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

2161–2184 of 17,825

Search insights Median review: 89d Cleared: 100% Top manufacturer: Baxter Healthcare Corp Lead specialty: General Hospital

Cleared Oct 07, 2020

Infrared Thermometer

Shenzhen Urion Technology Co., Ltd.

General Hospital · 194d

Cleared Oct 05, 2020

Neonatal Phototherapy System

Avalon Biomedical (Shenzhen) Limited

General Hospital · 272d

Cleared Oct 02, 2020

Latex Powder Free Surgical Glove with Protein Labelling Claim of 50 Microgram...

Hartalega Sdn Bhd

General Hospital · 98d

Cleared Oct 02, 2020

Infrared Thermometer Model E127

Bioland Technology, Ltd.

General Hospital · 155d

Cleared Oct 01, 2020

Infrared PT2L Digital No-Touch Thermometer

Andon Health Co, Ltd.

General Hospital · 197d

Cleared Sep 25, 2020

Surgical Face Mask

Jiangxi 3l Medical Products Group...

General Hospital · 45d

Cleared Sep 25, 2020

PUGGLE Enteral Feeding Pump and Feeding Set

Amsino International, Inc.

General Hospital · 259d

Cleared Sep 22, 2020

BD Cathena Safety IV Catheter

Becton Dickinson Infusion Therapy...

General Hospital · 91d

Cleared Sep 22, 2020

Halyard Pink Underguard Zero, Sterile Powder-Free Exam Gloves Tested with...

O&M Halyard, Inc.

General Hospital · 175d

Cleared Sep 18, 2020

Disposable Surgical Mask

Unisources Group, LLC

General Hospital · 22d

Cleared Sep 18, 2020

Medline Powder-Free Light Blue Nitrile Exam Gloves (Tested for Use with...

Medline Industires, Inc.

General Hospital · 114d

Cleared Sep 18, 2020

Intellifuse Administration and Intellifuse Blood Administration Sets

Smiths Medical Asd, Inc.

General Hospital · 385d

Cleared Sep 17, 2020

Single-Use Surgical Mask With Ear Loop

Qiqihar Hengxin Medical Supplies, Ltd.

General Hospital · 87d

Cleared Sep 16, 2020

Polychloroprene Powder Free Sterile Surgical Gloves, Low Dermatitis Potential...

Pt. Medisafe Technologies

General Hospital · 79d

Cleared Sep 11, 2020

TK Insulin Syringe with/without Saftey Retractable Device

Anhui Tiankang Medical Technology...

General Hospital · 450d

Cleared Sep 10, 2020

Disposable Vinyl Glove

Best Care Trading Co., Ltd.

General Hospital · 51d

Cleared Sep 09, 2020

SensiCare PI Evolution Surgical Glove (Tested for Use with Chemotherapy Drugs)

Medline Industries, Inc.

General Hospital · 69d

Cleared Sep 09, 2020

Blood Collection Needle with/without Holder, Safety Blood Collection Needle...

Jiangsu Caina Medical Co.,Ltd

General Hospital · 247d

Cleared Sep 09, 2020

Benesta Hysteroscope

Caldera Medical, Inc.

General Hospital · 344d

Cleared Sep 08, 2020

Surgical Mask-Model Number CW01

Hunan Heng Chang Pharmaceutical Co.,...

General Hospital · 20d

Cleared Sep 08, 2020

Disposable Medical Face Mask

General Hospital · 97d

Cleared Sep 04, 2020

Protective Face Mask for Medical Use

Shandong Shengquan New Material Co.,...

General Hospital · 88d

Cleared Sep 04, 2020

Plain Surgical Mask

Aok Tooling Limited

General Hospital · 88d

Cleared Sep 04, 2020

BD Syringe NRFit Lok and BD Syringe NRFit Slip

Becton, Dickinson and Company

General Hospital · 354d