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.

175,450 clearances · 1976 to present · Updated monthly from FDA records

Filters: Cleared only ×
174,955 results
73489–73512 of 174,955
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Oct 25, 2002
RINGLOC CONSTRAINED LINERS II
K021728 · KWZ
Biomet, Inc.
Orthopedic · 154d
Cleared Oct 25, 2002
GALEMED NEB-EASY NEBULIZER
K021742 · CAF
Galemed Corp.
Anesthesiology · 150d
Cleared Oct 25, 2002
DFV CPG COLPOSCOPE
K021854 · HEX
D.F. Vasconcellos S.A.
Obstetrics & Gynecology · 141d
Cleared Oct 25, 2002
FIBRON-1, FIBRON-4, QUIKCOAG, FIBRON
K021976 · KQG
Vital Scientific N.V.
Hematology · 130d
Cleared Oct 25, 2002
HORIZONS REUSABLE HOT BIOPSY FORCEPS
K022243 · KGE
Horizons Intl. Corp.
Gastroenterology & Urology · 105d
Cleared Oct 25, 2002
HORIZONS REUSABLE POLYPECTOMY SNARES
K022268 · FDI
Horizons Intl. Corp.
Gastroenterology & Urology · 102d
Cleared Oct 25, 2002
NICHOLS ADVANTAGE CHEMILUMINESCENCE HELICOBACTOR PYLORI IGG ANTIBODIES...
K022356 · LYR
Nichols Institute Diagnostics
Microbiology · 98d
Cleared Oct 25, 2002
SUMMIT MEDICAL LTD TRANSFUSION FILTER, MODEL LF400 & SUMMIT MEDICAL LTD...
K022477 · CAK
Summit Medical , Ltd.
General Hospital · 88d
Cleared Oct 25, 2002
COOK INJECTION NEEDLE
K022484 · FBK
Cook Urological, Inc.
Gastroenterology & Urology · 88d
Cleared Oct 25, 2002
UTERINE INJECTOR
K022503 · LKF
Thomas Medical, Inc.
Obstetrics & Gynecology · 88d
Cleared Oct 25, 2002
MEDCOMP VASCU-SHEATH INTRODUCER SET
K022513 · DYB
Medcomp
Cardiovascular · 87d
Cleared Oct 25, 2002
POWDER FREE ELASTIC VINYL EXAMINATION GLOVES
K022604 · LYZ
Sun Flower Gloves Co., Ltd.
General Hospital · 80d
Cleared Oct 25, 2002
HELIX HYDRO-JET
K022613 · FQH
Erbe USA, Inc.
General Hospital · 80d
Cleared Oct 25, 2002
SPSMEDICAL SPORVIEW STEAM BI TEST PACK
K022706 · FRC
Spsmedical Supply Corp.
General Hospital · 72d
Cleared Oct 25, 2002
REAL TIME HDR (220V), MODEL 132.001
K022739 · JAQ
Nucletron Corporation
Radiology · 67d
Cleared Oct 25, 2002
PHILIPS HARMONY RELEASE 1
K022788 · LLZ
Philips Medical Systems North America...
Radiology · 64d
Cleared Oct 25, 2002
VIZDEXTER VERSION 2.0
K022938 · LLZ
Volume Interactions Pte, Ltd.
Radiology · 51d
Cleared Oct 25, 2002
CLEARFIL AP-X PLT
K023002 · EBF
Kuraray Medical, Inc.
Dental · 46d
Cleared Oct 25, 2002
MODIFICATION TO SMART CONTROL NITINOL STENT TRANSHEPATIC BILIARY SYSTEM
K023217 · FGE
Cordis Corp.
Gastroenterology & Urology · 29d
Cleared Oct 25, 2002
VARISOURCE BREAST TEMPLATE SYSTEM
K023220 · JAQ
Varian Medical Systems
Radiology · 28d
Cleared Oct 25, 2002
INFUSION CATHETER EXTENSION SET
K023224 · KDI
Chf Solutions, Inc.
Gastroenterology & Urology · 28d
Cleared Oct 25, 2002
ECHELON POROUS PLUS HA HIP STEMS
K023302 · MEH
Smith & Nephew, Inc.
Orthopedic · 22d
Cleared Oct 25, 2002
LEFORTE SYSTEM BONE PLATE
K023360 · KTW
Jeil Medical Corporation
Orthopedic · 18d
Cleared Oct 25, 2002
MODIFICATION TO ESOP CO-CR FEMORAL HEADS
K023375 · LPH
Pro-Active Healthcare
Orthopedic · 17d