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
817–840 of 17,791
Search insights Median review: 89d Cleared: 100% Top manufacturer: Baxter Healthcare Corp Lead specialty: General Hospital
Cleared Mar 13, 2023
Surgical Face Mask
K221352 · FXX
Wuhan Huashida Protective Products...
General Hospital · 307d
Cleared Mar 12, 2023
High Protection Surgical Gown
K222456 · FYA
3A Medical Products Co., Ltd.
General Hospital · 209d
Cleared Mar 10, 2023
lntravascular Administration Sets with Stopcock and Manifold
K223175 · FMG
Baxter Healthcare Corporation
General Hospital · 150d
Cleared Mar 10, 2023
Vial Adapter
K222718 · LHI
Hangzhou Qiantang Longyue...
General Hospital · 183d
Cleared Mar 10, 2023
BD Vacutainer® Luer-Lok™ Access Device, BD Vacutainer® Blood Transfer Device
K222478 · JKA
Becton, Dickinson and Company
General Hospital · 206d
Cleared Mar 10, 2023
Avoset Infusion Pump System
K213744 · FRN
Eitan Medical , Ltd.
General Hospital · 466d
Cleared Mar 08, 2023
PRECISION ECO Compostable / Plant Based Procedural Mask with Earloops
K221209 · FXX
Padm Medical, Inc.
General Hospital · 316d
Cleared Mar 07, 2023
Disposable Surgical Gowns (S,M,L,XL,XXL,XXXL)
K223401 · FYA
Xiamen Probtain Medical Techology...
General Hospital · 118d
Cleared Mar 06, 2023
Savvy Surgical Mask - Level 3
K230383 · FXX
Alg Health, LLC
General Hospital · 21d
Cleared Mar 06, 2023
Procedure mask/Surgical mask/Face mask
K223232 · FXX
Winner Medical Co., Ltd.
General Hospital · 138d
Cleared Mar 06, 2023
Disposable Insulin Syringe
K222672 · FMF
Hantech Medical Device Co., Ltd.
General Hospital · 181d
Cleared Mar 02, 2023
Disposable 4 Layers Surgical Face Mask
K230093 · FXX
Social Medical Supply, LLC
General Hospital · 49d
Cleared Mar 02, 2023
Insulin Syringe
K223453 · FMF
Promisemed Hangzhou Meditech Co., Ltd.
General Hospital · 106d
Cleared Feb 28, 2023
Terragene® Bionova® Hyper Biological Indicator (BT98), Terragene® Bionova®...
K221641 · FRC
Terragene S.A.
General Hospital · 267d
Cleared Feb 24, 2023
Kawasumi Multiple Sample Adapter with Pre-Attached Holder (MBCH)
K223810 · JKA
Sb-Kawasumi Laboratories, Inc.
General Hospital · 66d
Cleared Feb 23, 2023
Disposable Surgical Gown, Level 4
K221559 · FYA
Stringking
General Hospital · 268d
Cleared Feb 22, 2023
Sterile Latex Examination Gloves Powder Free (S, M, L, Extra L)
K223298 · LYY
Shandong Intco Medical Products Co, Ltd.
General Hospital · 118d
Cleared Feb 17, 2023
Temp Pal (Smart Thermometer Patch) Model Number: STP-MB01-1
K222588 · FLL
Iweecare Co., Ltd.
General Hospital · 175d
Cleared Feb 17, 2023
Equashield Closed System Transfer Device
K221513 · ONB
Equashield Medical , Ltd.
General Hospital · 268d
Cleared Feb 17, 2023
Infrared Thermometer TET-351
K220276 · FLL
Truly Instrument Limited
General Hospital · 382d
Cleared Feb 16, 2023
Sterile Aesthetic Cannula and Hypodermic Needle
K223327 · FMI
Shanghai Kindly Enterprise...
General Hospital · 108d
Cleared Feb 16, 2023
Disposable Infusion Bag for Parenteral Nutrition
K222622 · KPE
Beijing L&Z Medical Technology...
General Hospital · 169d
Cleared Feb 16, 2023
Surgical Gown
K213844 · FYA
Bayteks Teknik Tekstil San. VE Tic. A.S.
General Hospital · 434d
Cleared Feb 15, 2023
Verisafe Safety sterile needles
K222271 · FMI
Promisemed Hangzhou Meditech Co., Ltd.
General Hospital · 201d