510(k) Device Clearances
Medical devices cleared through the FDA's 510(k) premarket notification process. Substantially equivalent to existing devices.
15,000 total clearances
Uterine Aspiration Set
Gcmedica Enterprise Ltd.(Wuxi)
Sensititre 20-24 hour Haemophilus influenzae/Streptococcus pneumoniae MIC, or Breakpoint Susceptibility System with Imip
Thermo Fisher Scientific
Talon Transseptal Sheath
Inari Medical, Inc.
C1210G LCD Monitor, JUSHA-C1210G LCD Monitor, C1210 LCD Monitor, JUSHA-C1210 LCD Monitor
Nanjing Jusha Display Technology Co., Ltd.
SI-TECHNOLOGY® SI-DESIS® X Sacroiliac Joint Fusion System
Si-Technology, LLC
808nm semiconductor laser hair removal machine
Xi'An Taibo Electronic Technology Co., Ltd.
Normatec Go
NormaTec Industries, LP
Power wheelchair (N6101)
Zhejiang Zhonglei Medical Technology Co. , Ltd.
SKR 3000
Konica Minolta, Inc.
Ziehm Vision RFD
Ziehm Imaging GmbH
InstruSafe Instrument Protection System
Summitt Medical, LLC
CastleLoc Pectus Bar System
L&K BIOMED Co., Ltd.
UroNav 4
Philips DS North America, LLC
ClearCalc Model RADCA V2.6
Radformation, Inc.
VOLT Ankle Trauma 2.7/3.5 Plating System; VOLT Calcaneus 2.7 Plating System
Synthes GmbH
Hepatus 7/Hepatus 6/Hepatus 5/Hepatus 7S/Hepatus 6S/Hepatus 5S/Hepatus7T/Hepatus 6T/Hepatus 5T/Fibrous 7/Fibrous 6/Fibro
Shenzhen Mindray Bio-Medical Electronics Co., Ltd.
Hudson RCI® Infant Dri-TechTM Breathing Circuits (HUD99060 / Dri-Tech with 78 Infant Circuit, HUD99060KIT / Dri-Tech wi
Medline Industries, LP
Cardiovascular Angiography System
Allengers Medical Systems Limited
QardioArm 2
Qardio, Inc.
Flyte
Pelvital USA, Inc.
DHF 0.2 Hemoconcentrator (DHF 02); DHF 0.6 Hemoconcentrator (DHF 06); SH 14 Hemoconcentrator (SH 14)
Sorin Group Italia S.R.L.
IPL Hair Removal Device, Model(s): FY-B505AL, FY-B505AG, FY-B505BL, FY-B505BG, FY-B507AL, FY-B507AG, FY-B507BL, FY-B507B
Shenzhen Xiazhifeng Electronic Co., Ltd.
CyClean Cord
SS GLOBAL
cobas CMV
Roche Molecular Systems, Inc.
TRIUX neo (NM27000N ); MEGreview (SW26241N-B)
Megin OY
Primescan 2
Dentsply Sirona, Inc.
LIAISON NES FLU A/B, RSV & COVID-19
Diasorin Molecular, LLC
Trigon HA Stand-Alone Wedge Fixation System
Nvision Biomedical Technologies, Inc.
Well-life TM Pen Needles, Well-life TM Safety Pen Needles
W. L. Med Co., Ltd.
Neodent Implant System - GM Narrow Implant System
Jjgc Industria E Comercio DE Materiais Dentarios S.A.
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