Search FDA 510(k) Clearance Records

Use this 510(k) search tool to find FDA medical device clearance records by K-number, device name, manufacturer, product code, or regulatory consultant. Explore individual submissions, review timelines, predicate device information, and links to official FDA records. Search the database for free, with no registration required.

176,583 clearances · 1976 to present · Updated monthly from FDA records · Free access · No registration required

Filters: Cleared only ×
176,076 results
169273–169296 of 176,076
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Sep 27, 1979
BJORK-SHILEY PULMONIC GRAFT VALVE
K791828 · DSY
Shiley, Inc.
Cardiovascular · 10d
Cleared Sep 27, 1979
CORALENT COAT 125I CORTISOL RADIOIMM.
K791835 · CGR
Radioassay Systems Laboratories, Inc.
Chemistry · 10d
Cleared Sep 26, 1979
WECK RACK (STERILIZING ACCESSORY TRAY)
K791743 · FSM
Edward Weck, Inc.
General & Plastic Surgery · 16d
Cleared Sep 26, 1979
EDWARDS PACEMAKER 30 UNIPOLAR GENERATOR
K791751 · DXY
Edwards Pacemaker Systems
Cardiovascular · 21d
Cleared Sep 26, 1979
AIR INCENTIVE SPIROMETER
K791819 · BWF
Airlife, Inc.
Anesthesiology · 12d
Cleared Sep 26, 1979
I.P.P.B. MANIFOLDS & NEB. SING. & DBL
K791820 · CAF
Airlife, Inc.
Anesthesiology · 12d
Cleared Sep 26, 1979
CORRUGATED FLEXIBLE POLYETHYLENE & EVA
K791821 · BYX
Airlife, Inc.
Anesthesiology · 12d
Cleared Sep 26, 1979
Y & ELBOW W/WO PORTS
K791856 · BZO
Airlife, Inc.
Anesthesiology · 7d
Cleared Sep 24, 1979
TEMP-GUARD TM
K790948 · FMT
Gordon Consultants, Inc.
General Hospital · 126d
Cleared Sep 24, 1979
THE GALASSIA SYSTEM
K791191
Ariel
General Hospital · 90d
Cleared Sep 24, 1979
ORTHO TSH RIA KIT
K791301 · JLW
Ortho Diagnostics, Inc.
Chemistry · 70d
Cleared Sep 24, 1979
ERIKA HPF 100
K791320 · FJI
Erika, Inc.
Gastroenterology & Urology · 74d
Cleared Sep 24, 1979
ERIKA HPF 200
K791321 · FJI
Erika, Inc.
Gastroenterology & Urology · 74d
Cleared Sep 24, 1979
ERIKA HPF 300
K791322 · FJI
Erika, Inc.
Gastroenterology & Urology · 74d
Cleared Sep 24, 1979
HERPES EIA TEST KIT
K791397 · GQM
Microbiological Assoc.
Microbiology · 59d
Cleared Sep 24, 1979
AGGLUTINOTEST-BRUCELLA
K791449 · GSO
Volu Sol Medical Industries
Microbiology · 49d
Cleared Sep 24, 1979
AGGLUTINOTEST-SALMONELLA
K791450 · GNC
Volu Sol Medical Industries
Microbiology · 49d
Cleared Sep 24, 1979
AGGLUTINOTEST-ECHINOCOCCOSIS
K791451 · GPF
Volu Sol Medical Industries
Microbiology · 49d
Cleared Sep 24, 1979
AGGLUTINOTEST-TUBERCULOSIS
K791452 · GRT
Volu Sol Medical Industries
Microbiology · 49d
Cleared Sep 24, 1979
AGGLUTINOTEST-STAPHYLOLISIN
K791453 · GTN
Volu Sol Medical Industries
Microbiology · 49d
Cleared Sep 24, 1979
AGGLUTINOTEST-PERTUSSIS
K791454 · GOX
Volu Sol Medical Industries
Microbiology · 49d
Cleared Sep 24, 1979
AGGLUTINOTEST-TOXOPLASMOSIS
K791456 · GMN
Volu Sol Medical Industries
Microbiology · 49d
Cleared Sep 24, 1979
AGGLUTINOTEST-SYPHILIS
K791457 · GMT
Volu Sol Medical Industries
Microbiology · 49d
Cleared Sep 24, 1979
AGGLUTINOTEST-LISTERIA
K791459 · GSH
Volu Sol Medical Industries
Microbiology · 49d