Atlas FDA

2010

2,807 FDA 510(k) clearances · Clearance year

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RecordFirmDate
ACE FREEDOM INTERNAL HEXAGON DENTAL IMPLANT SYSTEM (K102981)Ace Surgical Supply Company, Inc.2010-12-20
MINI AND MICRO FRAGMENTS RECONSTRUCTION SYSTEM-NEOFACE (K102641)Neoortho Produtos Ortopedicos S/A2010-12-20
TWISTCUT ENDOSORB SCREWS (K102777)Merete Medical GmbH2010-12-20
DANA REUSABLE TEST PACK FOR STEAM STERILIZATION (K102761)Dana Products, Inc.2010-12-20
PRELUDE II TOUNGE SUSPENSION SYSTEM (K103179)Siesta Medical, Inc.2010-12-20
SYNTHES ZERO-P (K093762)Synthes Spine2010-12-20
INERTIA PEDICLE SCREW SYSTEM (K101278)Nexxt Spine, LLC2010-12-20
MEDACTA TOTAL HIP PROSTHESIS SYSTEM - AMISTEM C & QUADRA C SHORT NECK (K103189)Medacta International S.A.2010-12-20
POWDER FREE VINYL PATIENT EXAMINATION GLOVES, CLEAR (NON-COLORED) (K102977)Heze Juxinyuan Food Co., Ltd.2010-12-20
RHEAD RADIAL HEAD EXTENDED STEMS (K102180)Small Bone Innovations, Inc.2010-12-20
COWELL IMPLANT SYSTEM (K100850)Cowellmedi Co., Ltd.2010-12-20
IMC PISTON SYRINGES (K102969)International Medsurg Connection2010-12-20
SYNTHES DENTOALVEOLAR BONE FIXATION SYSTEM (K102656)Synthes (Usa)2010-12-20
CAMINO 110-4B OLM INTRACRANIAL PRESSURE MNITORING KIT; CAMINO 110-4G POST CRANIOTOMY SUBDURAL PRESSURE MONITORING KIT; C (K102875)Integra LifeSciences Corporation2010-12-20
HITACHI ECHELON NV ATTACHMENT AND SMALL EXTREMITY COILS MODEL ECHELON (K102889)Hitachi Medical Systems America, Inc.2010-12-20
POWDER-FREE VINYL PATIENT EXAMINATION GLOVES (K103198)Youngshengplastic Co., Ltd.2010-12-20
POWDER-FREE VINYL PATIENT EXAMINATION GLOVES (K102724)Zibo Yuqun New Material Science and Technology CO2010-12-20
PT-MULTI-CALIBRATOR, MODEL OPAT07 (K093848)Dade Behring, Inc.2010-12-20
HIGH PRESSURE SETS-400 PSI (K100576)Icu Medical, Inc.2010-12-17
SMARTO (K101563)Jeil Medical Corporation2010-12-17
CHAD THERAPEUTIC EVOLUTION ELECTRONIC OXYGEN CONSERVER (K103392)Inovo, Inc.2010-12-17
PEAK PLASMABLADE PLUS TISSUE DISSECTION DEVICE (K102709)Peak Surgical, Inc.2010-12-17
HARDYDISK AST CEFTAROLINE, 30 UG MODEL Z939 (K103538)Hardy Diagnostics2010-12-17
UNITY NETWORK ID (K103432)Ge Medical Systems Information Technologies, Inc.2010-12-17
NIHON KHDEN PREFENSE EDNS-9000 SERIES CENTRAL NURSE STATION (K102106)Nihon Kohden Corp.2010-12-17
DIMENSION VISTA DIGITOXIN CALIBRATOR - DGTX CAL (K103360)Siemens Corp.2010-12-17
REGIONAL OXIMETER (K102715)Nonin Medical, Inc.2010-12-17
EXPEDIUM SPINE SYSTEM (K102249)Depuy Spine, A Johnson & Johnson Company2010-12-16
SUPERCROSS MICROCATHETER (130 CM), SUPERCROSS MICROCATHETER (150 CM) MODEL 5300, 5301 (K101659)Vascular Solutions, Inc.2010-12-16
NITRILE CORNFLOWER BLUE POWDER-FREE EXAMINATION GLOVES WITH TESTED FOR USE WITH CHEMOTHERAPY DRUG LABELING CLAIM (K103249)Cardinal Health, Inc.2010-12-16
ENDO FLIP (K102214)Crospon, Ltd.2010-12-16
AFFINITY PIXIE ARTERIAL FILTER WITH BALANCE BIOSURFACE (K100646)Medtronic, Inc.2010-12-16
CERALAS E/ 1470NM FIBER-COUPLED DIODE LASER FAMILY; CREALAS HPD MULTIWAVELENGHT 980NM/ 1470NM FIBER-COUPLED DIODE LASER (K102755)Biolitec, Inc.2010-12-16
GSP NEONATAL IRT KIT (3306-001U) (K102419)Wallac Oy, Subsidiary of Perkinelmer2010-12-16
GNR TRAFFIC LIGHT PNA FISH (K101558)Advandx, Inc.2010-12-16
IBED WIRELESS WITH IBED AWARENESS (K103536)Stryker Corporation2010-12-16
VIPI BLOCK (K102341)Vipi Industria,Comercio,Exportacao E Importacao DE2010-12-16
STRAUMANN MEMBRAGEL (K101956)Straumann USA (On Behalf of Institut Straumann Ag)2010-12-16
NOVEL III SPINAL FIXATION AND ADJUSTABLE BRIDGE SYSTEM (K103147)Medyssey Co, Ltd.2010-12-16
POSTERIOR LATERAL PLATES (K103408)DePuy Orthopaedics, Inc.2010-12-16
SYNTHES ORTHODONTIC BONE ANCHOR SYSTEM (K093299)Synthes (Usa)2010-12-16
EUROMI EVA SP6 (K101413)Euromi S.A2010-12-16
CERVICAL STANDALONE INTERVERTEBRAL BODY FUSION DEVICE (K102323)Theken Spine, LLC2010-12-16
PEAK PULSAR II GENERATOR MODEL PS100-102 (K102029)Peak Surgical, Inc.2010-12-16
STIMPOD NMS450 NERVE STIMULATOR (K102084)Xavant Technology (Pty), Ltd.2010-12-16
COMPOSIX L/P MESH WITH ECHO PS POSITIONING SYSTEM (K102766)C.R. Bard, Inc.2010-12-16
VU CPOD INTERVERTEBRAL BODU FUSION DEVICE (K101363)Musculoskeletal Clinical Regulatory Advisers2010-12-16
AVITA WRIST TYPE BLOOD PRESSURE MONITOR (K102624)Avita Corporation2010-12-16
IMMUNOCAP ALLERGEN F20, ALMOND MODEL: 14-4179-01 (K100999)Phadia AB2010-12-15
DEPUY GLOBAL UNITE SHOULDER SYSTEM (K101996)Depuy(Ireland)2010-12-15
ACTIVON TULLE (K101118)Calidad Solutions, Inc.2010-12-15
CONTOURS LAPIDUS PLATING SYSTEM (K102201)Orthofix, Inc.2010-12-15
V.A.C. GRANUFOAM SILVER SMALL DRESSING; V.A.C. GRANUFOAM SILVER MEDIUM DRESSING; V.A.C. GRANUFOAM SILVER LARGE DRESSING (K102956)Kci USA, Inc. (Kinetic Concepts, Inc.)2010-12-15
ANGIODYNAMICS, INC. VENACURE PROCEDURE KIT (K102796)AngioDynamics, Inc.2010-12-15
ELITECH CLINICAL SYSTEMS GLUCOSE PAP SL ELITECH CLINICAL SYSTEMS ELICAL 2, ELITECH CLINICAL SYSTEMS ELITROL 1 AND 2 (K100525)Seppim S.A.S.2010-12-15
V-TRUST HANDHELD PULSE OXIMETER MODEL: TD-8201 (K101012)Taidoc Technology Corporation2010-12-15
EON 100 CHEMISTRY ANALYZER WITH ISE , MODEL 77105, BICARBONATE REAGENT, MODEL 77475 (K100060)Vital Diagnostics (Manufacturing) Ptyltd2010-12-15
SPECIALTY ASSAYED CONTROL-2 (K100103)Helena Laboratories2010-12-15
VITAL SUTURES, SUTUREX, CIRUGIA PERUANA (K100780)Unilene Sac2010-12-14
INBONE TOTAL ANKLE SYSTEM MODEL 200347902 (K103374)Wrightmedicaltechnologyinc2010-12-14
SIMMETRY SACROILIAC JOINT FUSION SYSTEM (K102907)Zyga Technology, Inc.2010-12-14
SAFECT MODEL VER 1.0 (K100372)Medic Vision Brain Technologies, Ltd.2010-12-14
COMFORT STANDING WHEELCHAIR, HERO SERIES (K102734)Comfort Orthopedic Co., Ltd.2010-12-14
STRAUMANN CARES BRIDGE; STRAUMANN CARES DOLDER BAR (K101465)Institut Straumann AG2010-12-13
TRABECULAR METAL TIBIAL CONE AUGMENTS (K102896)Zimmer Trabecular Metal Technology2010-12-13
BIORAPTOR CURVED 2.3 PK SUTURE ANCHORS (K102660)Smith & Nephew Endoscopy, Inc.2010-12-13
VASCUTRAK PTA DILATATION CATHETER (K103459)C.R. Bard, Inc.2010-12-13
SUSTAIN SPACE MAINTENANCE SYSTEM (K100779)Medtronic Sofamor Danek USA, Inc.2010-12-13
POWDERED VINYL PATIENT EXAMINIATION GLOVES, CLEAR (NON-COLORED) (K102976)Heze Juxinyuan Food Co., Ltd.2010-12-13
TREVAIR CHAIR ADULT (K102061)Patmont Motor Werks, Inc.2010-12-13
MED-RX PEDIATRIC FEEDING TUBES AND ACCESSORIES (K100700)Benlan, Inc.2010-12-13
FRONTIER DEVICES NEURO SYSTEM (K100205)Folsom Metal Products, Inc.2010-12-13
DIGITAL THERMOMETER; DIGITAL THERMOMETER (K102718)International Regulatory Consultants, LLC (Irc)2010-12-13
EXACTECH EQUINOXE R UHMWPE POSTERIOR AUGMENT PEGGED GLENOIDS TM (K103419)Exactech, Inc.2010-12-13
ABL837 FLEX ANALYZER (K100777)Radiometer Medical Aps2010-12-10
U BY KOTEX CLICK UNSCENTED MENSTRUL TAMPONS (K103311)Kimberly Clark Corporation2010-12-10
APEX SPINE SYSTEM W/ COCR RODS (K102488)Spinecraft, LLC2010-12-10
INZONE DETACHMENT SYSTEM (K103008)Boston Scientific Corp2010-12-10
WILLOW/ELM PTA BALLOON DILATATION CATHETER (K102645)Creagh Medical, Ltd.2010-12-10
INFUSION SETS (K103344)Hospira, Inc.2010-12-10
PIXI PEDIATRIC MASK (K102224)Resmed, Ltd.2010-12-10
DEPUY ATTUNE KNEE SYSTEM (K101433)DePuy Orthopaedics, Inc.2010-12-10
VENTSTAR HEATED, INFINITY ID BREATHING CIRCUIT HEATED (K102618)Draeger Medical AG & Co. KG2010-12-10
PULSAIR INTELLIPUFF, PULSAIR DESKTOP MODEL 2414-P-2001, 2417-P-2000 (K093298)Keeler Instruments, Inc.2010-12-10
RII INFRARED EAR THERMOMETER, (K102187)Radiant Innovation, Inc.2010-12-10
PRIMATRIX AG ANTIMICROBIAL DERMAL DERMAL REPAIR SCAFFOLD (K100261)Tei Biosciences, Inc.2010-12-10
ENSEAL TISSUE SEALING DEVICES MODEL: NSEAL514H-535H, NSEAL514RH-535RH (K101520)Ethicon Endo-Surgery, Inc.2010-12-10
RAPIDVIT BLAST, RAPIDWARM BLAST (K101003)Vitrolife Sweden AB2010-12-10
QUANTA CYBER TM 150W (K102749)Quanta System Spa2010-12-10
LIMA-LIO SMR SHOULDER SYSTEM - HUMERAL STEMS, LIMA-LIO SMR SHOULDER SYSTEM - HUMERAL BODIES, (K100858)Lima-Lto S.P.A.2010-12-10
GENESYS SPINE INTERBODY FUSION SYSTEM (K103034)Genesys Spine2010-12-10
APTUS 1.5 TRILOCK (K102537)Medartis AG2010-12-10
VASCUCOMP (K103247)Thermotek, Inc.2010-12-10
MINISPACER DUAL-SPRAY MDI ADAPTER WITH 22MM (OR 15MM) OD / 22MM OD/ID CONNECTIONS / 15MM ID CONNECTIONS (K102658)Thayer Medical Corp.2010-12-10
ELECTRO INTERSTITIAL SCAN (K102166)Ld Technology, LLC2010-12-10
HIP SEXTANT INSTRUMENT SYSTEM (K093491)Surgical Planning Associates2010-12-09
2.4MM VA-LCP DORSAL DISTAL RADIUS PLATES (K102694)Synthes (Usa)2010-12-09
PREMIUM PLUS DISPOSABLE PROPHY ANGLE MODEL 3399 (K100854)Premium Plus International Limited2010-12-09
STOCKERT S5 SYSTEM AND GAS BLENDER AND SORIN C5 SYSTEM (K101046)Sorin Group Deutschland GmbH2010-12-09
SELF RETAINING SOFT TISSUE RETRACTOR (K101609)Koros USA, Inc.2010-12-09
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Every clearance here is in the API, with alerts when new ones post.