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
77449–77472 of 174,955
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Sep 27, 2001
EXEL INJECTION PLUG WITH CAP
K011405 · FPA
Exelint Intl. Co.
General Hospital · 142d
Cleared Sep 27, 2001
VANGUARD REPROCESSED ELECTRIC BIOPSY FORCEPS
K011800 · NLU
Vanguard Medical Concepts, Inc.
Gastroenterology & Urology · 111d
Cleared Sep 27, 2001
PF2
K012062 · KTT
Fixano SA
Orthopedic · 87d
Cleared Sep 27, 2001
RADIOFIX
K012078 · KTT
Fixano SA
Orthopedic · 87d
Cleared Sep 27, 2001
COMPCORE AF COMPOSITE CORE BUILD-UP MATERIAL, MODEL 3001408
K012160 · EBF
Premier Dental Products Co.
Dental · 78d
Cleared Sep 27, 2001
NUMARIS 4VA15A
K012202 · LNH
Siemens Medical Corp.
Radiology · 76d
Cleared Sep 27, 2001
COLOR-MONOGEN
K012901 · KTN
Instrumentation Laboratory CO
Immunology · 29d
Cleared Sep 27, 2001
AFFINITY 38 MICON ARTERIAL FILTER WITH TRILLIUM BIOPASSIVE SURFACE, MODEL 351T
K013084 · DTM
Medtronic Perfusion Systems
Cardiovascular · 13d
Cleared Sep 26, 2001
FF450 PLUS FUNDUS CAMERA AND VISUPAC DIGITAL IMAGE ARCHIVING SYSTEM, OR FF450...
K011877 · HKI
Carl Zeiss Jena GmbH
Ophthalmic · 103d
Cleared Sep 26, 2001
POWDER-FREE BUTADIENE COPOLYMER EXAM GLOVES WITH ALOE, VITAMINS E PH5.5
K011961 · LZA
Shen Wei (Usa), Inc.
General Hospital · 96d
Cleared Sep 26, 2001
BIOSAFE CHOLESTEROL PROFILE BLOOD COLLECTION AND TRANSPORT SYSTEM
K011970 · CHH
Biosafe Laboratories, Inc.
Chemistry · 93d
Cleared Sep 26, 2001
SONOREAL 3D
K012084 · IYO
Bio Medi Com
Radiology · 85d
Cleared Sep 26, 2001
THE INTUITIVE COLORIMETER
K012298 · NFD
Cerium Optical Technologies, Inc.
Ophthalmic · 68d
Cleared Sep 26, 2001
URISYS 2400 URINE TEST STRIP
K012397 · JIL
Roche Diagnostics Corp.
Chemistry · 61d
Cleared Sep 26, 2001
STERILE NITRILE SURGICAL GLOVES (POWDERED)
K012479 · KGO
Smart Glove Corp. Sdn Bhd
General Hospital · 55d
Cleared Sep 26, 2001
BLY-501 ADAPTOR
K012540 · DPS
Micromedical Industries, Ltd.
Cardiovascular · 50d
Cleared Sep 26, 2001
THE NEXGEN TMT TIBIA, MODELS 00-5886-XXYY, 05-120-XXYY-0
K012866 · JWH
Implex Corp.
Orthopedic · 30d
Cleared Sep 25, 2001
MODIFICATION TO HYBRID CAPTURE II CT/GC TEST, MODEL 03M90-01
K010891 · LSK
Digene Corp.
Microbiology · 183d
Cleared Sep 25, 2001
EASY GUIDE ELECTROSURGICAL ACCESS DEVICE
K012004 · GEI
Senorx, Inc.
General & Plastic Surgery · 90d
Cleared Sep 25, 2001
XBO1-824-18/19/20 BIOPSY FORCEPS
K012074 · OCZ
The Olympus Optical Co.
Gastroenterology & Urology · 85d
Cleared Sep 25, 2001
ACCUIMAGE SMARTGATE UPGRADE
K012106 · JAK
Accuimage Diagnostics Corp.
Radiology · 81d
Cleared Sep 25, 2001
HP-ONE
K012411 · LYR
Gi Supply
Microbiology · 57d
Cleared Sep 25, 2001
SUPERSTITCH VASCULAR SUTURING DEVICE
K012865 · GAW
Sutura, Inc.
General & Plastic Surgery · 29d
Cleared Sep 25, 2001
ULTRAFLEX EV HEMOSTASIS INTRODUCER
K012922 · DYB
St Jude Medical
Cardiovascular · 25d