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
119449–119472 of 174,955
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Oct 15, 1991
COLLAGEN SHIELD FOR ACUTE CARE
K913148 · MOE
Vitaphore Corp.
Ophthalmic · 91d
Cleared Oct 15, 1991
NIDEK MODEL NT-1000
K913189 · HKX
Nidek, Inc.
Ophthalmic · 89d
Cleared Oct 15, 1991
FASTLOK (STAPLE & BUCKLE) FIXATION SYSTEM
K913461 · JDR
Neoligaments, Ltd.
Orthopedic · 71d
Cleared Oct 15, 1991
RADIOGRAPHIC FILM MARKING SYSTEM
K913478 · JAC
Lorad Medical Systems, Inc.
Radiology · 70d
Cleared Oct 15, 1991
CERAVITAL MIDDLE EAR IMPLANT
K913619 · ETB
Friedrichsfeld Medizintechnik AG
Ear, Nose, Throat · 63d
Cleared Oct 15, 1991
DUCAL SIDE SHIELD SUNGLASS
K913745 · HQY
Ducal Trading Corp.
Ophthalmic · 62d
Cleared Oct 11, 1991
VIDAS CLOSTRIDIUM DIFFICILE TOXIN A (CDA) ASSAY
K905211 · LLH
Vitek Systems, Inc.
Microbiology · 325d
Cleared Oct 11, 1991
POLARIS
K910341 · GEX
Pfizer Laser Systems
General & Plastic Surgery · 256d
Cleared Oct 11, 1991
GUARDIAN GEL, SURGEON'S GLOVING CREAM
K910687 · KGQ
Guardian Angel Products, Inc.
General Hospital · 234d
Cleared Oct 11, 1991
POLARIS, GASTROENTEROLOGY/UROLOGY/PULMONARY, GI/GU
K911925 · GEX
Pfizer Laser Systems
General & Plastic Surgery · 169d
Cleared Oct 11, 1991
GORE-TEX EXPANDED POLY. CARD. PATCH 0.6 AND 0.4MM
K912107 · DXZ
W.L. Gore & Associates, Inc.
Cardiovascular · 151d
Cleared Oct 11, 1991
HYCOR PYLORAGEN HELICOBACTER PYLORI TEST
K912255 · LYR
Hycor Biomedical, Inc.
Microbiology · 142d
Cleared Oct 11, 1991
B-D(TM) MICROFINE(TM) IV PEN INJECTOR CAT. #328204
K912330 · FMF
Bd Becton Dickinson Vacutainer...
General Hospital · 140d
Cleared Oct 11, 1991
MODIFIED DURAPHASE(TM) IMPLANTED PENILE PROSTHESIS
K912344 · FAE
Dacomed Corp.
Gastroenterology & Urology · 136d
Cleared Oct 11, 1991
HAP BIO-GROOVE TOTAL HIP PROSTHESIS (BIO-COAT)
K912369 · MEH
Biomet, Inc.
Orthopedic · 135d
Cleared Oct 11, 1991
HAP BIO-GROOVE TOTAL HIP PROSTH (BIO-INTERFACES)
K912370 · MEH
Biomet, Inc.
Orthopedic · 135d
Cleared Oct 11, 1991
OPTICA 60 ND
K912703 · GEX
Xintec Corporation
General & Plastic Surgery · 114d
Cleared Oct 11, 1991
NATURAL POROUS HIP SYSTEM
K913060 · JDI
Intermedics Orthopedics
Orthopedic · 93d
Cleared Oct 11, 1991
KINEMAX PLUS TIBIAL INSERT
K913188 · JWH
Howmedica Corp.
Orthopedic · 85d
Cleared Oct 11, 1991
APR II NON-POROUS HIP STEM
K913208 · JDI
Intermedics Orthopedics
Orthopedic · 84d
Cleared Oct 11, 1991
TYPE FA10 AUDIOMETER
K913221 · EWO
Frye Electronics, Inc.
Ear, Nose, Throat · 84d
Cleared Oct 11, 1991
URINE/CSF MICROPROTEIN REAGENT
K913225 · CEK
Intersect Systems, Inc.
Chemistry · 84d
Cleared Oct 11, 1991
ABBOTT QUICKSTART TOTAL BILIRUBIN (TBIL) #5A21
K913307 · CIG
Em Diagnostic Systems, Inc.
Chemistry · 78d
Cleared Oct 11, 1991
VISI-NEISSERIA
K913456 · JSX
Kev Connecticut Diagnostics, Inc.
Microbiology · 67d