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), K011251, SPARC SLING SYSTEM
Regular price $149.00 USDRegular priceUnit price / per -
FDA 510(k), K011571, TRXF INTELLIGENT DOSING SYSTEM (IDS) -DOSING CALCULATOR SUITE
Regular price $149.00 USDRegular priceUnit price / per -
FDA 510(k), K010335, SLENDERTONE FLEX, MODEL, 512
Regular price $149.00 USDRegular priceUnit price / per -
FDA 510(k), K011812, SPECTRUM VENTRICULAR CATHETER
Regular price $149.00 USDRegular priceUnit price / per -
FDA 510(k), K013928, PAIN CARE 3200
Regular price $149.00 USDRegular priceUnit price / per -
FDA 510(k), K011702, VERTIS PNT CONTROL UNIT, VERTIS PNT SAFEGUIDE KIDS, MODELS CU100, SGXXX
Regular price $149.00 USDRegular priceUnit price / per -
FDA 510(k), K013289, BIOTEQUE VAGINAL PESSARIES
Regular price $149.00 USDRegular priceUnit price / per -
FDA 510(k), K013971, BD VACUTAINER SAFETY COAGULATION TUBE
Regular price $149.00 USDRegular priceUnit price / per -
FDA 510(k), K012439, DENTALEYE 2 DENTAL IMAGE MANAGEMENT SYSTEM
Regular price $149.00 USDRegular priceUnit price / per -
FDA 510(k), K020251, PARAGON INFUSION SYSTEM
Regular price $149.00 USDRegular priceUnit price / per -
FDA 510(k), K020660, HOMEPUMP, ECLIPSE, C-SERIES, PAINBUSTER, C-BLOC, ON-Q, EASYPUMP, ONE STEP KVO
Regular price $149.00 USDRegular priceUnit price / per -
FDA 510(k), K020659, DUREX LATEX CONDOM WITH MALE GENITAL DESENSITIZER LUBRICANT
Regular price $149.00 USDRegular priceUnit price / per -
FDA 510(k), K020988, PAIN CARE 4200
Regular price $149.00 USDRegular priceUnit price / per -
FDA 510(k), K021344, B-F200 BRONCHOSCOPE WITH BSS-F21 ENDOSHEATH SYSTEM
Regular price $149.00 USDRegular priceUnit price / per -
FDA 510(k), K020732, SS MATRIX
Regular price $149.00 USDRegular priceUnit price / per -
FDA 510(k), K003720, ANGEL OF WATER COLON HYDROTHERAPY SYSTEM
Regular price $149.00 USDRegular priceUnit price / per -
FDA 510(k), K020399, RESPERATE; MODEL RR-150
Regular price $149.00 USDRegular priceUnit price / per -
FDA 510(k), K021094, INTROCAN SAFETY IV CATHETER
Regular price $149.00 USDRegular priceUnit price / per -
FDA 510(k), K022149, CARDIAC DIAGNOSTIC SYSTEM, MODEL CH2000
Regular price $149.00 USDRegular priceUnit price / per -
FDA 510(k), K011741, CRIT-LINE MONITOR III TQA (CLM TQA)
Regular price $149.00 USDRegular priceUnit price / per -
FDA 510(k), K010727, FLEXLINE CLAMP
Regular price $149.00 USDRegular priceUnit price / per -
FDA 510(k), K021808, WECK HEM-O-LOK AUTOMATIC LIGATING CLIP APPLIER
Regular price $149.00 USDRegular priceUnit price / per -
FDA 510(k), K021792, BILAYER MATRIX WOUND DRESSING
Regular price $149.00 USDRegular priceUnit price / per -
FDA 510(k), K022782, DUALMESH EMERGE & EMERGE PLUS BIOMATERIAL
Regular price $149.00 USDRegular priceUnit price / per -
FDA 510(k), K022006, CONDUCTIVE GEL
Regular price $149.00 USDRegular priceUnit price / per -
FDA 510(k), K022869, SOAKER CATHETER
Regular price $149.00 USDRegular priceUnit price / per -
FDA 510(k), K023318, I-FLOW ELASTOMERIC PUMP WITH BOLUS
Regular price $149.00 USDRegular priceUnit price / per -
FDA 510(k), K020715, PHILIPS M5066A AND M5068A
Regular price $149.00 USDRegular priceUnit price / per -
FDA 510(k), K023075, BD VACUTAINER PLUS SST SERUM SEPARATOR TUBE
Regular price $149.00 USDRegular priceUnit price / per -
FDA 510(k), K023928, MAS UA CONTROL LIQUID ASSAYED URINALYSIS CONTROL, DADE ASSAYED URINALYSIS CONTROL
Regular price $149.00 USDRegular priceUnit price / per -
FDA 510(k), K023087, GLOBAL MODULAR REPLACEMENT SYSTEM (GMRS)
Regular price $149.00 USDRegular priceUnit price / per -
FDA 510(k), K024060, MODIFICATION TO ASNIS III CANNULATED SCREW SYSTEM
Regular price $149.00 USDRegular priceUnit price / per -
FDA 510(k), K023883, HOMEPUMP, ECLIPSE, C-SERIES, PAINBUSTER, C-BLOC, ON-Q, EASYPUMP, KVO
Regular price $149.00 USDRegular priceUnit price / per -
FDA 510(k), K020020, THE IZZZY-TENS (WL-2401), THE SLIM-TENS (WL-2402), THE MENS-TENS (WL2403), THE COMPACT TENS (WL-2302)
Regular price $149.00 USDRegular priceUnit price / per -
FDA 510(k), K022622, CEM-OSTETIC, MODELS CEMO-020O, CEMO-05P, CEMO-10P, CEMO-20P, AND CEMO-30P
Regular price $149.00 USDRegular priceUnit price / per -
FDA 510(k), K023183, MEDRAD STELLANT CT INJECTOR SYSTEM
Regular price $149.00 USDRegular priceUnit price / per