Regulations
159
Product codes
266
Devices
18,987
Device class distribution
Class I
296 (1.6%)
Class II
17,485 (92.1%)
Class III
1,206 (6.4%)
Top product codes by device count
CodeExample deviceDevices
DXN BP1000 Ultra-Compact Fingertip Blood Pressure Monitor (BP1000) 1,211
DQY Amplatzer TorqVue Delivery System 888
DQX FMD Peripheral Guide Wire F-14 Flex 6; FMD Peripheral Guide Wire F-14 Tapered 40; FMD Peripheral Guide Wire F-18 Flex SP; FMD Peripheral Guide Wire F-18 DP 25; FMD Peripheral Guide Wire F-18 Tapered 40 763
DQA Nasal Alar SpO2 Sensor (989803205381); Nasal Alar SpO2 Sensor (989803205391); Nasal Alar Sp02 Sensor (989803205401) 724
DYB Echo Large Bore Introducer Sheath 701
DPS MAC 7 Resting ECG Analysis System 575
DQO Arterial Pressure Monitoring Set/Tray 499
DTB BIOTRONIK ENDOCARDIAL PACING LEADS 487
DXY PIKOS 01, PIKOS E01, PIKOS 01-B, PIKOS E01-B, PIKOS 01-A, PIKOS E01-A 461
DQK EnSite™ X EP System 427
MHX Vista CMS 422
LIT Armada™ 14 NC PTA Catheter 402
DWF Elongated One-Piece Arterial (EOPA) 3D™ Arterial Cannulae 401
DSI BodyGuardian Remote Monitoring System (BGRMS v3.0) 398
JOW Compression Therapy Device (LGT-2202DVT) 350
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