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
74977–75000 of 174,955
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Jun 04, 2002
AMPHETAMINES ENZYME IMMUNOASSAY, CATALOG #0040 (500 TESTS KIT), CATALOG #0041...
K020395 · DKZ
Lin-Zhi International, Inc.
Toxicology · 118d
Cleared Jun 04, 2002
CARESIDE ALT
K020487 · CKA
Careside, Inc.
Chemistry · 111d
Cleared Jun 04, 2002
NLITE SYSTEM,MODEL A00-1051
K020729 · GEX
Icn Photonics , Ltd.
General & Plastic Surgery · 90d
Cleared Jun 04, 2002
UNICONDYLAR KNEE
K020741 · HRY
Encore Orthopedics, Inc.
Orthopedic · 90d
Cleared Jun 04, 2002
IGEL 55UV (METHAFILCON A) SOFT (HYDROPHILIC) CONTACT LENS FOR DAILY WEAR,IGEL...
K020855 · LPL
Igel Vision Care Pte , Ltd.
Ophthalmic · 81d
Cleared Jun 04, 2002
SAVIEW TORIC 55 (METHAFILCON A) SOFT (HYDROPHILIC) CONTACT LENSES FOR DAILY WEAR
K021295 · LPL
St. shine Optical Co., Ltd.
Ophthalmic · 41d
Cleared Jun 04, 2002
PARACON II/FECAL CONCENTRATOR II
K021420 · LKS
Para Scientific Co.
Microbiology · 32d
Cleared Jun 04, 2002
ANIMUS EZSERTER INFUSION SET INSERTER
K021700 · KZH
Animas Corp.
General Hospital · 12d
Cleared Jun 03, 2002
REPROCESSED ARTHROSCOPIC SHAPERS
K012667 · HRX
Surgical Instruments Service and...
Orthopedic · 294d
Cleared Jun 03, 2002
SYSTEM 100
K013733 · KDI
Chf Solutions, Inc.
Gastroenterology & Urology · 206d
Cleared Jun 03, 2002
FAMILY OF ALTUS MEDICAL MODIFIED COOLGLIDE AESTHETIC LASERS, MODELS COOLGLIDE...
K014040 · GEX
Altus Medical, Inc.
General & Plastic Surgery · 178d
Cleared Jun 03, 2002
TRIAGE DRUGS OF ABUSE PANEL PLUS PPX, MODEL CATALOG 92002
K014247 · DKZ
Biosite Incorporated
Toxicology · 159d
Cleared Jun 03, 2002
WALLACH LOOP ELECTRODE
K020711 · GEI
Wallach Surgical Devices, Inc.
General & Plastic Surgery · 90d
Cleared Jun 03, 2002
SECURLINE UMBILICAL CORD CLAMP #3505 STERILE #3515 NON-STERILE
K020718 · HFW
Precision Dynamics Corp.
Obstetrics & Gynecology · 90d
Cleared Jun 03, 2002
TRAATEK COTTONOID PATTIES
K020736 · HBA
Traatek, Inc.
Neurology · 89d
Cleared Jun 03, 2002
BCI 3178 PEDIATRIC PULSE OXIMETRY SENSOR
K020739 · DQA
Bci, Inc.
Anesthesiology · 89d
Cleared Jun 03, 2002
NAVIPRO
K020764 · HAW
Kinamed, Inc.
Neurology · 88d
Cleared Jun 03, 2002
MEDORAL HYGIENIC TOOTHBRUSH WITH DENTOSAN FILAMENTS
K020776 · EFW
Coronet Group North America, LLC
Dental · 84d
Cleared Jun 03, 2002
SCOUT (SINUS CORNARIUS UTILITY TOOL), MODEL 335 117
K020821 · DQX
Biotronik, Inc.
Cardiovascular · 82d
Cleared Jun 03, 2002
DEVILBISS MODEL 9200D HEATED HUMIDIFIER SYSTEM
K020900 · BTT
Sunrise Medical Hhg, Inc.
Anesthesiology · 75d
Cleared Jun 03, 2002
MICROSCAN MICROSTREP PLUS PANEL-MEROPENEM
K020938 · JWY
Dade Microscan, Inc.
Microbiology · 73d
Cleared Jun 03, 2002
ACTH IMMUNORADIOMETRIC (IRMA) DIAGNOSTIC ASSAY KIT, MODEL #3KG100
K021032 · CKG
Scantibodies Laboratory, Inc.
Chemistry · 66d
Cleared Jun 03, 2002
CHARE CARIOVASCULAR PATCH
K021129 · DXZ
Chase Medical, Inc.
Cardiovascular · 56d
Cleared Jun 03, 2002
ANA LINE BLOT, CATALOG NUMBER: KALABI (20 TESTS)
K021257 · LKJ
Diagnostic Products Corp.
Immunology · 45d