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
168433–168456 of 175,230
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
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
Cleared Sep 24, 1979
HYPERDERMIC NEEDLE WITH SENSOR #514
K791462 · FMI
Medtech Intl., Inc.
General Hospital · 70d
Cleared Sep 24, 1979
ANTI-NUCLEAR ANTIBODY TEST
K791493 · DHN
Meloy Laboratories, Inc.
Immunology · 53d
Cleared Sep 24, 1979
LUKENS BONE WAX (GAMMA RADIATION)
K791495 · MTJ
Lukens Corp.
General & Plastic Surgery · 52d
Cleared Sep 24, 1979
GOAT ANTI-HUMAN C-REACTIVE PROTEIN
K791560 · DCK
Protos Laboratories
Immunology · 38d
Cleared Sep 24, 1979
TOXOPLASMA ANTIBODY TEST SYSTEM
K791571 · GLZ
Zeus Scientific, Inc.
Microbiology · 42d
Cleared Sep 24, 1979
BETA-CELL
K791607 · JSG
Biologics Intl., Inc.
Chemistry · 41d