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
265–288 of 17,791
Search insights Median review: 89d Cleared: 100% Top manufacturer: Baxter Healthcare Corp Lead specialty: General Hospital
Cleared Apr 04, 2025
K-Pack Enhance Needle (KH-2713RBBTC and KH-2913RBBTC)
K243581 · FMI
Terumo Europe N.V.
General Hospital · 141d
Not Cleared Apr 04, 2025
Prapela SVS hospital bassinet pad (model P01)
DEN240031 · QVY
Prapela, Inc.
General Hospital · 291d
Cleared Apr 03, 2025
SureFine Pen Needle
K250658 · FMI
Shina Med Corporation
General Hospital · 29d
Cleared Apr 03, 2025
StaClear Syringe (SC250AN)
K243936 · QLY
Staclear, Inc.
General Hospital · 104d
Cleared Apr 02, 2025
Small Volume 0.2mL Syringe
K250138 · QNQ
Prosum Medical Limited
General Hospital · 75d
Cleared Apr 02, 2025
LifeShield Infusion Safety Software Suite
K242117 · PHC
Icu Medical, Inc.
General Hospital · 257d
Cleared Apr 02, 2025
Plum Duo™ Precision IV Pump
K242115 · FRN
Icu Medical, Inc.
General Hospital · 257d
Cleared Apr 02, 2025
Plum Solo™ Precision IV Pump
K242114 · FRN
Icu Medical, Inc.
General Hospital · 257d
Cleared Apr 01, 2025
Nitrile Examination Gloves Powder Free Tested for Use With Chemotherapy Drugs...
K250578 · LZA
Careglove Global Sdn. Bhd.
General Hospital · 33d
Cleared Mar 28, 2025
Synthes Graphic Case & Tray System
K241927 · KCT
Synthes GmbH
General Hospital · 270d
Cleared Mar 27, 2025
MallyaD injection pen adapter (MallyaD)
K250555 · QOG
Biocorp Production
General Hospital · 30d
Cleared Mar 27, 2025
HydroMID 5F Dual Lumen Midline Catheter - Basic Kit (70006102)
K244059 · FOZ
Access Vascular, Inc.
General Hospital · 86d
Cleared Mar 21, 2025
BD Vacutainer® Multiple Sample Luer Adapter
K243649 · JKA
Becton, Dickinson and Company
General Hospital · 115d
Cleared Mar 21, 2025
Autoclavable Cassette (Glidewell HT™ Implant Guided Surgical Kit, Glidewell...
K242564 · KCT
Prismatik Dentalcraft, Inc.
General Hospital · 205d
Cleared Mar 21, 2025
Arisure® Closed Male Luer with Spike Adapter (YM060)
K240761 · LHI
Yukon Medical, LLC
General Hospital · 366d
Cleared Mar 19, 2025
SafeSource Direct Blue Powder-Free Nitrile Exam Gloves (AMERI-TUFF Series...
K250502 · LZA
Safesource Direct, LLC
General Hospital · 27d
Not Cleared Mar 19, 2025
CORIS System
DEN240018 · SEW
Nanosonics Limited
General Hospital · 322d
Cleared Mar 18, 2025
Powder Free Nitrile Patient Examination Gloves, Blue Colored, Non Sterile,...
K242533 · LZA
Better Care Plastic Technology Co., Ltd.
General Hospital · 204d
Cleared Mar 14, 2025
AION TempShield™
K250401 · FLL
Aion Biosystems, Inc.
General Hospital · 30d
Cleared Mar 14, 2025
Arrow™ Endurance™ Extended Dwell Peripheral Catheter System (EDC-00818)
K243599 · FOZ
Arrow International, LLC (A...
General Hospital · 113d
Cleared Mar 14, 2025
Solution Administration Sets
K243529 · FPA
Baxter Healthcare Corporation
General Hospital · 120d
Cleared Mar 14, 2025
Promisemed Safety Huber Needles
K243332 · PTI
Promisemed Hangzhou Meditech Co., Ltd.
General Hospital · 141d
Cleared Mar 11, 2025
RemunityPRO™ Pump for Remodulin® (treprostinil) Injection
K250357 · FRN
Deka Research & Development Corp.
General Hospital · 32d
Cleared Mar 07, 2025
FRONT-LINE Field Sterilizer (FL135)
K243801 · FLE
Fort Defiance Industries, LLC
General Hospital · 86d