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
3433–3456 of 17,791
Search insights Median review: 89d Cleared: 100% Top manufacturer: Baxter Healthcare Corp Lead specialty: General Hospital
Cleared May 01, 2015
INVISIPORT
K141146 · LJT
Stealth Therapeutics, Incorporated
General Hospital · 361d
Cleared Apr 28, 2015
BD FlowSmart Set
K150059 · FPA
Becton, Dickinson Company
General Hospital · 105d
Cleared Apr 24, 2015
C3 Wave
K143238 · LJS
Medcomp ( Medical Components)
General Hospital · 163d
Cleared Apr 24, 2015
EndoTool SubQ
K142918 · NDC
Monarch Medical Technologies
General Hospital · 199d
Cleared Apr 23, 2015
Nitrile Powder Free Examination Glove with Colloidal Oatmeal USP Skin...
K150110 · LZA
Hartalega NGC Sdn. Bhd.
General Hospital · 93d
Cleared Apr 23, 2015
Nitrile Powder Free Examination Gloves (Orange) Tested For Use With...
K150103 · LZA
Hartalega Sdn Bhd
General Hospital · 93d
Cleared Apr 23, 2015
ConMed Mixing and Delivery Kit
K142535 · FMF
Conmed Corporation
General Hospital · 226d
Cleared Apr 16, 2015
Nitroglycerin Sets with DUO-VENT Spike
K150860 · FPA
Baxter Healthcare Corporation
General Hospital · 15d
Cleared Apr 15, 2015
InterActive Complete Surgical Tray
K142519 · KCT
Implant Direct Sybron Manufacturing, LLC
General Hospital · 219d
Cleared Apr 14, 2015
Revital-Ox RESERT Solution Test Strip
K143333 · JOJ
STERIS Corporation
General Hospital · 145d
Cleared Apr 14, 2015
HONGYU DISPOSABLE SURGICAL DRAPES
K141324 · KKX
Weihai Hongyu Nonwoven Fabric...
General Hospital · 329d
Cleared Apr 13, 2015
Lubricating Jelly
K142473 · KMJ
Sion Biotext Medical , Ltd.
General Hospital · 222d
Cleared Apr 10, 2015
ZM Powder Free Vinyl Patient Examination Gloves, Clear (non-colored)
K142911 · LYZ
Huailai ZM Plastic Products Co., Ltd.
General Hospital · 186d
Cleared Apr 10, 2015
Disposable sterile needle retractable safety syringe
K141349 · MEG
Guangdong Haiou Medical Apparatus...
General Hospital · 323d
Cleared Apr 09, 2015
BD INTIMA II CLOSED IV CATHETER
K143610 · FOZ
Becton Dickinson Infusion Therapy...
General Hospital · 111d
Cleared Apr 03, 2015
KIMGUARD ONE-STEP Sterilization Wrap
K143053 · FRG
Kimberly-Clark Health Care
General Hospital · 162d
Cleared Apr 03, 2015
STERRAD NX Sterilizer, STERRAD 100NX Sterilizer
K142454 · MLR
Advanced Sterilization Products
General Hospital · 213d
Cleared Apr 02, 2015
FLASHPAK STERILIZATION CONTAINER SYSTEM
K141826 · FRG
Symmetry Medical Inc- Manchester
General Hospital · 269d
Cleared Apr 01, 2015
K-Pack II Needle-21G x 2
K150263 · FMI
Terumo Europe N.V.
General Hospital · 56d
Cleared Mar 31, 2015
Xcela Power Injectable PICC
K150527 · LJS
Navilyst Medical, Inc.
General Hospital · 29d
Cleared Mar 27, 2015
WestTec Procedure Facemask
K141085 · FXX
Westtec, LLC
General Hospital · 333d
Cleared Mar 25, 2015
Powder-free Clear Vinyl Patient Examination Gloves
K142892 · LYZ
Shenyi (Shandong) Plastic Products...
General Hospital · 173d
Cleared Mar 24, 2015
Fluidshield* Surgical Mask with Expanded Chamber
K143287 · FXX
Halyard Health, Inc.
General Hospital · 127d
Cleared Mar 23, 2015
BIOGEL PS SURGICAL GLOVE SERIES, BIOGEL SKINSENSE SURGICAL GLOVE SERIES
K140477 · KGO
Molnlycke Health Care Us, LLC
General Hospital · 390d