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
KHEIRON® Spinal Fixation System, including patient specific K-ROD
S.M.A.I.O
Litho 60; Litho 100; Litho 150
Quanta System Spa
SQUALE
Implanet, S.A.
Samsung ECG App v 1.3 (ECG)
Samsung Electronics Co., Ltd.
Succession AFN System
Ortho Solutions UK , Ltd.
CPS AIM Universal II Slittable Inner Catheter
ABBOTT MEDICAL
MTS Ceftobiprole 0.002-32 µg/mL
Liofilchem s.r.l.
Flosteril Poly-reinforced Isolation Gowns Model 8120 (Catalogue Number 8120400), Flosteril Poly-reinforced Isolation Gow
Flomak Tekstil Makine Muh. Mum. Taah. San. Tic. Ltd. Sti.
CRYOcheck Chromogenic Factor VIII
Precision Biologic, Inc.
Power Wheelchair (D03, D05, D06, D09, D11, D16, D22, D23, D26, D36)
Anhui Jbh Medical Apparatus Co., Ltd.
Stela Automix System
Sdi Limited
Semi-Floating Temporary Pacing Electrode Catheter, Bipolar, Stainless Steel Electrodes, 115 cm, 4Fr. (006221P); Semi-Flo
C.R. Bard, Inc.
Arthrex 2.4 mm Volar Distal Radius Plate System
Arthrex, Inc.
SpectoMed (v1.0)
Specto Medical
Brainomix 360 e-ASPECTS
Brainomix Limited
Macro & Micro-Test HCG Pregnancy Test Midstream
Jiangsu Macro & Micro-Test Med-Tech Co., Ltd.
AirRay-mini 80A, AirRay-mini 90A, AirRay-mini 80F, AirRay-mini 90F (AirRay-mini)
Poskom Co., Ltd.
Olympus PK Electrosurgical Instruments, PK J-hook, PK Spatula, PK Needle
Gyrus Acmi, Inc.
7D Surgical System - Percutaneous Application (7D Flash Frame)
7D Surgical
CareSuperb COVID-19 Antigen Home Test
Access Bio, Inc.
Masimo Rad-G with Temperature
Masimo Corporation
MiniMed Go App
Medtronic Minimed
MAGENTIQ-COLO (ME-APDS)
Magentiq Eye, Ltd.
Image Navigator by Immuno Concepts, Immuno Concepts IgG Anti-nDNA Fluorescent Test System
Immuno Concepts, N.A. , Ltd.
Chartis Precision Catheter
Pulmonx Corporation
EyeBOX EBX-4.1
Oculogica, Inc.
AUTION MAX AX-4060 Urinalysis System
Arkray, Inc.
Accu-Chek Softclix Blood Lancing System
Roche Diabetes Care, Inc.
EndoPATx
Itamar Medical , Ltd.
Blood Collection Set, Blood Collection Set with Holder, Safety Blood Collection Set, Safety Blood Collection Set with Ho
Yangzhou Medline Industry, Co., Ltd.
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