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), K131528, NON-PYROGENIC ULTRASOUND TRANSDUCER COVER
Regular price $149.00 USDRegular priceUnit price / per -
FDA 510(k), K013721, SYNTHETIC POLYSIOPRENE ULTRASOUND TRANSDUCER COVER
Regular price $149.00 USDRegular priceUnit price / per -
FDA 510(k), K011265, ULTRASOUND TRANSDUCER COVER
Regular price $149.00 USDRegular priceUnit price / per -
FDA 510(k), K991818, ACRYDERM SILVER ANTI-MICROBIAL WOUND DRESSING, MODELS 1041, 1042, 1043, 1044, 1045
Regular price $149.00 USDRegular priceUnit price / per -
FDA 510(k), K151649, Valleylab FT10 Electrosurgical Platform
Regular price $149.00 USDRegular priceUnit price / per -
FDA 510(k), K160240, Perimeter Otis™ 1.0 Optical Coherence Tomography System
Regular price $149.00 USDRegular priceUnit price / per -
FDA 510(k), K141358, CELLVIZIO 100 SERIES WITH SYSTEM CONFOCAL MINIPROBES
Regular price $149.00 USDRegular priceUnit price / per -
FDA 510(k), K150831, Cellvizio 100 Series System with Confocal Miniprobes
Regular price $149.00 USDRegular priceUnit price / per -
FDA 510(k), K151593, Cellvizio 100 Series System with Confocal Miniprobes
Regular price $149.00 USDRegular priceUnit price / per -
FDA 510(k), K132071, BIOACTIVE BONE GRAFT PUTTY
Regular price $149.00 USDRegular priceUnit price / per -
FDA 510(k), K130744, LIGASURE 5MM BLUNT TIP LAPAROSCOPIC SEALER/DIVIDER
Regular price $149.00 USDRegular priceUnit price / per -
FDA 510(k), K931828, CARELET SAFETY LANCET
Regular price $149.00 USDRegular priceUnit price / per -
FDA 510(k), K140389, CHLORADERM ANTIMICROBIAL TRANSPARENT THIN FILM DRESSING, 2 3/8 X 2 3/4, 4 X 4 3/4
Regular price $149.00 USDRegular priceUnit price / per -
FDA 510(k), K111736, TUTTNAUER EZ PLUS SERIES ELECTRONIC TABLETOP AUTOCLAVES
Regular price $149.00 USDRegular priceUnit price / per -
FDA 510(k), K142805, Nitrile Powder Free Examination Glove with Colloidal Oatmeal USP Skin Protectant Drug- Dark Violet Blue (DVBU)
Regular price $149.00 USDRegular priceUnit price / per -
FDA 510(k), K153361, Lumipulse G 25-OH Vitamin D, Lumipulse G 25-OH Vitamin D Calibrators
Regular price $149.00 USDRegular priceUnit price / per -
FDA 510(k), K151650, SMARTez elastomeric infusion pump
Regular price $149.00 USDRegular priceUnit price / per -
FDA 510(k), K142463, Bio2 CLM BG Bioactive Scaffold
Regular price $149.00 USDRegular priceUnit price / per -
FDA 510(k), K150504, GUS ASTRA TEE Transesophageal Probe Reprocessor, GUS ASTRA VR Endovaginal/Endorectal Probe Reprocessor
Regular price $149.00 USDRegular priceUnit price / per -
FDA 510(k), K092780, INF 4160 PLUS, MODEL D-FJ31F
Regular price $149.00 USDRegular priceUnit price / per -
FDA 510(k), K142583, LaborView LV1000
Regular price $149.00 USDRegular priceUnit price / per -
FDA 510(k), K150942, Contour Next USB Blood Glucose Monitoring System
Regular price $149.00 USDRegular priceUnit price / per -
FDA 510(k), K130265, CONTOUR NEXT EZ BLOOD GLUCOSE METER
Regular price $149.00 USDRegular priceUnit price / per -
FDA 510(k), K140149, EPX-4440HD DIGITAL VIDEO PROCESSOR
Regular price $149.00 USDRegular priceUnit price / per -
FDA 510(k), K121190, CONTOUR NEXT BLOOD GLUCOSE METER
Regular price $149.00 USDRegular priceUnit price / per -
FDA 510(k), K061328, THINK POSITIVE DIABETES MANAGEMENT SYSTEM (T+DIABETES SYSTEM)
Regular price $149.00 USDRegular priceUnit price / per -
FDA 510(k), K043529, ACCU-CHEK ADVISOR INSULIN GUIDANCE SOFTWARE
Regular price $149.00 USDRegular priceUnit price / per -
FDA 510(k), K032164, DIABETES DATA MANAGEMENT SYSTEM (DDMS), MODEL 7333
Regular price $149.00 USDRegular priceUnit price / per -
FDA 510(k), K151398, K-Pack II Needle - 29G x 5/16 Thin Wall
Regular price $149.00 USDRegular priceUnit price / per -
FDA 510(k), K140516, Terumo Pen Injector Needle 34
Regular price $149.00 USDRegular priceUnit price / per -
FDA 510(k), K093789, INTOUCH DIABETES
Regular price $149.00 USDRegular priceUnit price / per -
FDA 510(k), K080587, EZ MANAGER MAX DIABETES MANAGEMENT SOFTWARE
Regular price $149.00 USDRegular priceUnit price / per -
FDA 510(k), K060298, PILL PHONE
Regular price $149.00 USDRegular priceUnit price / per -
FDA 510(k), K123766, NOVOPEN ECHO, A DIAL A DOSE INSULIN DELIVERY PEN
Regular price $149.00 USDRegular priceUnit price / per -
FDA 510(k), K133951, SMARTTOUCH
Regular price $149.00 USDRegular priceUnit price / per -
FDA 510(k), K053563, HUMAPEN MEMOIR
Regular price $149.00 USDRegular priceUnit price / per