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), K162479, Smart Pain Reliever, Model LT5019
Regular price $149.00 USDRegular priceUnit price / per -
FDA 510(k), K981091, NEOCOLLOID, ORTHOPRINT
Regular price $149.00 USDRegular priceUnit price / per -
FDA 510(k), K061365, CHECKPOINT WITH ACCUSTIM TECHNOLOGY
Regular price $149.00 USDRegular priceUnit price / per -
FDA 510(k), K062541, CALAVIEW COLORS (ETAFILCON A) SOFT (HYDROPHILIC) CONTACT LENS
Regular price $149.00 USDRegular priceUnit price / per -
FDA 510(k), K051477, MIGWANG COMFORT 38 (POLYMACON) SPHERICAL AND TORIC SOFT CONTACT LENS FOR DAILY WEAR (CLEAR, TINTED AND COSMETIC)
Regular price $149.00 USDRegular priceUnit price / per -
FDA 510(k), K080788, VIVASCOPE SYSTEM, MODEL 1500, 3000
Regular price $149.00 USDRegular priceUnit price / per -
FDA 510(k), K062551, NEXUS IRRIGATION TUBING SET
Regular price $149.00 USDRegular priceUnit price / per -
FDA 510(k), K161921, SwiftNINJA Microcatheter
Regular price $149.00 USDRegular priceUnit price / per -
FDA 510(k), K051247, SONOTIP II ULTRASOUND NEEDLE SYSTEM
Regular price $149.00 USDRegular priceUnit price / per -
FDA 510(k), K070129, SONOTIP II ULTRASOUND NEEDLE SYSTEM
Regular price $149.00 USDRegular priceUnit price / per -
FDA 510(k), K963160, HX-5/6-1 ENDOSCOPIC CLIPPING DEVICE
Regular price $149.00 USDRegular priceUnit price / per -
FDA 510(k), K990687, HX-5/6-1 ENDOSCOPIC CLIPPING DEVICE, ENDOSCOPIC CLIPS
Regular price $149.00 USDRegular priceUnit price / per -
FDA 510(k), K140626, MELUNA CLASSIC/SPORT MENSTRUAL CUP
Regular price $149.00 USDRegular priceUnit price / per -
FDA 510(k), K945802, DERMAGRAN WOUND CLEANSER WITH ZINC
Regular price $149.00 USDRegular priceUnit price / per -
FDA 510(k), K052195, EZ-MIO MANUAL DRIVER
Regular price $149.00 USDRegular priceUnit price / per -
FDA 510(k), K002911, XSCAN32 TELERADIOLOGY SOFTWARE
Regular price $149.00 USDRegular priceUnit price / per -
FDA 510(k), K112930, MOBILE MIM
Regular price $149.00 USDRegular priceUnit price / per -
FDA 510(k), K111495, COOK GI ENDOSCOPIC INJECTION GEL KIT, GEL-S, GEL-N, GEL-H, GEL-K
Regular price $149.00 USDRegular priceUnit price / per -
FDA 510(k), K152665, PolarCath Peripheral Dilatation System
Regular price $149.00 USDRegular priceUnit price / per -
FDA 510(k), K071042, POLARCATH PERIPHERAL DILATATION SYSTEM
Regular price $149.00 USDRegular priceUnit price / per -
FDA 510(k), K030742, POLARCATH PERIPHERAL BALLOON CATHETER SYSTEM
Regular price $149.00 USDRegular priceUnit price / per -
FDA 510(k), K962006, MENICON Z (TISILFOCON A) RIGID GAS PERMEABLE CONTACT LENS
Regular price $149.00 USDRegular priceUnit price / per -
FDA 510(k), K070628, OPTIMUM GP (ROFLUFOCON A,B,C,D&E) DAILY WEAR CONTACT LENS.
Regular price $149.00 USDRegular priceUnit price / per -
FDA 510(k), K151319, Eko Electronic Stethoscope System
Regular price $149.00 USDRegular priceUnit price / per -
FDA 510(k), K040051, MEGVISION, MODEL EQ1000C SERIES
Regular price $149.00 USDRegular priceUnit price / per -
FDA 510(k), K043380, MONEBO AUTOMATIC ARRHYTHMIA DETECTION SOFTWARE LIBRARY, VERSION 1
Regular price $149.00 USDRegular priceUnit price / per -
FDA 510(k), K063044, CARDIOBELT ELECTRODE BELT
Regular price $149.00 USDRegular priceUnit price / per -
FDA 510(k), K070803, INVIVODENTAL
Regular price $149.00 USDRegular priceUnit price / per -
FDA 510(k), K011703, LUMENIS VERSAPULSE POWERSUITE HOLMIUM (HO:YAG) AND DUAL WAVELENGTH (HO:YAG/ND:YAG) SURGICAL LASERS AND DELIVERY DEVICES
Regular price $149.00 USDRegular priceUnit price / per -
FDA 510(k), K140388, LUMENIS PULSE 120H
Regular price $149.00 USDRegular priceUnit price / per -
FDA 510(k), K965120, ALLCLENZ WOUND CLEANSER
Regular price $149.00 USDRegular priceUnit price / per -
FDA 510(k), K062282, MONEBO AUTOMATED ECG ANALYSIS AND INTERPRETATION SOFTWARE LIBRARY, VERSION 3.0
Regular price $149.00 USDRegular priceUnit price / per -
FDA 510(k), K131383, X10 HEADSET WITH X-SERIES BASIC SOFTWARE, X24 HEADSET WITH X-SERIES BASIC SOFTWARE
Regular price $149.00 USDRegular priceUnit price / per -
FDA 510(k), K150059, BD FlowSmart Set
Regular price $149.00 USDRegular priceUnit price / per -
FDA 510(k), K033862, BIOTEQ PIGTAIL DRAINAGE CATHETER SET (ONE STEP TYPE) WITH OR WITHOUT SAFETY STRING LOCK
Regular price $149.00 USDRegular priceUnit price / per -
FDA 510(k), K003126, BIPOLAR TRIGGER-FLEX PROBE
Regular price $149.00 USDRegular priceUnit price / per