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
Liv Pre-lubricated Intermittent Catheter
HR Healthcare
Alegria Flash SSA-60; Alegria Flash SSA-52; Alegria FLash SSB
Zeus Scientific
SPY Laparoscope
Stryker Endoscopy
KARL STORZ ICG Imaging System with RUBINA® Lens
Karl Storz SE & CO. KG
BIOFIRE® FILMARRAY® Pneumonia Panel (BIOFIRE Pneumonia Panel); BIOFIRE® FILMARRAY® Pneumonia Panel plus (BIOFIRE Pneumon
Biofire Diagnostics, LLC (Biomerieux)
Synovasure Alpha Defensin Lateral Flow Test Kit (1 Kit), Synovasure Alpha Defensin Lateral Flow Test Kit (5 Test), Synov
Cd Diagnostics, Inc.
Quantisal Oral Fluid Collection Device
Immunalysis Corporation
BeautiBond Xtreme
Shofu Dental Corporation
Ikshana
Immersivetouch
Identity Shoulder System
Zimmer, Inc.
Perfit CL
Vatech Mcis Co., Ltd.
X-FLO Fluid Management System
Thermedx, LLC
BPAP System
BMC Medical Co., Ltd.
C-Stem AMT LE Prosthesis
Depuy Ireland UC
LumenaTM Ureteral Access Sheath
Cathegenix (Xiamen) Co., Ltd.
AvalancheLase Family
Fotona D.O.O.
aprevo® anterior and lateral lumbar interbody system; aprevo® posterior and transforaminal lumbar interbody system; apre
Carlsmed, Inc.
Nitrile Patient Examination Gloves Tested For Use With Chemotherapy Drugs
Fitone Latex Products Co., Ltd. Guangdong
EliA Ro52, EliA Ro60
Phadia AB
BriefCase
Aidoc Medical , Ltd.
Portex BLUxl Extra Length Tracheostomy Tube, BLUxl Suctionaid Extra Length Tracheostomy Tube, BLUxl Extra Length Tracheo
Smiths Medical Asd, Inc.
Diode Laser Hair Removal
Wuhan Lotuxs Technology Co., Ltd.
Symbia Pro.specta VA20A Family
Siemens Medical Solutions USA, Inc.
AeroDVx Arm System
Sun Scientific, Inc.
Invisalign System, Pre-Formed Attachment System
Align Technology, Inc.
VersaWrap Nerve Protector (VTP-2201); VersaWrap Nerve Protector (VTP-1201)
Alafair Biosciences
Onera Sleep Test System (Onera STS)
Onera B.V.
Annabella Breast Pump
Annabella , Ltd.
Plato 17 Microcatheter
Scientia Vascular, Inc.
Reprocessed VersaCross Steerable Sheath; Reprocessed SureFlex Steerable Guiding Sheath
Innovative Health, LLC
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