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
125905–125928 of 175,230
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared May 18, 1990
LATEX PATIENT EXAMINATION GLOVE
K901855 · LYY
Tower Marketing Sdn. Bhd.
General Hospital · 24d
Cleared May 18, 1990
PATIENT EXAMINATION GLOVES
K901903 · LYY
Southland Products Co., Ltd.
General Hospital · 21d
Cleared May 18, 1990
LATEX PATIENT EXAMINATION GLOVES
K902017 · LYY
Taksin Rubber Industries Co., Ltd.
General Hospital · 15d
Cleared May 18, 1990
HEMAGEN ENA [JO-I] KIT
K902139 · DHN
Hemagen Diagnostics, Inc.
Immunology · 9d
Cleared May 17, 1990
EXTRACORPOREAL HEAT EXCHANGER HE SERIES
K896020 · DTR
Gish Biomedical, Inc.
Cardiovascular · 213d
Cleared May 17, 1990
VOSS DISPOSABLE CORONARY BYPASS FLUSHING CANNULA
K896338 · DWF
Voss Medical Products
Cardiovascular · 195d
Cleared May 17, 1990
PCI MODEL 2041-B TELEMETRY MONITOR
K896775 · DSI
Accucore, Inc.
Cardiovascular · 167d
Cleared May 17, 1990
MODEL 215M PATIENT SIMULATOR
K897074 · DSI
Dynatech/Nevada, Inc.
Cardiovascular · 146d
Cleared May 17, 1990
MICROPLATE REAGENT DISPENSER
K900599 · JQW
Denley Instruments, Inc.
Chemistry · 98d
Cleared May 17, 1990
HEPARINIZED ARTERIAL SCREEN BLOOD FILTER
K900758 · DTM
Cobe Laboratories, Inc.
Cardiovascular · 90d
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