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
2017–2040 of 17,825
Search insights Median review: 89d Cleared: 100% Top manufacturer: Baxter Healthcare Corp Lead specialty: General Hospital
Cleared Feb 25, 2021
TEVADAPTOR Bag Adaptor LL, TEVADAPTOR Bag Adaptor LL with ULTRASITE,...
K201142 · ONB
Simplivia Healthcare , Ltd.
General Hospital · 302d
Cleared Feb 24, 2021
Nitrile Powder Free Examination Glove, Blue Tested for Use with 32...
K202003 · LZA
Gmp Medicare Sdn. Bhd.
General Hospital · 219d
Cleared Feb 23, 2021
Molekule Air Mini, Molekule Air Mini +
K202339 · FRA
Molekule, Inc.
General Hospital · 190d
Cleared Feb 23, 2021
Velano ExT Extension Set
K200439 · FPA
Velano Vascular
General Hospital · 365d
Cleared Feb 22, 2021
Phyziofit Medical Surgical Mask
K201868 · FXX
Wellpower Sporting Goods Co., Ltd.
General Hospital · 230d
Cleared Feb 19, 2021
MiniLoad Syringe
K202432 · FMF
Ocuject, LLC
General Hospital · 178d
Cleared Feb 19, 2021
Safety Blood Collection Sets for Single Use
K202188 · JKA
Anhui Hongyu Wuzhou Medical...
General Hospital · 199d
Cleared Feb 19, 2021
iMask Disposable Surgical Face Mask
K201182 · FXX
Pac-Dent, Inc.
General Hospital · 294d
Cleared Feb 18, 2021
Surgical Face Mask (non-sterile)
K203426 · FXX
Nantong Taiweishi Medical Technology...
General Hospital · 90d
Cleared Feb 18, 2021
Infrared Forehead Thermometer, Model LFR30B, LFR50, LFR60
K202687 · FLL
Shenzhen Lepu Intelligent Medical...
General Hospital · 156d
Cleared Feb 18, 2021
BEGO SEMADOS Tr 58350
K201412 · KCT
Bego Implant Systems GmbH & Co. KG
General Hospital · 266d
Cleared Feb 17, 2021
Powder Free NR Latex Surgical Glove (Sterile) with Protein content labelling...
K202401 · KGO
Eco Medi Glove Sdn. Bhd.
General Hospital · 180d
Cleared Feb 16, 2021
EZ-Injec LDV Sterile Safety Needle
K210444 · QNS
Poonglim Pharmatech, Inc.
General Hospital
Cleared Feb 16, 2021
PLPT LDV (Low Dead Volume) Sterile Syringe
K210443 · QNQ
Poonglim Pharmatech, Inc.
General Hospital
Cleared Feb 16, 2021
Dukal Corporation Level 3 Surgical Face Masks with Ear loop, Dukal...
K201732 · FXX
Dukal Corporation
General Hospital · 236d
Cleared Feb 12, 2021
Vinyl Examination Gloves (Yellow)
K203702 · LYZ
Xinying Trading Co., Ltd.
General Hospital · 56d
Cleared Feb 12, 2021
LYDUS Nitrile Examination Gloves, Powder Free
K203191 · LZA
Nathan Trading Co., Ltd.
General Hospital · 108d
Cleared Feb 12, 2021
Infrared Thermometer
K202368 · FLL
Shandong Bittel Intelligent...
General Hospital · 177d
Cleared Feb 12, 2021
Disposable Surgical Mask
K202341 · FXX
Shanghai Jianzhong Medical Packaging...
General Hospital · 179d
Cleared Feb 12, 2021
Panda iRes Warmer, Giraffe Warmer
K201628 · FMT
Ge Healthcare
General Hospital · 241d
Cleared Feb 12, 2021
Surgical Face Mask
K201545 · FXX
Amphastar Nanjing Pharmaceuticals, Inc.
General Hospital · 248d
Cleared Feb 10, 2021
Standard Procedure Mask, Standard Surgical Mask
K202605 · FXX
Jiangsu Medplus Non-Woven...
General Hospital · 155d
Cleared Feb 10, 2021
Infrared Forehead Thermometer
K201536 · FLL
Hangzhou Qingyuan Medical Equipment...
General Hospital · 247d
Cleared Feb 09, 2021
nPro Surgical Mask
K203265 · FXX
Np Medical, Inc.
General Hospital · 96d