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), K041502, THROMBELASTOGRAPH (TEG) PLATELET MAPPING ASSAY
Regular price $149.00 USDRegular priceUnit price / per -
FDA 510(k), K152070, BioZorb LP Marker
Regular price $149.00 USDRegular priceUnit price / per -
FDA 510(k), K143484, BioZorb Marker
Regular price $149.00 USDRegular priceUnit price / per -
FDA 510(k), K113202, TISSUE MARKER
Regular price $149.00 USDRegular priceUnit price / per -
FDA 510(k), K143615, Antistatic Compact Space Chamber
Regular price $149.00 USDRegular priceUnit price / per -
FDA 510(k), K063367, 45L CORE INSUFFLATOR, MODEL F114
Regular price $149.00 USDRegular priceUnit price / per -
FDA 510(k), K120640, INSUFLOW SYNERGY PORT
Regular price $149.00 USDRegular priceUnit price / per -
FDA 510(k), K120151, NEBULAE I
Regular price $149.00 USDRegular priceUnit price / per -
FDA 510(k), K122766, THERMO SCIENTIFIC QMS EVEROLIMUS ASSAY
Regular price $149.00 USDRegular priceUnit price / per -
FDA 510(k), K100144, THERMO SCIENTIFIC QMS EVEROLIMUS REAGENTS, CALIBRATORS AND CONTROLS
Regular price $149.00 USDRegular priceUnit price / per -
FDA 510(k), K083846, XTAG CYSTIC FIBROSIS 39 KIT V2, (CFTR 39 KIT V2), MODEL I027C0231, I027D0266, I027E0267
Regular price $149.00 USDRegular priceUnit price / per -
FDA 510(k), K083845, XTAG CF60 KIT V2
Regular price $149.00 USDRegular priceUnit price / per -
FDA 510(k), K080315, DERMA SCIENCES MEDIHONEY DRESSINGS WITH ACTIVE MANUKA HONEY
Regular price $149.00 USDRegular priceUnit price / per -
FDA 510(k), K072956, MEDIHONEY PRIMARY DRESSINGS WITH ACTIVE MANUKA HONEY
Regular price $149.00 USDRegular priceUnit price / per -
FDA 510(k), K053095, HONEY ALGINATE DRESSING
Regular price $149.00 USDRegular priceUnit price / per -
FDA 510(k), K141757, ALERE I STREP A
Regular price $149.00 USDRegular priceUnit price / per -
FDA 510(k), K092271, GE LOGIQ E9 BT2010 DIAGNOSTIC ULTRASOUND SYSTEM, MODEL 5205000-3, 5205000-4
Regular price $149.00 USDRegular priceUnit price / per -
FDA 510(k), K110943, LOGIQ E9
Regular price $149.00 USDRegular priceUnit price / per -
FDA 510(k), K082185, GE LOGIQ E9 DIAGNOSTIC ULTRASOUND SYSTEM, MODELS 5205000, 5205000-2
Regular price $149.00 USDRegular priceUnit price / per -
FDA 510(k), K100305, ETURN SPINAL IMPLANT MODEL ETURN XX-12; ETURN XX-16 WHERE XX=07, 09, 11, 13, OR 15 AND ETURN XX-12 K; ETURN XX-16 K WHER
Regular price $149.00 USDRegular priceUnit price / per -
FDA 510(k), K141790, AQANIFE
Regular price $149.00 USDRegular priceUnit price / per -
FDA 510(k), K140638, PROPELLER SYSTEM - MODEL 2
Regular price $149.00 USDRegular priceUnit price / per -
FDA 510(k), K152525, TR BAND Radial Compression Device
Regular price $149.00 USDRegular priceUnit price / per -
FDA 510(k), K142359, Vasc Band hemostat
Regular price $149.00 USDRegular priceUnit price / per -
FDA 510(k), K063509, DEPUY PEAK FX HIP PLATE
Regular price $149.00 USDRegular priceUnit price / per -
FDA 510(k), K150409, VIVACE Electrosurgical System
Regular price $153.34 USDRegular priceUnit price / per -
FDA 510(k), K102525, BREATHE TECHNOLOGIES VENTILATOR AND ACCESSORIES (BT-V2S)
Regular price $149.00 USDRegular priceUnit price / per -
FDA 510(k), K100528, BREATHE TECHNOLOGIES VENTILATOR AND ACCESSORIES BT-V2S
Regular price $149.00 USDRegular priceUnit price / per -
FDA 510(k), K082982, BREATHE TECHNOLOGIES VENTILATOR AND ACCESSORIES
Regular price $149.00 USDRegular priceUnit price / per -
FDA 510(k), K151981, Turnpike catheter
Regular price $149.00 USDRegular priceUnit price / per -
FDA 510(k), K032526, BINDER CO2 INCUBATOR SERIE CB
Regular price $149.00 USDRegular priceUnit price / per -
FDA 510(k), K113215, MODEL 7600 REGIONAL OXIMETER SYSTEM WITH EQUANOX TECHNOLOGY
Regular price $149.00 USDRegular priceUnit price / per -
FDA 510(k), K090671, PULSE OXIMETER, MODELS CMS50E, CMS50F, CMS60C, CMS60D
Regular price $149.00 USDRegular priceUnit price / per -
FDA 510(k), K152033, Cook ECM Powder
Regular price $149.00 USDRegular priceUnit price / per -
FDA 510(k), K803311, LL100 CRYOSURGICAL SYSTEM
Regular price $149.00 USDRegular priceUnit price / per -
FDA 510(k), K153661, ImmunoCard STAT! HpSA
Regular price $149.00 USDRegular priceUnit price / per