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: Cleared only ×
175,230 results
11065–11088 of 175,230
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Feb 24, 2023
MectaLock TI Triple Loaded Suture Anchor
K223582 · MBI
Medacta International S.A.
Orthopedic · 85d
Cleared Feb 24, 2023
Arthrex SynergyID Endoscopic Imaging System
K223759 · GCJ
Arthex, Inc.
General & Plastic Surgery · 71d
Cleared Feb 24, 2023
Kawasumi Multiple Sample Adapter with Pre-Attached Holder (MBCH)
K223810 · JKA
Sb-Kawasumi Laboratories, Inc.
General Hospital · 66d
Cleared Feb 24, 2023
VySpan™ PCT System
K223852 · NKG
Vy Spine, LLC
Orthopedic · 64d
Cleared Feb 24, 2023
ELITONE Urge Urinary Incontinence Device
K223884 · QAJ
Elidah, Inc.
Gastroenterology & Urology · 59d
Cleared Feb 24, 2023
babyLance Safety Heelstick (BLM, BLN, BLP)
K223900 · FMK
Clinical Innovations, LLC
General & Plastic Surgery · 58d
Cleared Feb 24, 2023
Veloxion System
K230205 · FJL
Corinth Medtech, Inc.
Gastroenterology & Urology · 30d
Cleared Feb 24, 2023
EsoCheck Cell Collection Device
K230339 · EOX
Lucid Diagnostics, Inc.
Gastroenterology & Urology · 17d
Cleared Feb 23, 2023
Everion+ System
K213863 · MSX
Biofourmis Singapore Pte., Ltd.
Cardiovascular · 440d
Cleared Feb 23, 2023
Disposable Surgical Gown, Level 4
K221559 · FYA
Stringking
General Hospital · 268d
Cleared Feb 23, 2023
Brainomix 360 e-ASPECTS
K221564 · POK
Brainomix Limited
Radiology · 268d
Cleared Feb 23, 2023
Camera System (Camera Control Unit, Camera Head to be coupled to a fiberoptic...
K221591 · GCJ
Schoelly Fiberoptic GmbH
General & Plastic Surgery · 266d
Cleared Feb 23, 2023
Belun Sleep System BLS-100
K222579 · MNR
Belun Technology Company Limited
Anesthesiology · 182d
Cleared Feb 23, 2023
OXY-1 System
K223161 · DTZ
Abiomed, Inc.
Cardiovascular · 139d
Cleared Feb 23, 2023
Elekta Unity
K223209 · IYE
Elekta Solutions AB
Radiology · 129d
Cleared Feb 23, 2023
Symphony Thrombectomy System
K223216 · QEW
Truvic Medical, Inc.
Cardiovascular · 129d
Cleared Feb 23, 2023
MOSAIQ® OIS (Oncology Information System)
K223229 · IYE
Elekta Solutions AB
Radiology · 128d
Cleared Feb 23, 2023
Monaco RTP System
K223233 · MUJ
Elekta Solutions AB
Radiology · 127d
Cleared Feb 23, 2023
Renuvion® APR Handpiece
K223262 · GEI
Apyx Medical Corporation
General & Plastic Surgery · 122d
Cleared Feb 23, 2023
LED light therapy mask (FM-01, FM-02, FM-03)
K223544 · OHS
Guangdong Newdermo Biotech Co., Ltd.
General & Plastic Surgery · 90d
Cleared Feb 23, 2023
Neuro20 Pro System
K223797 · NGX
Neuro20 Technologies
Physical Medicine · 66d
Cleared Feb 23, 2023
OrthoButton AL
K230212 · MBI
Riverpoint Medical, LLC
Orthopedic · 28d
Cleared Feb 23, 2023
1688 4K Camera Control Unit with Advanced Imaging Modality (1688010000)
K230216 · GCJ
Stryker
General & Plastic Surgery · 28d
Cleared Feb 23, 2023
T-Line Hernia Mesh
K230227 · FTL
Deep Blue Medical Advances, Inc.
General & Plastic Surgery · 27d