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.

175,450 clearances · 1976 to present · Updated monthly from FDA records

Filters: Cleared only ×
174,955 results
115465–115488 of 174,955
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Nov 05, 1992
NICOLET VOYAGEUR
K921927 · GWQ
Nicolet Instrument Corp.
Neurology · 195d
Cleared Nov 05, 1992
ST 20 PORTABLE AUDIOMETER
K922746 · EWO
Maico Hearing Instruments, Inc.
Ear, Nose, Throat · 150d
Cleared Nov 05, 1992
WELLWASH 4 MARK II
K922803 · JQW
Denley Instruments, Inc.
Chemistry · 148d
Cleared Nov 05, 1992
VARIOUS CAMEO MED AMNIOCENTESIS TRAYS, DISPOSABLE
K922960 · HIO
Cameo, Inc.
Obstetrics & Gynecology · 140d
Cleared Nov 05, 1992
MEDTRONIC MODEL 3888 PISCES-QUAD PLUS LEAD
K923567 · GZB
Medtronic Vascular
Neurology · 111d
Cleared Nov 05, 1992
DENSPRO COARSE MINT PROPHY PASTE
K923674 · EJR
Teledyne Getz
Dental · 106d
Cleared Nov 05, 1992
DENSPRO MEDIUM MINT PROPHY PASTE
K923675 · EJR
Teledyne Getz
Dental · 106d
Cleared Nov 05, 1992
DOCUMENT CHEM III CALIBRATION VERIFICATION TEST
K923793 · JJX
Casco Standards
Chemistry · 100d
Cleared Nov 05, 1992
DOCUMENT CHEM II CALIBRATION VERIFICATION TEST SET
K923794 · JJX
Casco Standards
Chemistry · 100d
Cleared Nov 05, 1992
DOCUMENT CHEM I CALIBRATION VERIFICATION TEST SET
K923795 · JJY
Casco Standards
Chemistry · 100d
Cleared Nov 05, 1992
DOCUMENT CHEM V CALIBRATION VERIFICATION TEST SET
K923821 · JJX
Casco Standards
Chemistry · 98d
Cleared Nov 05, 1992
QUADRATURE CERVICAL CONTOUR COIL
K923881 · LNH
Magnetic Research, Inc.
Radiology · 93d
Cleared Nov 05, 1992
ALTEX MODEL UST-3000E
K924033 · HQC
Optro-Mechanics (Usa) Corp.
Ophthalmic · 86d
Cleared Nov 05, 1992
SPECTACLE FRAMES
K924232 · HQZ
Aptaker Co., Inc.
Ophthalmic · 73d
Cleared Nov 04, 1992
CURELLE
K915491 · HHK
Bioteque Corp.
Obstetrics & Gynecology · 334d
Cleared Nov 04, 1992
ZIRCONIA CERAMIC MODULAR HEAD 9TYPE II TAPER
K915641 · LZO
Biomet, Inc.
Orthopedic · 323d
Cleared Nov 04, 1992
AIT IMPLANT SYSTEM
K915865 · DZE
American Implant Technology, Inc.
Dental · 309d
Cleared Nov 04, 1992
BIOFORCE WIRE
K920905 · DZC
Gac Intl., Inc.
Dental · 251d
Cleared Nov 04, 1992
TYPE 1 DENTAL CEMENT
K921173 · EMA
Centrix, Inc.
Dental · 238d
Cleared Nov 04, 1992
TISSUE PATCH, TISSUE GRAFT
K921895 · DXZ
Bio-Vascular, Inc.
Cardiovascular · 196d
Cleared Nov 04, 1992
YSI MODEL 441A AIRWAY TEMPERATURE PROBE
K922007 · BZT
Yellow Springs Instrument Co., Inc.
Anesthesiology · 188d
Cleared Nov 04, 1992
AVOXIMETER
K922075 · DQA
A-Vox Systems, Inc.
Anesthesiology · 184d
Cleared Nov 04, 1992
PERSONAL 120/210 LAPTOP STRESS OPTION
K922291 · DPS
Biosound, Inc.
Cardiovascular · 173d
Cleared Nov 04, 1992
ECO/DENTAL GENERAL DENTAL PACK
K922988 · EKJ
Dyna-Pace Systems, Inc.
Dental · 135d