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
170233–170256 of 175,230
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Dec 04, 1978
CHOLESTEROL STANDARDS
K781853 · JIS
Bd Becton Dickinson Vacutainer...
Chemistry · 28d
Cleared Dec 04, 1978
PAD, B-D I.V. CATH.
K781854 · KGZ
Bd Becton Dickinson Vacutainer...
General & Plastic Surgery · 28d
Cleared Dec 04, 1978
REAGENT SYSTEM, NO 46-OV FOR CPK
K781859 · CGS
Sigma Chemical Co.
Chemistry · 28d
Cleared Dec 04, 1978
ASSAY, CHROMOGENIC ANTITHROMBIN III
K781860 · JBQ
Ortho Diagnostics, Inc.
Chemistry · 28d
Cleared Dec 04, 1978
IRON BINDING CAPICITY MODEL 0370
K781865 · JIY
Stanbio Laboratory
Chemistry · 28d
Cleared Dec 04, 1978
ASSAY KIT, THROMBO-SCREEN
K781880 · GIS
Pacific Hemostasis
Hematology · 28d
Cleared Dec 04, 1978
DILUTER, LSA 290 PIPETTER
K781883 · JQW
Kallestad Laboratories, Inc.
Chemistry · 27d
Cleared Dec 04, 1978
CHAMBER, MC-1 DISPOSABLE PRESSURE
K781890 · DXS
Delta Medical Industries
Cardiovascular · 28d
Cleared Dec 04, 1978
LOCATOR, FOREIGN BODY
K781892 · HPM
Keeler Optical Products , Ltd.
Ophthalmic · 26d
Cleared Dec 04, 1978
INSUFFALATOR LAPARAOSCOPIC
K781913 · HIF
Kli
Obstetrics & Gynecology · 20d
Cleared Dec 04, 1978
MUCUS ASPIRATOR
K781917 · FMF
Ovutime, Inc.
General Hospital · 21d
Cleared Dec 04, 1978
PLAQUE DETECTION SYSTEM
K781919 · NYH
Clairol, Inc.
Dental · 21d
Cleared Dec 04, 1978
VALVE, VENT-AWAY TWO-WAY
K781920 · CBP
Chesebrough-Pond'S U.S.A. Co.
Anesthesiology · 21d
Cleared Dec 04, 1978
DISPENSOR, XENON GAS
K781933 · IYT
Diagnostic Isotapes, Inc.
Radiology · 14d
Cleared Dec 04, 1978
PROCESSOR, MODEL M8
K781934 · IXW
Eastman Kodak Company
Radiology · 14d
Cleared Dec 04, 1978
SCANNER-EMI 7020 AND 7020R
K781936 · JAK
Emi Medical, Inc.
Radiology · 14d
Cleared Dec 04, 1978
MINIWASH
K781942 · JTC
Dynatech Laboratories, Inc.
Chemistry · 17d
Cleared Dec 04, 1978
TENDON ROD MODEL OR41PO3-6
K781943 · HXA
Holter-Hausner Intl.
Orthopedic · 17d
Cleared Dec 04, 1978
STROLLER, THERAPY
K781947 · LBE
Convaid Products, Inc.
Physical Medicine · 13d
Cleared Dec 04, 1978
GUN, CEMENT
K781955 · KIH
Depuy, Inc.
Orthopedic · 13d
Cleared Dec 04, 1978
MOBILE CARRIER
K781975 · IZL
General X-Ray, Inc.
Radiology · 7d
Cleared Dec 04, 1978
MOBILE X-RAY UNIT
K781976 · IZL
General X-Ray, Inc.
Radiology · 7d
Cleared Dec 04, 1978
INCLINOMETER, VERMONT
K781982 · IZL
Associates IN Radiology, Inc.
Radiology · 7d
Cleared Dec 04, 1978
EXPLORAMAT, COSMIC 2
K781983 · KPR
Siemens Corp.
Radiology · 10d