Device Directory
Browse 5,064 FDA-cleared medical devices
Synthgene Home Test HCG Test Strip; Synthgene Home Test HCG Test Cassette; Synthgene Home Test HCG Test Midstream (K242135)
Class Class II K242135 LCX
SwimCount® Harvester (1 mL); SwimCount® Harvester (3 mL) (K241348)
Class Class II K241348 MQK
Nitrile Powder-Free Exam Gloves Tested for Use with Chemotherapy Drugs, Opioid Fentanyl Citrate, Simulated Gastric Acid (Light blue, Dark blue) (K243441)
Class Class I K243441 LZA
Nuance Audio Hearing Aid Software (K243150)
Class Class II K243150 SCR
Semi-Floating Temporary Pacing Electrode Catheter, Bipolar, Stainless Steel Electrodes, 115 cm, 4Fr. (006221P); Semi-Floating Temporary Pacing Electrode Catheter, Bipolar, Stainless Steel Electrodes, 115 cm, 5Fr. (006225P); Semi-Floating Temporary Pacing Electrode Catheter, Bipolar, Stainless Steel Electrodes, 125 cm, 6Fr. (006241P); Semi-Floating Temporary Pacing Electrode Catheter, Bipolar, Stainless Steel Electrodes, 125 cm, 7Fr. (006242P); NBIH™ Temporary Pacing Electrode Catheter, (K241334)
Class Class II K241334 LDF
Gentuity® HF-OCT Imaging System with Vis-Rx Prime® Micro-Imaging Catheter (K242966)
Class Class II K242966 DQO
Mobility Scooter (MS160A) (K242982)
Class Class II K242982 INI
Game Ready system (550500-04); Game Ready Control Unit (550550-04); Game Ready Full Leg Boot Wrap – Medium (590923-04); Game Ready Full Leg Boot Wrap – Large (590922-04); Game Ready C-T Spine Wrap (590502-04); Game Ready Half Leg Boot (590906-04); Game Ready Back Wrap (590500-04); Game Ready Hand/Wrist Wrap (590811-04); Game Ready Flexed Elbow Wrap (590903-04); Game Ready Straight Elbow Wrap (590200-04); Game Ready Shoulder Wrap, Medium, Right (590422-04); Game Ready Shoulder Wrap, La (K243572)
Class Class II K243572 IRP
ZeTTA PACS (K241694)
Class Class II K241694 LLZ
AGILIS – Multi-function Physical Therapy Table (Model: Plus, Pro and Basic.) (K241193)
Class Class II K241193 JFB
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