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
433–456 of 17,825
Search insights Median review: 89d Cleared: 100% Top manufacturer: Baxter Healthcare Corp Lead specialty: General Hospital
Cleared Aug 22, 2024
INSULCLOCK® v2.0 PRO
K241803 · QOG
Insulcloud S.L.
General Hospital · 62d
Cleared Aug 22, 2024
Single-use Sterile High-pressure Angiographic Syringes and Accessories
K241109 · DXT
Shenzhen Boon Medical Supply Co., Ltd.
General Hospital · 122d
Cleared Aug 20, 2024
CELERITY HP Indicator Tape (PCC077)
K242189 · JOJ
Steris
General Hospital · 26d
Cleared Aug 20, 2024
Mon-a-Therm™ General Purpose Temperature Probe 400TM (90050, 90044)
K240077 · FLL
Covidien
General Hospital · 223d
Cleared Aug 15, 2024
Disposable Pen Injector Assembly
K240961 · FMF
Wuxi Nest Biotechnology Co., Ltd.
General Hospital · 129d
Cleared Aug 12, 2024
Ultravision2™ IonPencil
K240868 · PQM
Alesi Surgical Limited
General Hospital · 136d
Not Cleared Aug 12, 2024
SoClean 3+ Bacterial Reduction Device
DEN210037 · QXQ
Soclean, Inc.
General Hospital · 1062d
Cleared Aug 07, 2024
HALYARD* SMART-FOLD* Sterilization Wrap (H450)
K240330 · FRG
O&M Halyard, Inc.
General Hospital · 184d
Cleared Aug 06, 2024
Nitrile Powder Free Examination Gloves (Blue), Non-Sterile Low Dermatitis...
K241528 · LZA
Comfort Rubber Gloves Industries Sdn....
General Hospital · 68d
Cleared Aug 05, 2024
PlumeSafe X5 Smoke Management System
K240127 · FYD
Conmed Corporation
General Hospital · 201d
Cleared Aug 02, 2024
Powder Free Nitrile Examination Gloves (Blue), Tested for Use with...
K241970 · LZA
Kanglongda Vietnam Protection...
General Hospital · 28d
Cleared Aug 02, 2024
GCI Surgical Gown
K233571 · FYA
George Courey, Inc.
General Hospital · 270d
Cleared Aug 01, 2024
ViroZap Indoor Air Purifier, In Duct Model 1008
K241140 · FRA
Applied Photonix, LLC
General Hospital · 99d
Cleared Jul 31, 2024
SteriTite rigid reusable sterilization container with MediTray Products
K240898 · KCT
Case Medical
General Hospital · 121d
Cleared Jul 29, 2024
PowerGlide Pro™ Midline Catheter
K240359 · FOZ
Becton, Dickinson and Company (Bard...
General Hospital · 174d
Cleared Jul 29, 2024
Medical surgical mask
K233723 · FXX
Guangdong Kingfa Sci. & Tech.Co., Ltd.
General Hospital · 251d
Cleared Jul 26, 2024
Introcan Safety® 2 IV Catheter
K241845 · FOZ
B.Braun Medical, Inc.
General Hospital · 30d
Cleared Jul 26, 2024
Vent Vial Adapter
K233287 · LHI
Hangzhou Qiantang Longyue...
General Hospital · 301d
Cleared Jul 19, 2024
VACUETTE® QUICKSHIELD Complete (Plus)
K233979 · JKA
Greiner Bio-One North America, Inc.
General Hospital · 214d
Cleared Jul 16, 2024
CrossRoads Modular Tray System
K241050 · KCT
Crossroads Extremity Systems
General Hospital · 90d
Cleared Jul 13, 2024
Omnifix Syringe NRFit
K241385 · QEH
B.Braun Medical, Inc.
General Hospital · 59d
Cleared Jul 12, 2024
S.I.N. Instrument Kits
K241378 · KCT
S.I.N. ? Sistema DE Implante Nacional...
General Hospital · 58d
Not Cleared Jul 12, 2024
Terragene Bionova Photon Biological Indicator (BT225)
DEN220042 · QVB
Terragene S.A.
General Hospital · 742d
Cleared Jul 05, 2024
STERRAD™ Chemical Indicator (CI) Strip (14100)
K234084 · JOJ
Advanced Sterilization Products, Inc.
General Hospital · 196d