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
Ingenix Spinal System
Ingenium Spine
RCT700
Ray Co., Ltd.
Endomina EZFuse system
Endo Tools Therapeutics S.A.
Digital Radiography CXDI-CS01
Canon, Inc.
MagnetOs Granules
Kuros Biosciences B.V
BodyTom 64
Neurologica Corporation
INTRABEAM (700); And accessories (INTRABEAM SMART Stand, INTRABEAM SMART Spherical Applicator, INTRABEAM Spherical Sizer
Carl Zeiss Meditec, AG
Arthrex VAL and VAL KreuLock Compression Screw System
Arthrex, Inc.
Genesys Spine Sacroiliac Joint Fusion System with Navigation
Genesys Spine
VELMENI for DENTISTS (V4D) 3D
Velmeni, Inc.
Epicardial Access System
Baylis Medical Company, Inc.
ACUSON Sequoia Diagnostic Ultrasound System; ACUSON Sequoia Select Diagnostic Ultrasound System; ACUSON Origin Diagnosti
Siemens Medical Solutions USA, Inc.
Polyfusion IV Administration Sets
Poly Medicure Limited
syngo.CT Dual Energy
Siemens Medical Solutions USA, Inc.
AI Contouring (VA10A)
Varian Medical Systems
aprevo® anterior and lateral lumbar interbody fusion device, aprevo® transforaminal lumbar interbody fusion device
Carlsmed, Inc.
Life Ultra 25L Tabletop Mono Chamber Steam Sterilizer
Lucas Lifecare
SubtleMR (2.3.x)
Subtle Medical, Inc.
Atellica® CI Analyzer, Atellica® IMThyroid Stimulating Hormone 3-Ultra (TSH3-UL), Atellica® CH Albumin BCP (AlbP)
Siemens Healthcare Diagnostics, Inc.
Endomat Select (UP220)
KARL STORZ SE & CO. KG
restor3d MTP Implant
Restor3D, Inc.
Bright Impress-Light, Bright Impress-Medium, Bright Impress-Heavy, Bright Impress-Bite, Bright Impress-Putty
Genoss Co., Ltd.
Tixel i (TXLI0001)
Novoxel , Ltd.
ISE Reagents, Glucose, CRP Latex, DxC 500 AU Clinical Chemistry Analyzer
Beckman Coulter Laboratory Systems (Suzhou) Co., Ltd.
Horizon® 3.0 TMS Therapy System (Horizon 3.0 Inspire); Horizon® 3.0 TMS Therapy System (Horizon 3.0 with StimGuide Pro);
The Magstim Company Limited
Panther Fusion GI Expanded Bacterial Assay
Hologic, Inc.
NovaLine SP-C35 Transducer Protector (956007)
Bain Medical Equipment (Guangzhou) Co., Ltd.
Medical Picosecond ND: YAG Laser System (PZ-6)
Zhengzhou PZ Laser Slim Technology Co., Ltd.
CHOLESTEROL; HDL-cholesterol ; LDL-cholesterol; TRIGLYCERIDES
Medicon Hellas S.A
Tandry Q-Locking Plate System
Microware Precision Co., Ltd.
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