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
Powered Breast Pump (Models 7V and 7X)
Haenim Co., Ltd.
Identity Imprint Knee Replacement System (including Identity Imprint Posterior Stabilized (PS) KRS and Identity Imprint
Conformis, Inc.
Tablo® Hemodialysis System
Outset Medical, Inc.
Latex Powder Free Surgical Glove with Protein Labeling Claim of 50 Microgram or Less per Gram of Glove and Tested for Us
Hartalega NGC Sdn. Bhd.
OptiCrossTM HD Coronary Imaging Catheter, OptiCrossTM 6 HD Coronary Imaging Catheter
Boston Scientific Corporation
Diagnostic Ultrasound System (Nano C5, Nano C5 EXP, Nano L12, and Nano L12 EXP)
Edan Instruments, Inc.
Trigon HA Stand-Alone Wedge Fixation System
Nvision Biomedical Technologies, Inc.
AlphaVac Multipurpose Mechanical Aspiration (MMA) F1885 System
AngioDynamics, Inc.
Powder Free Vinyl Examination Gloves
Shanghai Shengda Medical Applications Co., Ltd.
Powered Inflatable Tube Massager - SLIM UP DRAIN
Foggiare Technologies, LLC
VersaCross Connect Transseptal Dilator
Baylis Medical Company, Inc.
RhythmStar System (SL)
RhythMedix, LLC
Lung-CAD
Imagen Technologies, Inc.
Sonosite iLOOK Ultrasound System
FUJIFILM Sonosite, Inc.
LED Light Therapy Mask (model: MK66R-B)
Light Tree Ventures Europe B.V.
I.T.S. Pelvic Reconstruction System (PRS RX & PRS Phoenix)
I.T.S. GmbH
CoverScan (CoverScan v1.1)
Perspectum
Renova Spine Balloon Catheter
Biopsybell S.R.L.
AZUR HydroPack 18 (45-880005; 45-880010; 45-880020; 45-880035; 45-880050; 45-880060)
MicroVention, Inc.
Elekta Unity
Elekta Solutions AB
MTA vpt
Voco GmbH
RadiForce RX270
Eizo Corporation
Sysmex XQ-Series (XQ-320) Automated Hematology Analyzer
Sysmex America, Inc.
CONDUIT LLIF Straight Inserters
Enztec Limited
QP-Brain®
Quibim S.L.
BD Surgiphor Antimicrobial Irrigation System (910110)
Becton, Dickinson and Company (BD)
nordicMEDiVA
Nordicneurolab AS
BD Microtainer® Contact-Activated Lancets; BD Microtainer® Quikheel Lancets
Becton, Dickinson and Company
Aneroid Sphygmomanometer with Stethoscope; Aneroid Sphygmomanometer
Wenzhou Longwan Medical Device Factory
Disposable Nitrile Examination gloves
Fujian Yuanxin Safety Protection Technology Co., Ltd.
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