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Available for immediate download.
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FDA 510(k), K091703, HD GUIDE CATHETER, MODEL 90019, 90022, 90023, 90120, 90121, 90130, 90131
Regular price $89.00 USDRegular priceUnit price / perSale price $89.00 USD -
FDA 510(k), K091757, OTC TENS FOR ARM AND LEG PAIN RELIEF, MODEL WL-2407
Regular price $89.00 USDRegular priceUnit price / perSale price $89.00 USD -
FDA 510(k), K091760, DERMAPORT PORTED VASCULAR ACCESS SYSTEM (PVAS)
Regular price $89.00 USDRegular priceUnit price / perSale price $89.00 USD -
FDA 510(k), K091781, GUIDED MEDICAL POSITIONING SYSTEM (GMPS)
Regular price $89.00 USDRegular priceUnit price / perSale price $89.00 USD -
FDA 510(k), K091799, CABLE READY CABLE GRIP SYSTEM CABLE BUTTON
Regular price $89.00 USDRegular priceUnit price / perSale price $89.00 USD -
FDA 510(k), K091882, AZUR PERIPHERAL HYDROCOIL ENDOVASCULAR EMBOLIZATION SYSTEM
Regular price $191.03 USDRegular priceUnit price / perSale price $191.03 USD -
FDA 510(k), K092086, AMERIGEL WOUND DRESSING PLUS 1/2 OZ. (15G TUBE), MODEL A2025; 1 OZ. (30G TUBE), MODEL A2026; 3 OZ (90G TUBE),MODEL A2027
Regular price $89.00 USDRegular priceUnit price / perSale price $89.00 USD -
FDA 510(k), K092090, ERBELIFT HAND PUMP AND FLEXIBLE PROBE
Regular price $89.00 USDRegular priceUnit price / perSale price $89.00 USD -
FDA 510(k), K092148, HAMILTON-C2
Regular price $842.88 USDRegular priceUnit price / perSale price $842.88 USD -
FDA 510(k), K092150, COBALT MV WITH GENTAMICIN (AKA COBALT G-MV) BONE CEMENT
Regular price $89.00 USDRegular priceUnit price / perSale price $89.00 USD -
FDA 510(k), K092156, CAD 12, COLONOSCOPY ASSIST DEVICE
Regular price $210.54 USDRegular priceUnit price / perSale price $210.54 USD -
FDA 510(k), K092178, AXSOS STRYKER LOCKED PLATING SYSTEM LINE EXTENSION OF CABLE PLUGS
Regular price $89.00 USDRegular priceUnit price / perSale price $89.00 USD -
FDA 510(k), K092224, TIGR SURGICAL MESH , MODEL WK-6
Regular price $89.00 USDRegular priceUnit price / perSale price $89.00 USD -
FDA 510(k), K092271, GE LOGIQ E9 BT2010 DIAGNOSTIC ULTRASOUND SYSTEM, MODEL 5205000-3, 5205000-4
Regular price $89.00 USDRegular priceUnit price / perSale price $89.00 USD -
FDA 510(k), K092283, DIMENSION VISTA IMMUNOGLOBULIN IGG SUBCLASSS 1FLEX REAGENT CARTRIDGE, DIMENSION VISTA IMMUNOGLOBULIN IGG
Regular price $89.00 USDRegular priceUnit price / perSale price $89.00 USD -
FDA 510(k), K092351, POLY FIT + ABSORBING AND HIGH ABSORBING ANTIMICROBIAL DRESSINGS, POLYREMEDY, INC.
Regular price $89.00 USDRegular priceUnit price / perSale price $89.00 USD -
FDA 510(k), K092365, INREACH SYSTEM, MODEL AAS00161-02
Regular price $89.00 USDRegular priceUnit price / perSale price $89.00 USD -
FDA 510(k), K092467, VECTORVISION CRANIAL, VECTORVISION ENT, KOLIBRI CRANIAL, KOLIBRI ENT, CRANIAL ESSENTIAL, CRANIAL UNLIMITED
Regular price $89.00 USDRegular priceUnit price / perSale price $89.00 USD -
FDA 510(k), K092573, NIHON KOHDEN QP-160AK EEG TREND PROGRAM
Regular price $944.42 USDRegular priceUnit price / perSale price $944.42 USD -
FDA 510(k), K092586, MALE LATEX CONDOM (STRAIGHT SIDE OR CONTOURED OR FLARED IN SHAPE, EITHER TEXTURED OR NON-TEXTURED , LUBRICATED OR NON-LU
Regular price $179.34 USDRegular priceUnit price / perSale price $179.34 USD -
FDA 510(k), K092590, PDS PLATES
Regular price $504.86 USDRegular priceUnit price / perSale price $504.86 USD -
FDA 510(k), K092602, FREESTYLE Lite Blood Glucose Monitoring System and Freestyle Freedom Lite Blood Glucose Monitoring System
Regular price $89.00 USDRegular priceUnit price / perSale price $89.00 USD -
FDA 510(k), K092746, MICRONJET 600
Regular price $89.00 USDRegular priceUnit price / perSale price $89.00 USD -
FDA 510(k), K092780, INF 4160 PLUS, MODEL D-FJ31F
Regular price $89.00 USDRegular priceUnit price / perSale price $89.00 USD -
FDA 510(k), K092849, BLOOD COLLECTION TUBE SAMPLES FOR USE WITH POINT OF CARE BLOOD ANALYZER
Regular price $509.04 USDRegular priceUnit price / perSale price $509.04 USD -
FDA 510(k), K092926, ACELL MATRISTEM WOUND SHEET
Regular price $89.00 USDRegular priceUnit price / perSale price $89.00 USD -
FDA 510(k), K092944, DANA REUSABLE TEST PACK FOR STEAM STERILIZATION
Regular price $89.00 USDRegular priceUnit price / perSale price $89.00 USD -
FDA 510(k), K093002, AZUR PERIPHERAL HYDROCOIL ENDOVASCULAR EMBOLIZATION SYSTEM-DETACHABLE 35, MODELS 45-450405, 45-450410, 45-450610
Regular price $210.53 USDRegular priceUnit price / perSale price $210.53 USD -
FDA 510(k), K093138, MT9000 SERIES ELECTRO-STIMULATOR, MODELS MT9000, MT9002, MT9001, MT9004 AND MT9003
Regular price $89.00 USDRegular priceUnit price / perSale price $89.00 USD -
FDA 510(k), K093160, HEADWAY 21 MICROCATHETER, MODEL: MC212150S
Regular price $210.53 USDRegular priceUnit price / perSale price $210.53 USD -
FDA 510(k), K093395, OLYMPUS GF TYPE UC180, OLYMPUS GF TYPE UCT180 EVIS EXERA II ULATRASOUND GASTROVIDEOSCOPE
Regular price $1,560.63 USDRegular priceUnit price / perSale price $1,560.63 USD -
FDA 510(k), K093397, TRAXCESS 14EX GUIDEWIRE AND TRAXCESS DOCKING WIRE
Regular price $89.00 USDRegular priceUnit price / perSale price $89.00 USD -
FDA 510(k), K093460, COAGUCHEK XS PRO SYSTEM
Regular price $1,489.69 USDRegular priceUnit price / perSale price $1,489.69 USD -
FDA 510(k), K093479, DISPOSABLE SUCTION AND IRRIGATION SYSTEM
Regular price $89.00 USDRegular priceUnit price / perSale price $89.00 USD -
FDA 510(k), K093489, IN VISION-PLUS NANO WITH NEUTRAL ADVANTAGE TECHNOLOGY
Regular price $89.00 USDRegular priceUnit price / perSale price $89.00 USD -
FDA 510(k), K093520, VIVOSIGHT TOPICAL OCT SYSTEM
Regular price $322.33 USDRegular priceUnit price / perSale price $322.33 USD