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), K061597, EPOC BLOOD ANALYSIS SYSTEM
Regular price $149.00 USDRegular priceUnit price / per -
FDA 510(k), K152127, CorMatrix Tyke
Regular price $149.00 USDRegular priceUnit price / per -
FDA 510(k), K183593, Lung Vision System
Regular price $149.00 USDRegular priceUnit price / per -
FDA 510(k), K163622, Lung Vision
Regular price $149.00 USDRegular priceUnit price / per -
FDA 510(k), K171414, qEEG-Pro
Regular price $149.00 USDRegular priceUnit price / per -
FDA 510(k), K052767, AFIBALERT ATRIAL FIBRILLATION DETECTOR
Regular price $149.00 USDRegular priceUnit price / per -
FDA 510(k), K093395, OLYMPUS GF TYPE UC180, OLYMPUS GF TYPE UCT180 EVIS EXERA II ULATRASOUND GASTROVIDEOSCOPE
Regular price $1,560.63 USDRegular priceUnit price / per -
FDA 510(k), K960224, GERATHERM MERCUIRY FREE CLINICAL THERMOMETER
Regular price $149.00 USDRegular priceUnit price / per -
FDA 510(k), K990519, PHOENIX EPIDURAL & SPINAL NEEDLES
Regular price $322.34 USDRegular priceUnit price / per -
FDA 510(k), K150095, ReDs Wearable System
Regular price $149.00 USDRegular priceUnit price / per -
FDA 510(k), K213562, DTX Studio Clinic 3.0
Regular price $876.26 USDRegular priceUnit price / per -
FDA 510(k), K083670, UNIVERSAL, AESTHETICA, NATEA, NATURA
Regular price $149.00 USDRegular priceUnit price / per -
FDA 510(k), K210365, Second Opinion
Regular price $149.00 USDRegular priceUnit price / per -
FDA 510(k), K951919, B-D PEN ULTRA
Regular price $149.00 USDRegular priceUnit price / per -
FDA 510(k), K981797, B-D PEN ULTRA
Regular price $149.00 USDRegular priceUnit price / per -
FDA 510(k), K142577, PANTHER Endo Linear Cutter Staplers with Single Use Loading Units
Regular price $149.00 USDRegular priceUnit price / per -
FDA 510(k), K152618, PANTHER Cutter Stapler
Regular price $149.00 USDRegular priceUnit price / per -
FDA 510(k), K103470, PANTHER GROUP OF SURGICAL INCLUDES: OANTHER CIRCULAR STAPLER; PANTHER HEMORRHOIDAL CIRCULAR STAPLER; PANTHER LINEAR STAP
Regular price $149.00 USDRegular priceUnit price / per -
FDA 510(k), K112595, COFLEX-F
Regular price $149.00 USDRegular priceUnit price / per -
FDA 510(k), K202415, VirtueRF
Regular price $149.00 USDRegular priceUnit price / per -
FDA 510(k), K942543, ANEROID SPHYGMOMANOMETERS/MERCURIAL SPHYGMOMANOMETERSRS
Regular price $506.25 USDRegular priceUnit price / per -
FDA 510(k), K945952, VACUTAINER(R) BRAND PLUS PST(TM) PLASMA SEPARATION TUBE
Regular price $149.00 USDRegular priceUnit price / per -
FDA 510(k), K092011, NORM SPINAL SYSTEM
Regular price $149.00 USDRegular priceUnit price / per -
FDA 510(k), K192415, Study Watch with Irregular Pulse Monitor
Regular price $506.25 USDRegular priceUnit price / per -
FDA 510(k), K151837, CS 3D Imaging
Regular price $149.00 USDRegular priceUnit price / per -
FDA 510(k), K161461, BostonSight PD Prosthetic Device
Regular price $149.00 USDRegular priceUnit price / per -
FDA 510(k), K123701, HEARLAB ACA
Regular price $149.00 USDRegular priceUnit price / per -
FDA 510(k), K220205, 3D Anatomic Models
Regular price $149.00 USDRegular priceUnit price / per -
FDA 510(k), K812564, ZEE LIFE SUPPORT AIR PANTS
Regular price $149.00 USDRegular priceUnit price / per -
FDA 510(k), K953763, GLADIATOR ANTISHOCK PANTS
Regular price $367.15 USDRegular priceUnit price / per -
FDA 510(k), K101896, MASIMO LNCS/M-LNCS OXIMETRY SENSORS
Regular price $149.00 USDRegular priceUnit price / per -
FDA 510(k), K191151, JKH Stimulator Plus
Regular price $149.00 USDRegular priceUnit price / per -
FDA 510(k), K972382, UB ANALYZER UA-2, REAGENT KIT AND BILIRUBIN CONTROL
Regular price $149.00 USDRegular priceUnit price / per -
FDA 510(k), K013672, BRUGES DISTRACTION - ANCHORING - OSTEOSYNTHESIS SYSTEM
Regular price $149.00 USDRegular priceUnit price / per -
FDA 510(k), K213815, SiJoin®T3
Regular price $149.00 USDRegular priceUnit price / per -
FDA 510(k), K211878, LiquiBand XL
Regular price $149.00 USDRegular priceUnit price / per