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), K940189, COIL POSITIONER SET
Regular price $149.00 USDRegular priceUnit price / per -
FDA 510(k), K944254, OKTAS STEREO VIEWING SYSTEM
Regular price $149.00 USDRegular priceUnit price / per -
FDA 510(k), K942823, MAHE INSTRUMENTS
Regular price $149.00 USDRegular priceUnit price / per -
FDA 510(k), K942902, SHARPS-TAINER SMALL OPENING W/NEEDLE REMOVER
Regular price $149.00 USDRegular priceUnit price / per -
FDA 510(k), K941327, CROSSTEX SELF-SEALING STERILIZATION POUCH
Regular price $149.00 USDRegular priceUnit price / per -
FDA 510(k), K926139, CATHLINK 20 TITANIUM PORT W/ATT. POLYURETHANE CATH
Regular price $149.00 USDRegular priceUnit price / per -
FDA 510(k), K935094, BALLOON DILATION CATHETER
Regular price $149.00 USDRegular priceUnit price / per -
FDA 510(k), K940852, CHIEF STANDUP WHEELCHAIR
Regular price $149.00 USDRegular priceUnit price / per -
FDA 510(k), K941507, THEMO-FLO SYSTEM 3 LAPAROSCOPIC/HYSTEROSCOPIC SYSTEM
Regular price $149.00 USDRegular priceUnit price / per -
FDA 510(k), K942694, STABILITY SYSTEM (110V) MODEL 945-300; STABILITY SYSTEM (220V) MODEL #945-302
Regular price $149.00 USDRegular priceUnit price / per -
FDA 510(k), K950729, OLYMPUS PR-23Q DISPOSABLE CANNULA (BALL TIP)
Regular price $149.00 USDRegular priceUnit price / per -
FDA 510(k), K950339, KSEA STEINER ELECTROMECHANIC MORCELLATOR
Regular price $149.00 USDRegular priceUnit price / per -
FDA 510(k), K951123, CAVICIDE SURFACE DISINFECTANT/DECONTAMINANT CLEANER
Regular price $149.00 USDRegular priceUnit price / per -
FDA 510(k), K950700, BARD BILISYSTEM ENDOSCOPIC RETROGRADE CHOLANGIOPANCREATOGRAPHY (ERCP) CANNULA
Regular price $149.00 USDRegular priceUnit price / per -
FDA 510(k), K940951, RW RESUCITAIRE INFANT RADIANT WARMER
Regular price $149.00 USDRegular priceUnit price / per -
FDA 510(k), K922688, EXTRA PROTECTION POLYURETHANE CONDOM
Regular price $149.00 USDRegular priceUnit price / per -
FDA 510(k), K952164, EMI MODEL FFF-IA
Regular price $149.00 USDRegular priceUnit price / per -
FDA 510(k), K946147, KSE STEINER ELECTROMECHANIC MORCELLATOR
Regular price $149.00 USDRegular priceUnit price / per -
FDA 510(k), K934086, MEDRAD ENVISION CT INJECTOR AND QWIK FIT SYRINGE
Regular price $149.00 USDRegular priceUnit price / per -
FDA 510(k), K944957, TEMPORARY MYOCARDIAL PACING LEAD, MODEL 6500
Regular price $149.00 USDRegular priceUnit price / per -
FDA 510(k), K953235, SCREW IMPLANTS, GRADE 3; UNCOATED, HA, TP-K3
Regular price $149.00 USDRegular priceUnit price / per -
FDA 510(k), K944524, SNAP TESTING DEVICE
Regular price $149.00 USDRegular priceUnit price / per -
FDA 510(k), K920633, PESSARY FLEXIBLE SILICONE NICHOLS
Regular price $149.00 USDRegular priceUnit price / per -
FDA 510(k), K943305, OLYMPUS 3D SURGICAL ENDOSCOPY SYSTEM
Regular price $149.00 USDRegular priceUnit price / per -
FDA 510(k), K953876, PENTAX ULTRASOUND ENDOSCOPE MODEL FG-32UA (MODIFICATION)
Regular price $149.00 USDRegular priceUnit price / per -
FDA 510(k), K955300, TOTAL BILIRUBIN PROCEDURE
Regular price $149.00 USDRegular priceUnit price / per -
FDA 510(k), K953967, ENDOSCOPIC CATHETER
Regular price $149.00 USDRegular priceUnit price / per -
FDA 510(k), K953746, ARROW HIGH FLOW FLUID ADMINSITRATION SET W/BLOOD FILTER & EXTENSION SET
Regular price $149.00 USDRegular priceUnit price / per -
FDA 510(k), K960091, ENZYME IMMUNOASSAY ANTI-DOUBLE STRANDED DNA (DSDNA) TEST KIT
Regular price $149.00 USDRegular priceUnit price / per -
FDA 510(k), K954828, ISO-GARD HEPA FILTER-HME, ISO-ARD HEPA FILTER-HME W/PORT
Regular price $149.00 USDRegular priceUnit price / per -
FDA 510(k), K960673, OSAP
Regular price $149.00 USDRegular priceUnit price / per -
FDA 510(k), K961158, SUPRASSON P5 BOOSTER
Regular price $149.00 USDRegular priceUnit price / per -
FDA 510(k), K960167, SYSTEM, THERMAL REGULATING 74-DWJ
Regular price $149.00 USDRegular priceUnit price / per -
FDA 510(k), K950944, AMBULATORY (HOLTER) RECORDING SYSTEM
Regular price $149.00 USDRegular priceUnit price / per -
FDA 510(k), K961878, SHARPS-TAINER
Regular price $149.00 USDRegular priceUnit price / per -
FDA 510(k), K961725, OSCAR ORTHOSONICS SYSTEM FOR CEMENTED ARTHROPLASTY REVISION
Regular price $149.00 USDRegular priceUnit price / per