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
2041–2064 of 17,825
Search insights Median review: 89d Cleared: 100% Top manufacturer: Baxter Healthcare Corp Lead specialty: General Hospital
Cleared Feb 08, 2021
HydroMID
K203069 · FOZ
Access Vascular, Inc.
General Hospital · 122d
Cleared Feb 05, 2021
Freudenberg Surgical Mask
K210063 · FXX
Freudenberg Performance Materials LP
General Hospital · 25d
Cleared Feb 05, 2021
Dukal Corporation Level 2 Surgical Mask with Ear Loops
K201421 · FXX
Dukal Corporation
General Hospital · 252d
Cleared Feb 04, 2021
Medical Face Mask
K202493 · FXX
Gemtier Medical (Shanghai), Inc.
General Hospital · 157d
Cleared Feb 03, 2021
Medical Face Masks
K202627 · FXX
Guilin Hbm Sanitary Protections, Inc.
General Hospital · 145d
Cleared Feb 02, 2021
Disposable Medical Surgical Mask
K202511 · FXX
Improve Medical (Hunan) Co., Ltd.
General Hospital · 155d
Cleared Feb 02, 2021
Medical Face Mask
K202331 · FXX
Gemtier Medical (Shanghai), Inc.
General Hospital · 169d
Cleared Feb 02, 2021
Disposable Medical Surgical Masks
K202323 · FXX
Tianjin Teda Jinshan Easy Packing...
General Hospital · 169d
Cleared Feb 02, 2021
3-ply EcoGuard B with Earloop, 3-ply EcoGuard B with Tie-On
K202096 · FXX
Ecoguard, Inc.
General Hospital · 188d
Cleared Feb 02, 2021
Easydrip Pen Needle, Easydrip Plus Pen Needle
K193422 · FMI
Sandstone Medical (Suzhou), Inc.
General Hospital · 421d
Cleared Feb 01, 2021
Medispo Rubber Surgical Gloves, Medispo Polyisoprene Surgical Gloves
K203483 · KGO
Guilin Hbm Health Protections, Inc.
General Hospital · 66d
Cleared Jan 29, 2021
Protective Face Mask for Medical Use
K202358 · FXX
Hunan Heng Chang Pharmaceutical Co.,...
General Hospital · 163d
Cleared Jan 29, 2021
Wildcat PE Surgical Isolation Gown Open Back, Wildcat PE Surgical Isolation...
K202310 · FYC
Wildcat Ppe, LLC
General Hospital · 168d
Cleared Jan 28, 2021
Reliance EPS Endoscope Processing System and Reliance DG Dry Germicide
K203223 · NZA
Steris
General Hospital · 87d
Cleared Jan 28, 2021
Standard Sterilizable Tray
K202524 · KCT
Implant Direct Sybron Manufacturing, LLC
General Hospital · 149d
Cleared Jan 25, 2021
Non-Contact Forehead Thermometer (Models UT306H & UT308H)
K203747 · FLL
Uni-Trend Technology (China) Co., Ltd.
General Hospital · 34d
Cleared Jan 25, 2021
BD Hypodermic Syringe
K203453 · FMF
Becton, Dickinson and Company
General Hospital · 63d
Cleared Jan 22, 2021
Non-Contact Forehead Thermometer (UT30H)
K203656 · FLL
Uni-Trend Technology (China) Co., Ltd.
General Hospital · 38d
Cleared Jan 22, 2021
Surgical Mask
K202640 · FXX
Jiangsu Medpure Biological Technology...
General Hospital · 133d
Cleared Jan 21, 2021
AEROCURE-MD
K203189 · FRA
Aerobiotix, Inc.
General Hospital · 86d
Cleared Jan 21, 2021
Surgical Face Mask
K202904 · FXX
Jiangxi Feilikang Medical Technology...
General Hospital · 114d
Cleared Jan 21, 2021
Precision Delivery Infusion Set
K202672 · FPA
Quest Medical, Inc.
General Hospital · 128d
Cleared Jan 21, 2021
Premier Guard USA 3 Layer Ear Loop ASTM Level 3 Surgical Face Mask
K202595 · FXX
Premier Guard USA, LLC
General Hospital · 135d
Cleared Jan 15, 2021
Medical Protective Mask
K202107 · FXX
Guangdong Kingfa Sci. & Tech.Co., Ltd.
General Hospital · 170d