Device Directory
Browse 5,064 FDA-cleared medical devices
Celerity 5 HP Biological Indicator (LCB052); Celerity 5 HP Challenge Pack (LCB059); Celerity 20 HP Biological Indicator (LCB044); Celerity 20 HP Challenge Pack (LCB045) (K250044)
Class Class II K250044 FRC
BPS – Bone Fragment Fixation Plates, Screws and Washers (K250055)
Class Class II K250055 HRS
Disposable Powder Free Nitrile Examination Glove, Blue Color, Tested For Use With Chemotherapy Drugs and Fentanyl Citrate and Xylazine (K244034)
Class Class I K244034 LZA
Scorpio Universal Dome Patella; Scorpio Total Stabilizer Insert; Scorpio-Flex Posterior Stabilized Tibial Insert; Scorpio-Flex Cruciate Retaining Tibial Insert; Scorpio NRG Tibial Bearing Insert – Cruciate Retaining Insert; Scorpio NRG Tibial Bearing Insert – Posteriorly Stabilized Insert (K243817)
Class Class II K243817 JWH
Diode Laser Hair Removal Device (EVOLUTION MEDICAL); Diode Laser Hair Removal Device (M-I-X MEDICAL); Diode Laser Hair Removal Device (GENESIS); Diode Laser Hair Removal Device (Lotus); Diode Laser Hair Removal Device (Ultimate) (K243465)
Class Class II K243465 GEX
VIVACE (K242111)
Class Class II K242111 HGX
Dochek® Fentanyl Urine Test Strip, Dochek® Fentanyl Urine Test Strip Plus, Dochek® Fentanyl Urine Test Card, Dochek® Fentanyl Urine Test Card Plus, Dochek® Fentanyl Urine Test Cup and Dochek® Fentanyl Urine Test Cup Plus (K242428)
Class Class II K242428 NGL
Disposable Sphincterotome (K242192)
Class Class II K242192 KNS
308nm Excimer Phototherapy Device (CN-308E, KN-4003B3, KN-4003B4, KN-5000C KN-5000D, KN-5000H, KN-5000K) (K242977)
Class Class II K242977 FTC
DUTAU-NOVATECH® (K242324)
Class Class II K242324 EOQ
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