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
164809–164832 of 175,230
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Dec 30, 1980
LARGE WOUND DRESSING KIT
K803119 · KDD
American Medical Disposable, Inc.
General & Plastic Surgery · 20d
Cleared Dec 30, 1980
MENTOR 150 TRANSCUTANEOUS NERVE STIMULA
K803121 · GZJ
George H. Frisch
Neurology · 19d
Cleared Dec 30, 1980
ECG & ULTRASOUND GELS, CREAMS & LOTION
K803151 · GYB
Abco Dealers, Inc.
Neurology · 18d
Cleared Dec 30, 1980
CONPHAR PERCUSSION HAMMER(BUCK TYPE)
K803174 · GWZ
Conphar, Inc.
Neurology · 15d
Cleared Dec 23, 1980
CUSTOM DRESSING TRAY WET TO DRY
K803117 · KDD
American Medical Disposable, Inc.
General & Plastic Surgery · 13d
Cleared Dec 22, 1980
BELLCO SINGLE NEEDLE DOUBLE HEAD PUMP
K802230 · FIF
Cardio Med Supplies, Inc.
Gastroenterology & Urology · 97d
Cleared Dec 22, 1980
INTRAJECT
K802332 · KYG
General Medical Engineering Corp.
Ophthalmic · 90d
Cleared Dec 22, 1980
MICRO THIN-DII, #0521
K802352 · DXY
Cardiac Pacemakers, Inc.
Cardiovascular · 88d
Cleared Dec 22, 1980
MICRO THIN-PII, #0523
K802353 · DXY
Cardiac Pacemakers, Inc.
Cardiovascular · 88d
Cleared Dec 22, 1980
GAMBRO LUNDIA PLATE DISP. DIALYZER
K802389 · FJG
Gambro, Inc.
Gastroenterology & Urology · 84d
Cleared Dec 22, 1980
KERATOPLASTY SUTURING LENS
K802593 · HPX
Paris Contact Lens Laboratory
Ophthalmic · 62d
Cleared Dec 22, 1980
EMERG. OXYGEN KIT #65350 & #65399 CASE
K802644 · CAN
B & F Medical Products, Inc.
Anesthesiology · 59d
Cleared Dec 22, 1980
PRO-OPHTA STICKS
K802794 · HOZ
Secol Co.
Ophthalmic · 48d
Cleared Dec 22, 1980
CORNING NORMAL GLYCOSYLATED HEMOGLOBIN
K802884 · JBD
Corning Medical & Scientific
Hematology · 35d
Cleared Dec 22, 1980
COBE CENTRY 2 VARIABLE CONCENTRATE-18-
K802895 · KDC
Cobe Laboratories, Inc.
General & Plastic Surgery · 35d
Cleared Dec 22, 1980
PLASTIC FRACTURE CAST BRACE KNEE JOINT
K802910 · IQI
Orthomedics
Physical Medicine · 35d
Cleared Dec 22, 1980
HELENA AT-III QUIPLATE PROCEDURE
K802912 · JBQ
Helena Laboratories
Hematology · 34d
Cleared Dec 22, 1980
QUANTIMUNE E3 RIA
K802944 · CGI
Bio-Rad
Toxicology · 33d
Cleared Dec 22, 1980
MYCOLOGY CULTURE SYSTEM
K802946 · JSJ
Orion Diagnostica, Inc.
Microbiology · 33d
Cleared Dec 22, 1980
ORICULT DTM
K802947 · JSI
Orion Diagnostica, Inc.
Microbiology · 33d
Cleared Dec 22, 1980
GAMBRO A-V FISTULA NEEDLE SET
K802956 · FIE
Gambro, Inc.
Gastroenterology & Urology · 32d
Cleared Dec 22, 1980
MUELLER HINTON BROTH
K802957 · JTZ
Gibco Laboratories Life Technologies,...
Microbiology · 35d
Cleared Dec 22, 1980
CHEM-ASSAY STANDARD-CONTROLS
K802962 · JJY
National Bio-Technical Laboratories
Chemistry · 31d
Cleared Dec 22, 1980
UNIPOLAR ENDOCARDIAL LASER DRILLED ELEC
K802968 · DTB
Telectronics, Inc.
Cardiovascular · 31d