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
162769–162792 of 176,076
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Nov 10, 1981
MULTI CLOT-#819
K812122 · JPA
Volu Sol Medical Industries
Hematology · 106d
Cleared Nov 10, 1981
BACTEC RESIN CULTURE MED. 16A
K812315 · MDB
Bd Becton Dickinson Vacutainer...
Microbiology · 85d
Cleared Nov 10, 1981
LINUS
K812398 · IYO
Fischer Imaging Corp.
Radiology · 82d
Cleared Nov 10, 1981
IMMUNO-CELL IMMUNO-SEP KIT
K812411 · JCF
Kallestad Laboratories, Inc.
Hematology · 81d
Cleared Nov 10, 1981
UNIVERSAL SUTURE PASSER
K812566 · GDL
Ortho Pared Instruments, Inc.
General & Plastic Surgery · 62d
Cleared Nov 10, 1981
RELIEF
K812567 · LKX
American Pharmaceutical Co., Inc.
Gastroenterology & Urology · 62d
Cleared Nov 10, 1981
KT-1000 DEVICE
K812806 · LYH
Medmetric Corp.
Neurology · 35d
Cleared Nov 10, 1981
NEUTRAL DUFFERED FORMA-SCENT
K812817 · IFP
Meridian Diagnostics, Inc.
Pathology · 34d
Cleared Nov 10, 1981
CHANG MEDIUM
K812820 · KIT
Hana Biologics, Inc.
Pathology · 34d
Cleared Nov 10, 1981
QUANTUMATIC DUAL-WAVELENGTH SPECTRO
K812865 · JJQ
Abbott Laboratories
Chemistry · 28d
Cleared Nov 10, 1981
SYRINGE, PISTON
K812888 · FMF
Frisco Products, Inc.
General Hospital · 26d
Cleared Nov 10, 1981
ACUPRESS VIBRATOR
K812902 · IRO
Eicona Corp.
Physical Medicine · 25d
Cleared Nov 10, 1981
DSD
K812983 · JQW
Pm America, Inc.
Chemistry · 15d
Cleared Nov 10, 1981
MOXALACTOM 30MCG ANTIMICROBIAL SUS. DISK
K812993 · JTN
General Diagnostics
Microbiology · 15d
Cleared Nov 10, 1981
PROTECT-O-SEAL
K813014 · JOJ
Tri-Med, Inc.
General Hospital · 14d
Cleared Nov 10, 1981
STANDING FRAME
K813025
Barnett Medical
Physical Medicine · 13d
Cleared Nov 10, 1981
ULTRACHEM TP, ITEM #64974
K813038 · CEK
Harleco
Chemistry · 13d
Cleared Nov 10, 1981
ULTRACHEM E-CHOL, ITEM #65025
K813039 · CHH
Harleco
Chemistry · 13d
Cleared Nov 10, 1981
ULTRACHEM CA, ITEM #64975
K813040 · CJY
Harleco
Chemistry · 13d
Cleared Nov 10, 1981
ULTRAZYME-GT, ITEM #64959 & 65032
K813041 · JQB
Harleco
Chemistry · 13d
Cleared Nov 10, 1981
ULTRACHEM GLUC-DH SET, ITEM #65048
K813042 · LFR
Harleco
Chemistry · 13d
Cleared Nov 10, 1981
ULTRACHEM CREA ITEM #64972
K813043 · CGX
Harleco
Chemistry · 13d
Cleared Nov 10, 1981
ULTRACHEM ALB, ITEM #64970
K813044 · CIX
Harleco
Chemistry · 13d
Cleared Nov 10, 1981
E2508 DISPOSABLE HANDSWITCHING PENCIL
K813071 · GEI
Valleylab, Inc.
General & Plastic Surgery · 8d