Device Directory
Browse 5,064 FDA-cleared medical devices
MicroScan Dried Gram-Negative MIC/Combo Panels with Cefepime (CPE) (0.12-64 µg/mL) (MicroScan) (K243804)
Class Class II K243804 LTT
Distal Xtremities System (K252061)
Class Class II K252061 HRS
Wearable Breast Pump (Model W6) (K250383)
Class Class II K250383 HGX
Methinks CTA Stroke (K251590)
Class Class II K251590 QAS
T2 Alpha Humerus Nailing System; IMN Screws System; T2 Nailing System (K251400)
Class Class II K251400 HSB
ACUSON Sequoia Diagnostic Ultrasound System; ACUSON Sequoia Select Diagnostic Ultrasound System; ACUSON Origin Diagnostic Ultrasound System; ACUSON Origin ICE Diagnostic Ultrasound System (K251481)
Class Class II K251481 IYN
Salix Coronary Plaque (V1.0.0) (K251837)
Class Class II K251837 QIH
T1D1 (K252104)
Class Class II K252104 NDC
MTS Sulbactam-Durlobactam 0.004/4 – 64/4 µg/mL (SUD) (K251580)
Class Class II K251580 JWY
WELLlife Flu A&B Home Test; WELLlife Influenza A&B Test (K251563)
Class Class II K251563 SCA
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