Search FDA 510(k) Clearance Records

Use this 510(k) search tool to find FDA medical device clearance records by K-number, device name, manufacturer, product code, or regulatory consultant. Explore individual submissions, review timelines, predicate device information, and links to official FDA records. Search the database for free, with no registration required.

176,583 clearances · 1976 to present · Updated monthly from FDA records · Free access · No registration required

Filters: Cleared only ×
176,076 results
64777–64800 of 176,076
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Sep 26, 2005
TRANS1 FACET SCREWS
K051856 · MRW
Trans1 Incorporated
Orthopedic · 80d
Cleared Sep 26, 2005
QUILL NONABSORBABLE POLYPROPYLENE BARBED SUTURE
K052373 · GAW
Quill Medical, Inc.
General & Plastic Surgery · 27d
Cleared Sep 26, 2005
AXXESS BUTTERFLY ANCHOR
K052418 · GZB
Advanced Neuromodulation Systems
Neurology · 24d
Cleared Sep 26, 2005
NISSIN SERIES MECHANICAL WHEELCHAIR
K052521 · IOR
Nissin Medical Industries Co., Ltd.
Physical Medicine · 12d
Cleared Sep 26, 2005
WU'S POWERED WHEELCHAIR, MAMBO 2
K052559 · ITI
Wu'S Tech Co., Ltd.
Physical Medicine · 10d
Cleared Sep 23, 2005
I-NEB AAD SYSTEM
K042991 · CAF
Profile Therapeutics Plc
Anesthesiology · 326d
Cleared Sep 23, 2005
CHROMOPEP PC, CHROMOPEP AT, MODELS 2.5 AND 5
K050448 · GGP
Horiba Abx
Hematology · 213d
Cleared Sep 23, 2005
REPROCESSED PHACOEMUISIFICATION TIPS
K050518 · NKX
Alliance Medical, Inc.
Ophthalmic · 206d
Cleared Sep 23, 2005
ENCOMPASS CEMENTED HIP STEM & 10/12 COBALT-CHROME FEMORAL HEADS
K050637 · JDI
Ortho Development Corp.
Orthopedic · 196d
Cleared Sep 23, 2005
SURGISIS STAPLE LINE REINFORCEMENT II
K051048 · FTM
Cook Biotech, Inc.
General & Plastic Surgery · 151d
Cleared Sep 23, 2005
AV-S ANAESTHESIA VENTILATOR
K051222 · CBK
Penlon Limited
Anesthesiology · 134d
Cleared Sep 23, 2005
VANISHPOINT I.V. CATHETER
K051355 · FOZ
Retractable Technologies, Inc.
General Hospital · 122d
Cleared Sep 23, 2005
SYSMEX MODEL XE-2100DC AUTOMATED HEMATOLOGY ANALYZER
K051459 · GKZ
Sysmex America, Inc.
Hematology · 113d
Cleared Sep 23, 2005
BLEAS ESIRIUC ANAESTHSIA SYSTEM, MODELS 3000, 2000
K051629 · BSZ
Blease USA, Inc.
Anesthesiology · 95d
Cleared Sep 23, 2005
SAF-T-SYRINGE/SAF-T-NEEDLE
K051762 · MEG
Safety Medical International,...
General Hospital · 85d
Cleared Sep 23, 2005
NPAC MULTI-USE EAR THERMOMETER, MODELS TP 700,TP 702
K051835 · FLL
Norm Pacific Automation Corp.
General Hospital · 79d
Cleared Sep 23, 2005
SISTEMA DE IMPLANTE NACIONAL (S.I.N.)
K051859 · DZE
Sin Sistema DE Implante Nacional Ltda
Dental · 77d
Cleared Sep 23, 2005
TRABECULAR METAL VERTEBRAL BODY REPLACEMENT
K051978 · MQP
Implex Corp.
Orthopedic · 64d
Cleared Sep 23, 2005
DATA-TROL N NORMAL CONTROL SERUM, DATA-TROL A ABNORMAL CONTROL SERUM
K052056 · JJY
Thermo-Electron Corp.
Chemistry · 56d
Cleared Sep 23, 2005
SYNTHES PANGEA SYSTEM
K052123 · KWP
Synthes (Usa)
Orthopedic · 49d
Cleared Sep 23, 2005
ACCENT AND EXCEED SERIES ORTHODONTIC CERAMIC BRACKETS
K052245 · NJM
Lar Mfg., LLC
Dental · 37d
Cleared Sep 23, 2005
MODIFICATION TO: VERTEX RECONSTRUCTION SYSTEM
K052376 · KWP
Medtronic Sofamor Danek
Orthopedic · 24d
Cleared Sep 23, 2005
VERTEX RECONSTRUCTION SYSTEM
K052402 · KWP
Medtronic Sofamor Danek
Orthopedic · 22d
Cleared Sep 23, 2005
MODIFICATION TO: IVENT 201 PORTABLE VENTILATOR
K052554 · CBK
Versamed Medical Systems, Inc.
Anesthesiology · 7d