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
155785–155808 of 175,230
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Aug 31, 1983
EMBOLECTOMY CATHETER
K832023 · DXE
Bionomy, Inc.
Cardiovascular · 79d
Cleared Aug 31, 1983
LIGHT CURING BONDING AGENT
K832061 · EBF
Johnson & Johnson Professionals, Inc.
Dental · 65d
Cleared Aug 31, 1983
ADAPTIC*FAST SET DENTAL RESTORATIVE
K832062 · EBF
Johnson & Johnson Professionals, Inc.
Dental · 65d
Cleared Aug 31, 1983
NO-MIX 30 ORTHODONTIC BONDING SYSTEM
K832112 · DYH
Scientific Pharmaceuticals, Inc.
Dental · 62d
Cleared Aug 31, 1983
NICE PACK
K832193 · IME
Universal Medical Instrument Corp.
Physical Medicine · 54d
Cleared Aug 31, 1983
PRO PULSE PERIODONTAL IRRIGATOR 7618
K832222 · EFS
Vipont Laboratories, Inc.
Dental · 54d
Cleared Aug 31, 1983
PERIODONTAL IRRIGATOR #7620
K832223 · EFS
Vipont Laboratories, Inc.
Dental · 54d
Cleared Aug 31, 1983
SIGMA PROCEDURE #550 DETERM. BILIRUB
K832236 · CIG
Sigma Chemical Co.
Chemistry · 51d
Cleared Aug 31, 1983
NEUROMOD COMFORT WAVE #7721 DUAL-
K832238 · GZJ
Medtronic Vascular
Neurology · 51d
Cleared Aug 31, 1983
X-704
K832253 · EJS
Unitek Corp.
Dental · 51d
Cleared Aug 31, 1983
AUTO-TACH
K832291 · DYH
Dentsply Intl.
Dental · 49d
Cleared Aug 31, 1983
S2MEDIAN
K832295 · GXY
Anstek Corp.
Neurology · 49d
Cleared Aug 31, 1983
S2 POSTERIOR-TIB
K832296 · GXY
Anstek Corp.
Neurology · 49d
Cleared Aug 31, 1983
DIRECT BONDED BRACKET REMOVER
K832301 · JCX
Northwest Orthopedics
General & Plastic Surgery · 49d
Cleared Aug 31, 1983
BRAEGEN III 10-CHANNEL TRANSMITTER-
K832304 · GYE
Electro-Bio-Medical Services, Inc.
Neurology · 48d
Cleared Aug 31, 1983
PRISMA III
K832320 · EBZ
Dentsply Intl.
Dental · 47d
Cleared Aug 31, 1983
STRATUS AMIKACIN FLUOROMETRIC
K832336 · KLQ
American Dade
Chemistry · 44d
Cleared Aug 31, 1983
AUTO-TENS MODEL V
K832337 · GZJ
Cbc Corp.
Neurology · 44d
Cleared Aug 31, 1983
CORNING'S MAGIC T3(125I) RADIOIMMUNO-
K832353 · CDP
Corning Medical & Scientific
Chemistry · 44d
Cleared Aug 31, 1983
IDT ANA STIQ ASSAY
K832383 · DHN
Intl. Diagnostic Technology
Immunology · 43d
Cleared Aug 31, 1983
CENTRAL VENOUS ACCESS CATHETER CVAC
K832396 · DOY
Gish Biomedical, Inc.
Toxicology · 42d
Cleared Aug 31, 1983
HYBRITECH 405-500 NM FILTER MODULE
K832397 · JJQ
Hybritech, Inc.
Chemistry · 42d
Cleared Aug 31, 1983
ENZYMATIC TRIGLYCERIDES #2000
K832444 · CDT
Stanbio Laboratory
Chemistry · 37d
Cleared Aug 31, 1983
STRATUS GENTAMICIN FLUOROMETRIC ENZYM
K832445 · LCD
American Dade
Chemistry · 37d