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: General Hospital ×
17,791 results
3985–4008 of 17,791
Search insights Median review: 89d Cleared: 100% Top manufacturer: Baxter Healthcare Corp Lead specialty: General Hospital
Cleared Jan 23, 2013
DURABLUE STERILIZATION WRAP
K123857 · FRG
Cardinal Health200, LLC
General Hospital · 40d
Cleared Jan 23, 2013
HEPAIRX VENTILATING AIR PURIFIER
K112728 · FRF
Air Innovations, Inc.
General Hospital · 491d
Cleared Jan 22, 2013
CATHETER CONNECTIONS' DARK BLUE DUALCAP FOR MALE LUERS
K123967 · QBP
Catheter Connections, Inc.
General Hospital · 27d
Cleared Jan 22, 2013
TBA
K121269 · FPA
Migada Plant
General Hospital · 271d
Cleared Jan 18, 2013
POWDER FREE NITRILE EXAMINATION GLOVES, BLUE AND BLACK
K123328 · LZA
Nitrilist Gloves Manufacturing Sdn Bhd
General Hospital · 88d
Cleared Jan 18, 2013
BD PEN NEEDLE
K123300 · FMI
Becton, Dickinson & CO
General Hospital · 87d
Cleared Jan 18, 2013
POWDER FREE BLUE NITRILE EXAMINATION GLOVE TESTED WITH CHEMOTHERAPY DRUGS
K121592 · LZA
Tekmedic (M) Sdn Bhd
General Hospital · 232d
Cleared Jan 17, 2013
BD NEXIVA DIFFUSICS CLOSED IV CATHETER SYSTEM
K123734 · FOZ
Becton Dickinson Infusion Therapy...
General Hospital · 43d
Cleared Jan 17, 2013
TEXTURED, NATURAL TO OFF-WHITE, LATEX, STERILE, POWDER FREE EXAMINATION...
K122788 · LYY
Northstar Healthcare Holdings
General Hospital · 128d
Cleared Jan 17, 2013
POWDER FREE NITRILE EXAMINATION GLOVES (BLACK, WHITE, GREEN)
K122408 · LZA
Hongye Plastic Products Co., Ltd.
General Hospital · 162d
Cleared Jan 10, 2013
INTERLINK SYSTEM BURETROL SOLUTION SETS, INTERLINK SYSTEM BURETROL SOLUTION...
K123874 · FPA
Baxter Healthcare Corp
General Hospital · 24d
Cleared Jan 09, 2013
BD PHASEAL CLOSED SYSTEM TRANSFER DEVICE
K123213 · ONB
Becton, Dickinson & CO
General Hospital · 86d
Cleared Jan 08, 2013
INTERLINK SYSTEM LEVER LOCK CANNULA WITH CHECK VALVE, SECONDARY MEDICATION...
K123868 · FPA
Baxter Healthcare Corp
General Hospital · 22d
Cleared Jan 04, 2013
OLYMPUS MAJ-172 INSTRUMENT TRAY FOR LTF VIDEOSCOPE
K122818 · KCT
Olympus Keymed (Medical & Industrial...
General Hospital · 112d
Cleared Jan 03, 2013
CG+ ARROW PICC POWERED BY ARROW VPS STYLET
K123759 · LJS
Arrow International, Inc. (Subsidiary...
General Hospital · 27d
Cleared Jan 03, 2013
PEARL DIABETES MANAGEMENT SYSTEM
K122483 · LZG
Asante Solutions, Inc.
General Hospital · 142d
Cleared Dec 28, 2012
NEO DELTA SELF SAFE T, NEO DELTA SELF SAFE T, NEO DELTA SELF SAFE 1, NEO...
K121007 · FOZ
Delta Med Srl
General Hospital · 269d
Cleared Dec 27, 2012
NON-STERILE, POWDER-FREE NITRILE EXAMINATION GLOVE, BLUE
K121549 · LZA
Siam Sempermed Corp., Ltd.
General Hospital · 216d
Cleared Dec 26, 2012
STERRAD CYCLESURE 24 BIOLOGICAL INDICATOR MODEL 14324
K123017 · FRC
Advanced Sterilization Products
General Hospital · 89d
Cleared Dec 21, 2012
VERSARATE FLOW RATE CONTROLER
K123729 · FPA
Emed Technologies Corporation
General Hospital · 16d
Cleared Dec 21, 2012
FACE MASK, SURGICAL MASK, PROCEDURE MASK, SURGICAL FACE MASK
K122717 · FXX
Tiger Medical Products, Ltd.
General Hospital · 107d
Cleared Dec 20, 2012
FUTURO (TM) TRAVEL KNEE-HIGHS
K123085 · DWL
3M Company
General Hospital · 80d
Cleared Dec 20, 2012
HM SURGICAL GOWN, NON REINFORCED HM SURGICAL GOWN, FABRIC REINFORCED HM...
K121998 · FYA
Changzhou Holymed Products Co., Ltd.
General Hospital · 164d
Cleared Dec 20, 2012
ENDOSCOPE REPROCESSOR OER-MINI
K120357 · FEB
Olympus Medical Systems Corp.
General Hospital · 318d