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
1897–1920 of 17,825
Search insights Median review: 89d Cleared: 100% Top manufacturer: Baxter Healthcare Corp Lead specialty: General Hospital
Cleared May 07, 2021
Blue Nitrile Powder Free Patient Examination Glove, Non Sterile
K210366 · LZA
Onetexx Sdn Bhd
General Hospital · 88d
Cleared May 07, 2021
SURGICAL MASK, Model Name:C015
K210218 · FXX
Qingdao Hainuo Biological Engineering...
General Hospital · 100d
Cleared May 07, 2021
Karl Storz Radel Sterilization Trays
K203572 · KCT
KARL STORZ Endoscopy-America, Inc.
General Hospital · 151d
Cleared May 07, 2021
Non Sterile Powder Free Polyurethane Examination Gloves (Blue and Black colors)
K203036 · LZA
Central Medicare Sdn Bhd
General Hospital · 214d
Cleared May 06, 2021
Defender Safety Procedure Mask Level 1, Defender Safety Procedure Mask Level...
K210705 · FXX
Defender Safety, Inc.
General Hospital · 58d
Cleared May 06, 2021
3 Layer Surgical Mask with Ear Loops Level 1, 3 Layer Surgical Mask with Ties...
K202598 · FXX
3A Medical Products Co., Ltd.
General Hospital · 240d
Cleared May 06, 2021
SmartSite Bag 500mL, SmartSite Bag 250 mL, SmartSite Bag 100 mL
K201936 · KPE
Gilero, LLC
General Hospital · 297d
Cleared May 06, 2021
Umbilical Vessels Catheter
K201697 · FOS
Haolang Medical USA Corporation
General Hospital · 318d
Cleared May 04, 2021
Surgical Mask
K210304 · FXX
Jin Pin Electrical Co., Ltd. Zhuhai...
General Hospital · 90d
Cleared May 04, 2021
ProntoPump Sterile Tube Set
K200893 · LHI
Ipax, Inc.
General Hospital · 396d
Cleared Apr 29, 2021
Powder Free Nitrile Examination Glove, Tested for Use with Chemoterapy Drugs...
K210944 · LZA
Harbour Health, LLC
General Hospital · 30d
Cleared Apr 29, 2021
Infrared Thermometer
K203454 · FLL
Shandong Zhushi Pharmaceutical Group...
General Hospital · 157d
Cleared Apr 29, 2021
M1 Surgical Face Mask
K202457 · FXX
CHISON Medical Technologies Co., Ltd.
General Hospital · 245d
Cleared Apr 28, 2021
Medical Mask
K210020 · FXX
Zhende Medical Co., Ltd.
General Hospital · 114d
Cleared Apr 28, 2021
Disposable Nitrile Examination Gloves
K203436 · LZA
Shandong Zhushi Pharmaceutical Group...
General Hospital · 156d
Cleared Apr 26, 2021
Powder Free Blue Nitrile Examination Glove
K203512 · LZA
Vip Glove Sdn Bhd
General Hospital · 147d
Cleared Apr 26, 2021
Surgical Mask
K202647 · FXX
Ningbo Green Textile Co., Ltd.
General Hospital · 227d
Cleared Apr 23, 2021
Medical Surgical Mask
K210030 · FXX
Tianjin Aoshang Outdoor Equipment...
General Hospital · 108d
Cleared Apr 23, 2021
Face Mask
K210007 · FXX
Jinhua Jingdi Medical Supplies Co., Ltd.
General Hospital · 109d
Cleared Apr 23, 2021
Surgical Mask - Level 3 - Blue - 50 pcs, Surgical Mask - Level 3 - White - 50...
K202607 · FXX
String King Lacrosse, LLC
General Hospital · 226d
Cleared Apr 23, 2021
SIGMA Sterilization Pouch and Roll
K202462 · FRG
Sigma Medical Supplies Corporation
General Hospital · 239d
Cleared Apr 23, 2021
Disposable Surgical Face Mask
K202387 · FXX
Guangdong Bida Medical Technology...
General Hospital · 245d
Cleared Apr 23, 2021
Naton Disposable Surgical Face Mask
K201853 · FXX
Naton Biotechnology (Beijing) Co., Ltd.
General Hospital · 291d
Cleared Apr 22, 2021
Verifine Safety Type Insulin Pen Needle
K210065 · FMI
Promisemed Hangzhou Meditech Co., Ltd.
General Hospital · 101d