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
107185–107208 of 174,955
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Jul 28, 1994
PENTHOUSE CONDOMS
K933153 · HIS
Kuron Health Products Corp.
Obstetrics & Gynecology · 394d
Cleared Jul 28, 1994
GORE-TEX FACIAL IMPLANT
K933367 · FWP
W.L. Gore & Associates, Inc.
General & Plastic Surgery · 384d
Cleared Jul 28, 1994
SUNSOR ULTRAVIOLET METER
K934728 · EAQ
Sunsor, Inc.
Dental · 302d
Cleared Jul 28, 1994
TD50 ELECTROMYOGRAPH
K935017 · JXE
Medelec Intl. Corp.
Neurology · 282d
Cleared Jul 28, 1994
SOUTHLAND STERILE DENTAL SYSTEM
K935127 · EKJ
Southland, Ltd.
Dental · 273d
Cleared Jul 28, 1994
DEBUSK TEMPERATURE SYSTEMS PREMIER AND SIGNATURE SERIES MULTI-PURPOSE...
K940169 · BZT
Deroyal Industries, Inc.
Anesthesiology · 202d
Cleared Jul 28, 1994
ANA SCREEN ELISA TEST SYSTEM
K940362 · LLL
Zeus Scientific, Inc.
Immunology · 183d
Cleared Jul 28, 1994
OPUS FT4 TEST SYSTEM
K940507 · CEC
Pb Diagnostic Systems, Inc.
Chemistry · 176d
Cleared Jul 28, 1994
STAPHYTECT-OD
K940557 · LHJ
Unipath , Ltd.
Microbiology · 171d
Cleared Jul 28, 1994
ALGINATE FIBER
K941176 · KMF
Adri/Technam
General & Plastic Surgery · 136d
Cleared Jul 28, 1994
MERIT
K941408 · LNH
Philips Medical Systems (Cleveland),...
Radiology · 127d
Cleared Jul 28, 1994
SERUM VOLATILES CONTROL - LEVELS 1 AND 2
K941698 · JJY
More Diagnostics
Chemistry · 113d
Cleared Jul 28, 1994
WHOLE BLOOD VOLATILES CONTROL, LEVELS 1 AND 2
K941876 · JJY
More Diagnostics
Chemistry · 101d
Cleared Jul 28, 1994
FISHER-PRICE DRY NIGHT MONITOR
K942057 · KPN
Fisher Price
Gastroenterology & Urology · 91d
Cleared Jul 28, 1994
ESSTECH PS ASPHERIC
K942186 · LPL
Szabocsik and Assoc.
Ophthalmic · 85d
Cleared Jul 28, 1994
ESSTECH SV(POLYMACON) SOFT (HYDROPHILIC) CONTACT LENS
K942187 · LPL
Szabocsik and Assoc.
Ophthalmic · 85d
Cleared Jul 28, 1994
H55 HYDROPHILIC CONTACT LENS
K942214 · LPL
Martin S. Knopf Assoc., Inc.
Ophthalmic · 83d
Cleared Jul 28, 1994
GORETEX SAM FACIAL IMPLANT
K942280 · FWP
W.L. Gore & Associates, Inc.
General & Plastic Surgery · 79d
Cleared Jul 28, 1994
CEDIA(R) DAU BARBITURATE ASSAY, MODIFICATION
K942404 · DIS
Microgenics Corp.
Toxicology · 129d
Cleared Jul 28, 1994
ALKO FLUIDS PACKS FOR NOVA 8 ANALYZERS
K942549 · JIX
Alko Diagnostic Corp.
Chemistry · 58d
Cleared Jul 28, 1994
CEDIA T4 MAB ASSAY
K942575 · KLI
Microgenics Corp.
Chemistry · 58d
Cleared Jul 28, 1994
AVL COMPACT 2 PH/BLOOD GAS ANALYZER
K942616 · CHL
Avl Scientific Corp.
Chemistry · 56d
Cleared Jul 28, 1994
HIGH PERFORMANCE TIPS
K943102 · HQC
Surgin Surgical Instrumentation, Inc.
Ophthalmic · 29d
Cleared Jul 28, 1994
CORE DYNAMICS' LAPAROSCOPIC SMOKE ELIMINATOR
K943172 · GCJ
Core Dynamics, Inc.
General & Plastic Surgery · 38d