FDA 510(k) Searchable Database - Search 174,000+ Clearances

Search 174,000+ FDA 510(k) clearances by K-number, device name, manufacturer or product code — with real review time data, denied submission rates and regulatory intelligence no other searchable 510(k) database provides.

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

Filters: Cleared only ×
175,230 results
146617–146640 of 175,230
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Sep 24, 1985
VESSA FLIVVA
K853594 · ITI
Vessa , Ltd.
Physical Medicine · 28d
Cleared Sep 24, 1985
BURS FOR MICRO SURGICAL DRILL SYSTEM
K853658 · GFF
Acumed Instruments Corp.
General & Plastic Surgery · 21d
Cleared Sep 24, 1985
POWERED IRRIGATION FOR MICRO SURGICAL DRILL
K853659
Acumed Instruments Corp.
General & Plastic Surgery · 21d
Cleared Sep 24, 1985
MICRO SURGICAL DRILL SYSTEM
K853660
Acumed Instruments Corp.
General & Plastic Surgery · 21d
Cleared Sep 24, 1985
MUELLER CURVED STEM HEMI-PROSTHESIS
K853662 · KWL
Protek, Inc.
Orthopedic · 21d
Cleared Sep 24, 1985
KAMBIN SPINAL INSTRUMENT SET
K853678 · HTZ
Pilling Co.
General & Plastic Surgery · 21d
Cleared Sep 23, 1985
SONOLAYER-L SAL-32B
K851240 · ITX
Toshiba Medical Systems
Radiology · 180d
Cleared Sep 23, 1985
HERAENIUM CA
K851515 · EJH
Heraeus Dental Gold Corp.
Dental · 161d
Cleared Sep 23, 1985
SEPTOJECT STERILE DISPOSABLE INJECTION NEEDLE
K851524 · DZM
Specialites Septodont
Dental · 160d
Cleared Sep 23, 1985
CONVEX PROBE, PVE-393M
K851526 · ITX
Toshiba Medical Systems
Radiology · 161d
Cleared Sep 23, 1985
METRONIC MODEL F7700 HEART VALVE SIZERS
K852612 · DTI
Medtronic Vascular
Cardiovascular · 96d
Cleared Sep 23, 1985
CALCITITE BONE GRAFT MAT/ORAL & MAXILLOFACIAL SURG
K852682 · LYC
Calcitek, Inc.
Dental · 90d
Cleared Sep 23, 1985
DURA CONDITIONER
K852741 · EBI
Reliance Dental Mfg. Co.
Dental · 88d
Cleared Sep 23, 1985
UNIVAR UNIVERSAL DENTIN VARNISH
K852755 · LBH
Scientific Pharmaceuticals, Inc.
Dental · 87d
Cleared Sep 23, 1985
HA-2000 HYDROXYLAPATITE
K852765 · LYC
Orthomatrix, Inc.
Dental · 87d
Cleared Sep 23, 1985
DENAR DENTAL IMPLANT
K852802 · DZE
Denar Corp.
Dental · 82d
Cleared Sep 23, 1985
HEARTECH MODEL(HTC) (HERITAGE)
K853218 · ESD
Hearing Tech, Inc.
Ear, Nose, Throat · 53d
Cleared Sep 23, 1985
HEARTECH MODEL CH
K853219 · ESD
Hearing Tech, Inc.
Ear, Nose, Throat · 53d
Cleared Sep 23, 1985
HEARTECH MODEL ILLUSION
K853220 · ESD
Hearing Tech, Inc.
Ear, Nose, Throat · 53d
Cleared Sep 23, 1985
HEARING AID MODEL 337D
K853264 · ESD
Telex Communications, Inc.
Ear, Nose, Throat · 49d
Cleared Sep 23, 1985
DAHLBERG EA BEHING-THE-EAR HEARING AID
K853323 · ESD
Miracle-Ear/Dahlberg, Inc.
Ear, Nose, Throat · 46d
Cleared Sep 23, 1985
DAHLBERG EB BEHING-THE-EAR HEARING AID
K853324 · ESD
Miracle-Ear/Dahlberg, Inc.
Ear, Nose, Throat · 46d
Cleared Sep 23, 1985
DAHLBERG EC BEHIND-THE-EAR HEARING AID
K853325 · ESD
Miracle-Ear/Dahlberg, Inc.
Ear, Nose, Throat · 46d
Cleared Sep 23, 1985
JUFREY CORP. UNIV. DISPOS. SCALP VEIN INFUSION SET
K853527 · FPA
Jufrey Multimed Corp.
General Hospital · 46d