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.

175,972 clearances · 1976 to present · Updated monthly from FDA records

Filters: Cleared only ×
175,468 results
72505–72528 of 175,468
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Mar 28, 2003
BLACKSTONE CLASSIC ANTERIOR CERVICAL PLATE
K022965 · KWQ
Blackstone Medical, Inc.
Orthopedic · 203d
Cleared Mar 28, 2003
SEEDLINKS, MODELS 70301, 70302, 70303
K023210 · KXK
Sourcetech Medical, LLC
Radiology · 183d
Cleared Mar 28, 2003
ENDOSCOPIC LASER DELIVERY SYSTEM-LASERTX
K023257 · GEX
Prosurg, Inc.
General & Plastic Surgery · 179d
Cleared Mar 28, 2003
OXICHECK
K023565 · CCL
Caradyne, Ltd.
Anesthesiology · 156d
Cleared Mar 28, 2003
RUSCH CRYSTAL CLEAR TRACHEOSTOMY SETS, CUFFED AND CUFFLESS
K023918 · JOH
Rusch Intl.
Anesthesiology · 123d
Cleared Mar 28, 2003
EXPRESS BLOOD GLUCOSE MONITORING SYSTEM
K024347 · CGA
Hypoguard USA, Inc.
Chemistry · 88d
Cleared Mar 28, 2003
TEOAE25
K030016 · EWO
Interacoustics A/S, Assens
Ear, Nose, Throat · 85d
Cleared Mar 28, 2003
VERMED A10021 RESTING EKG TAB ELECTRODE
K030073 · DRX
Vermont Medical, Inc.
Cardiovascular · 79d
Cleared Mar 28, 2003
LAWRENCE CSERION, MODEL CS-1
K030162 · KXK
Isoray, Inc.
Radiology · 71d
Cleared Mar 28, 2003
POWDERFREE LATEX EXAMINATION GLOVES WITH BUBBLEGUM
K030325 · LYY
Pt.Shamrock Manufacturing Corp.
General Hospital · 56d
Cleared Mar 28, 2003
STAINLESS STEEL SURGICAL SUTURE, NON-ABSORBABLE
K030351 · GAQ
Cp Medical
General & Plastic Surgery · 53d
Cleared Mar 28, 2003
POWDER FREE SYNTHETIC NITRILE NEOPRENE EXAMINATION GLOVES, SIZES...
K030386 · LZA
Shamrock Manufacturing Company
General Hospital · 51d
Cleared Mar 28, 2003
ACUVANCE PLUS SAFETY IV CATHETER, PROTECTIV PLUS SAFETY IV CATHETER, OPTIVA...
K030571 · FOZ
Ethicon Endo-Surgery, Inc.
General Hospital · 32d
Cleared Mar 28, 2003
SPINAL CONCEPTS INC. PATHFINDER
K030625 · NKB
Spinal Concepts, Inc.
Orthopedic · 29d
Cleared Mar 28, 2003
THE OBSIDIAN PACS SYSTEM
K030635 · LLZ
Obsidian Medical Technology, Inc.
Radiology · 28d
Cleared Mar 28, 2003
VECTORSURGE 5 MODEL 470
K030648 · IPF
Metron Medical Australia, Pty, Ltd.
Physical Medicine · 28d
Cleared Mar 28, 2003
MODIFICATION TO AXXESS SPINAL CORD STIMULATION LEAD
K030674 · GZB
Advanced Neuromodulation Systems
Neurology · 24d
Cleared Mar 28, 2003
ECHELON MICRO CATHETER, MODEL 105-5092-150
K030688 · KRA
Micro Therapeutics, Inc.
Cardiovascular · 23d
Cleared Mar 28, 2003
MPM-NET
K030825 · DXN
Aerotel Medical Systems (1998) , Ltd.
Cardiovascular · 14d
Cleared Mar 28, 2003
ER800 SERIES ECG EVENT RECORDER
K030856 · MWJ
Braemar Corp.
Cardiovascular · 10d
Cleared Mar 28, 2003
GE 3.0T SIGNA INFINITY TWINSPEED WITH EXCITE MR SYSTEM
K030874 · LNH
General Electric Co.
Radiology · 8d
Cleared Mar 28, 2003
ACCOUSONIC, MODEL AS-270
K030878 · IMI
Metron Medical Australia, Pty, Ltd.
Physical Medicine · 8d
Cleared Mar 27, 2003
EXEL BUTTERFLY SCALP VEIN SET
K020189 · FPA
Exelint International, Co.
General Hospital · 433d
Cleared Mar 27, 2003
FLU OIA A/B TEST KIT
K023556 · PSZ
Thermo Biostar, Inc.
Microbiology · 155d