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Available for immediate download.
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FDA 510(k), K072845, PRECISION FLOW
Regular price $89.00 USDRegular priceUnit price / per -
FDA 510(k), K072870, MICROWAVE TISSUE COAGULATION SYSTEM (MTCS)
Regular price $89.00 USDRegular priceUnit price / per -
FDA 510(k), K072883, ICE-SENSE
Regular price $503.47 USDRegular priceUnit price / per -
FDA 510(k), K072983, SATURN 9000-750
Regular price $89.00 USDRegular priceUnit price / per -
FDA 510(k), K073039, SPERMCHECK VASECTOMY, PRINCETON BIOMEDITECH CORP.
Regular price $89.00 USDRegular priceUnit price / per -
FDA 510(k), K073102, BIOLOX DELTA CERAMIC HEADS WITH 100KGY E-POLY ACETABULAR LINERS
Regular price $89.00 USDRegular priceUnit price / per -
FDA 510(k), K073311, OSTEOTRANS-OT PIN
Regular price $89.00 USDRegular priceUnit price / per -
FDA 510(k), K073423, MRI POWERPORT IMPLANTED PORT WITH 9.6 FR SILICONE CATHETER
Regular price $89.00 USDRegular priceUnit price / per -
FDA 510(k), K073690, INTERLACE MEDICAL HYSTEROSCOPIC MORCELLATION SYSTEM
Regular price $89.00 USDRegular priceUnit price / per -
FDA 510(k), K073707, GE DATEX-OHMEDA AISYS
Regular price $262.53 USDRegular priceUnit price / per -
FDA 510(k), K080092, ELECSYS ANTI-TSHR IMMUNOASSAY, ELECSYS PRECICONTROL THYROAB
Regular price $89.00 USDRegular priceUnit price / per -
FDA 510(k), K080093, PKS PLASMA MORCELLATOR, MODELS 962000PK, 3620PK
Regular price $89.00 USDRegular priceUnit price / per -
FDA 510(k), K080118, ZELTIQ AESTHETICS CLN1 DERMAL COOLING DEVICE
Regular price $89.00 USDRegular priceUnit price / per -
FDA 510(k), K080180, MODIFICATION TO RETINAL FUNCTION IMAGER (RFI)
Regular price $89.00 USDRegular priceUnit price / per -
FDA 510(k), K080228, ORALIEF OTC TOOTHPASTE FOR SENSITIVE TEETH
Regular price $170.24 USDRegular priceUnit price / per -
FDA 510(k), K080252, MODIFICATION TO MAMMAPRINT
Regular price $89.00 USDRegular priceUnit price / per -
FDA 510(k), K080271, INREACH SYSTEM
Regular price $89.00 USDRegular priceUnit price / per -
FDA 510(k), K080275, NPD 1000 NEGATIVE PRESSURE WOUND THERAPY SYSTEM
Regular price $89.00 USDRegular priceUnit price / per -
FDA 510(k), K080295, CHARLOTTE CLAW 3.5
Regular price $89.00 USDRegular priceUnit price / per -
FDA 510(k), K080330, SEGMENTAL DISTAL FEMORAL COMPONENTS AND PROXIMAL FEMORAL BODIES WITH A COMPRESS FEMALE TAPER
Regular price $89.00 USDRegular priceUnit price / per -
FDA 510(k), K080355, LEKSELL STEREOTACTIC SYSTEM WITH REUSABLE FIXATION SCREWS
Regular price $527.12 USDRegular priceUnit price / per -
FDA 510(k), K080383, AQUACEL HYDROFIBER WOUND DRESSING AND AG HYDROFIBER DRESSING
Regular price $89.00 USDRegular priceUnit price / per -
FDA 510(k), K080403, XTJF TYPE Q160VF1
Regular price $89.00 USDRegular priceUnit price / per -
FDA 510(k), K080591, TANDA SKINCARE SYSTEM, MODEL: PTSCS
Regular price $89.00 USDRegular priceUnit price / per -
FDA 510(k), K080595, CELLAVISION DM96 WITH THE BODY FLUID APPLICATION
Regular price $89.00 USDRegular priceUnit price / per -
FDA 510(k), K080613, CLEAR-VU SYSTEM, MODELS: CVL-01-1000, CVL-01-1030, CVL-01-1045
Regular price $89.00 USDRegular priceUnit price / per -
FDA 510(k), K080631, CLEANSE.FRESHEN.GO; ALIGNER CLEANSING TOWELETTE AND DENTAL APPLIANCE CLEANSER
Regular price $89.00 USDRegular priceUnit price / per -
FDA 510(k), K080668, G2 EXPRESS FILTER SYSTEM-FEMORAL (RF400F) AND JUGULAR/SUBCLAVIAN (RF400J) DELIVERY KITS
Regular price $89.00 USDRegular priceUnit price / per -
FDA 510(k), K080795, ULTRA SURGICAL GOWN & FLUID BARRIER SURGICAL GOWN
Regular price $89.00 USDRegular priceUnit price / per -
FDA 510(k), K080863, TRAXCESS 0.014 HYDROPHILIC GUIDEWIRE
Regular price $241.73 USDRegular priceUnit price / per -
FDA 510(k), K080950, STIWELL MED4
Regular price $840.09 USDRegular priceUnit price / per -
FDA 510(k), K081010, BARD 3DMAX MESH
Regular price $89.00 USDRegular priceUnit price / per -
FDA 510(k), K081048, PINNACLE PELVIC FLOOR REPAIR KIT II
Regular price $89.00 USDRegular priceUnit price / per -
FDA 510(k), K081050, PARIETEX PROGRIP MESH
Regular price $153.34 USDRegular priceUnit price / per -
FDA 510(k), K081070, INTERLACE MEDICAL OPERATIVE HYSTEROSCOPY SYSTEM
Regular price $89.00 USDRegular priceUnit price / per -
FDA 510(k), K081092, MODIFICATION TO MAMMAPRINT
Regular price $89.00 USDRegular priceUnit price / per