FDA 510(k) Searchable Database - Search 175,000+ Clearances

Search 175,000+ FDA 510(k) clearances by K-number, device name, manufacturer or product code. Includes real review time data, denied submission rates and regulatory intelligence not available on any other searchable 510(k) database.

175,972 clearances · 1976 to present · Updated monthly from FDA records

Filters: Cleared only ×
175,468 results
73993–74016 of 175,468
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Oct 25, 2002
DORNIER DIODE LASER FAMILY MEDILAS D, MEDILAS D SKINPULSE & MEDILAS D...
K020339 · GEX
Dornier Medtech America, Inc.
General & Plastic Surgery · 266d
Cleared Oct 25, 2002
DR. JAPAN FACIL POINT SPINAL NEEDLE
K020934 · BSP
Myco Medical, Inc.
Anesthesiology · 217d
Cleared Oct 25, 2002
SENSUA!
K021125 · HIS
Aac Consulting Group, Inc.
Obstetrics & Gynecology · 200d
Cleared Oct 25, 2002
CONDOMI NATURE, CONDOMI STIMULATION, CONDOMI VANILLA GOLD, CONDOMI SUPERSAFE,...
K021186 · HIS
Condomi Erfert...
Obstetrics & Gynecology · 193d
Cleared Oct 25, 2002
PT-S TEST STRIPS FOR THE COAGUCHEK SYSTEM, MODEL# 2032422
K021190 · GJS
Roche Diagnostics Corp.
Hematology · 193d
Cleared Oct 25, 2002
VECTORVISION CT-FREE KNEE
K021306 · HAW
Brainlab AG
Neurology · 184d
Cleared Oct 25, 2002
INCOMPASS SPINAL FIXATION SYSTEM
K021564 · KWQ
Spinal Concepts, Inc.
Orthopedic · 165d
Cleared Oct 25, 2002
BOSTON SCIENTIFIC EXPRESS BILIARY LD PREMOUNTED STENT SYSTEM
K021630 · FGE
Boston Scientific Corp
Gastroenterology & Urology · 161d
Cleared Oct 25, 2002
RINGLOC CONSTRAINED LINERS
K021661 · KWZ
Biomet Orthopedics, Inc.
Orthopedic · 158d
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