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
Patient Monitor, models LM-8, LM-10, LM-12 and LM-15
Caf Medical Solutions, Inc.
SkinStylus SteriLock® MicroSystem, Model Number MP1209SL
Esthetic Medical, Inc.
Manual Wheelchair (7101L, 7102LHD)
Foshan Nanhai Hongchen Medical Equipment Co., Ltd.
TENS 7000 Rechargeable 4 Channel (TENS 7000H)
Shenzhen Dongdixin Technology Co., Ltd.
Insufflator (wAlcor C50A, wAlcor C50B, wAlcor C50C, wAlcor C35A, wAlcor C35B, wAlcor C35C)
Weyo Surgical Technology , Ltd.
SMR Reverse HP Shoulder System
Lima Corporate S.P.A.
Powder Free Nitrile Examination Gloves (Blue), Tested for Use with Chemotherapy Drugs
Shanxi Hongjin Plastic Technology Co., Ltd.
CoolSculpting Elite System
Zeltiq Aesthetics, Inc.
AllSource Drug Detector FenTest; AllSource Drug Detector Fentanyl Test
Allsource Screening Solutions
Triathlon® Total Knee System - Triathlon® Pro Posterior Stabilized (PS) Femoral Component
Howmedica Osteonics Corp., Dba Stryker Orthopaedics
iotaSOFT® Insertion System
Iotamotion, Inc.
Little Wave Arc; Little Wave Flip
Ki Mobility, LLC
Solas OR
Cirdan Imaging, Ltd.
Clarius Ultrasound Scanner
Clarius Mobile Health Corp.
AMSCO 600 Medium Steam Sterilizer
STERIS Corporation
Infinity OCT System and PASS OCT Spinal System
Medicrea International
Otsuka Digital Feedback Device
Otsuka America Pharmaceutical, Inc.
Pain Therapy Device(Model: P.T.S-X)
Guangzhou Xinbo Electronic Co., Ltd.
Arthrex Self Punching SwiveLock Suture Anchors
Arthrex, Inc.
Pulse Oximeter
Beijing Choice Electronic Technology Co., Ltd.
EndoScreener
Chengdu Wision Medical Device Co., Ltd.
Stim2Go
PAJUNK GmbH Medizintechnologie
Microwave Ablation System (BD-GT)
Betters(Suzhou) Medical Co., Ltd.
Insulin Syringe
Promisemed Hangzhou Meditech Co., Ltd.
UniFit Dental Implant System
Adin Dental Implant Systems , Ltd.
AUXILIARY WATER TUBE MAJ-855
Olympus Medical Systems Corporation
Vital Spinal Fixation System
Zimvie Spine (Zimmer Biomet Spine, Inc.)
Perifix FX Catheter; Contiplex FX Catheter
B.Braun Medical, Inc.
Klockner Abutments
SOADCO, S.L.
Powered Mobility Scooter (Models: PMS101, GUT112, PMS103, GUT140)
Intradin (Shanghai) Machinery Co., Ltd.
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