Disclaimer: This site aggregates publicly available data from official government sources (FDA, ClinicalTrials.gov, PubMed, SEC EDGAR, NMPA) for general reference only. It does NOT constitute medical advice, diagnosis, treatment recommendations, or investment advice.

FDA 510(k) Clearances

510(k) cleared devices tracked by MedTracker

DYB 2024-11-08

Introducer Sheath (PFlexi00L065, PFlexi00L070, PFlexi00L075, PFlexi00L080, PFlexi00L090, PFlexi30L065, PFlexi30L070, PFlexi30L075, PFlexi30L080, PFlexi30L090, PFlexi45L065, PFlexi45L070, PFlexi45L075, PFlexi45L080, PFlexi45L090, PFlexi60L065, PFlexi60L070, PFlexi60L075, PFlexi60L080, PFlexi60L090)

Applicant Pulnovo Medical (Wuxi) Co., Ltd.

K-Number K242756

View Details →

ODC 2024-11-08

Defendo Single Use Cleaning Adapter for Olympus Endoscopes (100322, 100323, 4000096, 4003269, 4003280)

Applicant STERIS Corporation

K-Number K243075

View Details →

OHT 2024-11-07

Intense Pulse Light Therapeutic Apparatus (IPL-18 BF, IPL-18 FG)

Applicant Shenzhen Greatro Electronic Technology Co., Ltd.

K-Number K242595

View Details →

KWQ 2024-11-07

OZARK Cervical Plate System; PYRENEES® Cervical Plate System; EVEREST® Spinal System; MESA® Spinal System; MESA® Small Stature Spinal System; CASPIAN® Spinal System; DENALI® Spinal System; DENALI® MI Spinal System; YUKON OCT Spinal System; Xia® 3 Spinal System; K2M Patient Specific; CASCADIA Interbody System; CAYMAN® Plate System; CAYMAN® Plate System-MI

Applicant Stryker Spine

K-Number K242361

View Details →

KIF 2024-11-07

VioSeal

Applicant Spident Co., Ltd.

K-Number K242702

View Details →

JAQ 2024-11-07

Titanium Fletcher-Style Applicator Set Defined Geometry; Smit Cervical Sleeve

Applicant Varian Medical Systems, Inc.

K-Number K241853

View Details →

DZE 2024-11-07

LL Implant System

Applicant Ossvis Co., Ltd.

K-Number K242379

View Details →

OLO 2024-11-07

Mako Shoulder Application (1.0)

Applicant Mako Surgical Corp.

K-Number K242373

View Details →

CCK 2024-11-07

MicroTrend System

Applicant Exostat Medical, Inc.

K-Number K212425

View Details →

PBF 2024-11-07

Newclip Patient-matched instrumentation non sterile PSI

Applicant Newclip Technics

K-Number K240415

View Details →

QBS 2024-11-07

icobrain aria

Applicant Icometrix NV

K-Number K240712

View Details →

NEU 2024-11-07

Trilogy Tissue Marker

Applicant Inrad, Inc.

K-Number K240429

View Details →

Page 412 of 2685

↑