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
163081–163104 of 176,076
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Oct 02, 1981
VASCULAB #R12B
K812608 · DSF
Medasonics, Inc.
Cardiovascular · 17d
Cleared Oct 02, 1981
VASCULAB #VSC21
K812609 · JOM
Medasonics, Inc.
Cardiovascular · 17d
Cleared Oct 02, 1981
QUANTICOAT NEONATAL 125 T4 RADIOIMMUNO
K812611 · CDP
Kallestad Laboratories, Inc.
Chemistry · 17d
Cleared Oct 02, 1981
VITROGEN TM 100
K812617 · KIT
Collagen Corp.
Chemistry · 17d
Cleared Oct 02, 1981
ASSURE NATURAL FIT TAMPON
K812618 · HIL
Personal Products Co.
Obstetrics & Gynecology · 17d
Cleared Oct 02, 1981
ANEMIA CONTROL
K812635 · JJY
Environmental Chemical Specialties
Chemistry · 17d
Cleared Oct 02, 1981
UNICUFF
K812639 · DXP
Frontier Products
Cardiovascular · 16d
Cleared Oct 02, 1981
URE SIL EMBOLECTOMY/THROMBECTOMY CATH
K812640 · DXE
Uresil Corp.
Cardiovascular · 16d
Cleared Oct 02, 1981
URIC ACID REAGENT-ENZYMATIC-COLOR-520 NM
K812641 · KNK
Reagents Applications, Inc.
Chemistry · 16d
Cleared Oct 02, 1981
EMIT AUTO CAROUSEL
K812647 · JQW
Syva Co.
Chemistry · 15d
Cleared Oct 02, 1981
ACA IMMUNOGLOBULIN G ANALYTICAL TEST
K812664 · DEW
E.I. Dupont DE Nemours & Co., Inc.
Immunology · 11d
Cleared Oct 02, 1981
THYROXINE (T4) 125I
K812666 · CDP
Pcl-Ria, Inc.
Chemistry · 11d
Cleared Oct 02, 1981
SEATTLE II TOTAL HIP SYSTEM
K812669 · JDG
Hexcel Medical
Orthopedic · 11d
Cleared Oct 02, 1981
SANDARE FAST 340 PHOSPHORUS PROCEDURE
K812670 · CED
Sandare Chemical Co., Inc.
Chemistry · 11d
Cleared Oct 02, 1981
EMBRITROL CK-MB CONTROLS
K812671 · JJT
Intl. Immunoassay Laboratories, Inc.
Chemistry · 11d
Cleared Oct 02, 1981
UNITEST-POTASSIUM
K812677 · CEJ
Biodynamics Corp.
Chemistry · 10d
Cleared Oct 02, 1981
BRIGHAM II TOTAL HIP SYSTEM
K812687 · JDG
Hexcel Medical
Orthopedic · 10d
Cleared Oct 02, 1981
QI 1150-1T INFUSION T
K812688 · FPA
Quinton, Inc.
General Hospital · 10d
Cleared Sep 29, 1981
INSUFFLATOR
K812200 · HIF
Reznik Instruments
Obstetrics & Gynecology · 56d
Cleared Sep 29, 1981
FIBER OPTIC LIGHT SOURCE
K812202 · HIH
Reznik Instruments
Obstetrics & Gynecology · 56d
Cleared Sep 29, 1981
DIALYSATE CONCENTRATE
K812330 · FKQ
Central Biological Co.
Gastroenterology & Urology · 42d
Cleared Sep 29, 1981
CLIRANS TE12 HOLLOW FIBER DIALYZER
K812498 · KOC
Terumo Medical Corp.
Gastroenterology & Urology · 29d
Cleared Sep 29, 1981
PLATELET AGITATOR
K812533 · KSQ
Helmer Labs, Inc.
Hematology · 27d
Cleared Sep 29, 1981
TISSUE-TEK III ACCU-CUT ROTARY MICROTOME
K812558 · IDO
Miles Laboratories, Inc.
Hematology · 21d