Device Directory
Browse 313 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) (K251452)
Class Class II K251452 FRC
GCI Sterilization Wrappers (K250321)
Class Class II K250321 FRG
Steam Sterilizer (2545D) (K243994)
Class Class II K243994 FLE
Nitrile Powder Free Examination Glove with Tremella Fuciformis Extract, Tested for Use with Chemotherapy Drugs and Fentanyl Citrate – Blue (K243694)
Class Class I K243694 LZA
MallyaG Injection Pen Adapter (MallyaG) (K251500)
Class Class II K251500 QOG
Nitrile Powder Free Examination Gloves with Low Dermatitis Potential, Tested for Use with Chemotherapy Drugs, Fentanyl Citrate and Gastric Acid (K243133)
Class Class I K243133 LZA
PowerPort™ isp Implantable Port; PowerPort™ Slim Implantable Port; PowerPort™ M.R.I. ™ Implantable Port; PowerPort™ M.R.I.™ isp Implantable Port (K251253)
Class Class II K251253 LJT
Halyard Purple Nitrile* Powder-Free Exam Gloves, Sterile Pairs; Halyard Purple Nitrile* Powder-Free Exam Gloves, Sterile Singles (K243172)
Class Class I K243172 LZA
BD Intelliport System; BD Intelliport Reader (516230); BD Intelliport Sensor (516229); BD Intelliport Gateway (516232); BD Intelliport Mount (516233); BD Intelliport Charger (516231) (K243062)
Class Class II K243062 PHC
Reusable Temperature Probe (T1306, T2306, T3306, T4306); Disposable Temperature Probe (T5106, T6106) (K243000)
Class Class II K243000 FLL
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