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
1657–1680 of 17,825
Search insights Median review: 89d Cleared: 100% Top manufacturer: Baxter Healthcare Corp Lead specialty: General Hospital
Cleared Sep 26, 2021
Cardinal Health Protexis PI Blue with Neu-Thera Surgical Glove
K201592 · KGO
Cardinal Health200, LLC
General Hospital · 471d
Cleared Sep 24, 2021
IV Administration Sets
K202618 · FPA
B.Braun Medical, Inc.
General Hospital · 379d
Cleared Sep 23, 2021
Synthetic Vinyl Examination Gloves
K212002 · LYZ
Yunnan Huazhiyuan Medical Technology...
General Hospital · 87d
Cleared Sep 23, 2021
Level 3 Fluid Resistant Procedure/Surgical Mask (model:15604F, 1570F)
K211827 · FXX
Zhejiang Lanhine Medical Products, Ltd.
General Hospital · 101d
Cleared Sep 23, 2021
OnGuard2 Chemfort Closed Administration (CADM)
K210707 · ONB
Simplivia Healthcare , Ltd.
General Hospital · 197d
Cleared Sep 23, 2021
Sterile Hypodermic Needles for Single Use
K210232 · FMI
Zhejiang Kangkang Medical-Devices...
General Hospital · 238d
Cleared Sep 23, 2021
Infrared thermometer, Models: YRK-002A, T8, T9, T10, T11
K203662 · FLL
Yibin Junxin Electronics Technology...
General Hospital · 282d
Cleared Sep 22, 2021
Banyan USA Surgical Mask Level 3
K211097 · FXX
Banyan USA, LLC
General Hospital · 162d
Cleared Sep 22, 2021
3-Layer Medical Face Masks (XMM3L3C), 3-Layer Medical Face Masks with ties...
K210772 · FXX
Vr Vertical, LLC Dba Xrgo
General Hospital · 191d
Cleared Sep 21, 2021
Disposable Nitrile Examination Gloves
K211073 · LZA
Foshan Kangkang Biotechnology Co., Ltd.
General Hospital · 162d
Cleared Sep 20, 2021
Medline Digital Thermometer Non-Lubricated Probe Sheath
K211931 · FLL
Medline Industries, Inc.
General Hospital · 90d
Cleared Sep 20, 2021
Latex Examination Powder Free Gloves
K211477 · LYY
Aspen Glove Sdn. Bhd.
General Hospital · 131d
Cleared Sep 17, 2021
Vinyl Glove
K211904 · LYZ
Jiangsu Dihong Industry and Trade...
General Hospital · 88d
Cleared Sep 17, 2021
WELLTRUST WT-III Mask with Flat Earloop
K211751 · FXX
Lonestar Meadows, LLC
General Hospital · 102d
Cleared Sep 17, 2021
Unifine SafeControl
K210399 · FMI
Owen Mumford, Ltd.
General Hospital · 219d
Cleared Sep 17, 2021
Surgical Mask (Procedure Mask) (Models: OH02-01, OH02-01 (Bandage))
K203418 · FXX
Ningbo Ouhan Medical Device Co., Ltd.
General Hospital · 302d
Cleared Sep 16, 2021
Blue Nitrile Examination Glove Powder Free
K211479 · LZA
Aspen Glove Sdn. Bhd.
General Hospital · 127d
Cleared Sep 16, 2021
Sterile Latex Surgical Gloves Powder Free
K211478 · KGO
Aspen Glove Sdn. Bhd.
General Hospital · 127d
Cleared Sep 16, 2021
Disposable Medical Mask
K203112 · FXX
Yangzhou Runyi Arts & Crafts Co., Ltd.
General Hospital · 336d
Cleared Sep 15, 2021
Disposable Nitrile Gloves
K212009 · LZA
Jiangsu Shenglijie Safety Products...
General Hospital · 79d
Cleared Sep 15, 2021
TrueCare Biomedix Tamper Evident Cap
K210818 · FMF
Us Infusion Inc. D/B/A Truecare...
General Hospital · 181d
Cleared Sep 15, 2021
INFRARED BODY THERMOMETER (Model: YK-001)
K210118 · FLL
Longnan Renzhong Medical Equipment...
General Hospital · 239d
Cleared Sep 15, 2021
Instrument tray, for semi-rigid ureteroscope
K203492 · KCT
Olympus Winter & Ibe GmbH
General Hospital · 300d
Cleared Sep 14, 2021
Nitta M&T Safety Box
K211464 · MMK
Nitta M&T (Thailand) Co., Ltd.
General Hospital · 126d