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
154489–154512 of 175,230
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Jan 03, 1984
TAMPONADE BALLOON CUFF
K833859 · GCP
American Endoscopy, Inc.
Gastroenterology & Urology · 57d
Cleared Jan 03, 1984
PENASE
K833888 · MDB
Oxoid U.S.A., Inc.
Microbiology · 55d
Cleared Jan 03, 1984
BICARBOLYTE HEMO-DIAL
K833896 · KOC
Edlaw Pharmaceuticals, Inc.
Gastroenterology & Urology · 50d
Cleared Jan 03, 1984
NEGATIVE PRESSURE ARTERIAL BLOOD
K833905 · KOC
Erika, Inc.
Gastroenterology & Urology · 50d
Cleared Jan 03, 1984
NEGATIVE PRESSURE VENOUS BLOOD LINE
K833906 · KOC
Erika, Inc.
Gastroenterology & Urology · 50d
Cleared Jan 03, 1984
UMI PERCUTANEOUS TRANSHEPATIC CHOLAN
K833937 · FGE
Universal Medical Instrument Corp.
Gastroenterology & Urology · 49d
Cleared Jan 03, 1984
NOVEL DISPENSER/PACKAGE
K833955 · EIY
Dentsply Intl.
Dental · 48d
Cleared Jan 03, 1984
SELECTIVE STREPTOCOCCUS AGAR
K834005 · JSJ
Micro Media Laboratories
Microbiology · 43d
Cleared Jan 03, 1984
BRUCELLA MEDIA
K834006 · JSG
Micro Media Laboratories
Microbiology · 43d
Cleared Jan 03, 1984
DERMATOPHYTE TEST MEDIUM
K834010 · JSJ
Micro Media Laboratories
Microbiology · 43d
Cleared Jan 03, 1984
SARNS CARDIOPLEGIA CANNULA Y
K834025 · DWF
3M Health Care, Sarns
Cardiovascular · 42d
Cleared Jan 03, 1984
INFANT VENT CATHETER 12001 W/SIDE VENT
K834039 · DWF
Dlp, Inc.
Cardiovascular · 41d
Cleared Jan 03, 1984
MSI-HC HEMATOLOGY CONTROL
K834043 · JPK
Medical Specialties, Inc.
Hematology · 41d
Cleared Jan 03, 1984
LEGIONELLA DIFFERENTIATION DISK
K834067 · GRO
Remel Co.
Microbiology · 39d
Cleared Jan 03, 1984
CEB
K834068 · JSJ
Remel Co.
Microbiology · 39d
Cleared Jan 03, 1984
MIDDLEBROOK & COHN 7H11 AGAR BASE
K834204 · JSH
Acumedia Manufacturers, Inc.
Microbiology · 29d
Cleared Jan 03, 1984
MIDDLEBROOK & COHN 7H10 AGAR BASE
K834205 · JSH
Acumedia Manufacturers, Inc.
Microbiology · 29d
Cleared Jan 03, 1984
EUGONIC AGAR
K834206 · JSG
Acumedia Manufacturers, Inc.
Microbiology · 29d
Cleared Jan 03, 1984
MINI-1 TRANSCUTANEOUS ELEC-NERVE STIM
K834215 · GZJ
Th Charters, Inc.
Neurology · 29d
Cleared Jan 01, 1984
DRUG STANDARDS
K833276 · DKB
Supelco, Inc.
Toxicology · 101d
Cleared Dec 30, 1983
PRE-ROLLED TUBULAR STOCKINETTE
K831936
Ormed Mfg., Inc.
General & Plastic Surgery · 198d
Cleared Dec 30, 1983
STRATUS THEOPHYLLINE ASSAY
K832965 · KLS
American Dade
Chemistry · 120d
Cleared Dec 30, 1983
DERMA STRIP-TM SKIN CLOSURES
K833083 · FPX
Howmedica Corp.
General & Plastic Surgery · 109d
Cleared Dec 30, 1983
LASER PROTECTIVE EYESHIELD
K833232 · HQF
Stefanovsky & Assoc.
Ophthalmic · 115d