FDA 510(k) Searchable Database - Search 175,000+ Clearances

Search 175,000+ FDA 510(k) clearances by K-number, device name, manufacturer or product code. Includes real review time data, denied submission rates and regulatory intelligence not available on any other searchable 510(k) database.

175,972 clearances · 1976 to present · Updated monthly from FDA records

Filters: General Hospital ×
17,791 results
1753–1776 of 17,791
Search insights Median review: 89d Cleared: 100% Top manufacturer: Baxter Healthcare Corp Lead specialty: General Hospital
Cleared Jul 22, 2021
Single-use medical face mask
K210391 · FXX
Zhuhai Herald Datanetics Limited.
General Hospital · 162d
Cleared Jul 22, 2021
Standard Surgical Gown (AAMI Level 3), Reinforced Surgical Gown (AAMI Level 3)
K210143 · FYA
Foshan Nanhai Plus Medical Co, Ltd.
General Hospital · 184d
Cleared Jul 22, 2021
Temp Pal
K202603 · FLL
Iweecare Co., Ltd.
General Hospital · 317d
Cleared Jul 21, 2021
Single-Use Surgical Mask Model FE2311B
K210970 · FXX
Byd Precison Manufacturer Co., Ltd.
General Hospital · 112d
Cleared Jul 21, 2021
AERO CHROME* Select Breathable Performance Surgical Gown, AERO CHROME* A-Line...
K210688 · FYA
O&M Halyard, Inc.
General Hospital · 135d
Cleared Jul 21, 2021
Nitrile Patient Examination Glove
K210686 · LZA
Yunnan Huazhiyuan Medical Technology...
General Hospital · 135d
Cleared Jul 21, 2021
Promisemed Insulin Pen Needle
K210059 · FMI
Promisemed Hangzhou Meditech Co., Ltd.
General Hospital · 191d
Cleared Jul 21, 2021
Surgical face mask (Model: Flat Ear Loop/CN102)
K203534 · FXX
Crown Name Disposable Hygiene...
General Hospital · 231d
Cleared Jul 21, 2021
CHIRAVAC Blood Collection Needles
K201009 · JKA
Chirana T. Injecta
General Hospital · 460d
Cleared Jul 20, 2021
Disposable Nitrile Medical Examination Glove
K210684 · LZA
Jiangsu Cureguard Glove Co., Ltd.
General Hospital · 134d
Cleared Jul 17, 2021
Vinyl Patient Examination Gloves
K211239 · LYZ
Jiangxi Shengda Medical Technology...
General Hospital · 82d
Cleared Jul 17, 2021
Powder Free Vinyl Patient Examination Gloves
K211177 · LYZ
Shijiazhuang Hongjun Plastic...
General Hospital · 88d
Cleared Jul 16, 2021
Velguard Surgical Face Mask
K210761 · FXX
Esstee Exports Health Care Division
General Hospital · 123d
Cleared Jul 16, 2021
SAFEWAY, LIFELONG PREMIUM, LIFELONG MATRIX
K210103 · FMF
Lifelong Meditech Private Limited
General Hospital · 183d
Cleared Jul 15, 2021
Edma Nitrile Examination Gloves (Tested for Use with Chemotherapy Drugs)
K211547 · LZA
Edma Group, LLC
General Hospital · 57d
Cleared Jul 15, 2021
Disposable Procedural Ear-loop Face Mask
K211042 · FXX
Changzhou Dsb Medical Co., Ltd.
General Hospital · 98d
Cleared Jul 15, 2021
Crosstex VH2O2 Chemical Indicators
K200096 · JOJ
Crosstex International, Inc. (A...
General Hospital · 546d
Cleared Jul 14, 2021
Surgical Face Mask, Surgical Mask
K201844 · FXX
Lear Corporation
General Hospital · 373d
Cleared Jul 12, 2021
Nitrile Examination Gloves
K210776 · LZA
5r Med Instruments (Chengdu) Co., Ltd.
General Hospital · 119d
Cleared Jul 12, 2021
Nitrile Patient Examination Glove
K210723 · LZA
Jiangxi Zhonghong Pulin Medical...
General Hospital · 124d
Cleared Jul 12, 2021
Disposable Medical Face Mask
K210244 · FXX
Suzhou Bolisi Medical Technology Co.,...
General Hospital · 164d
Cleared Jul 10, 2021
Medical Nitrile Examination Gloves (Power free, Blue)
K210578 · LZA
Jiangxi Hongda Medical Equipment...
General Hospital · 134d
Cleared Jul 09, 2021
Medical PVC Examination Gloves
K210821 · LYZ
Jiangxi Hongda Medical Equipment...
General Hospital · 112d
Cleared Jul 09, 2021
Powder Free White Sterilized Polyisoprene Surgical Gloves-Tested for Use with...
K200915 · KGO
Gx Corporation Sdn Bhd
General Hospital · 459d