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
2665–2688 of 17,791
Search insights Median review: 89d Cleared: 100% Top manufacturer: Baxter Healthcare Corp Lead specialty: General Hospital
Cleared Jun 01, 2018
Omnipod DASH Insulin Management System
K180045 · LZG
Insulet Corporation
General Hospital · 144d
Cleared Jun 01, 2018
NEOSHIELD
K172499 · ONB
JMS North America Corporation
General Hospital · 287d
Cleared May 30, 2018
MN-111
K172825 · FLE
W&H Sterilization S.R.L.
General Hospital · 254d
Cleared May 29, 2018
VERIFY Spore Test Strip for S40 Sterilant
K180553 · OVY
STERIS Corporation
General Hospital · 89d
Cleared May 25, 2018
Infrared Thermometer
K172889 · FLL
Shenzhen Pacom Medical Instruments...
General Hospital · 246d
Cleared May 25, 2018
DripAssist Plus
K172242 · FLN
Shift Labs, Inc.
General Hospital · 303d
Cleared May 21, 2018
VACUETTE SAFELINK Holder with male luer lock
K180545 · FMI
Greiner Bio-One Na, Inc.
General Hospital · 81d
Cleared May 21, 2018
Biowy PlCC Catheter
K173956 · LJS
Biowy Corporation
General Hospital · 144d
Cleared May 18, 2018
Sterile Hypodermic Needle for Single Use
K180259 · FMI
Jiangsu Shenli Medical Production...
General Hospital · 108d
Cleared May 18, 2018
VESTEX Apparel
K180217 · QBW
Vestagen Protective Technologies, Inc.
General Hospital · 113d
Cleared May 18, 2018
Smoklean
K173108 · FYD
Sejong Medical Co., Ltd.
General Hospital · 231d
Cleared May 17, 2018
Infrared Thermometer
K172894 · FLL
Shenzhen Jiacom Technology CO ., Ltd.
General Hospital · 237d
Cleared May 17, 2018
CADD Yellow High Volume Administration Set with NRFit connector
K172592 · PWH
Smiths Medical Asd, Inc.
General Hospital · 261d
Cleared May 15, 2018
Powder Free Nitrile Examination Gloves Tested for Use with Chemotherapy Drugs
K180476 · LZC
Comfort Rubber Gloves Industries Sdn....
General Hospital · 82d
Cleared May 14, 2018
RELI Safety Blood Collection Tube Holder, RELI Blood Collection Tube Holder
K173279 · FMI
Myco Medical Supplies, Inc.
General Hospital · 213d
Cleared May 11, 2018
Infrared Body Thermometer
K180385 · FLL
Hetaida Technology Co., Ltd.
General Hospital · 88d
Cleared May 11, 2018
Spectrum IQ Infusion System, Dose IQ Safety Software
K173084 · FRN
Baxter Healthcare Corporation
General Hospital · 224d
Cleared May 11, 2018
HealthBeacon HB2 Sharps Bin
K172719 · MMK
Healthbeacon, Ltd.
General Hospital · 245d
Cleared May 10, 2018
Graftgun Universal Graft Delivery System
K180937 · FMF
SurGenTec, LLC
General Hospital · 30d
Cleared May 10, 2018
OsteoMed QuickFix Hybrid MMF Sterilization Tray
K173391 · KCT
Osteomed, LLC
General Hospital · 192d
Cleared May 10, 2018
Nitrile Examination Powder Free Glove, Black, Nitrile Examination Powder Free...
K172867 · LZA
Gmp Medicare Sdn Bhd (F25)
General Hospital · 232d
Cleared May 09, 2018
STERIZONE VP4 Sterilizer
K172191 · PJJ
Tso3, Inc.
General Hospital · 293d
Cleared May 04, 2018
MEDRAD® Imaging Bulk Package Transfer Set
K173913 · PQH
Bayer U.S., LLC
General Hospital · 133d
Cleared May 02, 2018
Non-Sterile Powder Free Blue Nitrile Examination Gloves Tested for Use with...
K172864 · LZC
Maxter Glove Manufacturing Sdn Bhd
General Hospital · 224d