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
InThrill Thrombectomy System
Inari Medical, Inc.
Zimmer Biomet Ceramic Heads (22.2mm diameter)
Zimmer Biomet
X-PAC® LLIF Expandable Lateral Cage System
Expanding Innovations, Inc.
Harvest Conceal ZR Block Out
Harvest Dental Products, LLC
Advcare Vial Direct to Bag (VDB) Needle-free Admixture Devices
Advcare Medical
Gemini Cervical Fusion Cage System
ZheJiang Decans Medical Devices Co., Ltd.
BAC
DeepHealth, Inc.
UltraPrint-Dental Denture UV
Guangzhou Heygears IMC., Inc.
BentrioTM Allergy Blocker
Altamira Therapeutics, Inc.
LVivo IQS
Dia Imaging Analysis, Ltd.
Hammertoe Truss System (HTS)
4Web Medical, Inc.
TENS AND EMS (TENS and Muscle Stimulator) ( Model AS8012C,AS8016,AS8019,AS9020E,AS9026)
Shenzhen Astec Technology Co., Ltd.
Microthin Natural Rubber Latex Condom
Suretex Limited
Secret Line up (FC1938E80 FC1950E90 FC1960E100 FC1970E120 FC1990E150 FC19100E150 FC19100E280 FC19100E420 FC2038E80 FC205
Hyundae Meditech Co., Ltd.
Nitta M&T Safety Box
Nitta M&T (Thailand) Co., Ltd.
MagnetOs MIS
Kuros Biosciences B.V
IntelliBlate Microwave Ablation System Console (IB-CON); IntelliBlate Microwave Ablation System Mobile Cart (IB-CART); I
Varian Medical Systems, Inc.
Infinity OCT System
Medtronic Sofamor Danek USA, Inc.
Turnpike catheter, Turnpike Spiral catheter, Turnpike LP catheter, Turnpike Gold catheter, GuideLiner V3 catheter, TrapL
Vascular Solutions, LLC
Game Ready system (550500-04); Game Ready Control Unit (550550-04); Game Ready Full Leg Boot Wrap - Medium (590923-04);
Avanos Medical, Inc.
Venus Cervical Plate System
Artfx Medical, LLC
Alexis Contained Extraction System
Applied Medical Resources Corporation
Combo Electrotherapy Device
Shenzhen Roundwhale Technology Co. , Ltd.
MBT Compass HT CA Software; MBT FAST Shuttle US IVD
Bruker Daltonics GmbH & Co. KG
Préime DermaFacial Collagen+
EMA Aesthetics , Ltd.
CareTaker Monitor App
Caretaker Medical, LLC
Ki Mobility Focus CR, Ki Mobility Focus CRe, Ki Mobility Focus CR TTL
Ki Mobility, LLC
Porous Biologic Scaffold
Ventris Medical
Surgical Gown
Bayteks Teknik Tekstil San. VE Tic. A.S.
Fibresolve
Imvaria, Inc.
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