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
116545–116568 of 174,955
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Jul 27, 1992
SUNGLASSES
K920836 · HQY
A Toz Importing Co.
Ophthalmic · 154d
Cleared Jul 27, 1992
PHARMACIA CMV IGM ELISA
K921011 · LFZ
Pharmacia Diagnostics, Inc.
Microbiology · 146d
Cleared Jul 27, 1992
DADE RECOMBOPLASTIN S
K921326 · GJS
Baxter Diagnostics, Inc.
Hematology · 131d
Cleared Jul 27, 1992
XENON LIGHT SOURCE AND ACCESSORIES
K921390 · GCT
Coopervision Surgical
Gastroenterology & Urology · 126d
Cleared Jul 27, 1992
NOVA NUCLEUS CLINICAL CHEMICAL SYST, MODIFICATION
K921937 · JGS
Nova Biomedical Corp.
Chemistry · 94d
Cleared Jul 27, 1992
CAG-02A
K922098 · KXJ
Toshiba America Medical Systems, In.C
Radiology · 82d
Cleared Jul 27, 1992
ATC725, ATC525, AND AP300
K922165 · IZO
Gendex Corp.
Radiology · 80d
Cleared Jul 27, 1992
AMERICAN MEDICAL MFG. LUMBAR CPM
K922493 · BXB
American Medical Corp.
Physical Medicine · 61d
Cleared Jul 27, 1992
VENTREX ALLERGEN DISC
K922538 · DHB
Hycor Biomedical, Inc.
Immunology · 59d
Cleared Jul 27, 1992
COULTER MAXM W/ AUTOLOADER
K922704 · GKZ
Coulter Electronics, Inc.
Hematology · 52d
Cleared Jul 27, 1992
MODIFIED SITE DIAPHRAGM CASSETTE FOR OPHTHALMICS
K922996 · KYG
Chiron Vision Corp.
Ophthalmic · 35d
Cleared Jul 27, 1992
OPTICAL FRAMES
K923177 · HQZ
A Toz Importing Co.
Ophthalmic · 32d
Cleared Jul 24, 1992
ATRAUMATIC SPECIAL SPROTTE NEEDLE
K911221 · BSP
Pajunk GmbH
Anesthesiology · 493d
Cleared Jul 24, 1992
MEDIX NEBULIZING SYSTEM CODE NO. 2000 AND 2001
K914772 · CAF
Medix Corp.
Anesthesiology · 312d
Cleared Jul 24, 1992
LASERSCOPE'S MICROSPOT DERMASTAT
K914918 · GEX
Laserscope
General & Plastic Surgery · 263d
Cleared Jul 24, 1992
MEDROYAL ANGIOGRAPHIC CONTROL SYRINGE
K920135 · DXT
Medroyal, Inc.
Cardiovascular · 193d
Cleared Jul 24, 1992
HYPO-GARD
K921913 · MMK
Epi Medical Products, Inc.
General Hospital · 92d
Cleared Jul 24, 1992
JAGWIRE(TM) RECANALIZATION GUIDEWIRE
K922302 · DQX
Boston Scientific Corp
Cardiovascular · 70d
Cleared Jul 24, 1992
THE TERMINATOR
K922535 · IOR
Top End Wheelchair Sports, Inc.
Physical Medicine · 57d
Cleared Jul 23, 1992
DISPOSABLE SPECIALTY SPONGES (DISSECTORS)/MODIFIED
K913302 · GDY
Carwild Corp.
General & Plastic Surgery · 364d
Cleared Jul 23, 1992
URETHRAL ELECTRODE SHEATH
K915219 · FAS
Applied Urology, Inc.
Gastroenterology & Urology · 246d
Cleared Jul 23, 1992
BICUT
K915608 · GEI
Berchtold Holding GmbH
General & Plastic Surgery · 220d
Cleared Jul 23, 1992
BIOTRACK PHENYTOIN TEST CARTRIDGE
K915755 · DIP
Biotrack, Inc.
Toxicology · 213d
Cleared Jul 23, 1992
BIOTRACK CARBAMAZEPINE TEST CARTRIDGE
K915756 · KLT
Biotrack, Inc.
Toxicology · 213d