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
2089–2112 of 17,791
Search insights Median review: 89d Cleared: 100% Top manufacturer: Baxter Healthcare Corp Lead specialty: General Hospital
Cleared Nov 24, 2020
Promisemed Triple Safety Pen Needle
K202682 · FMI
Promisemed Hangzhou Meditech Co., Ltd.
General Hospital · 70d
Cleared Nov 24, 2020
NUVO Implant System – NUVO Instrument Kit Cases
K202515 · KCT
Jjgc Industria E Comercio DE...
General Hospital · 84d
Cleared Nov 24, 2020
Medical surgical mask
K201622 · FXX
Guangdong Kingfa Sci. & Tech.Co., Ltd.
General Hospital · 162d
Cleared Nov 24, 2020
ACENT™ Central Venous Catheter
K193158 · FOZ
Global Medikit Limited
General Hospital · 376d
Cleared Nov 23, 2020
Medical surgical mask
K201991 · FXX
Shenzhen Everwin Precision Technology...
General Hospital · 129d
Cleared Nov 23, 2020
Digital Thermometer-(Model BT-301, BT-302, BT-303, BT-305, BT-306, BT-308,...
K193621 · FLL
Dongguan E-Test Technology Co., Ltd.
General Hospital · 333d
Cleared Nov 22, 2020
Biogel Eclipse / Biogel Eclipse Indicator Underglove, Biogel Surgeons /...
K202090 · KGO
Molnlycke Health Care Us, LLC
General Hospital · 117d
Cleared Nov 20, 2020
Medical surgical mask
K202139 · FXX
Guangdong Kingfa Sci. & Tech.Co., Ltd.
General Hospital · 112d
Cleared Nov 19, 2020
Sapphire Infusion Pump, Sapphire administration sets
K192860 · FRN
Q Core Medical , Ltd.
General Hospital · 412d
Cleared Nov 18, 2020
Signature Latex LT, Powder-Free, Surgical Glove, Tested for Use with...
K202449 · KGO
Medline Industries, Inc.
General Hospital · 84d
Cleared Nov 18, 2020
Liebel-Flarsheim IBP Transfer Set
K193010 · PQH
Liebel-Flarsheim Company, LLC
General Hospital · 386d
Cleared Nov 12, 2020
Sharps container
K201523 · MMK
Zhejiang Gongdong Medical Technology...
General Hospital · 157d
Cleared Nov 12, 2020
Tyvek Sterilization Pouches with Chevron Seal
K200336 · FRG
Andersen Sterilizers, Inc.
General Hospital · 275d
Cleared Nov 12, 2020
Sterisheet Sterilization Wrap
K200335 · FRG
Andersen Sterilizers, Inc.
General Hospital · 275d
Cleared Nov 12, 2020
AN1036 Dosimeter
K200334 · JOJ
Andersen Sterilizers, Inc.
General Hospital · 275d
Cleared Nov 12, 2020
EOGas 4 Endo-SteriTest
K192980 · FRC
Andersen Sterilizers, Inc.
General Hospital · 385d
Cleared Nov 12, 2020
EOGas 4 Ethylene Oxide Gas Sterilizer
K192978 · FLF
Andersen Sterilizers, Inc.
General Hospital · 385d
Cleared Nov 09, 2020
BD PureHub Disinfecting Cap
K193190 · QBP
Becton, Dickinson and Company
General Hospital · 356d
Cleared Nov 06, 2020
Amsco Evolution Medium Steam Sterilizer (Models HC-900 and HC-1200),Evolution...
K203061 · FLE
STERIS Corporation
General Hospital · 29d
Cleared Nov 06, 2020
APTUS Cannulated Compression Screws, APTUS headed Cannulated Compression...
K202589 · HWC
Medartis AG
General Hospital · 59d
Cleared Nov 05, 2020
Eclipse DermaFlex Cannula
K200017 · FMI
Eclipse Medcorp, LLC
General Hospital · 307d
Cleared Nov 04, 2020
Sweden & Martina Surgical Tray (Model ZSHORTY-INT)
K182084 · KCT
Sweden & Martina S.P.A.
General Hospital · 825d
Cleared Oct 29, 2020
OsteoMed ExtremiFix Mini & Small System Tray
K202105 · KCT
Osteomed, LLC
General Hospital · 92d
Cleared Oct 29, 2020
Female Luer Lock Cap
K200425 · FPA
Medsafety Solutions, LLC
General Hospital · 252d