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
EOlife®
Archeon
Sleepio®
Big Health, Inc.
Medical Face Mask (M001)
Xingyu Medical Tech Co., Ltd.
Surgical Mask (Model: WK1701-02A, WK1701-03A, WK1701-04A)
Jiangmen Ningrui Medical Supplies Co., Ltd.
Bonvadis®
Oneness Biotech Co., Ltd.
FIX-C 3D Ti ACIF System
Jeil Medical Corporation
Arthrex Elbow Fracture Plating System
Arthrex, Inc.
uCT 780 with uWS-CT-Dual Energy Analysis
Shanghai United Imaging Healthcare Co., Ltd.
Revolution Peripheral Atherectomy System
Rex Medical, L.P.
MAGNABOND SE; MAGNABOND UNIVERSAL; MAGNABOND UNIVERSAL DCA
Dmp Dental Industry S.A.
OptaBlate RF Generator, OptaBlate Probes, OptaBlate Microinfuser Infusion Device
Stryker Corporation
uSONIQUE Nova, uSONIQUE Nova Elite, uSONIQUE Vita, uSONIQUE Vita Elite, uSONIQUE Grace, uSONIQUE Grace Elite
Wuhan United Imaging Healthcare Co.,Ltd
s-Clean ScanHealing Abutment
Dentis Co., Ltd.
A8 INTEGR8 Porous Pedicle Screws
Allumin8, Inc.
Revian Lyte (10011)
Revian, Inc.
AccurECG Analysis System (v2.0)
Accurkardia, Inc.
Spectricept Skin and Wound Cleanser
Spectrum Antimicrobials, Inc. (Subsidiary of Collidion, Inc.
KARL STORZ Pediatric Cysto-Urethro-Fiberscope (11274BCU1)
Karl Storz SE & CO. KG
Precision Align
Precision Align, LLC
BodySculp
Rohrer Aesthetics, LLC
Accu-Chek Safe-T-Pro Uno Lancing Device
Roche Diabetes Care, Inc.
TE Air Diagnostic Ultrasound System
Shenzhen Mindray Bio-Medical Electronics Co., Ltd.
HF Surgery Generator 400KHZ
Richard Wolf Medical Instruments Corporation
Kii Structural Balloon Access System
Applied Medical Resources Corp.
Access Toxo IgG
Beckman Coulter, Inc.
SyMRI
Syntheticmr AB (Publ.)
Single-use Flexible Ureteroscope (Single-use Flexible Ureteroscope: SUV-5C-B)
Scivita Medical Technology Co., Ltd.
Thunderbolt System
Responsive Arthroscopy, Inc.
Electric breast pump (MY-375,MY-376,MY-378,MY-379,MY-380,V3)
Shenzhen Changkun Technology Co., Ltd.
ID NOW Influenza A & B 2; ID NOW RSV; ID NOW Strep A 2; ID NOW COVID-19 2.0
Abbott Diagnostics Scarborough, Inc.
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