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
120001–120024 of 174,955
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Sep 04, 1991
STERILE DISPOSABLE URINE COLLECTOR & ACCESSORIES
K913223 · KNX
Medical Device Inspection Co., Inc.
Gastroenterology & Urology · 47d
Cleared Sep 04, 1991
MODEL #810 STEALTH-STIM ADULT STIMULATION PADS
K913226 · DRX
Cardiotronics, Inc.
Cardiovascular · 47d
Cleared Sep 04, 1991
KODAK EKTASCAN STORAGE PHOSPHOR READER MODEL 1A
K913354 · IXW
Eastman Kodak Company
Radiology · 40d
Cleared Sep 03, 1991
CPI MODEL 2215 & SEAMED MODEL 3400
K912507 · DTE
Seamed Corp.
Cardiovascular · 89d
Cleared Aug 30, 1991
ARTIFICIAL SCLERAL SHELL
K904961 · HQT
Midwest Eye Laboratories, Inc.
Ophthalmic · 298d
Cleared Aug 30, 1991
EYE ARTIFICIAL CUSTOM
K904962 · HQH
Midwest Eye Laboratories, Inc.
Ophthalmic · 298d
Cleared Aug 30, 1991
LYME-SPOT IF KIT
K910230 · LSR
Vitek Systems, Inc.
Microbiology · 224d
Cleared Aug 30, 1991
METROLAB MODEL 1500
K910806 · JJQ
Laboratorio Rodriguez Corswant S.R.L.
Chemistry · 185d
Cleared Aug 30, 1991
RUBELLA VIRUS IMMUNOLOGICAL TEST SYSTEM
K911444 · LFX
Wampole Laboratories
Microbiology · 151d
Cleared Aug 30, 1991
PATIENT DOSE MONITOR
K912249 · KPZ
Theta Systems, Inc.
Radiology · 101d
Cleared Aug 30, 1991
TRANSDUCER PROTECTOR
K912394 · FIB
Filtertek, Inc.
Gastroenterology & Urology · 94d
Cleared Aug 30, 1991
KAPS 90 DEGREE FIBEROPTIC ADAPTOR
K912885 · EQH
Jedmed Instrument Co.
Ear, Nose, Throat · 60d
Cleared Aug 30, 1991
INNOFLUOR(TM) DIGITOXIN CALIBRATOR SET
K913186 · DLJ
Intl. Bioclinical, Inc.
Toxicology · 43d
Cleared Aug 30, 1991
SCIMED 7 FR. & 8 FR.
K913364 · DQO
Scimed Life Systems, Inc.
Cardiovascular · 32d
Cleared Aug 30, 1991
QMS - DIGOXIN
K913562 · LCS
Seradyn, Inc.
Chemistry · 21d
Cleared Aug 30, 1991
ROSYS MODELS 100 AND 200
K913664 · JQW
Packard Instrument Co., Inc.
Chemistry · 14d
Cleared Aug 29, 1991
LP-PLUS
K903774 · DPS
Fidelity Medical, Inc.
Cardiovascular · 374d
Cleared Aug 29, 1991
VENTROFIL TENSION RELIEF SUTURE SET
K904435 · KGS
Aesculap, Inc.
General & Plastic Surgery · 335d
Cleared Aug 29, 1991
STERILE SURGICAL PACK
K904873 · KKX
Angelica Healthcare Services
General Hospital · 303d
Cleared Aug 29, 1991
BARD PERIPHERAL BALLOON DILATATION CATHETER
K910822 · LIT
C.R. Bard, Inc.
Cardiovascular · 184d
Cleared Aug 29, 1991
EDENTEC MODEL 3711 DIGITAL RECORDER
K910870 · DRT
Edentec Corp.
Cardiovascular · 181d
Cleared Aug 29, 1991
EDENTEC DIGITAL CHARTER MODEL 3710
K910871 · DSF
Edentec Corp.
Cardiovascular · 181d
Cleared Aug 29, 1991
ABC LAPAROSCOPIC HANDPROBE
K910889 · GEI
Birtcher Medical Systems, Inc.
General & Plastic Surgery · 178d
Cleared Aug 29, 1991
MASK, SURGICAL APPAREL
K911334 · FXX
Thai Hospital Products Co., Ltd.
General Hospital · 156d