Search FDA 510(k) Clearance Records

Use this 510(k) search tool to find FDA medical device clearance records by K-number, device name, manufacturer, product code, or regulatory consultant. Explore individual submissions, review timelines, predicate device information, and links to official FDA records. Search the database for free, with no registration required.

176,583 clearances · 1976 to present · Updated monthly from FDA records · Free access · No registration required

Filters: General Hospital ×
17,825 results
289–312 of 17,825
Search insights Median review: 89d Cleared: 100% Top manufacturer: Baxter Healthcare Corp Lead specialty: General Hospital
Cleared Apr 25, 2025
Self Sealing Sterilization Pouches
K243721 · FRG
Wellmed Dental Medical Supply Co., Ltd.
General Hospital · 143d
Cleared Apr 25, 2025
Infrared Thermometer
K243082 · FLL
Guangzhou Daxin Health Technology...
General Hospital · 207d
Cleared Apr 24, 2025
GO-PEN®
K250262 · FMF
Go-Pen Aps
General Hospital · 85d
Cleared Apr 23, 2025
Nitrile Powder Free Examination Glove, Blue Tested for Use with 60...
K250944 · LZA
Gmp Medicare Sdn. Bhd.
General Hospital · 26d
Cleared Apr 18, 2025
DMRX 100ml Empty Container Solution
K250459 · KPE
Technoflex Sas.
General Hospital · 59d
Cleared Apr 18, 2025
FROG (Filter Removal of Glass)
K240355 · FMI
Carrtech Corp
General Hospital · 438d
Cleared Apr 14, 2025
STERRAD® 100NX Sterilizer with ALLClear™ Technology (10104)
K250802 · MLR
Advanced Sterilization Products, Inc.
General Hospital · 31d
Cleared Apr 09, 2025
CentroVena Central Venous Catheter (CVC) with the CentroVena One Insertion...
K242429 · SEF
Becton Dickinson Inc. (Bd)
General Hospital · 237d
Cleared Apr 08, 2025
Disposable Aqueous Humor Collector (SnovoDAHC I-50, SnovoDAHC II-50,...
K243027 · QLY
Hangzhou Sightnovo Medical Technology...
General Hospital · 193d
Cleared Apr 04, 2025
Turbett Surgical Instrument Pod (TS1500)
K250011 · FRG
Turbett Surgical
General Hospital · 92d
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