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
2185–2208 of 17,825
Search insights Median review: 89d Cleared: 100% Top manufacturer: Baxter Healthcare Corp Lead specialty: General Hospital
Cleared Sep 03, 2020
Biodegradable Nitrile Examination Powder Free Glove, Green
K192111 · LZA
Top Glove Sdn. Bhd.
General Hospital · 395d
Cleared Sep 01, 2020
Endoscope Reprocessor OER-Elite
K201920 · FEB
Olympus Medical Systems Corp.
General Hospital · 53d
Cleared Aug 26, 2020
Motex Anti-Fog Surgical Face Mask
K201549 · FXX
Modern Healthcare Corp.
General Hospital · 78d
Cleared Aug 26, 2020
Single-use Surgical Mask
K200923 · FXX
Byd Precision Manufacturer Co., Ltd.
General Hospital · 141d
Cleared Aug 26, 2020
Deltaven Fast Flash Closed I.V. Catheter Systems
K200373 · FOZ
Delta Med Spa
General Hospital · 194d
Cleared Aug 26, 2020
TK Intravascular Administration Set
K191640 · FPA
Anhui Tiankang Medical Technology...
General Hospital · 434d
Cleared Aug 25, 2020
Nitrile Powder Free Examination Gloves with Low Dermatitis Potential Claim...
K201772 · LZA
Hartalega NGC Sdn. Bhd.
General Hospital · 57d
Cleared Aug 25, 2020
Med-link Reusable Temperature Probes, Med-link Disposable Temperature Probes
K193338 · FLL
Shenzhen Med-Link Electronics Tech...
General Hospital · 267d
Cleared Aug 25, 2020
Injection Pen Needle
K192464 · FMI
Gangan Medical Technology Jiangsu...
General Hospital · 351d
Cleared Aug 20, 2020
Synthetic Nitrile Patient Exam Gloves, Powder Free, Blue, Tested for Use...
K200093 · LZA
Anhui Lntco Medical Products Co., Ltd.
General Hospital · 217d
Cleared Aug 20, 2020
TidalPort-AP Implantable Apheresis Vascular Access Port
K192291 · PTD
Norfolk Medical Products, Inc.
General Hospital · 363d
Cleared Aug 19, 2020
Asept Surgical Face Mask
K201137 · FXX
Pfm Medical, Inc.
General Hospital · 113d
Cleared Aug 12, 2020
Surgical Mask
K201871 · FXX
C & S Paper Yunfu Co., Ltd.
General Hospital · 36d
Cleared Aug 12, 2020
BD PhaSeal Optima Closed System Drug Transfer Device
K201099 · ONB
Becton, Dickinson and Company
General Hospital · 110d
Cleared Aug 11, 2020
0.9% Sodium Chloride I.V. Flush Syringe for Sterile Delivery, 1...
K201286 · NGT
Nurse Assist, LLC
General Hospital · 89d
Cleared Aug 10, 2020
1ml Luer Slip or Luer Lock Syringe, Syringe with permanently attached needle,...
K192551 · MEG
Jiangsu Caina Medical Co.,Ltd
General Hospital · 328d
Cleared Aug 07, 2020
MedSource CathMED IV Catheter
K193278 · FOZ
Medsource Labs
General Hospital · 254d
Cleared Aug 07, 2020
Sterile High-pressure Angiographic Syringes for Single-use
K192657 · DXT
Shenzhen Boon Medical Supply Co., Ltd.
General Hospital · 317d
Cleared Aug 07, 2020
ProSeal™ Closed System drug Transfer Device (CSTD)
K192075 · ONB
Epic Medical Pte. , Ltd.
General Hospital · 371d
Cleared Aug 06, 2020
Mini Sterilizable Tray
K200858 · KCT
Implant Direct Sybron Manufacturing, LLC
General Hospital · 127d
Cleared Aug 06, 2020
Steripack cases and Tray Systems
K193066 · KCT
Avalign Technologies, Inc.
General Hospital · 276d
Cleared Aug 06, 2020
TK Safety Needle
K191644 · FMI
Anhui Tiankang Medical Technology...
General Hospital · 414d
Cleared Aug 05, 2020
Sterile Nitrile Powder Free Examination Glove Tested for Use with...
K201531 · LZA
Hartalega Sdn Bhd
General Hospital · 58d
Cleared Aug 05, 2020
Nitrile Powder Free Examination Glove Tested for Use with Chemotherapy Drugs...
K201530 · LZA
Hartalega NGC Sdn. Bhd.
General Hospital · 58d