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
2113–2136 of 17,825
Search insights Median review: 89d Cleared: 100% Top manufacturer: Baxter Healthcare Corp Lead specialty: General Hospital
Cleared Dec 07, 2020
YUWELL Infrared Thermometer
K201864 · FLL
Jiangsu Yuyue Medical Equipment&...
General Hospital · 154d
Cleared Dec 03, 2020
TempTraq
K201977 · FLL
Blue Spark Technologies, Inc.
General Hospital · 140d
Cleared Dec 03, 2020
Medical Mask
K201729 · FXX
Zhende Medical Co., Ltd.
General Hospital · 162d
Cleared Dec 02, 2020
WAVICIDE-OPA MEC Indicator
K202565 · JOJ
Serim Research Corporation
General Hospital · 89d
Cleared Dec 02, 2020
Palm Care Blue Nitrile Examination Gloves Powder Free
K202384 · LZA
Hi-Care Thai Gloves Co. , Ltd.
General Hospital · 104d
Cleared Dec 02, 2020
EZ-TRAX Stryker Mako Total Knee with Triathlon Containment Device
K202270 · KCT
K1 Medical, LLC
General Hospital · 113d
Cleared Dec 01, 2020
RAS 12 Rack / RAS 12 Long Rack, used in RAS Cycle of AMSCO 7052HP / 7053HP...
K203199 · NVE
STERIS Corporation
General Hospital · 33d
Cleared Dec 01, 2020
Palm Care Latex Examination Powder Free Gloves
K202377 · LYY
Hi-Care Thai Gloves Co. , Ltd.
General Hospital · 103d
Cleared Dec 01, 2020
BASE4 Disposable Medical Mask
K202069 · FXX
Base4 Group, Inc.
General Hospital · 127d
Cleared Nov 30, 2020
Kimtech Prizm Multi-Layered Exam Glove Tested for use with Chemotherapy...
K202416 · LZA
Kimberly Clark Corporation
General Hospital · 98d
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