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.

175,450 clearances · 1976 to present · Updated monthly from FDA records

Filters: Cleared only ×
174,955 results
104209–104232 of 174,955
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Feb 22, 1995
ABUSIGN(TM) THC, DOA-THC, ACCUSIGN(TM) THC, DOA-THC, DIOSIGN(TM) THC, DOA-THC
K945550 · LDJ
Princeton BioMeditech Corp.
Toxicology · 100d
Cleared Feb 22, 1995
ABUSIGN(TM) COC, DOA-COC, ACCUSIGN(TM) COC, DOA-COC, DIOSIGN(TM) COC, DOA-COC
K945609 · DIO
Princeton BioMeditech Corp.
Toxicology · 99d
Cleared Feb 22, 1995
VAPOFIL
K945993 · CAD
Southmedic, Inc.
Anesthesiology · 96d
Cleared Feb 22, 1995
TOTAL CHOLESTEROL AND HDL CHOLESTEROL PANEL
K946063 · CHH
Cholestech Corp.
Chemistry · 99d
Cleared Feb 22, 1995
TOTAL CHOLESTEROL CASSETTE
K946064 · CHH
Cholestech Corp.
Chemistry · 99d
Cleared Feb 22, 1995
TOTAL CHOLESTEROLM HDL CHOLESTEROL AND TRIGLYCERIDES PANEL
K946065 · CHH
Cholestech Corp.
Chemistry · 99d
Cleared Feb 22, 1995
TOTAL CHOLESTEROL, HDL CHOLESTEROL AND GLUCOSE PANEL
K946066 · CHH
Cholestech Corp.
Chemistry · 99d
Cleared Feb 22, 1995
TOTAL CHOLESTEROL, HDL CHOLESTEROL, TRIGLYCERIDES AND GLUCOSE PANEL
K946067 · CHH
Cholestech Corp.
Chemistry · 99d
Cleared Feb 22, 1995
HEMAGEN ENA SS-B KIT (EIA METHOD)
K946120 · LLL
Hemagen Diagnostics, Inc.
Immunology · 69d
Cleared Feb 22, 1995
HEMAGEN ENA SS-A KIT (EIA METHOD)
K946121 · LLL
Hemagen Diagnostics, Inc.
Immunology · 69d
Cleared Feb 22, 1995
HEMAGEN ENA SCL-70 KIT (EIA METHOD)
K946122 · LLL
Hemagen Diagnostics, Inc.
Immunology · 69d
Cleared Feb 22, 1995
HEMAGEN ENA SM KIT (EIA METHOD)
K946123 · LLL
Hemagen Diagnostics, Inc.
Immunology · 69d
Cleared Feb 22, 1995
HEMAGEN ENA JO-1 KIT (EIA METHOD)
K946124 · LLL
Hemagen Diagnostics, Inc.
Immunology · 69d
Cleared Feb 22, 1995
DIGOXIN FLEX(TM) REAGENT CARTRIDGE
K946153 · KXT
E.I. Dupont DE Nemours & Co., Inc.
Toxicology · 68d
Cleared Feb 22, 1995
RADIAS TOTAL T4 ENZYME IMMUNOASSAY
K946163 · KLI
Bio-Rad
Chemistry · 65d
Cleared Feb 22, 1995
CLINITEK ATLAS AUTOMATED URINE CHEMISTRY ANALYZER
K946183 · KQO
Heraeus Kulzer, Inc.
Chemistry · 64d
Cleared Feb 22, 1995
SUNGLASSES
K946381 · HQY
Ialin Optical Mfg., (H.K.) Co. , Ltd.
Ophthalmic · 118d
Cleared Feb 22, 1995
DRUGS OF ABUSE CONTROLS
K950138 · DIF
E.I. Dupont DE Nemours & Co., Inc.
Toxicology · 40d
Cleared Feb 22, 1995
DRUGS OF ABUSE CALIBRATOR
K950139 · DKB
E.I. Dupont DE Nemours & Co., Inc.
Toxicology · 40d
Cleared Feb 22, 1995
OLYMPUS KD-6G1-9Q WIRE GUIDED PAPILLOTOMU KNIFE
K950166 · KNS
Olympus America, Inc.
Gastroenterology & Urology · 36d
Cleared Feb 22, 1995
DSL ACTIVE IGFBP-3 IRMA (DSL 6600)
K950228 · CFL
Diagnostic Systems Laboratories, Inc.
Chemistry · 42d
Cleared Feb 22, 1995
RNA MEDICAL'S EQUIL PLUS WITH GLUCOSE CONTROL
K950399 · JJY
Bionostics, Inc.
Chemistry · 21d
Cleared Feb 21, 1995
OXYCARE(TM) OXYGEN CONTROLLER/MONITOR
K924679 · KLK
Air-Shields Vickers, Inc.
Anesthesiology · 888d
Cleared Feb 21, 1995
INTRODUCER NEEDLE (SEVERAL SIZES)
K933522 · DYB
Mediziv Medical Products 1987 , Ltd.
Cardiovascular · 581d