FDA 510(k) Searchable Database - Search 176,325+ Clearances

Search 176,325+ 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.

176,325 clearances · 1976 to present · Updated monthly from FDA records · Free access · No registration required

Filters: Cleared only ×
175,820 results
121849–121872 of 175,820
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Jun 06, 1991
MY-O-MATIC 5000I
K902226 · GZJ
Monad Corp.
Neurology · 385d
Cleared Jun 06, 1991
NEEDLE, ASPIRATION & INJECTION, DISPOSABLE
K902422 · FMI
Gainor Medical Europe, Ltd.
General Hospital · 371d
Cleared Jun 06, 1991
NEW TRIAD VLC CROWN & BRIDGE PROVISIONAL MATERIAL
K904251 · EBG
Dentifax Intern, Inc.
Dental · 266d
Cleared Jun 06, 1991
STEREOTACTIC IRRADIATION SYSTEM
K904908 · IYE
Northwest Medical Physics Center
Radiology · 218d
Cleared Jun 06, 1991
PALAVIT GLC
K904928 · EGD
Kulzer, Inc.
Dental · 218d
Cleared Jun 06, 1991
PALAVIT L
K905058 · EBH
Kulzer, Inc.
Dental · 210d
Cleared Jun 06, 1991
EAGLE VISION FREEMAN RADIOPAGUE PUNCTUM PLUG
K905427 · LZU
Eagle Vision, Inc.
Ophthalmic · 184d
Cleared Jun 06, 1991
MODEL M1251A MON. FULL DISCLOSURE REVIEW SYSTEM
K905788 · DXJ
Hewlett-Packard Co.
Cardiovascular · 161d
Cleared Jun 06, 1991
VACUUM-ASSISTED BLOOD COLLECTION SYSTEM
K905818 · DTN
Jtl Medical Corp.
Cardiovascular · 157d
Cleared Jun 06, 1991
CUTTERSIL MUCOSA
K910165 · ELW
Heraeus Kulzer, Inc.
Dental · 142d
Cleared Jun 06, 1991
CUTTERSIL XL
K910166 · ELW
Heraeus Kulzer, Inc.
Dental · 142d
Cleared Jun 06, 1991
PERFOURM PUTTY SOFT
K910189 · ELW
Heraeus Kulzer, Inc.
Dental · 141d
Cleared Jun 06, 1991
CUTTERSIL FUNCTION ACTIVATOR
K910360 · ELW
Heraeus Kulzer, Inc.
Dental · 128d
Cleared Jun 06, 1991
SDU 500 DIAGNOSTIC ULTRASOUND INSTRUMENT
K910426 · HEM
Shimadzu Medical Systems
Obstetrics & Gynecology · 127d
Cleared Jun 06, 1991
MELIODENT, DENTURE RESIN
K910465 · EBI
Heraeus Kulzer, Inc.
Dental · 122d
Cleared Jun 06, 1991
SELECTOR MD (50KW AND 80 KW)
K910650 · IZO
Hofmann-Nagel Medical Systems, Inc.
Radiology · 112d
Cleared Jun 06, 1991
CINEMEASURE (TM)
K910654 · IZI
Syracuse Research Corp.
Radiology · 112d
Cleared Jun 06, 1991
MEDISYSTEMS ANTI-STICK INJECTION SITE NEEDLE
K910733 · FMI
Medisystems Corp.
General Hospital · 105d
Cleared Jun 06, 1991
COMFOR-BOARD
K910880 · KMK
Medway
General Hospital · 97d
Cleared Jun 06, 1991
PROBE REFILL KIT
K911073 · ITX
Interspec, Inc.
Radiology · 87d
Cleared Jun 06, 1991
HEMOSTATIC Y CONNECTOR
K911130 · LIT
Thomas Medical Products, Inc.
Cardiovascular · 84d
Cleared Jun 06, 1991
GESCO PER-Q-CATH NEEDLE
K911215 · LIT
Gesco Intl., Inc.
Cardiovascular · 79d
Cleared Jun 06, 1991
THE MEDISCUS PEDCARE MANAGEMENT SYSTEM-MODEL 2
K911246 · INX
The Medical Group, Inc.
Physical Medicine · 77d
Cleared Jun 06, 1991
HYDENT
K911259 · EFH
Pascal Co., Inc.
Dental · 76d