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
162985–163008 of 175,230
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Jul 15, 1981
DISPOSABLE TRACH T OXYGENATOR
K811890 · BZA
Airlife, Inc.
Anesthesiology · 14d
Cleared Jul 15, 1981
AMES TDA CARBAMAZEPINE TEST
K811952 · KLT
Miles Laboratories, Inc.
Toxicology · 8d
Cleared Jul 13, 1981
AXISONIC II
K810697 · HDR
Teknar, Inc.
Obstetrics & Gynecology · 119d
Cleared Jul 13, 1981
MILLIPORE DUAL RATE INTRAVENOUS CASSETTE
K811432 · LDR
Millipore Corp.
General Hospital · 52d
Cleared Jul 13, 1981
BACTAGARD
K811773 · FPB
Tri-Med, Inc.
General Hospital · 21d
Cleared Jul 13, 1981
ROSS-EMERSON PUMP, MODEL 55-R
K811779 · KQT
J. H. Emerson Co.
Gastroenterology & Urology · 20d
Cleared Jul 13, 1981
SEA MEDICAL PRODUCTS LO-VOL
K811847 · FPK
Sea Medical Products, Inc.
General Hospital · 12d
Cleared Jul 10, 1981
LIGHTNING DIALYZER
K810871 · DHY
Clintox Laboratories, Inc.
Immunology · 101d
Cleared Jul 10, 1981
MRI PROLACTIN RIA KIT
K810949 · CFT
Microanalytic Research, Inc.
Immunology · 94d
Cleared Jul 10, 1981
FIBRINOGEN CONTROL PLASMA
K811069 · KQJ
American Dade
Hematology · 81d
Cleared Jul 10, 1981
BUN RATE REAGENT
K811193 · CDS
Chem-Elec, Inc.
Chemistry · 71d
Cleared Jul 10, 1981
CT/T DATALINK-B7875 AA/B7875 AB
K811227 · JAK
General Electric Co.
Radiology · 67d
Cleared Jul 10, 1981
CASSETTE READER
K811253 · DSH
American Edwards Laboratories
Cardiovascular · 66d
Cleared Jul 10, 1981
PAPER CHART RECORDER
K811254 · DSF
American Edwards Laboratories
Cardiovascular · 66d
Cleared Jul 10, 1981
RAZEL MODEL C
K811272 · FRN
Razel Scientific Instruments, Inc.
General Hospital · 64d
Cleared Jul 10, 1981
SODIUM/POTASSIUM REAGENT KITS
K811310 · CEM
Chem-Elec, Inc.
Chemistry · 60d
Cleared Jul 10, 1981
INSIGHT
K811345 · GZJ
Staodynamics, Inc.
Neurology · 59d
Cleared Jul 10, 1981
PLAYTEX PROCESS MACHINERY CHANGE
K811386 · HIL
Playtex, Inc.
Obstetrics & Gynecology · 53d
Cleared Jul 10, 1981
HCG RADIOIMMUNOASSAY KIT (125I)
K811421 · JHI
Bd Becton Dickinson Vacutainer...
Chemistry · 51d
Cleared Jul 10, 1981
NOVATRACER RECORDER
K811453 · DSF
Novametrix Medical Systems, Inc.
Cardiovascular · 49d
Cleared Jul 10, 1981
EPILATOR, MULTIPLE NEEDLE-MODEL EM-20
K811501 · KCW
Rcx-Western, Inc.
General & Plastic Surgery · 44d
Cleared Jul 10, 1981
EPILATOR, BLEND-MODEL EB-200 & ET-1
K811503 · KCW
Rcx-Western, Inc.
General & Plastic Surgery · 44d
Cleared Jul 10, 1981
RADIATION BOLUS
K811528 · JAD
Action Products, Inc.
Radiology · 39d
Cleared Jul 10, 1981
MGN FEEDING TUBE
K811533 · KNT
Mgn Medical Manufacturing, Inc.
Gastroenterology & Urology · 39d