Search FDA 510(k) Devices

Cleared Aug 14, 2025

Reprocessed HARMONIC 700 Shears (HAR723/Reprocessed HARMONIC 700, 5mm...

K250898 · NLQ

Stryker Sustainability Solutions

General & Plastic Surgery · 142d

Cleared Aug 14, 2025

BIOFIRE SPOTFIRE Respiratory/Sore Throat Panel Mini

K243544 · QOF

Biofire Diagnostics, LLC

Microbiology · 272d

Cleared Aug 13, 2025

HS Fiber

K252201 · GAT

Riverpoint Medical

General & Plastic Surgery · 30d

Cleared Aug 13, 2025

Bone Screw

K251569 · DZL

Osstem Implant Co., Ltd.

Dental · 83d

Cleared Aug 13, 2025

T2 Alpha Femur Retrograde Nailing System

K250163 · HSB

Stryker GmbH

Orthopedic · 204d

Cleared Aug 13, 2025

KARL STORZ HOPKINS Telescopes for Urology

K243653 · FAJ

Karl Storz SE & CO. KG

Gastroenterology & Urology · 260d

Cleared Aug 13, 2025

DOLORCLAST Focused Shock Waves

K243279 · PZL

E.M.S Electro Medical Systems S.A

General & Plastic Surgery · 301d

Cleared Aug 12, 2025

14F Duo-Flow® Side X Side Double Lumen Catheter

K250836 · MPB

Medical Components, Inc.

Gastroenterology & Urology · 145d

Cleared Aug 12, 2025

DS Core Diagnosis

K250755 · QIH

Dentsply Sirona, Inc.

Radiology · 153d

Cleared Aug 12, 2025

Straumann® RidgeFit Implants

K250294 · DZE

Institut Straumann AG

Dental · 193d

Cleared Aug 11, 2025

External Fixation Bone Distractor

K251862 · KTT

Paragon 28, Inc.

Orthopedic · 55d

Cleared Aug 11, 2025

XERF

K251327 · GEI

Lutronic Corporation

General & Plastic Surgery · 103d

Cleared Aug 11, 2025

Identity Revision Humeral Stems

K251098 · MBF

Zimmer, Inc.

Orthopedic · 123d

Cleared Aug 08, 2025

BD Phoenix Automated Microbiology System - GN Eravacycline (0.125-2 µg/mL)

K251713 · LON

Becton, Dickinson and Company

Microbiology · 66d

Cleared Aug 08, 2025

Parkell Pit and Fissure Sealant

K243254 · EBC

Parkell, Inc.

Dental · 297d

Cleared Aug 07, 2025

BTL-199

K250309 · QPL

BTL Industries, Inc.

Physical Medicine · 185d

Cleared Aug 07, 2025

Longboard Revision Hip Stem

K243021 · LZO

Signature Orthopaedics Pty, Ltd.

Orthopedic · 314d

Cleared Aug 05, 2025

AltiVate Reverse® Glenoid

K252141 · PHX

Encore Medical, L.P.

Orthopedic · 28d

Cleared Aug 05, 2025

uMR Jupiter

K250246 · LNH

Shanghai United Imaging Healthcare...

Radiology · 190d

Cleared Aug 04, 2025

iHealth Compare Wireless Blood Pressure Monitor(BP-300C)

K251113 · DXN

Andon Health Co, Ltd.

Cardiovascular · 115d

Cleared Aug 01, 2025

eZSURE™ Empty Fluid Container

K252094 · KPE

Epic Medical Pte. , Ltd.

General Hospital · 29d

Cleared Aug 01, 2025

Revolution Vibe

K250941 · JAK

Ge Medical Systems, LLC

Radiology · 126d

Cleared Aug 01, 2025

Access hsTnI

K243483 · MMI

Beckman Coulter, Inc.

Chemistry · 266d

Cleared Aug 01, 2025

Equinoxe® Shoulder System

K243448 · PHX

Exactech, Inc.

Orthopedic · 267d