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), K131248, ETCH GEL
Regular price $149.00 USDRegular priceUnit price / per -
FDA 510(k), K151455, 3Shape Abutment Designer Software
Regular price $149.00 USDRegular priceUnit price / per -
FDA 510(k), K101491, UROSKOP OMNIA
Regular price $149.00 USDRegular priceUnit price / per -
FDA 510(k), K971130, DEFEND FLUID RESISTANT PLEATED MASK
Regular price $149.00 USDRegular priceUnit price / per -
FDA 510(k), K151123, Pac-Dent Barrier Sleeve, Cover-It(TM) Barrier Film
Regular price $149.00 USDRegular priceUnit price / per -
FDA 510(k), K141813, RHYTHMSTAR SYSTEM
Regular price $149.00 USDRegular priceUnit price / per -
FDA 510(k), K020041, IALUSET HYDROCOLLOID
Regular price $149.00 USDRegular priceUnit price / per -
FDA 510(k), K160420, SpeqT
Regular price $149.00 USDRegular priceUnit price / per -
FDA 510(k), K071160, REFLECTION, TANDEM UNIPOLAR
Regular price $149.00 USDRegular priceUnit price / per -
FDA 510(k), K933772, PUNCH SURGICAL
Regular price $149.00 USDRegular priceUnit price / per -
FDA 510(k), K151476, Beactive Brace
Regular price $149.00 USDRegular priceUnit price / per -
FDA 510(k), K102404, PROVENT PROFESSIONAL SLEEP APNEA THERAPY (PROVENT 80); PROVENT PROFESSIONAL SLEEP APNEA THERAPY (PROVENT 50)
Regular price $149.00 USDRegular priceUnit price / per -
FDA 510(k), K040491, CHIN-UP STRIP
Regular price $149.00 USDRegular priceUnit price / per -
FDA 510(k), K071560, PROVENT NASAL DILATOR, MODEL BR2
Regular price $149.00 USDRegular priceUnit price / per -
FDA 510(k), K160172, Laparoscope Lens Shield Device
Regular price $149.00 USDRegular priceUnit price / per -
FDA 510(k), K021896, HSA-SOLUTION, MODEL 10034/10064
Regular price $149.00 USDRegular priceUnit price / per -
FDA 510(k), K073671, PLICATOR GSX SUTURING SYSTEM, PLICATOR GSX, PLICATOR INSTRUMENT, PLICATOR GSX SUTURE CARTRIDGE
Regular price $149.00 USDRegular priceUnit price / per -
FDA 510(k), K123662, THE JUSTRIGHT SURGICAL VESSEL SEALING SYSTEM
Regular price $149.00 USDRegular priceUnit price / per -
FDA 510(k), K111572, NOVAE SUNFIT TH DUAL MOBILITY ACETABULAR CUP MODEL SUNFIT TH (METAL-BACK), NOVAE E TH DUAL MOBILITY ACETABULAR CUP MODEL
Regular price $149.00 USDRegular priceUnit price / per -
FDA 510(k), K161507, Cianna Medical SAVI Scout Reflector and SAVI Scout System
Regular price $149.00 USDRegular priceUnit price / per -
FDA 510(k), K061640, INTEGRA MOBIUS MULTI-MODALITY MONITORING SYSTEM
Regular price $149.00 USDRegular priceUnit price / per -
FDA 510(k), K060554, CMA CEREBRAL TISSUE MONITORING SYSTEM
Regular price $149.00 USDRegular priceUnit price / per -
FDA 510(k), K003759, AESCULAP SPIEGELBERG BRAIN PRESSURE MONITOR
Regular price $149.00 USDRegular priceUnit price / per -
FDA 510(k), K050702, NEUROSYSTEMS 1TM MONITOR
Regular price $149.00 USDRegular priceUnit price / per -
FDA 510(k), K992703, CARDIOTRON EKG MULTI-PHASE INFORMATION ANALYSIS SYSTEM, MODELS 3800, 6800, 8800
Regular price $149.00 USDRegular priceUnit price / per -
FDA 510(k), K102973, SILVER DENTAL ARREST
Regular price $149.00 USDRegular priceUnit price / per -
FDA 510(k), K110212, INRATIO2 PI/NR MONITORING SYSTEM; INRATIO PT/INR TEST STRIP
Regular price $149.00 USDRegular priceUnit price / per -
FDA 510(k), K093460, COAGUCHEK XS PRO SYSTEM
Regular price $149.00 USDRegular priceUnit price / per -
FDA 510(k), K994349, COAGUCHEK S SYSTEM, MODEL 2138280
Regular price $149.00 USDRegular priceUnit price / per -
FDA 510(k), K142962, PROTOCOL Incision Dressing
Regular price $149.00 USDRegular priceUnit price / per -
FDA 510(k), K132841, ZYNO MEDICAL ADMINISTRATION SET
Regular price $149.00 USDRegular priceUnit price / per -
FDA 510(k), K080749, RADIANCE
Regular price $149.00 USDRegular priceUnit price / per -
FDA 510(k), K141580, STERIZONE SELF-CONTAINED BIOLOGICAL INDICATOR
Regular price $149.00 USDRegular priceUnit price / per -
FDA 510(k), K141698, STERIZONE CHEMICAL INDICATOR
Regular price $149.00 USDRegular priceUnit price / per -
FDA 510(k), K100120, ALEXIS ORTHOPAEDIC WOUND RETRACTOR
Regular price $149.00 USDRegular priceUnit price / per -
FDA 510(k), K122205, EXINI
Regular price $149.00 USDRegular priceUnit price / per