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
2089–2112 of 17,825
Search insights Median review: 89d Cleared: 100% Top manufacturer: Baxter Healthcare Corp Lead specialty: General Hospital
Cleared Dec 28, 2020
Self-Contained Biological Indicator
K200970 · FRC
True Indicating, LLC
General Hospital · 259d
Cleared Dec 28, 2020
Novaerus NV1050
K200321 · FRF
Novaerus Us, Inc.
General Hospital · 322d
Cleared Dec 23, 2020
Medical Face mask
K202061 · FXX
Jiangsu Province Jianerkang Medical...
General Hospital · 149d
Cleared Dec 23, 2020
DeRoyal Temperature Monitoring Probe
K200631 · FLL
Deroyal Industries, Inc.
General Hospital · 288d
Cleared Dec 22, 2020
Disposable Medical Surgical Face Masks
K202211 · FXX
Guangdong Kaidi Garments Co.,Ltd
General Hospital · 138d
Cleared Dec 19, 2020
Signature Latex and Signature Latex Micro, Powder-Free, Surgical Glove,...
K202668 · KGO
Medline Industries, Inc.
General Hospital · 96d
Cleared Dec 19, 2020
NovoFine Plus 32G Tip x 4 mm
K202005 · FMI
Novo Nordisk, Inc.
General Hospital · 151d
Cleared Dec 18, 2020
Infrared Thermometer
K201980 · FLL
Contec Medical Systems Co.,Ltd
General Hospital · 155d
Cleared Dec 18, 2020
BD Insyte Autoguard Shielded IV Catheter, BD Insyte Autoguard BC Shielded IV...
K201075 · FOZ
Becton, Dickinson and Company
General Hospital · 240d
Cleared Dec 18, 2020
Fever Garde
K191978 · FLL
Hubdic Co., Ltd.
General Hospital · 513d
Cleared Dec 17, 2020
ACIST CVi1 Contrast Delivery System, ACIST CVi Contrast Delivery System
K203004 · DXT
Acist Medical Systems, Inc.
General Hospital · 77d
Cleared Dec 17, 2020
S dispensing line
K192770 · FMF
Aea Srl
General Hospital · 444d
Cleared Dec 16, 2020
Medical Surgical Mask
K202029 · FXX
Beijing Biosis Healing Biolog Ical...
General Hospital · 147d
Cleared Dec 16, 2020
NRFit® Caps, Male and Female Neuraxial Tip Caps
K201031 · QEH
International Medical Industries, Inc.
General Hospital · 240d
Cleared Dec 14, 2020
Medical Face Mask
K201629 · FXX
Shandong Shengquan New Material Co.,...
General Hospital · 181d
Cleared Dec 14, 2020
Sterile Hypodermic Syringe for Single Use, with/without needle,...
K201284 · FMF
Set Medikal Sanayi VE Ticaret Anonim...
General Hospital · 215d
Cleared Dec 11, 2020
3M Comply Hydrogen Peroxide Chemical Indicator 1248
K203458 · JOJ
3M Company
General Hospital · 17d
Cleared Dec 11, 2020
3M Attest Rapid Readout Biological Indicator
K200996 · FRC
3M Company
General Hospital · 239d
Cleared Dec 10, 2020
3M Comply Hydrogen Peroxide Indicator Tape 1228
K203285 · JOJ
3M Company
General Hospital · 31d
Cleared Dec 09, 2020
Disposable Surgical Mask
K201893 · FXX
Xiamen Probtain Medical Techology...
General Hospital · 154d
Cleared Dec 09, 2020
Mini Spike Plus 6/8R
K201469 · LHI
B.Braun Medical, Inc.
General Hospital · 189d
Cleared Dec 09, 2020
Infrared Body Thermometer
K200781 · FLL
Heitaida Technology Co., Ltd.
General Hospital · 273d
Cleared Dec 08, 2020
Evis Exera III Duodenovideoscope Olympus TJF-Q190V
K202661 · FDT
Olympus Medical Systems Corp.
General Hospital · 85d
Cleared Dec 07, 2020
3M Attest Vaporized Hydrogen Peroxide Tri-Metric Chemical Indicator
K203284 · QKM
3M Company
General Hospital · 28d