FDA 510(k) Searchable Database - Search 175,000+ Clearances

Search 175,000+ FDA 510(k) clearances by K-number, device name, manufacturer or product code. Includes real review time data, denied submission rates and regulatory intelligence not available on any other searchable 510(k) database.

175,972 clearances · 1976 to present · Updated monthly from FDA records

Filters: General Hospital ×
17,791 results
2209–2232 of 17,791
Search insights Median review: 89d Cleared: 100% Top manufacturer: Baxter Healthcare Corp Lead specialty: General Hospital
Cleared Jun 01, 2020
Polyisoprene Powder Free Surgical Underglove for Use with Chemotherapy Drugs...
K200897 · KGO
Hartalega Sdn Bhd
General Hospital · 59d
Cleared Jun 01, 2020
3MTM AttestTM Rapid 5 Steam-Plus Test Pack
K200536 · FRC
3M Complany
General Hospital · 90d
Cleared May 29, 2020
Aspire Mechanical Aspirator G
K200629 · FMF
Control Medical Technology
General Hospital · 80d
Cleared May 22, 2020
VERIFY Assert Self-Contained Biological Indicator
K200126 · FRC
STERIS Corporation
General Hospital · 122d
Cleared May 22, 2020
Surgical Gown
K192560 · FYA
Shandong Kangli Medical Equipment...
General Hospital · 248d
Cleared May 22, 2020
SmartPort+ Implantable Ports, SmartPort Plastic Implantable Ports
K190559 · LJT
AngioDynamics, Inc.
General Hospital · 444d
Cleared May 21, 2020
Getinge Assured MI Steam Migrating Integrator
K200252 · JOJ
Steritec Products Mfg Co, Inc.
General Hospital · 108d
Cleared May 20, 2020
LifeFlow Blood System
K191362 · FPA
410 Medical, Inc.
General Hospital · 364d
Cleared May 14, 2020
Reliance Endoscope Processing System
K200989 · NZA
STERIS Corporation
General Hospital · 29d
Cleared May 12, 2020
EZ-Inject Single use Needle
K192222 · FMI
Poonglim Pharmatech, Inc.
General Hospital · 270d
Cleared May 07, 2020
Chemfort CSTD
K192866 · ONB
Simplivia Healthcare , Ltd.
General Hospital · 213d
Cleared May 04, 2020
Ultravision Visual Field Clearing System
K200035 · PQM
Alesi Surgical, Ltd.
General Hospital · 117d
Cleared May 01, 2020
NON-STERILE, POWDER FREE NITRILE EXAMINATION GLOVES, LOW DERMATITIS...
K200453 · LZA
Yty Industry (Manjung) Sdn Bhd
General Hospital · 67d
Cleared Apr 30, 2020
Turbett Instrument Pod
K200240 · FRG
Turbett Surgical, Inc.
General Hospital · 90d
Cleared Apr 30, 2020
50g SMS Standard Surgical Gown, 45g SMS Surgical Gown with Reinforcement, 68g...
K192290 · FYA
Xuchang Zhengde Environstar Medical...
General Hospital · 251d
Cleared Apr 30, 2020
Biowy PICC Catheter S Kit
K192246 · LJS
Biowy Corporation
General Hospital · 255d
Cleared Apr 28, 2020
Vicks VNT200 No Touch Forehead Thermometer
K193213 · FLL
Kaz USA, Inc., A Helen of Troy Company
General Hospital · 159d
Cleared Apr 26, 2020
ControlRad Sterile Cover
K200238 · KKX
Controlrad, Inc.
General Hospital · 86d
Cleared Apr 25, 2020
Biodegradable Nitrile Powder Free Examination Gloves Tested for Use with...
K200581 · LZA
Hartalega NGC Sdn. Bhd.
General Hospital · 51d
Cleared Apr 23, 2020
Surgical Face Mask
K200847 · FXX
Mexpo International, Inc.
General Hospital · 23d
Cleared Apr 23, 2020
MF SAFECATH
K192230 · FOZ
Medifirst Co., Ltd.
General Hospital · 251d
Cleared Apr 22, 2020
Infrared Forehead Thermometer
K190984 · FLL
Xiamen Ants Bro Technology Co., Ltd.
General Hospital · 373d
Cleared Apr 21, 2020
Bevel Up Holder
K193074 · JKA
Nsp Tech Pte, Ltd.
General Hospital · 169d
Cleared Apr 21, 2020
Droplet Pen Needle 34G
K192082 · FMI
Htl-Strefa S.A
General Hospital · 263d