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
1849–1872 of 17,791
Search insights Median review: 89d Cleared: 100% Top manufacturer: Baxter Healthcare Corp Lead specialty: General Hospital
Cleared May 17, 2021
Ear-Friendly Mask
K211105 · FXX
Ray Co., Ltd.
General Hospital · 34d
Cleared May 17, 2021
NitriTec Vinyl Glove Powder Free Blue
K210460 · LYZ
Zhonghong Pulin Medical Products Co.,...
General Hospital · 90d
Cleared May 17, 2021
Needleless Connector
K210217 · FPA
Jiangsu Caina Medical Co.,Ltd
General Hospital · 110d
Cleared May 14, 2021
Powder Free Vinyl Patient Examination Gloves
K210799 · LYZ
Yunnan Huazhiyuan Medical Technology...
General Hospital · 59d
Cleared May 14, 2021
Powder Free Vinyl Patient Examination Gloves, Clear (non-colored)
K210780 · LYZ
Shandong Shangwei Medical Products...
General Hospital · 60d
Cleared May 14, 2021
Powder Free Vinyl Patient Examination Gloves, Clear (non-colored)
K210774 · LYZ
Shandong Jieshi Medical Products Co.,...
General Hospital · 60d
Cleared May 14, 2021
Disposable Medical mask
K210302 · FXX
Anhui Jbh Medical Apparatus Co., Ltd.
General Hospital · 100d
Cleared May 14, 2021
1 ml Sterile Hypodermic Syringe For Single Use. With/Without Needle....
K210200 · FMF
Set Medikal Sanayi VE Ticaret Anonim...
General Hospital · 109d
Cleared May 13, 2021
Disposable Face Mask
K210815 · FXX
Biobase Scientific (Shandong) Co., Ltd.
General Hospital · 56d
Cleared May 13, 2021
Powder Free Nitrile Examination Glove
K210369 · LZA
Pastel Glove Sdn Bhd
General Hospital · 94d
Cleared May 13, 2021
United Sewing High Fluid Resistant Disposable Face Mask, United Sewing High...
K202697 · FXX
United Sewing Automation, Inc.
General Hospital · 239d
Cleared May 12, 2021
SYSTEM 1E Liquid Chemical Sterilant Processing System, SYSTEM 1 endo Liquid...
K210737 · MED
STERIS Corporation
General Hospital · 62d
Cleared May 10, 2021
Single-use medical poly (vinyl chloride) examination glove
K201504 · LYZ
Anhui Bytech Medical Supplies Co., Ltd.
General Hospital · 339d
Cleared May 07, 2021
Powder Free Nitrile Patient Examination Gloves, Non-Sterile (Blue)
K210755 · LZA
Meditech Gloves Sdn Bhd
General Hospital · 53d
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