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Available for immediate download.
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FDA 510(k) K073652, ND LOW SPEED AIRMOTOR AND HANDPIECE, HIGHSPEED AIRTURBINE HANDPIECE, E-TYPE STRAIGHT NOSECONE AND CONTRA ANGLE, by Nakamura Magnifier Co., Ltd.
Regular price $89.00 USDRegular priceUnit price / perSale price $89.00 USD -
FDA 510(k) K073690, INTERLACE MEDICAL HYSTEROSCOPIC MORCELLATION SYSTEM, by Interlace Medical, Inc.
Regular price $89.00 USDRegular priceUnit price / perSale price $89.00 USD -
FDA 510(k) K073693, COSTORSOL, by Preservation Solutions, Inc.
Regular price $477.30 USDRegular priceUnit price / perSale price $477.30 USD -
FDA 510(k) K073707, GE DATEX-OHMEDA AISYS, by Datex-Ohmeda, Inc.
Regular price $262.53 USDRegular priceUnit price / perSale price $262.53 USD -
FDA 510(k) K080092, ELECSYS ANTI-TSHR IMMUNOASSAY, ELECSYS PRECICONTROL THYROAB, by Roche Diagnostics Corp.
Regular price $89.00 USDRegular priceUnit price / perSale price $89.00 USD -
FDA 510(k) K080093, PKS PLASMA MORCELLATOR, MODELS 962000PK, 3620PK, by Gyrus Acmi, Inc.
Regular price $89.00 USDRegular priceUnit price / perSale price $89.00 USD -
FDA 510(k) K080118, ZELTIQ AESTHETICS CLN1 DERMAL COOLING DEVICE, by Zeltiq Aesthetics
Regular price $89.00 USDRegular priceUnit price / perSale price $89.00 USD -
FDA 510(k) K080180, MODIFICATION TO RETINAL FUNCTION IMAGER (RFI), by Optical Imaging , Ltd.
Regular price $89.00 USDRegular priceUnit price / perSale price $89.00 USD -
FDA 510(k) K080228, ORALIEF OTC TOOTHPASTE FOR SENSITIVE TEETH, by Novamin Technology, Inc.
Regular price $170.24 USDRegular priceUnit price / perSale price $170.24 USD -
FDA 510(k) K080252, MODIFICATION TO MAMMAPRINT, by Agendia BV
Regular price $89.00 USDRegular priceUnit price / perSale price $89.00 USD -
FDA 510(k) K080271, INREACH SYSTEM, by Superdimension, Ltd.
Regular price $89.00 USDRegular priceUnit price / perSale price $89.00 USD -
FDA 510(k) K080275, NPD 1000 NEGATIVE PRESSURE WOUND THERAPY SYSTEM, by Iasis Medical, Inc.
Regular price $89.00 USDRegular priceUnit price / perSale price $89.00 USD -
FDA 510(k) K080295, CHARLOTTE CLAW 3.5, by Wrightmedicaltechnologyinc
Regular price $89.00 USDRegular priceUnit price / perSale price $89.00 USD -
FDA 510(k) K080330, SEGMENTAL DISTAL FEMORAL COMPONENTS AND PROXIMAL FEMORAL BODIES WITH A COMPRESS FEMALE TAPER, by Biomet, Inc.
Regular price $89.00 USDRegular priceUnit price / perSale price $89.00 USD -
FDA 510(k) K080355, LEKSELL STEREOTACTIC SYSTEM WITH REUSABLE FIXATION SCREWS, by Elekta Instrument AB
Regular price $527.12 USDRegular priceUnit price / perSale price $527.12 USD -
FDA 510(k) K080383, AQUACEL HYDROFIBER WOUND DRESSING AND AG HYDROFIBER DRESSING, by Convatec, A Division of E.R. Squibb & Sons, LLC
Regular price $89.00 USDRegular priceUnit price / perSale price $89.00 USD -
FDA 510(k) K080403, XTJF TYPE Q160VF1, by Olympus Medical Systems Corporation
Regular price $89.00 USDRegular priceUnit price / perSale price $89.00 USD -
FDA 510(k) K080445, LION SE ONE STEP ORTHODONTIC ADHESIVE, by Classone Orthodontics, Inc.
Regular price $273.70 USDRegular priceUnit price / perSale price $273.70 USD -
FDA 510(k) K080591, TANDA SKINCARE SYSTEM, MODEL: PTSCS, by Pharos Life Corporation
Regular price $89.00 USDRegular priceUnit price / perSale price $89.00 USD -
FDA 510(k) K080595, CELLAVISION DM96 WITH THE BODY FLUID APPLICATION, by CellaVision AB
Regular price $89.00 USDRegular priceUnit price / perSale price $89.00 USD -
FDA 510(k) K080613, CLEAR-VU SYSTEM, MODELS: CVL-01-1000, CVL-01-1030, CVL-01-1045, by Minimally Invasive Devices, LLC
Regular price $89.00 USDRegular priceUnit price / perSale price $89.00 USD -
FDA 510(k) K080631, CLEANSE.FRESHEN.GO; ALIGNER CLEANSING TOWELETTE AND DENTAL APPLIANCE CLEANSER, by Oral Health Technologies, LLC
Regular price $89.00 USDRegular priceUnit price / perSale price $89.00 USD -
FDA 510(k) K080668, G2 EXPRESS FILTER SYSTEM-FEMORAL (RF400F) AND JUGULAR/SUBCLAVIAN (RF400J) DELIVERY KITS, by C.R. Bard, Inc.
Regular price $89.00 USDRegular priceUnit price / perSale price $89.00 USD -
FDA 510(k) K080795, ULTRA SURGICAL GOWN & FLUID BARRIER SURGICAL GOWN, by Kimberly-Clark Corp.
Regular price $89.00 USDRegular priceUnit price / perSale price $89.00 USD -
FDA 510(k) K080863, TRAXCESS 0.014 HYDROPHILIC GUIDEWIRE, by MicroVention, Inc.
Regular price $241.73 USDRegular priceUnit price / perSale price $241.73 USD -
FDA 510(k) K080950, STIWELL MED4, by Otto Bock, Austria GmbH
Regular price $840.09 USDRegular priceUnit price / perSale price $840.09 USD -
FDA 510(k) K081010, BARD 3DMAX MESH, by Davol Inc., Sub. C. R. Bard, Inc.
Regular price $89.00 USDRegular priceUnit price / perSale price $89.00 USD -
FDA 510(k) K081048, PINNACLE PELVIC FLOOR REPAIR KIT II, by Boston Scientific Corp
Regular price $89.00 USDRegular priceUnit price / perSale price $89.00 USD -
FDA 510(k) K081050, PARIETEX PROGRIP MESH, by Sofradim Production
Regular price $153.34 USDRegular priceUnit price / perSale price $153.34 USD -
FDA 510(k) K081070, INTERLACE MEDICAL OPERATIVE HYSTEROSCOPY SYSTEM, by Interlace Medical, Inc.
Regular price $89.00 USDRegular priceUnit price / perSale price $89.00 USD -
FDA 510(k) K081092, MODIFICATION TO MAMMAPRINT, by Agendia
Regular price $89.00 USDRegular priceUnit price / perSale price $89.00 USD -
FDA 510(k) K081151, COMPUMEDICS NEUVO, by Compumedics USA, Ltd.
Regular price $649.53 USDRegular priceUnit price / perSale price $649.53 USD -
FDA 510(k) K081311, POWERPORT IMPLANTED PORT WITH GROSHONG CATHETER, by C.R. Bard, Inc.
Regular price $89.00 USDRegular priceUnit price / perSale price $89.00 USD -
FDA 510(k) K081379, MODIFICATION TO INREACH SYSTEM, by Superdimension, Ltd.
Regular price $89.00 USDRegular priceUnit price / perSale price $89.00 USD -
FDA 510(k) K081440, BIVONA ADJUSTABLE AND FIXED NECKFLANGE HYPERFLEX TRACHEOSTOMY TUBES, by Smiths Medical Asd, Inc.
Regular price $248.35 USDRegular priceUnit price / perSale price $248.35 USD -
FDA 510(k) K081459, CUSA SELECTOR NXT ULTRASONIC TISSUE ABLATION SYSTEM, by Integra Radionics, Inc.
Regular price $89.00 USDRegular priceUnit price / perSale price $89.00 USD