Collection: FDA 510(k)
FDA 510K documents available for fast-track requests typically delivered within 1 to 2 weeks. Publicly Available documents delivered within 24 business hours.
Use Search below to find the 510k you are looking for by:
- Device Name
- Manufacturer
- Device Classification Name
- Regulation Number
- Classification Product Code
- Date Received
- Decision Date
- Regulation Medical Specialty
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FDA 510(k), K163358, Introcan Safety 3 Closed IV Catheter
Regular price $149.00 USDRegular priceUnit price / per -
FDA 510(k), K142029, MYOSURE HYSTEROSCOPIC TISSUE REMOVAL SYSTEM
Regular price $149.00 USDRegular priceUnit price / per -
FDA 510(k), K100559, MYOSURE HYSTEROSCOPIC TISSUE REMOVAL SYSTEM
Regular price $149.00 USDRegular priceUnit price / per -
FDA 510(k), K091100, MYOSURE HYSTEROSCOPIC TISSUE REMOVAL SYSTEM
Regular price $149.00 USDRegular priceUnit price / per -
FDA 510(k), K905119, PLAZLYTE(TM)
Regular price $149.00 USDRegular priceUnit price / per -
FDA 510(k), K923739, ABTOX SERILIZATION PROCESS BIOLOGICAL INDICATOR
Regular price $149.00 USDRegular priceUnit price / per -
FDA 510(k), K923442, ABTOX PLAZLYTE PROCESS MONITOR
Regular price $149.00 USDRegular priceUnit price / per -
FDA 510(k), K031041, FLUENCY TRACHEOBRONCHIAL STENT GRAFT
Regular price $149.00 USDRegular priceUnit price / per -
FDA 510(k), K122950, LASER HELMET
Regular price $149.00 USDRegular priceUnit price / per -
FDA 510(k), K160915, Elecsys CYFRA 21-1, Elecsys CYFRA 21-1 CalSet, PreciControl Tumor Marker
Regular price $149.00 USDRegular priceUnit price / per -
FDA 510(k), K163015, Liquichek Tumor Marker Control-Level 1; Liquichek Tumor Marker Control-Level 2; Liquichek Tumor Marker Control-Level 3; Liquichek Tumor Marker Control- Trilevel MiniPak
Regular price $149.00 USDRegular priceUnit price / per -
FDA 510(k), K081051, SPINEVU ENDOSCOPIC SPINE SYSTEM (SESS), SPINEVU MINISCOPE
Regular price $149.00 USDRegular priceUnit price / per -
FDA 510(k), K002931, METRX SYSTEM
Regular price $149.00 USDRegular priceUnit price / per -
FDA 510(k), K042032, MAESTRO TOTAL WRIST
Regular price $149.00 USDRegular priceUnit price / per -
FDA 510(k), K123866, TANYX
Regular price $149.00 USDRegular priceUnit price / per -
FDA 510(k), K163306, Lithoplasty Peripheral Balloon Dilatation Catheter; Lithoplasty Generator And Connector Cable; Lithoplasty Connector Cable
Regular price $149.00 USDRegular priceUnit price / per -
FDA 510(k), K023116, CORDIS OPTEASE PERMANENT VENA CAVA FILTER, MODELS 466-F200A, 466-F200B
Regular price $149.00 USDRegular priceUnit price / per -
FDA 510(k), K032818, INOGEN ONE OXYGEN CONCENTRATOR
Regular price $149.00 USDRegular priceUnit price / per -
FDA 510(k), K101522, ULTRA SEAL STERILE LUBRICATING JELLY
Regular price $149.00 USDRegular priceUnit price / per -
FDA 510(k), K063148, SOCK IT! ORAL PAIN GEL
Regular price $149.00 USDRegular priceUnit price / per -
FDA 510(k), K122160, VANGUARD XP KNEE SYSTEM
Regular price $149.00 USDRegular priceUnit price / per -
FDA 510(k), K153657, Vanguard XP Knee System
Regular price $149.00 USDRegular priceUnit price / per -
FDA 510(k), K133502, 5000Z FIREFLY SYSTEM
Regular price $149.00 USDRegular priceUnit price / per -
FDA 510(k), K124026, LOBSTER AUTO-INJECTOR
Regular price $149.00 USDRegular priceUnit price / per -
FDA 510(k), K862198, SIGMA II - DUAL PLACE HYPERBARIC CHAMBER
Regular price $149.00 USDRegular priceUnit price / per -
FDA 510(k), K012530, AA-1 SYSTEM
Regular price $149.00 USDRegular priceUnit price / per -
FDA 510(k), K092639, INNOVA VISION, MODEL S18751VN, INNOVA TRACKVISION, MODEL S18751VT, INNOVA EPVISION, MODEL S18751EP
Regular price $149.00 USDRegular priceUnit price / per -
FDA 510(k), K143608, NovaCross Microcatheter
Regular price $149.00 USDRegular priceUnit price / per -
FDA 510(k), K010094, A & I WHEELCHAIRS
Regular price $149.00 USDRegular priceUnit price / per -
FDA 510(k), K122609, VASCULAIRE COMPRESSION SYSTEM MODEL FLS-0003; VASCULAIRE SLEEVE (FOOT & CALF) MODEL FLS-0002; VASCULAIRE SLEEVE (CALF) F
Regular price $149.00 USDRegular priceUnit price / per -
FDA 510(k), K020936, 10F X 18CM PEDIATRIC ASH SPLIT CATH XL, MODEL ASPC18P-XL; 10F X 24CM PEDIATRIC ASH SPLIT-CATH XL, MODEL ASPC24P-XL
Regular price $149.00 USDRegular priceUnit price / per -
FDA 510(k), K061050, GYNECARE MORCELLEX TISSUE MORCELLATOR, MODELS MX0100 AND MX0100R
Regular price $149.00 USDRegular priceUnit price / per -
FDA 510(k), K972027, ELITE H-D HYDROPHILIC VINYL POLYSILOXANE IMPRESSION MATERIALS (LIGHT BODY/NORMAL,LIGHT BODY/FAST SETTING,REGULAR BODY,)
Regular price $149.00 USDRegular priceUnit price / per -
FDA 510(k), K160668, HumaPen Savvio
Regular price $149.00 USDRegular priceUnit price / per -
FDA 510(k), K151686, HumanPen Ergo II
Regular price $149.00 USDRegular priceUnit price / per -
FDA 510(k), K142518, HumaPen Luxura
Regular price $149.00 USDRegular priceUnit price / per