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
3337–3360 of 17,791
Search insights Median review: 89d Cleared: 100% Top manufacturer: Baxter Healthcare Corp Lead specialty: General Hospital
Cleared Oct 21, 2015
NITRILE POWDER FREE EXAMINATION GLOVES-PINK, NITRILE POWDER FREE EXAMINATION...
K151836 · LZA
Hartalega NGC Sdn. Bhd.
General Hospital · 107d
Cleared Oct 20, 2015
MTS300 Multiple Tray Sterilization System
K152014 · KCT
Pmbs, LLC
General Hospital · 91d
Cleared Oct 20, 2015
Temple Touch Pro (TTP) Non-invasive temperature monitoring system
K150160 · FLL
Medisim, Ltd.
General Hospital · 270d
Cleared Oct 16, 2015
Terumo SurGuard 3 Safety Hypodermic Needle
K152362 · FMI
Terumo (Philippines) Corporation
General Hospital · 57d
Cleared Oct 16, 2015
MIS Spine Frame Instrument Case
K151347 · KCT
Thompson Surgical Instruments
General Hospital · 149d
Cleared Oct 14, 2015
Mini Needle
K151571 · FMI
Ocujet, LLC
General Hospital · 126d
Cleared Oct 13, 2015
DripAssist
K150687 · FLN
Shift Labs
General Hospital · 210d
Cleared Oct 09, 2015
Powder Free Nitrile (Black) Examination Gloves
K151528 · LZA
Gallant Quality Sdn. Bhd.
General Hospital · 123d
Cleared Oct 09, 2015
SterilContainer S
K151242 · KCT
Aesculap, Inc.
General Hospital · 151d
Cleared Oct 08, 2015
Podimetrics Remote Temperature Monitoring System
K150557 · OIZ
Podimetrics,Inc.
General Hospital · 218d
Cleared Oct 02, 2015
Disposable Insulin Syringe
K151949 · FMF
Jiangyin Caina Technology Co., Ltd.
General Hospital · 79d
Cleared Oct 01, 2015
3M Comply Hydrogen Peroxide Indicator Tape 1228
K150694 · JOJ
3M Company
General Hospital · 197d
Cleared Sep 30, 2015
Q2 Intravenous Adminstration Sets and Extension Sets
K151079 · FPA
Quest Medical, Inc.
General Hospital · 161d
Cleared Sep 29, 2015
Intradermal Adapter
K151777 · FMF
West Pharmaceutical Services, Inc.
General Hospital · 90d
Cleared Sep 29, 2015
3M Comply Hydrogen Peroxide Chemical Indicator 1248
K150622 · JOJ
3M Company
General Hospital · 202d
Cleared Sep 24, 2015
Xcela PICC with PASV, Xcela Hybrid PICC with PASV, Xcela Power Injectable PICC
K152409 · LJS
Navilyst Medical, Inc.
General Hospital · 29d
Cleared Sep 24, 2015
U & U Intravascular Administration Set
K151151 · FPA
U&U Medical Technology Co, Ltd.
General Hospital · 147d
Cleared Sep 18, 2015
Nitrile Powder Free Examination Glove with Low Dermatitis Potential Claim(Blue)
K151684 · LZA
Hartalega NGC Sdn. Bhd.
General Hospital · 88d
Cleared Sep 18, 2015
Sensiflex Plus Sterile Latex Green Surgical Glove Powder Free with Protein...
K151392 · KGO
Terang Nusa Sdn Bhd
General Hospital · 115d
Cleared Sep 14, 2015
Powder Free Nitrile Examination Glove
K151208 · LZA
Vrg Khai Hoan Joint Stock Company
General Hospital · 131d
Cleared Sep 14, 2015
KleenGel Dispenser
K143177 · KYX
Kleengel, LLC
General Hospital · 314d
Cleared Sep 09, 2015
U&U Sterilization Pouch and Roll
K143637 · FRG
U&U Medical Technology Co, Ltd.
General Hospital · 261d
Cleared Sep 04, 2015
PUREWAY SHARPS COLLECTOR 1.2 GALLON, PUREWAY SHARPS COLLECTOR 2 GALLON,...
K151249 · MMK
Pureway Compliance, Inc.
General Hospital · 115d
Cleared Sep 02, 2015
The Belmont Hyperthermia Pump
K152208 · LGZ
Belmont Instrument Corporation
General Hospital · 26d