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
162313–162336 of 175,230
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Sep 24, 1981
BOVINE CHEMISTRY CONTROL I.X. & II.X.
K812583 · JJY
American Dade
Chemistry · 14d
Cleared Sep 24, 1981
ULTRA CHEM E-TRIG #65024
K812589 · CDT
Harleco
Chemistry · 13d
Cleared Sep 24, 1981
ULTRA ZYME PLUS LDH #64950, 65038 & 39
K812590 · CFJ
Harleco
Chemistry · 13d
Cleared Sep 24, 1981
ULTRA ZYME PLUS GPT, #64956, 65035 & 36
K812591 · CKA
Harleco
Chemistry · 13d
Cleared Sep 24, 1981
ULTRA ZYME PLUS GOT #64953, 65033 & 34
K812592 · CIT
Harleco
Chemistry · 13d
Cleared Sep 24, 1981
DELTA-A.V. FISTULA CANNULATION SET
K812621 · FIE
Amisco Trading Corp.
Gastroenterology & Urology · 9d
Cleared Sep 24, 1981
HEMODIALYSIS VENOUS & ARTERIAL SET
K812622 · FKH
Amisco Trading Corp.
Gastroenterology & Urology · 9d
Cleared Sep 23, 1981
CYBERLITH IX IMPLANTABLE PULSE GENERATOR
K801337 · DXY
Intermedics, Inc.
Cardiovascular · 476d
Cleared Sep 23, 1981
TELEMETRY DECODER
K801339 · DXY
Intermedics, Inc.
Cardiovascular · 476d
Cleared Sep 23, 1981
BLOOD FREEZING BAG
K810500 · KSR
Delmed, Inc.
Hematology · 211d
Cleared Sep 23, 1981
ALPHA PLASTIC PLASMA BOTTLE
K810897 · KSR
Alpha Therapeutic Corp.
Hematology · 173d
Cleared Sep 23, 1981
MODEL 535-01 TRACE-A-PACE EKG/TELEMETRY
K811464 · DXH
Intermedics, Inc.
Cardiovascular · 120d
Cleared Sep 23, 1981
CYTOMEGELISA TEST KIT
K812123
M.A. Bioproducts
Microbiology · 58d
Cleared Sep 23, 1981
EM-X
K812222 · KSG
Biological Corp. of America
Immunology · 47d
Cleared Sep 23, 1981
SKIN ADHESIVE-50XX
K812249 · KNX
Manfred Sauer Corp.
Gastroenterology & Urology · 43d
Cleared Sep 23, 1981
PREZA-PAK II, ARTERIAL BLOOD SAMPLING SY
K812338 · CBT
Terumo Medical Corp.
Anesthesiology · 36d
Cleared Sep 23, 1981
TITERTEK MICROPLATE INCUBATOR
K812340 · JTQ
Flow Laboratories, Inc.
Chemistry · 36d
Cleared Sep 23, 1981
BECKMAN R.PR CONTROL SERUM SET
K812425 · GMP
Beckman Instruments, Inc.
Hematology · 30d
Cleared Sep 23, 1981
CARTMILL/BARRY FEEDING TUBE
K812427 · KNT
Impra, Inc.
Gastroenterology & Urology · 29d
Cleared Sep 23, 1981
DALE COMBO TRACHEOSTOMY TUBE HOLDER
K812429 · EQH
Dale Medical Products, Inc.
Ear, Nose, Throat · 29d
Cleared Sep 23, 1981
FACTOR VIII DEFICIENT PLASMA #B8D
K812431 · GGP
Sigma Chemical Co.
Hematology · 29d
Cleared Sep 23, 1981
DIAGNOSTIC KITS & KIT COMPONENTS
K812434 · LHT
Diagnostica, Inc.
Microbiology · 29d
Cleared Sep 23, 1981
CAMPY THIOGLYCOLLATE (TUBE)
K812451 · JSD
Granite Diagnostics, Inc.
Chemistry · 26d
Cleared Sep 23, 1981
SCRIPPSYSTEM IMMUNOGLOBIN RID KIT
K812453 · DEW
Scripps-Miles, Inc.
Immunology · 26d