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
1825–1848 of 17,825
Search insights Median review: 89d Cleared: 100% Top manufacturer: Baxter Healthcare Corp Lead specialty: General Hospital
Cleared Jun 28, 2021
Violet Nitrile Powder Free Patient Examination Glove, Non Sterile
K210587 · LZA
Onetexx Sdn Bhd
General Hospital · 122d
Cleared Jun 25, 2021
Safety Winged Blood Collection Sets
K211293 · FMI
Promisemed Hangzhou Meditech Co., Ltd.
General Hospital · 60d
Cleared Jun 25, 2021
Nitrile Glove
K211252 · LZA
Jiangsu Dihong Industry and Trade...
General Hospital · 60d
Cleared Jun 24, 2021
SMARTRELEASE Endoscopic Soft Tissue Release System
K211297 · HRX
Microaire Surgical Instruments
General Hospital · 57d
Cleared Jun 24, 2021
ENCORE Latex Ortho, Powder Free Latex Surgical Gloves with Protein Content...
K210656 · KGO
Careplus (M) Sdn Bhd
General Hospital · 112d
Cleared Jun 24, 2021
Powder Free Black Nitrile Examination Glove
K201428 · LZA
Vietglove Corporation
General Hospital · 391d
Cleared Jun 23, 2021
Synthetic Vinyl Examination Gloves
K211045 · LYZ
Jiangsu Huayuan Medical Technology...
General Hospital · 76d
Cleared Jun 23, 2021
NovoFine
K210258 · FMI
Novo Nordisk, Inc.
General Hospital · 142d
Cleared Jun 22, 2021
Disposable Surgical Mask
K210840 · FXX
Safeway Industry Healthcare.
General Hospital · 92d
Cleared Jun 21, 2021
Steri-Dot Process Indicator
K210866 · JOJ
Propper Manufacturing Co., Inc.
General Hospital · 90d
Cleared Jun 21, 2021
Powder Free Blue Nitrile Examination Glove
K210375 · LZA
Duramitt Sdn Bhd
General Hospital · 133d
Cleared Jun 21, 2021
Biodegradable Powder Free Neoprene Examination Glove, Low Dermatitis...
K202085 · LZA
Shen Wei (Usa), Inc.
General Hospital · 329d
Cleared Jun 18, 2021
Intravascular Extension Set
K210430 · FPA
Baxter Healthcare Corporation
General Hospital · 126d
Cleared Jun 18, 2021
iBed Wireless with iBed Mobile
K202964 · FNL
Stryker Corporation
General Hospital · 261d
Cleared Jun 17, 2021
Infrared Thermometer
K202440 · FLL
Shenzhen Sonida Digital Technology...
General Hospital · 296d
Cleared Jun 16, 2021
Disposable Vinyl Examination Glove
K211336 · LYZ
Inner Mongolia Cureguard Medical...
General Hospital · 44d
Cleared Jun 16, 2021
AMADEX - Nitrile Powder Free Examination Gloves Non-Sterile (Blue, Black,...
K211310 · LZA
Megine Industries Sdn Bhd
General Hospital · 47d
Cleared Jun 16, 2021
Disposable Medical Surgical Face Mask
K203200 · FXX
Guangdong Haiou Medical Apparatus...
General Hospital · 230d
Cleared Jun 15, 2021
Amerishield Surgical Mask
K211520 · FXX
Premiumestore, LLC
General Hospital · 29d
Cleared Jun 14, 2021
Surgical Face Mask
K210518 · FXX
Shandong Haidike Medical Products...
General Hospital · 111d
Cleared Jun 13, 2021
Microflex Nitrile Patient Examination Gloves Blue Colored Tested for Use with...
K210401 · LZA
Ansell Healthcare Products, LLC
General Hospital · 123d
Cleared Jun 11, 2021
Surgical Face Mask
K203732 · FXX
Zhuhai Gaoge Medical Technology Co.,...
General Hospital · 172d
Cleared Jun 11, 2021
Radius T wearable thermometer
K203215 · FLL
Masimo Corporation
General Hospital · 221d
Cleared Jun 11, 2021
POWDER FREE NITRILE SURGICAL GLOVE, STERILE, TESTED FOR USE WITH CHEMOTHERAPY...
K203030 · KGO
Wrp Asia Pacific Sdn. Bhd.
General Hospital · 252d