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
158881–158904 of 175,230
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Sep 30, 1982
FERMCOTEST CO2 REAGNET
K822117 · JFL
Fermco Biochemics, Inc.
Chemistry · 73d
Cleared Sep 30, 1982
FERMCOTEST CREATININE TEST REAGENT
K822118 · CGX
Fermco Biochemics, Inc.
Chemistry · 73d
Cleared Sep 30, 1982
ACA URINARY PROTEIN ANALYTICAL TEST PACK
K822231 · JGQ
E.I. Dupont DE Nemours & Co., Inc.
Chemistry · 65d
Cleared Sep 30, 1982
DSL 1400
K822314 · CGI
Diagnostic Systems Laboratories, Inc.
Chemistry · 58d
Cleared Sep 30, 1982
BOSTON SOLUTION INFUSION SETS
K822406 · FPA
The Boston Medical Group
General Hospital · 51d
Cleared Sep 30, 1982
BOSTON SCALP VEIN INFUSION SETS
K822407 · FPA
The Boston Medical Group
General Hospital · 51d
Cleared Sep 30, 1982
BOSTON INFUSION SETS
K822408 · FPA
The Boston Medical Group
General Hospital · 51d
Cleared Sep 30, 1982
BOSTON BLOOD TRANSFUSION SETS
K822409 · BRZ
The Boston Medical Group
General Hospital · 51d
Cleared Sep 30, 1982
BOSTON BLOOD DONOR SETS
K822410 · BRZ
The Boston Medical Group
General Hospital · 51d
Cleared Sep 30, 1982
ANTISERA TO HUMAN FERRITIN
K822472 · DBF
Kent Laboratories, Inc.
Microbiology · 44d
Cleared Sep 30, 1982
INFECTION CONTROL TOWEL
K822484 · LDQ
American Threshold Industries, Inc.
General & Plastic Surgery · 44d
Cleared Sep 30, 1982
LE CASE HARD CONTACT LENS STORAGE CASE
K822495 · HPX
Optikem International, Inc.
Ophthalmic · 43d
Cleared Sep 30, 1982
OBSTETRICAL KIT
K822505 · HHD
Parr Emergency Product Sales, Inc.
Obstetrics & Gynecology · 43d
Cleared Sep 30, 1982
AUTOMATED BLOOD CELL SEPARATOR
K822521 · GKT
Cryosan, Inc.
Hematology · 38d
Cleared Sep 30, 1982
ANAEROBE PEA PLATE
K822527 · JSJ
Granite Diagnostics, Inc.
Microbiology · 38d
Cleared Sep 30, 1982
CIDEX*DIALYZER DISINFECTING SOLUTION
K822535 · FKQ
Surgikos, Inc.
Chemistry · 37d
Cleared Sep 30, 1982
LEECO T3% DIAGNOSTIC KIT
K822575 · KHQ
Leeco Diagnostics, Inc.
Chemistry · 36d
Cleared Sep 30, 1982
BOSCH STAR 66F-SP HEARING AID
K822579 · ESD
Bosch Hearing Instruments, Inc.
Ear, Nose, Throat · 36d
Cleared Sep 30, 1982
AUTO PERIOMETER 3000
K822580 · HPT
Dicon, Inc.
Ophthalmic · 36d
Cleared Sep 30, 1982
FIXATION MONITOR
K822601 · HPT
West Coast Optical Instruments, Inc.
Ophthalmic · 34d
Cleared Sep 30, 1982
T3 UPTAKE KITS
K822612 · KHQ
Pcl-Ria, Inc.
Chemistry · 31d
Cleared Sep 30, 1982
QUANTAPHOS ACID PHOSPHATOSE CONT. SERUM
K822646 · JJT
Beckman Instruments, Inc.
Chemistry · 28d
Cleared Sep 30, 1982
SUPER DONUT
K822650 · KME
Alimed, Inc.
General Hospital · 28d
Cleared Sep 30, 1982
YEAST ASSIMILATION BROTH
K822694 · JSF
Granite Diagnostics, Inc.
Microbiology · 23d