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
1393–1416 of 17,825
Search insights Median review: 89d Cleared: 100% Top manufacturer: Baxter Healthcare Corp Lead specialty: General Hospital
Cleared Feb 17, 2022
Safety Pen Needle
K210864 · FMI
Sandstone Medical (Suzhou), Inc.
General Hospital · 331d
Cleared Feb 15, 2022
Sterile Auto-Disable Syringes with/without Needle for Single Use
K210229 · MEG
Zhejiang Kangkang Medical-Devices...
General Hospital · 383d
Cleared Feb 14, 2022
Vinyl Powder Free Examination Glove
K212011 · LYZ
Top Glove Vietnam Company Limited
General Hospital · 231d
Cleared Feb 11, 2022
B. Braun Introcan Safety 2 IV Catheter
K213664 · FOZ
B.Braun Medical, Inc.
General Hospital · 81d
Cleared Feb 11, 2022
Surgical Face Mask
K213617 · FXX
Megasoft (China) Co., Ltd.
General Hospital · 88d
Cleared Feb 10, 2022
Instylla Delivery Kit
K213632 · FMF
Instylla, Inc.
General Hospital · 85d
Cleared Feb 08, 2022
O'Star Nitrile Examination Gloves Powder Free
K213058 · LZA
Star Investment and Trade Joint Stock...
General Hospital · 139d
Cleared Feb 04, 2022
BD Vacutainer UltraTouch Push Button Blood Collection Set
K212724 · JKA
Becton, Dickinson and Company
General Hospital · 161d
Cleared Jan 28, 2022
Disposable Medical Nitrile Examination Gloves- Tested for Use With...
K213325 · LZC
Anhui Xinyisheng Medical Technology...
General Hospital · 115d
Cleared Jan 28, 2022
Biodegradable Powder Free Flock-Lined Nitrile Examination Glove, Black and...
K213142 · LZA
Shen Wei (Usa), Inc.
General Hospital · 123d
Cleared Jan 28, 2022
Non-contact Infrared Thermometer, Models JXB-315, JXB-319, JXB-320, JXB-311
K213082 · FLL
Guangzhou Berrcom Medical Device Co.,...
General Hospital · 127d
Cleared Jan 28, 2022
iHealth infrared Ear thermometer PT5
K212598 · FLL
Andon Health Co, Ltd.
General Hospital · 165d
Cleared Jan 28, 2022
Surgical Masks
K212120 · FXX
Hubei Xinxin Non-Woven Co., Ltd.
General Hospital · 205d
Cleared Jan 27, 2022
Sterile Auto-Disable Syringes with/without Needle for Single Use
K211210 · FMF
Azur Medical Company, Inc.
General Hospital · 279d
Cleared Jan 26, 2022
Surgical Face Mask
K212610 · FXX
Foshan Nanhai Plus Medical Co, Ltd.
General Hospital · 162d
Cleared Jan 26, 2022
American-Made Surgical Mask
K210101 · FXX
Armbrust, Inc.
General Hospital · 377d
Cleared Jan 25, 2022
ADI Medical Surgical Face Mask
K213347 · FXX
Asia Dynamics Inc., D/B/A Adi Medical
General Hospital · 109d
Cleared Jan 24, 2022
Disposable Syringe with Needle
K211482 · FMF
Shandong Qinkai Medical Industry Co.,...
General Hospital · 257d
Cleared Jan 23, 2022
D-Care Surgical Face Mask 3 Ply, D-Care Medical Face Mask 3 Ply
K213970 · FXX
Danameco Medical Joint Stock Corporation
General Hospital · 34d
Cleared Jan 23, 2022
Myflon Surgical Mask Level 3
K212111 · FXX
Feliks Plastik Laminasyon VE Ambalaj...
General Hospital · 201d
Cleared Jan 23, 2022
Steiking Packaging for Medical Devices
K210810 · FRG
Wipak OY
General Hospital · 312d
Cleared Jan 23, 2022
Thermoplastic Elastomer (TPE) Hybrid Examination Glove
K210463 · LZA
Xuzhou Full Sun Medical Products , Ltd.
General Hospital · 341d
Cleared Jan 21, 2022
VERIFY STEAM Integrating Indicator, VERIFY STEAM Integrating Indicator 5CM
K213412 · JOJ
Steris Corparation
General Hospital · 94d
Cleared Jan 21, 2022
Nitrile Examination Gloves
K213044 · LZA
Jiangsu Huayuan Medical Technology...
General Hospital · 121d