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
Swedge Pedicle Screw Fixation System Bezier Rod
Spinal Resources, Inc.
Pounce XL Thrombectomy System (PTS-1011-7F135)
Surmodics,Inc.
KARL STORZ Trocars with Valve Seals
Karl Storz SE & CO. KG
Air Compression Leg Massager (K-705)
Jiale Health Technology Shenzhen Co., Ltd.
Mini-ClotTriever Thrombectomy System
Inari Medical
Apollo TMS Therapy System
Mag & More GmbH
ArtFx Corpectomy Cages (Espinax and Distractania Corpectomy Cages)
Arftx Medical, LLC
Zimmer Persona Personalized Knee System
Zimmer, Inc.
Non-variola Orthopoxvirus Real-time PCR Primer and Probe Set
Centers for Disease Control and Prevention
XBody Go USA, XBody Pro USA
Xbody Hungary Kft.
HAVAb IgG II
Abbott Laboratories
MIM Monte Carlo Dosimetry
Mim Software, Inc.
Guiding Catheter
CenterPoint Systems, LLC
OrthoNext Platform System
Orthofix Srl
Combo Electrotherapy Device
Shenzhen Roundwhale Technology Co. , Ltd.
ArcSP Suprapubic Sling System
Urocure, LLC
INTRABEAM (700); And accessories (INTRABEAM SMART Stand, INTRABEAM SMART Spherical Applicator, INTRABEAM Spherical Sizer
Carl Zeiss Meditec, AG
Triathlon® Total Knee System - Triathlon® Gold Femoral Components
Howmedica Osteonics Corp., Dba Stryker Orthopaedics
LINK Endo-Model EVO Knee System
Waldemar Link GmbH & Co. KG
Atlan (A100); Atlan (A100 XL); Atlan(A350); Atlan (A350 XL)
Drägerwerk AG Co. Kgaa
Finger Clip Pulse Oximeter
Guangdong Genial Technology Co., Ltd.
FlexCath Cross Transseptal Solution
Acutus Medical, Inc.
iFuse-TORQ® Implant System
SI-BONE, Inc.
Electro Lube NXT
Steris
InThrill Thrombectomy System
Inari Medical, Inc.
Activmotion S DTO
Newclip Technics
Universal Tendon Spacer
Askorn Medical
Stable-L Standalone Lumbar Interbody System
Nexus Spine, LLC
BriefCase
Aidoc Medical , Ltd.
NIBP Cuff (BCS-112, BCS-212, BCS-312, BCS-412, BCS-512, BCS-612, BCS-712, BCS-122, BCS-222, BCS-322, BCS-422, BCS-522, B
Shenzhen Best Electronics Co., Ltd.
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