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
39841–39864 of 175,230
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Aug 27, 2013
SMARTCOAT 2.5% NAF VARNISH
K131376 · LBH
Elevate Oral Care
Dental · 105d
Cleared Aug 27, 2013
KENDALL SCD 700 SEQUENTIAL COMPRESSION CONTROLLER
K132360 · JOW
Covidien
Cardiovascular · 28d
Cleared Aug 26, 2013
FIRST RESPONSE EARLY RESULT PREGNANCY TEST
K123436 · LCX
Church & Dwight Co., Inc.
Chemistry · 292d
Cleared Aug 26, 2013
ATG/SM-OSA APPLIANCES
K130130 · LQZ
Selane Products, Inc.
Dental · 221d
Cleared Aug 26, 2013
SEVIIN SURFACE REPLACEMENT SHOULDER
K130635 · HSD
Ingen Orthopedics, LLC
Orthopedic · 168d
Cleared Aug 26, 2013
INTERFORM INTERBODY CAGE SYSTEM
K131082 · MAX
Next Orthosurgical
Orthopedic · 130d
Cleared Aug 26, 2013
ITERO SOFTWARE
K131101 · NHA
Cadent, Ltd. an Align Technology Company
Dental · 129d
Cleared Aug 26, 2013
PREMIER CERAMIC PRIMER
K131212 · KLE
Premier Dental Products Co.
Dental · 119d
Cleared Aug 26, 2013
LOGIQ S8
K131527 · IYN
Ge Healthcare
Radiology · 90d
Cleared Aug 26, 2013
AEM DISPOSABLE SUCTION IRRIGATION ELECTRODES
K131949 · GEI
Encision, Inc.
General & Plastic Surgery · 60d
Cleared Aug 26, 2013
PRODESSE PROFAST+ ASSAY
K132237 · OQW
Gen-Probe Prodesse, Inc.
Microbiology · 39d
Cleared Aug 26, 2013
PROPARAFLU+ ASSAY
K132238 · OOU
Gen-Probe Prodesse, Inc.
Microbiology · 39d
Cleared Aug 23, 2013
VANISHPOINT BLOOD COLLECTION SET
K122355 · JKA
Retractable Technologies, Inc.
Chemistry · 385d
Cleared Aug 23, 2013
ACCUSONIC ADVANTAGE
K124010 · IMI
Metron Medical Australia, Pty, Ltd.
Physical Medicine · 239d
Cleared Aug 23, 2013
BIOSONIC SUVI PIEZEOELECTRIC SCALER AND POLISHER
K130137 · ELC
Coltene/Whaledent
Dental · 217d
Cleared Aug 23, 2013
DIATRUE PLUS BLOOD GLUCOSE MONITORING SYSTEM
K130244 · NBW
Delbio Incorporation
Chemistry · 204d
Cleared Aug 23, 2013
BD PROBETEC TRICHOMONAS VAGINALIS (TV) QX AMPLIFIED DNA ASSAY
K130268 · OUY
Becton, Dickinson & CO
Microbiology · 200d
Cleared Aug 23, 2013
MAGSTIM DOUBLE 70-2 COIL
K130403 · GWF
The Magstim Company , Ltd.
Neurology · 185d
Cleared Aug 23, 2013
CARDIODAY
K130516 · DQK
Getemed Medizin- Und...
Cardiovascular · 177d
Cleared Aug 23, 2013
PRE-FORMED GUIDEWIRES
K130798 · DQX
Lake Region Medical, Inc.
Cardiovascular · 154d
Cleared Aug 23, 2013
SUTTER BIPOLAR FORCEPS - SUPERGLISS
K131012 · GEI
Sutter Medizintechnik GmbH
General & Plastic Surgery · 134d
Cleared Aug 23, 2013
TEMPUS(TM) CERVICAL PLATE SYSTEM
K131374 · KWQ
Neurostructures, LLC
Orthopedic · 102d
Cleared Aug 23, 2013
LLIAD, KORA, ZENIUS PEDICLE SCREW SYSTEM
K131878 · NKB
Medyssey USA, Inc.
Orthopedic · 60d
Cleared Aug 23, 2013
SELECTRA ACCESSORY KIT, SELECTRA SLITTER TOOL
K131978 · DQY
Biotronik, Inc.
Cardiovascular · 56d