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
3913–3936 of 17,791
Search insights Median review: 89d Cleared: 100% Top manufacturer: Baxter Healthcare Corp Lead specialty: General Hospital
Cleared May 15, 2013
3F PRO-PICC
K123617 · LJS
Medical Components, Inc.
General Hospital · 173d
Cleared May 13, 2013
FINESSIS POLYISOPRENE POWDERFREE SURGICAL GLOVES
K123629 · KGO
Lucenxia Prescience AG
General Hospital · 171d
Cleared May 09, 2013
NMI PICC MAXIMAL BARRIER NURSING KITS
K131038 · LJS
Navilyst Medical, Inc.
General Hospital · 24d
Cleared May 09, 2013
UNITOX BOTOX SYRINGE
K123710 · FMF
Bio-Med USA, Inc.
General Hospital · 156d
Cleared May 09, 2013
SAKURA STEAM STERILIZAER MODEL ASSV-AH06
K122774 · FLE
Sakura Seiki Co., Ltd.
General Hospital · 241d
Cleared May 08, 2013
SOL-CARE SAFETY NEEDLE
K123684 · FMI
Sol-Millennium Medical
General Hospital · 159d
Cleared May 07, 2013
LATEX POWDER FREE EXAMINATION GLOVES WITH COLLOIDAL OATMEAL USP SKIN PROTECTANT
K123368 · LYY
Hartalega Sdn Bhd
General Hospital · 187d
Cleared May 06, 2013
MODEL NUMBER: RMS1-2604, RMS1-2614, RMS1-2404, RMS1-2414, RMS2-2604,...
K122404 · FPA
Repro-Med Systems, Inc. Dba Rms...
General Hospital · 272d
Cleared May 03, 2013
ARTIGLASS L. O.R. GLASS SYRINGE
K122416 · FMF
Artiglass Srl
General Hospital · 268d
Cleared May 02, 2013
GETINGE 633HC STEAM STERILIZER AIR GLIDE SYSTEM
K120532 · PEC
Getinge Sourcing, LLC
General Hospital · 435d
Cleared May 01, 2013
AGILIA INFUSION SYSTEM
K121613 · FRN
Fresenius Kabi AG
General Hospital · 334d
Cleared Apr 30, 2013
MINI-MIDLINE EXTENDED DWELL SAFETY CATHETER
K130518 · FOZ
Luther Needlesafe Products, Inc.
General Hospital · 62d
Cleared Apr 30, 2013
STERITEC GREEN CARD PACK BOWIE-DICK TEST MODEL BD 126
K122945 · JOJ
Steritec Products Mfg Co, Inc.
General Hospital · 218d
Cleared Apr 30, 2013
NMI PORT
K122767 · LJT
Navilyst Medical, Inc.
General Hospital · 232d
Cleared Apr 26, 2013
CG+ ARROW PICC POWERED BY ARROW VPS STYLET
K130876 · LJS
Arrow International, Inc.
General Hospital · 28d
Cleared Apr 23, 2013
ENCIRCLE COMPRESSION THERAPY STOCKING
K122485 · DWL
Encircle Medical Devices , Ltd.
General Hospital · 252d
Cleared Apr 17, 2013
MODIFIED ARGYLE POLYURETHANE UMBILICAL VESSEL CATHETER 2.5FR, 3.5FR, 5 FR.
K130725 · FOS
Covidien Lp, Formerly Registered AS...
General Hospital · 30d
Cleared Apr 12, 2013
MIDAS TOUCH, NITRILE EXAMINATION GLOVES, POWDER-FREE, ORANGE
K122464 · LZA
Industrial Clothings, Ltd.
General Hospital · 242d
Cleared Apr 05, 2013
MIDAS TOUCH, NITRILE EXAMINATION GLOVES, POWDER-FREE, GREY
K122453 · LZA
Industrial Clothings, Ltd.
General Hospital · 235d
Cleared Apr 03, 2013
K100 NEUTRAL DISPLACEMENT NEEDLE FREE CONNECTOR
K130023 · FPA
Np Medical, Inc.
General Hospital · 90d
Cleared Apr 02, 2013
CELSITE IMPLANTABLE ACCESS PORT SYSTEMS
K130576 · LJT
B. Braun Interventional Systems, Inc.
General Hospital · 28d
Cleared Apr 02, 2013
THERMOFINDER
K130361 · FLL
Hubdic Co., Ltd.
General Hospital · 48d
Cleared Apr 02, 2013
BOSSONG HOSIERY MEDICAL COMPRESSION STOCKINGS 8-15 MMHG, BOSSONG HOSIERY...
K123820 · DWL
Bossong Hosiery Mills, Inc.
General Hospital · 111d
Cleared Mar 29, 2013
NEXUS IR30 NON-CONTACT INFRARED FOREHEAD THERMOMETER
K122221 · FLL
Taidoc Technology Corporation
General Hospital · 247d