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), K150009, Baide
Regular price $149.00 USDRegular priceUnit price / per -
FDA 510(k), K142418, I.T.S. Hand Locking Plates System - HLS
Regular price $149.00 USDRegular priceUnit price / per -
FDA 510(k), K141825, IDEAL Locking Plate System
Regular price $149.00 USDRegular priceUnit price / per -
FDA 510(k), K141102, HOSPIRA MEDNET MEDICATION MANAGEMENT SUITE
Regular price $149.00 USDRegular priceUnit price / per -
FDA 510(k), K141389, SAPPHIRE INFUSION PUMP
Regular price $149.00 USDRegular priceUnit price / per -
FDA 510(k), K123229, REMOTE PRESENCE SYSTEM, MODEL RP-VITA
Regular price $149.00 USDRegular priceUnit price / per -
FDA 510(k), K120500, THE PAIN PILOT (A.K.A PAIN PILOT)
Regular price $149.00 USDRegular priceUnit price / per -
FDA 510(k), K090042, PAINMASTER MCT PATCH
Regular price $149.00 USDRegular priceUnit price / per -
FDA 510(k), K083580, ANTI-WRINKLE LIGHT, MODEL 1302 AND PAIN THERAPY LIGHT, MODEL 1301
Regular price $149.00 USDRegular priceUnit price / per -
FDA 510(k), K123421, OLYMPUS SMALL INTESTINAL CAPSULE ENDOSCOPE SYSTEM
Regular price $149.00 USDRegular priceUnit price / per -
FDA 510(k), K092239, ROSA SURGICAL DEVICE, MODEL ROSA 1.1
Regular price $149.00 USDRegular priceUnit price / per -
FDA 510(k), K070598, MEMOMETAL INTRA-MEDULLARY BONE FASTENER, MODELS SMART TOE / X-FUSE
Regular price $149.00 USDRegular priceUnit price / per -
FDA 510(k), K093642, NEUTRASAL
Regular price $149.00 USDRegular priceUnit price / per -
FDA 510(k), K072134, SCHICK COMPUTED ORAL RADIOLOGY SYSTEM
Regular price $149.00 USDRegular priceUnit price / per -
FDA 510(k), K131146, ARTASSIST AND VENASSIST
Regular price $149.00 USDRegular priceUnit price / per -
FDA 510(k), K942530, ART-ASSIST MODEL AA-1000
Regular price $149.00 USDRegular priceUnit price / per -
FDA 510(k), K103008, INZONE DETACHMENT SYSTEM
Regular price $149.00 USDRegular priceUnit price / per -
FDA 510(k), K121891, NEWPORT AURA VENTILATOR
Regular price $149.00 USDRegular priceUnit price / per -
FDA 510(k), K124029, MICROLINE FLEXIBLE LIGATING SHEARS
Regular price $149.00 USDRegular priceUnit price / per -
FDA 510(k), K140459, ALTRUS THERMAL TISSUE FUSION ENERGY SOURCE, ALTRUS THERMAL TISSUE FUSION HANDPIECE, ALTRUS THERMAL TISSUE FUSION SYSTEM
Regular price $149.00 USDRegular priceUnit price / per -
FDA 510(k), K151632, Symphony Breastpump, Symphony reconditioned, Symphony Preemie+ Breastpump, Symphony Plus Breastpump (battery version), Symphony Consignment, Preemie Consignment Pump, Symphony Rental, Symphony Plus Rental, Symphony Preemie+ Rental
Regular price $149.00 USDRegular priceUnit price / per -
FDA 510(k), K140366, ENDLESSFIBER REUSABLE SURGICAL LASER FIBER
Regular price $149.00 USDRegular priceUnit price / per -
FDA 510(k), K092710, PENTAX ED-3490TK, VIDEO DUODENOSCOPE
Regular price $149.00 USDRegular priceUnit price / per -
FDA 510(k), K123633, TRS CRANIAL BONE VOID FILLER(TRS C-BVF)
Regular price $149.00 USDRegular priceUnit price / per -
FDA 510(k), K073057, PULSAR GENERATOR, MODEL PS100-100, AND PEAK PLASMABLADE TISSUE DISSECTION DEVICE, MODEL PS200-040
Regular price $149.00 USDRegular priceUnit price / per -
FDA 510(k), K083415, PEAK PLASMABLADE TNA TONSIL AND ADENOID TISSUE DISSECTION DEVICE
Regular price $149.00 USDRegular priceUnit price / per -
FDA 510(k), K080398, SI JOINT FUSION SYSTEM
Regular price $149.00 USDRegular priceUnit price / per -
FDA 510(k), K051296, SIJF CANNULATED SCREW SYSTEM
Regular price $149.00 USDRegular priceUnit price / per -
FDA 510(k), K021932, SYNTHES 6.5 MM CANNULATED SCREW
Regular price $149.00 USDRegular priceUnit price / per -
FDA 510(k), K092264, ATLANTIS HYPERBARIC CHAMBER VENTILATOR
Regular price $149.00 USDRegular priceUnit price / per -
FDA 510(k), K133718, ZERONA
Regular price $149.00 USDRegular priceUnit price / per -
FDA 510(k), K093548, AVIE A1C TEST SYSTEM
Regular price $149.00 USDRegular priceUnit price / per -
FDA 510(k), K140306, CORMATRIX PROTECT ECM ENVELOPE
Regular price $149.00 USDRegular priceUnit price / per -
FDA 510(k), K112514, APNEA RISK EVALUATION SYSTEM (ARES)
Regular price $149.00 USDRegular priceUnit price / per -
FDA 510(k), K103477, PERMOBIL M300 / M400
Regular price $149.00 USDRegular priceUnit price / per -
FDA 510(k), K130738, ENDOSCOPIC LINEAR CUTTING STAPLERS WITH SINGLE USE LOADING UNITS
Regular price $149.00 USDRegular priceUnit price / per