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
162241–162264 of 175,230
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
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
Cleared Sep 29, 1981
ULTRA CHEM E-GLU #64976 & 65040
K812595 · CFR
Harleco
Chemistry · 18d
Cleared Sep 29, 1981
ULTRA ZYME PLUS ALP #64962, 65029 & 30
K812596 · CJE
Harleco
Chemistry · 18d
Cleared Sep 29, 1981
RABBIT COAGULASE PLASMA
K812602 · JTL
Dutchland Laboratories, Inc.
Microbiology · 14d
Cleared Sep 29, 1981
ACA PLASMINOGEN TEST PACK
K812625 · DDX
E.I. Dupont DE Nemours & Co., Inc.
Immunology · 14d
Cleared Sep 29, 1981
ACA IMMUNOGLOBULIN G CALIBRATOR
K812630 · DEW
E.I. Dupont DE Nemours & Co., Inc.
Immunology · 14d
Cleared Sep 29, 1981
ACA IMMUNOGLOBIN A TEST PACK
K812631 · CZP
E.I. Dupont DE Nemours & Co., Inc.
Immunology · 14d