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.

175,730 clearances · 1976 to present · Updated monthly from FDA records

Filters: Cleared only ×
175,230 results
151057–151080 of 175,230
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Sep 28, 1984
QUALIFY I & II AMER. MONITOR 2009 & 2010
K843611 · JJY
American Monitor Corp.
Chemistry · 15d
Cleared Sep 28, 1984
FIAX 420 DILUTOR
K843621 · JQW
Intl. Diagnostic Technology
Chemistry · 14d
Cleared Sep 28, 1984
MATCHED COMPONENT SET FOR RADIOIMMUNO-
K843635 · JKC
Cambridge Medical Technology
Chemistry · 11d
Cleared Sep 28, 1984
SYSTEMATE A AMYLASE HEM 67204
K843645 · CIJ
Em Diagnostic Systems, Inc.
Chemistry · 11d
Cleared Sep 27, 1984
MEDICALEX
K833377 · GEA
Medicalex
General & Plastic Surgery · 364d
Cleared Sep 27, 1984
MK 700 ULTRASOUND SYSTEM
K842093 · IYO
Advanced Technology Laboratories, Inc.
Radiology · 126d
Cleared Sep 27, 1984
BOSWORTH SUPER BOND DENTAL ADHESIVE
K842448 · DYH
Harry J. Bosworth Co.
Dental · 97d
Cleared Sep 27, 1984
CLEAR LINER
K842576 · EBI
Harry J. Bosworth Co.
Dental · 86d
Cleared Sep 27, 1984
ANDROSTENEDIONE BY RIA
K842960 · CIZ
Radioassay Systems Laboratories, Inc.
Chemistry · 62d
Cleared Sep 27, 1984
FLEXI-POST
K843018 · ECR
Essential Dental Systems, Inc.
Dental · 57d
Cleared Sep 27, 1984
COMMAND ULTRASEAL PIT & FISSURE SEALANT
K843024 · EBC
Kerr Corporation (Danbury)
Dental · 57d
Cleared Sep 27, 1984
KERR GELLED PHOSPHORIC ACID ETCHANT
K843026 · EBF
Kerr Corporation (Danbury)
Dental · 57d
Cleared Sep 27, 1984
RELIANCE TREATMENT CABINET
K843046 · ETF
F. & F. Koenigkramer
Ear, Nose, Throat · 56d
Cleared Sep 27, 1984
INSTRUMENTS FOR MICRO ANASTOMOSIS
K843100 · GAD
Downs Surgical , Ltd.
General & Plastic Surgery · 51d
Cleared Sep 27, 1984
STABILIZING RETAINER
K843143 · EJF
Dental Advancements, Inc.
Dental · 48d
Cleared Sep 27, 1984
ANTERIOR ALVEOLAR RIDGE SIZER
K843153 · LYC
Interpore Intl.
Dental · 48d
Cleared Sep 27, 1984
TPS SCREW DENTAL IMPLANTS
K843218 · DZE
Artech Corp.
Dental · 43d
Cleared Sep 27, 1984
FLOW CONTROLLER
K843223 · BTM
Precision Medical, Inc.
Anesthesiology · 42d
Cleared Sep 27, 1984
MPL HYPO BRAND BREECH LOAD ASPIR SYRINGE
K843314 · EJI
Smith & Nephew, Mpl Division
Dental · 34d
Cleared Sep 27, 1984
GONO-PAK W/THAYER-MARTIN AGAR/GONO-PAK
K843341 · JTW
Bd Becton Dickinson Vacutainer...
Microbiology · 31d
Cleared Sep 27, 1984
URINE TRANSPORT KIT
K843359 · JTW
Applied Polytechnology, Inc.
Microbiology · 31d
Cleared Sep 27, 1984
ISO-DATA IMMUNOASSAY NETWORK SYSTEM
K843365 · JQP
Iso-Data, Inc.
Chemistry · 30d
Cleared Sep 27, 1984
EOSIN Y 1% ALCOHOLIC
K843426 · HYB
Accra Laboratories, Inc.
Pathology · 23d
Cleared Sep 27, 1984
BIOFIX
K843428 · LDZ
Accra Laboratories, Inc.
Pathology · 23d