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
457–480 of 17,825
Search insights Median review: 89d Cleared: 100% Top manufacturer: Baxter Healthcare Corp Lead specialty: General Hospital
Cleared Jul 05, 2024
STERRAD® 100NX Sterilizer with ALLClear™ Technology and ULTRA GI™ Cycle (10104)
K234082 · MLR
Advanced Sterilization Products
General Hospital · 196d
Cleared Jul 02, 2024
Non-sterile, Powder-Free Nitrile Examination Glove Tested for use with 55...
K240930 · LZA
Sri Trang Gloves (Thailand) Public...
General Hospital · 89d
Cleared Jul 02, 2024
ZIEN IO Intraosseous Access System
K240915 · FMI
Zien Medical Technologies, Inc.
General Hospital · 90d
Cleared Jul 02, 2024
FLUIDSHIELD* 1 Fog-Free Procedure Mask with SO SOFT* Lining and SO SOFT*...
K232824 · FXX
Owens & Minor (O&M) Halyard, Inc.
General Hospital · 293d
Cleared Jul 01, 2024
FLUIDSHIELD* 1 Procedure Mask with SO SOFT* Lining and SO SOFT* Earloops,...
K232777 · FXX
Owens & Minor (O&M) Halyard, Inc.
General Hospital · 294d
Cleared Jun 27, 2024
3M™ Attest™ Super Rapid Vaporized Hydrogen Peroxide Clear Challenge Pack...
K241542 · FRC
3M Company
General Hospital · 27d
Cleared Jun 27, 2024
3M™ Attest™ Rapid Readout Biological Indicator 1295 and 3M™ Attest™ Vaporized...
K240717 · FRC
3M Company
General Hospital · 104d
Cleared Jun 27, 2024
SteroScope® Sterilization Technology System
K233762 · MLR
Ideate Medical, Inc.
General Hospital · 216d
Cleared Jun 26, 2024
Ultraphon Chemical Indicator (TRO-T and TRO-B)
K233413 · JOJ
True Indicating, LLC
General Hospital · 264d
Cleared Jun 26, 2024
FlowArt Valve for Vial Access
K232987 · LHI
Asset Medikal Tasarim Sanayi VE...
General Hospital · 278d
Cleared Jun 25, 2024
Disposable Medical Nitrile Examination Gloves (Non sterile) (QN-N001,...
K240824 · LZA
Ningxia Qiaoen Medical Technology...
General Hospital · 91d
Cleared Jun 21, 2024
ToxiSeal™ Vial Adaptor with External Flip Balloon
K241476 · ONB
Epic Medical Pte. , Ltd.
General Hospital · 28d
Cleared Jun 21, 2024
eZSURE™ Empty Fluid Container with ProSeal™ Injection Site
K241442 · KPE
Epic Medical Pte. , Ltd.
General Hospital · 30d
Cleared Jun 21, 2024
Medicom Sterilization Wrap
K240862 · FRG
Medicom Group, Inc.
General Hospital · 85d
Cleared Jun 21, 2024
SteadyTemp
K233280 · FLL
Steadysense GmbH
General Hospital · 266d
Cleared Jun 21, 2024
PRESSUREALERT® Pressure Monitoring System
K233096 · SBO
Position Health, LLC
General Hospital · 269d
Cleared Jun 21, 2024
Fluidshield* 1 Procedure Mask with SO SOFT* Lining and SO SOFT Earloops (25869)
K232807 · FXX
Owens & Minor (O&M) Halyard, Inc.
General Hospital · 283d
Cleared Jun 18, 2024
Pen Injector
K240774 · FMF
Wuxi Nest Biotechnology Co., Ltd.
General Hospital · 89d
Cleared Jun 14, 2024
Airdog X8 Air Purifier (KJ800F-X8)
K240696 · FRF
Suzhou Beiang Smart Technology Co., Ltd.
General Hospital · 92d
Cleared Jun 14, 2024
Fluidshield* 2 Fog-Free Surgical Mask (62113)
K232812 · FXX
Owens & Minor (O&M) Halyard, Inc.
General Hospital · 276d
Cleared Jun 14, 2024
Disposable High-pressure Extension Lines
K230668 · DXT
Precision Medical Plastics , Ltd.
General Hospital · 462d
Cleared Jun 12, 2024
EO Chex Indicator Tape
K240910 · JOJ
Propper Manufacturing Co., Inc.
General Hospital · 71d
Cleared Jun 12, 2024
Remunity System
K240256 · QJY
Deka Research and Development
General Hospital · 133d
Cleared Jun 12, 2024
Sterile Disposable Syringe, Sterile Disposable Syringe with needle, Sterile...
K232950 · FMF
Perfect Medical Industry (Vn) Co., Ltd.
General Hospital · 266d