FDA 510(k) Searchable Database - Search 175,000+ Clearances

Search 175,000+ FDA 510(k) clearances by K-number, device name, manufacturer or product code. Includes real review time data, denied submission rates and regulatory intelligence not available on any other searchable 510(k) database.

175,730 clearances · 1976 to present · Updated monthly from FDA records

Filters: 2026–2026 ×
1,922 results
1489–1512 of 1,922
Search insights Median review: 132d Cleared: 99% Top manufacturer: Arthrex, Inc. Lead specialty: Orthopedic
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
ANNE Maternal
K253021 · HGM
Sibel Health, Inc.
Obstetrics & Gynecology · 160d
Cleared Feb 26, 2026
RIB LINK™ Fixation System
K252166 · HRS
Globus Medical, Inc.
Orthopedic · 231d
Cleared Feb 26, 2026
Copioumed AAMI 3 Surgical Gown
K251860 · FYA
Copioumed International, Inc.
General Hospital · 254d
Cleared Feb 26, 2026
Ganymede 2cm diameter (FG100300)
K251700 · QSY
Speciality Fibres and Materials Limited
General & Plastic Surgery · 269d
Cleared Feb 25, 2026
Mako Total Knee Application
K260222 · OLO
Mako Surgical Corp.
Orthopedic · 30d
Cleared Feb 25, 2026
BD Surgiphor™ Antimicrobial Irrigation System (910110)
K253996 · FQH
Becton, Dickinson and Company (BD)
General & Plastic Surgery · 75d
Cleared Feb 25, 2026
Electric wheelchair
K253789 · ITI
Zhejiang Yikang Medical Technology...
Physical Medicine · 89d
Cleared Feb 25, 2026
Ventana™ A Anterior Lumbar Interbody System
K253559 · OVD
Spinal Elements, Inc.
Orthopedic · 100d
Cleared Feb 25, 2026
FIREFLY® Pedicle Screw Navigation Guide
K253472 · PQC
Mighty Oak Medical
Orthopedic · 138d
Cleared Feb 25, 2026
Remi Impression Material
K251724 · SHI
Grindguard, Inc.
Dental · 266d
Cleared Feb 25, 2026
Konig Bell Circumcision Clamp
K251687 · HFX
Medline Industries, LP
Obstetrics & Gynecology · 268d
Cleared Feb 24, 2026
XSense Cryoablation System with CryoProbes
K260377 · GEH
IceCure Medical , Ltd.
General & Plastic Surgery · 19d
Cleared Feb 24, 2026
SP Electrocautery Device (SP20)
K260287 · GEI
Single Pass, Inc.
General & Plastic Surgery · 26d
Cleared Feb 24, 2026
AI Platform 2.2 (AIP002)
K260217 · QIH
Exo Imaging
Radiology · 32d
Cleared Feb 24, 2026
NanoPress 760A-BT (760A-BT)
K254267 · JOW
Mego Afek , Ltd.
Cardiovascular · 56d
Cleared Feb 24, 2026
OSTEOMNI SPINAL FIXATION SYSTEM
K254247 · NKB
OSTEOMNI, Inc.
Orthopedic · 57d
Cleared Feb 24, 2026
OSSIOfiber® Suture Anchor
K254055 · MAI
OSSIO , Ltd.
Orthopedic · 69d
Cleared Feb 24, 2026
Universal Seal (5-12 mm)
K253978 · GCJ
Intuitive Surgical, Inc.
General & Plastic Surgery · 74d
Cleared Feb 24, 2026
IntraSight Plus
K253714 · IYO
Philips Image Guided Therapy Corporation
Cardiovascular · 92d
Cleared Feb 24, 2026
Electric wheelchair (W1,W3)
K253707 · ITI
Shenzhen Zhimahuaerkai Technology...
Physical Medicine · 92d
Cleared Feb 24, 2026
HemoSphere Nano Monitor (HSNANO1)
K253186 · DQK
Edwards Lifesciences, LLC
Cardiovascular · 151d
Cleared Feb 24, 2026
Diode Laser Therapy Systems (WLA-02)
K252599 · GEX
Wingderm Electro-Optics , Ltd.
General & Plastic Surgery · 190d