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
5473–5496 of 175,230
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Nov 21, 2024
Versalock Mini and Micro Plating System
K242596 · HRS
GM Dos Reis Industria e Comercio Ltda.
Orthopedic · 83d
Cleared Nov 21, 2024
MIRARI® Cold Plasma System ( GV-M2-01)
K242553 · PBX
General Vibronics, Inc.
General & Plastic Surgery · 86d
Cleared Nov 21, 2024
TiLink-P Joint Fusion System
K242414 · OUR
SurGenTec, LLC
Orthopedic · 99d
Cleared Nov 21, 2024
Jazz Classic
K241495 · LLZ
Jazz Imaging
Radiology · 177d
Cleared Nov 21, 2024
SKR 3000
K241319 · MQB
Konica Minolta, Inc.
Radiology · 195d
Cleared Nov 21, 2024
Luja Coude
K241210 · EZD
Coloplast Corp.
Gastroenterology & Urology · 205d
Cleared Nov 21, 2024
Secret MAX Multi-platform RF System
K241157 · GEI
Ilooda Co,., Ltd.
General & Plastic Surgery · 209d
Cleared Nov 21, 2024
FESL FINK Chamber
K240569 · CBF
Fink Engineering Pty, Ltd.
Anesthesiology · 266d
Cleared Nov 21, 2024
Fingertip Pulse Oximeter, models Alpine20, Alpine20A, Alpine20H, Alpine20HA,...
K232520 · DQA
Shenzhen Smallsignal Technology Co.,...
Anesthesiology · 461d
Cleared Nov 20, 2024
INDIBA COMPACT devices
K243164 · PBX
Indiba S. A. U.
General & Plastic Surgery · 51d
Cleared Nov 20, 2024
ETERBIO Fentanyl/Norfentanyl Rapid Test (Colloidal Gold)
K243064 · NGL
Eterbio, Inc.
Toxicology · 54d
Cleared Nov 20, 2024
Estar-ZE
K242521 · EIH
Osstem Implant Co., Ltd.
Dental · 89d
Cleared Nov 20, 2024
Element Vascular Access System
K242520 · DYB
Penumbra, Inc.
Cardiovascular · 89d
Cleared Nov 20, 2024
ProAM ACDF System
K242517 · OVE
Pro Surgical, Inc.
Orthopedic · 89d
Cleared Nov 20, 2024
HIGHERDOSE Red Light Hat (HG-120K)
K242363 · OAP
Shenzhen Kaiyan Medical Equipment...
General & Plastic Surgery · 103d
Cleared Nov 20, 2024
Strain AI (SAI001)
K242359 · QIH
Exo, Inc.
Radiology · 103d
Cleared Nov 20, 2024
SOL-M Luer Lock Syringe (Low Dead Space) w/o Needle, SOL-M Slip Tip Syringe...
K242291 · QNQ
Sol-Millennium Medical, Inc.
General Hospital · 110d
Cleared Nov 20, 2024
TD-7301 Spirometer (TD-7301)
K241843 · BZG
Gostar Co., Ltd.
Anesthesiology · 147d
Cleared Nov 20, 2024
Powered Wheelchair (NXN20-208, NXN20-211)
K241603 · ITI
Zhejiang Nysin Medical Co., Ltd.
Physical Medicine · 169d
Cleared Nov 20, 2024
Hip Spacer Molds
K240856 · MBB
Osartis GmbH
Orthopedic · 237d
Cleared Nov 20, 2024
Neurovascular Access System Family
K240746 · QJP
Q'Apel Medical, Inc.
Neurology · 246d
Cleared Nov 20, 2024
AETOS Shoulder System Stemless Humeral Prosthesis
K240716 · PKC
Smith & Nephew, Inc.
Orthopedic · 250d
Cleared Nov 20, 2024
Leg Massager (Models:RP-ALM070H, RP-ALM071H)
K232965 · IRP
Shenzhen Ruiyi Business Technology...
Physical Medicine · 426d
Cleared Nov 19, 2024
Iconix Knotless Anchor
K243323 · MBI
Riverpoint Medical
Orthopedic · 27d