Inc.2005-02-07
POWDER-FREE VINYL PATIENT EXAMINATION GLOVES, WHITE (NON-COLORED) (K050154)Zibo Zhuangyuan Plastic & Rubber Co., Ltd.2005-02-07
NUVASIVE COROENT SYSTEM (K043405)Nuvasive, Inc.2005-02-07
POWDERED VINYL PATIENT EXAMINATION GLOVES, WHITE (NON-COLORED) (K050155)Zibo Zhuangyuan Plastic & Rubber Co., Ltd.2005-02-07
FREQUENCY DOUBLED ND: YAG PHOTOCOAGULATOR, MODEL VITRA (K043236)Quantel Medical2005-02-07
VITROS CHEMISTRY PRODUCTS TOBRA REAGENT, CALIBRATOR KIT 14 AND TDM PERFORMANCE VERIFIERS I, II AND III (K043384)Ortho-Clinical Diagnostics, Inc.2005-02-07
POWDER FREE SYNTHETIC VINYL EXAMINATION GLOVES, SMALL, MEDIUM, LARGE, X-LARGE (K043499)Shijaizhuang Brilliant Ocean Plastic Co., Ltd.2005-02-04
ZOLL AED PRO EXTERNAL DEFIBRILLATOR (K041892)ZOLL Medical Corporation2005-02-04
INSCOPE 3-STAGE BALLOON DILATOR (K043605)Cordis Europa, N.V.2005-02-04
AFFINITY (CABINET NAME), AC440, HIT440, OR THE COMBINATION OF SYSTEMS (K043219)Interacoustics AS2005-02-04
EMMEBI CENTRAL VENOUS CATHETER KIT WITH LESTEP SAFETY INTRODUCER (K043446)Emmebi Srl2005-02-04
GE DATEX-OHMEDA AESTIVA/5 MRI ANESTHESIA SYSTEM (K050055)Datex-Ohmeda, Inc.2005-02-04
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Every clearance here is in the API, with alerts when new ones post.