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
172345–172368 of 175,230
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Nov 02, 1977
FEVER TESTER
K771980 · KPD
American Thermometer Company, Inc.
General Hospital · 16d
Cleared Nov 02, 1977
888 ARTERIAL/VENOUS CATHETER INTRODUCER
K771982 · DYB
Usci, Div. C.R. Bard, Inc.
Cardiovascular · 15d
Cleared Nov 02, 1977
FILTER SAMPLER BLOOD SERUM FILTER
K771985 · GIM
Clasrock
Hematology · 14d
Cleared Nov 02, 1977
MICROPULSE 26U PULSE GENERATOR
K771987 · DXY
Edwards Pacemaker Systems
Cardiovascular · 14d
Cleared Nov 02, 1977
L-501 CARDIAC PACEMAKER
K771992 · DXY
Coratomic, Inc.
Cardiovascular · 12d
Cleared Nov 02, 1977
AFT SYSTEM
K771993 · DBM
Calbiochem
Immunology · 12d
Cleared Nov 02, 1977
ELECTROTHERM MODEL HT-1
K771994 · FLL
Electromedics, Inc.
Chemistry · 12d
Cleared Nov 02, 1977
SARNES HELP
K772001 · DTQ
3M Health Care, Sarns
Cardiovascular · 12d
Cleared Nov 02, 1977
PLATES FOR HUMAN C4 COMPLEMENT
K772002 · DBI
G.D. Searle and Co.
Immunology · 12d
Cleared Nov 02, 1977
AMES T-4 STRIP TEST
K772014 · CDX
Miles Laboratories, Inc.
Immunology · 8d
Cleared Nov 02, 1977
CLOTH ADHESIVE TAPE
K772020 · FPX
Johnson & Johnson Professionals, Inc.
General & Plastic Surgery · 7d
Cleared Nov 02, 1977
TRC STAINLESS STEEL SAFETY SPRING GUIDES
K772021 · DQX
Usci, Div. C.R. Bard, Inc.
Radiology · 7d
Cleared Oct 28, 1977
SURGICAL INSTRUMENT PROTECTOR
K771123 · KCT
Devon Industries, Inc.
General Hospital · 128d
Cleared Oct 28, 1977
INSTRUMENT TRAY PAD
K771124 · KCT
Devon Industries, Inc.
General Hospital · 128d
Cleared Oct 28, 1977
UREAPLASMA DIFFERENTIAL BASAL AGAR MED.
K771686 · JSH
Gibco Laboratories Life Technologies,...
Microbiology · 52d
Cleared Oct 28, 1977
ACA BILIRUBIN CALIBRATOR
K771798 · JJX
E.I. Dupont DE Nemours & Co., Inc.
Chemistry · 35d
Cleared Oct 28, 1977
PHOSPHORUS TEST KIT
K771848 · CEO
Mallinckrodt Critical Care
Chemistry · 30d
Cleared Oct 28, 1977
ARGYLE PEOCUSSOR SYSTEM
K771876 · BYI
Sherwood Medical Industries
Anesthesiology · 24d
Cleared Oct 28, 1977
HUMAN O BUFFER
K771956 · GOK
Flow Laboratories, Inc.
Microbiology · 11d
Cleared Oct 28, 1977
RUBELLA HEMAGGLUTINATION REAGENT KIT
K771957 · GOK
Flow Laboratories, Inc.
Microbiology · 11d
Cleared Oct 28, 1977
WHIRLPOOL BATH MODEL 2274
K771965 · ILJ
Dozey Products Co.
Physical Medicine · 11d
Cleared Oct 28, 1977
WHIRLPOOL BATH MODEL 2270
K771967 · ILJ
Dazey Products Co.
Physical Medicine · 11d
Cleared Oct 28, 1977
WHIRLPOOL BATH MODEL 2273
K771968 · ILJ
Dazey Products Co.
Physical Medicine · 11d
Cleared Oct 28, 1977
ARTERIAL BLOOD SAMPLING TRAY
K771975 · CBT
Respiratory Care, Inc.
Anesthesiology · 11d