FDA 510(k) Searchable Database - Search 176,325+ Clearances

Search 176,325+ FDA 510(k) clearances by K-number, device name, manufacturer or product code. Includes real review time data, denied submission rates and regulatory intelligence not available on any other searchable 510(k) database.

176,325 clearances · 1976 to present · Updated monthly from FDA records · Free access · No registration required

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175,820 results
126505–126528 of 175,820
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared May 17, 1990
AMS OPTILUME INFLATION SYRINGE
K900760 · KOE
American Medical Systems, Inc.
Gastroenterology & Urology · 90d
Cleared May 17, 1990
AMS OPTILUME(TM) PROSTATE BALLOON DILATOR
K900761 · KOE
American Medical Systems, Inc.
Gastroenterology & Urology · 90d
Cleared May 17, 1990
BARD SHORT RIGID URETEROSCOPE
K900813 · FGB
C.R. Bard, Inc.
Gastroenterology & Urology · 85d
Cleared May 17, 1990
PCI MODEL 2041-PC TELEMETRY MONITOR
K901031 · DRT
Accucore, Inc.
Cardiovascular · 72d
Cleared May 17, 1990
EZ-BEAD PHENYTOIN ENZYME IMMUNOASSAY KIT
K901080 · DIP
Immunotech Corp.
Chemistry · 71d
Cleared May 17, 1990
IRON/TOTAL IRON BINDING CAPACITY
K901561 · JIY
Tech-Co, Inc.
Chemistry · 44d
Cleared May 17, 1990
MILENIA(TM) CANNABINOIDS
K901568 · LDJ
Diagnostic Products Corp.
Toxicology · 43d
Cleared May 17, 1990
MILENIA(TM) OPIATES
K901577 · DJG
Diagnostic Products Corp.
Toxicology · 43d
Cleared May 16, 1990
CONDOMS (MULTIPLE BRANDS)
K897129 · HIS
Sagami, Inc.
Obstetrics & Gynecology · 141d
Cleared May 16, 1990
SPQ TEST SYSTEM II FOR FIB (SERUM PROTEIN QUANTI.)
K900939 · KQJ
Incstar Corp.
Hematology · 77d
Cleared May 16, 1990
LATEX SURGEON GLOVES
K901398 · KGO
Sinochem (Usa), Inc.
General Hospital · 51d
Cleared May 16, 1990
LATEX CONDOMS - CODE NO. 401, 421 & 1002
K901667 · HIS
Allercare/Nsl, Inc.
Obstetrics & Gynecology · 36d
Cleared May 16, 1990
LATEX CONDOMS - CODE NO. 402, CODE NO. 1028
K901668 · HIS
Allercare/Nsl, Inc.
Obstetrics & Gynecology · 36d
Cleared May 16, 1990
LATEX CONDOMS - CODE NO. 404, NO. 424 & NO. 1000
K901669 · HIS
Allercare/Nsl, Inc.
Obstetrics & Gynecology · 36d
Cleared May 16, 1990
LATEX CONDOMS - CODE NO. 403, 406, 421 & 1033
K901696 · HIS
Allercare/Nsl, Inc.
Obstetrics & Gynecology · 34d
Cleared May 16, 1990
MODIFIED AOR-SULLIVAN PROTECTIVE OVERGLOVE
K902016 · LYU
Aor-Sullivan
General Hospital · 16d
Cleared May 15, 1990
KING OF HEARTS CDM
K896040 · DXH
Instromedix, Inc.
Cardiovascular · 211d
Cleared May 15, 1990
BIOMER(R) F COMPOSITE LUTING CEMENT
K896340 · EMA
Dentsply Intl.
Dental · 193d
Cleared May 15, 1990
CELLOGNOST SYPHILIS H
K896410 · GMT
Behring Diagnostics, Inc.
Microbiology · 189d
Cleared May 15, 1990
PUREBRUSH ULTRAVIOLET TOOTHBRUSH SANITIZER
K896481 · MCF
Purebrush Assoc.
Dental · 181d
Cleared May 15, 1990
INTERFACE BONDING SYSTEM
K896769 · EBF
Smile Horizons, Inc.
Dental · 165d
Cleared May 15, 1990
PALFIQUE LIGHT LINER
K896980 · EBI
Tokuyama America, Inc.
Dental · 153d
Cleared May 15, 1990
TOKUSO REBASE
K896981 · EBI
Tokuyama America, Inc.
Dental · 153d
Cleared May 15, 1990
PALFIQUE LIGHT BONDING AGENT
K897009 · KLE
Tokuyama America, Inc.
Dental · 153d