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
91777–91800 of 174,955
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Oct 03, 1997
VTU-1 VACUUM ERECTION SYSTEM
K971257 · LKY
Mckenna & Cuneo
Gastroenterology & Urology · 182d
Cleared Oct 03, 1997
INNOSAN TRAVELAIR S PLUS PORTABLE OXYGEN CONCENTRATOR, CODE NO. M407001853...
K971947 · CAW
Sim Italia S.R.L.
Anesthesiology · 128d
Cleared Oct 03, 1997
MEDI-PLUS, HEALTH-PLUS, SANITEX, RELIANCE
K972169 · LZA
Pwa Industries Sdn. Bhd.
General Hospital · 116d
Cleared Oct 03, 1997
LASEREX LP1532 PHOTOCOAGULATOR
K972514 · HQF
Ellex Medical Pty, Ltd.
Ophthalmic · 88d
Cleared Oct 03, 1997
EYE SPHERE, CONFORMERS
K972661 · HPZ
Gulden Ophthalmics
Ophthalmic · 79d
Cleared Oct 03, 1997
AIA-PACK IGE II ASSAY
K972697 · DGC
Tosoh Medics, Inc.
Immunology · 77d
Cleared Oct 03, 1997
TEMP BOND CLEAR
K972844 · EMA
Kerr Dental Materials Center
Dental · 63d
Cleared Oct 03, 1997
VIDAS ROTAVIRUS (RTV) ASSAY
K972895 · LIQ
Biomerieux Vitek, Inc.
Microbiology · 59d
Cleared Oct 03, 1997
PLS-96P
K973088 · EJJ
Southern Dental Industries, Inc.
Dental · 46d
Cleared Oct 03, 1997
INNOVATOME MICROKERATOME
K973294 · HNO
Innovative Optics, Inc.
Ophthalmic · 31d
Cleared Oct 03, 1997
CHEMMATE UCHL1 (CD45RO) PREDILUTED ANTIBODY FOR IMMUNOHISTOCHEMICAL STAINING
K973389 · DEM
Ventana Medical Systems, Inc.
Immunology · 85d
Cleared Oct 03, 1997
CHEMMATE L26 (CD20)
K973390 · DEM
Ventana Medical Systems, Inc.
Immunology · 85d
Cleared Oct 03, 1997
CHEMMATE KAPPA
K973391 · DEM
Ventana Medical Systems, Inc.
Immunology · 85d
Cleared Oct 03, 1997
CHEMMATE LAMBDA
K973392 · DEM
Ventana Medical Systems, Inc.
Immunology · 86d
Cleared Oct 02, 1997
MEDCORP FLOW I.V. REGULATOR EXTENSION SET
K971004 · FPA
Medcorp Intl.
General Hospital · 197d
Cleared Oct 02, 1997
2 BOND 2
K971733 · KLE
Heraeus Kulzer, Inc.
Dental · 146d
Cleared Oct 02, 1997
PULPDENT OX-OUT
K972445 · EMA
Pulpdent Corp.
Dental · 94d
Cleared Oct 02, 1997
SENSOR AMPLIFIER
K972515 · GWL
Pro-Tech Services, Inc.
Neurology · 91d
Cleared Oct 02, 1997
THUMPER
K972525 · DRM
Michigan Instruments, Inc.
Cardiovascular · 87d
Cleared Oct 02, 1997
BIO TROL
K972723 · HCC
Mindmedia Labs, Inc.
Neurology · 73d
Cleared Oct 02, 1997
GENESIS
K972871 · ELW
Pacific Rim Dental, Inc.
Dental · 59d
Cleared Oct 02, 1997
CAVIT-LC
K972892 · EBF
Espe GmbH & Co. Kg.
Dental · 58d
Cleared Oct 02, 1997
ONE STEP URINE DRUG OF ABUSE BARBITURATE TEST
K973047 · DIS
Drial Consultants, Inc.
Toxicology · 48d
Cleared Oct 02, 1997
AMSINO I.V. ADMINISTRATION SET
K973107 · FPA
Amsino Intl., Inc.
General Hospital · 44d