Search FDA 510(k) Database

6,850 clearances indexed · Search by device name, K-number, manufacturer or product code

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174,061 results
15385–15408 of 174,061
Cleared May 25, 2021
Air Relax Plus Model AR-3.0
K211460 · IRP
Diode Art Engineering Doing Business...
Physical Medicine · 14d
Cleared May 24, 2021
NuVasive Modulus Expandable Posterior Lumbar MOD-EX PL Interbody System
K210214 · MAX
Nu Vasive, Incorporated
Orthopedic · 117d
Cleared May 24, 2021
Catalyft PL Expandable Interbody System
K210425 · MAX
Medtronic Sofamor Danek USA, Inc.
Orthopedic · 102d
Cleared May 24, 2021
UltraLight LED System
K210535 · GEX
Rohrer Aesthetics, LLC
General & Plastic Surgery · 89d
Cleared May 24, 2021
Bausch + Lomb (kalifilcon A) Soft (hydrophilic) Contact Lens for Presbyopia
K210975 · LPL
Bausch & Lomb, Incorporated
Ophthalmic · 53d
Cleared May 24, 2021
LEGION CR Porous Plus HA Femoral Components
K211246 · MBH
Smith & Nephew, Inc.
Orthopedic · 28d
Cleared May 22, 2021
Neuro-IOM system with Neuro-IOM.NET software
K190703 · GWF
Neurosoft , Ltd.
Neurology · 796d
Cleared May 21, 2021
Impla-NX (Model: ISE-270M)
K201192 · EBW
Micro-Nx Co., Ltd.
Dental · 382d
Cleared May 21, 2021
Manual Wheelchair, Model A011
K201461 · IOR
Ningbo Shenyu Medical Equipment Co.,Ltd
Physical Medicine · 353d
Cleared May 21, 2021
Ultrasonic Surgical Aspirator System
K202299 · LFL
Smtp Technology Co., Ltd.
General & Plastic Surgery · 281d
Cleared May 21, 2021
Zio Monitor
K202359 · DSH
iRhythm Technologies, Inc.
Cardiovascular · 275d
Cleared May 21, 2021
Zio ECG Utilization Software (ZEUS) System
K202527 · DQK
iRhythm Technologies, Inc.
Cardiovascular · 262d
Cleared May 21, 2021
JWX-1 Plus (Navigo 16/Navigo 24)
K203806 · ITI
Yamaha Motor Co., Ltd.
Physical Medicine · 144d
Cleared May 21, 2021
IPL Hair Removal Device (Model: KCA423)
K210119 · ONF
Shenzhen Boyuan Intelligent...
General & Plastic Surgery · 122d
Cleared May 21, 2021
Neurescue device
K210358 · MJN
Neurescue Aps
Cardiovascular · 102d
Cleared May 21, 2021
Harmonic Hand Piece, Blue, Harmonic Hand Piece, Gray
K211273 · LFL
Ethicon Endo-Surgery, LLC
General & Plastic Surgery · 24d
Cleared May 21, 2021
Universal Viewer
K211312 · LLZ
Ge Healthcare
Radiology · 21d
Cleared May 21, 2021
Rover
K211423 · IZL
Micro-X Limited
Radiology · 14d
Cleared May 20, 2021
Ignite Anatomic Shoulder System
K202716 · MBF
Ignite Orthopedics, LLC
Orthopedic · 245d
Cleared May 20, 2021
Procedure Mask, Surgical Mask
K202899 · FXX
Kenpax International Limited
General Hospital · 233d
Cleared May 20, 2021
ATS 5000 Automatic Tourniquet Instrument
K202919 · KCY
Mcewen and Associates Consulting , Ltd.
General & Plastic Surgery · 233d
Cleared May 20, 2021
Quick-20m
K203331 · GWL
Cgx, LLC
Neurology · 189d
Cleared May 20, 2021
VR101 Lubricating Intravaginal Ring
K203377 · QPD
J3 Bioscience, Inc.
Obstetrics & Gynecology · 184d
Cleared May 20, 2021
Surgical Isolation Gown
K203415 · FYC
Yanbian Pacific Textile Co., Ltd.
General Hospital · 182d