Search FDA 510(k) Devices

4,872 clearances indexed · Search by device name, K-number, or manufacturer

4,872 results for "Orthopedic Systems, Inc."
73–96 of 4,872
Cleared Feb 26, 2026
BriefCase-Triage: CARE Multi-Triage CT for Pneumothorax
K253578 · QAS
Aidoc Medical , Ltd.
Radiology · 101d
Cleared Feb 26, 2026
GMK 3D Metal Tibial Tray Extension
K253328 · MBH
Medacta International S.A.
Orthopedic · 149d
Cleared Feb 26, 2026
RIB LINK™ Fixation System
K252166 · HRS
Globus Medical, Inc.
Orthopedic · 231d
Cleared Feb 25, 2026
Mako Total Knee Application
K260222 · OLO
Mako Surgical Corp.
Orthopedic · 30d
Cleared Feb 25, 2026
Ventana™ A Anterior Lumbar Interbody System
K253559 · OVD
Spinal Elements, Inc.
Orthopedic · 100d
Cleared Feb 25, 2026
Konig Bell Circumcision Clamp
K251687 · HFX
Medline Industries, LP
Obstetrics & Gynecology · 268d
Cleared Feb 24, 2026
Universal Seal (5-12 mm)
K253978 · GCJ
Intuitive Surgical, Inc.
General & Plastic Surgery · 74d
Cleared Feb 24, 2026
HemoSphere Nano Monitor (HSNANO1)
K253186 · DQK
Edwards Lifesciences, LLC
Cardiovascular · 151d
Cleared Feb 23, 2026
Ingenia, Ingenia CX, Ingenia Elition S/X, Ingenia Ambition S/X, BlueSeal...
K253648 · LNH
Philips Medical Systems Nederland B.V.
Radiology · 95d
Cleared Feb 23, 2026
ZeniCore™ Automatic Biopsy Instrument (863212100 / ZeniCore Automatic Biopsy...
K252795 · KNW
Argon Medical Devices, Inc.
General & Plastic Surgery · 174d
Cleared Feb 23, 2026
Rubber Utility Catheter
K251864 · KOD
C.R. Bard, Inc.
Gastroenterology & Urology · 251d
Cleared Feb 22, 2026
Single Use Distal Cover MAJ-2315 (MAJ-2315)
K253646 · FDT
Olympus Medical Systems Corp.
Gastroenterology & Urology · 94d
Cleared Feb 21, 2026
Advanced Tissue Resection Device
K251692 · FDI
Micro-Tech (Nanjing) Co., Ltd.
Gastroenterology & Urology · 264d
Cleared Feb 20, 2026
KLS Martin Ixos System
K254162 · HRS
KLS-Martin L.P.
Orthopedic · 60d
Cleared Feb 20, 2026
KLS Martin Pure Pectus System
K253660 · HRS
KLS-Martin L.P.
Orthopedic · 92d
Cleared Feb 20, 2026
Xpert Hemorrhagic Fever
K253653
Cepheid
Microbiology · 92d
Cleared Feb 20, 2026
CARTO™ 3 EP Navigation System V8.4
K252972 · DQK
Biosense Webster, Inc.
Cardiovascular · 156d
Cleared Feb 19, 2026
Access anti-HBc Total
K253687 · SEI
Beckman Coulter, Inc.
Microbiology · 90d
Cleared Feb 19, 2026
Spine Guidance 5.4 Software
K253623 · OLO
Stryker Leibinger GmbH & Co KG
Orthopedic · 93d
Cleared Feb 19, 2026
Acclarent AERA Eustachian Tube Balloon Dilation System
K253612 · PNZ
Acclarent, Inc.
Ear, Nose, Throat · 93d
Cleared Feb 19, 2026
Retrograde Coronary Sinus Perfusion Cannulae
K253203 · DWF
Medtronic, Inc.
Cardiovascular · 146d
Cleared Feb 19, 2026
ATLAS™ Expandable Osteotomy Wedge System
K252733 · PLF
MiRus, LLC
Orthopedic · 175d
Cleared Feb 19, 2026
Valence Robotic Navigation System
K252597 · OLO
Alphatec Spine, Inc.
Orthopedic · 188d
Cleared Feb 19, 2026
Erchonia DPN Laser (Model# EVRL)
K251903 · NHN
Erchonia Corporation
Physical Medicine · 244d