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
1345–1368 of 17,825
Search insights Median review: 89d Cleared: 100% Top manufacturer: Baxter Healthcare Corp Lead specialty: General Hospital
Cleared Mar 04, 2022
Surgical Mask
K213358 · FXX
Shenzhen Safesecure Medical Infection...
General Hospital · 143d
Cleared Mar 04, 2022
Surgical Trays
K212281 · KCT
Dentsply Sirona, Inc.
General Hospital · 226d
Cleared Mar 04, 2022
Medcare Powder-Free Blue Nitrile Patient Examination Gloves
K211808 · LZA
Dongguan Grinvald Technology Co., Ltd.
General Hospital · 266d
Cleared Mar 04, 2022
Powder Free Black Nitrile Examination Gloves, Non-Sterile, Tested for Use...
K210330 · LZA
Wrp Asia Pacific Sdn. Bhd.
General Hospital · 393d
Cleared Mar 04, 2022
Disposable Automatically Retractable Insulin Safety Syringe
K210216 · MEG
Shantou Wealy Medical Instrument Co.,Ltd
General Hospital · 401d
Cleared Mar 03, 2022
IV Administration Set
K213778 · FPA
B.Braun Medical, Inc.
General Hospital · 90d
Cleared Mar 02, 2022
Giraffe Incubator Carestation CS1
K213553 · FMZ
Datex-Ohmeda, Inc.
General Hospital · 114d
Cleared Mar 02, 2022
Giraffe Omnibed Carestation CS1
K213551 · FMT
Datex-Ohmeda, Inc.
General Hospital · 114d
Cleared Mar 02, 2022
Fort Defiance Industries FRONT-LINE Field Sterilizer FL120, Fort Defiance...
K213457 · FLE
Fort Defiance Industries, LLC
General Hospital · 126d
Cleared Mar 02, 2022
Plus Medical Isolation Gown Level 3
K212698 · FYC
Foshan Nanhai Plus Medical Co, Ltd.
General Hospital · 189d
Cleared Mar 02, 2022
Sterile Syringe with Fixed Safety Needle for Single Use
K212652 · MEG
Gemtier Medical (Shanghai), Inc.
General Hospital · 191d
Cleared Mar 02, 2022
Southern Implants Instrument Trays
K210923 · KCT
Southern Implants (Pty), Ltd.
General Hospital · 338d
Cleared Mar 02, 2022
ASTM Level 1/EN14683 Type IIR 3-Ply disposable Surgical Mask, Model number:...
K203376 · FXX
Medtecs (Taiwan) Corp.
General Hospital · 470d
Cleared Mar 01, 2022
Sterile Disposable Temperature Probe
K212945 · FLL
Shenzhen Envisen Industry Co., Ltd.
General Hospital · 167d
Cleared Mar 01, 2022
Sterile Latex Surgical Gloves Powder Free
K212596 · KGO
Amazing Rubber Products Pvt, Ltd.
General Hospital · 197d
Cleared Mar 01, 2022
Microlife Non-Contact Infrared Forehead Thermometer, Model FR1MF1-B (NC150 BT)
K211776 · FLL
Microlife Intellectual Property GmbH
General Hospital · 265d
Cleared Mar 01, 2022
Disposable Sterile Syringe with Safety Needle
K211484 · MEG
Shinva Ande Healthcare Apparatus Co.,...
General Hospital · 293d
Cleared Mar 01, 2022
Sure-Fine Insulin Syringes
K210848 · FMF
Shina Med Corporation
General Hospital · 344d
Cleared Mar 01, 2022
Vigilant Software Suite – Vigilant Master Med
K210075 · PHC
Fresenius Kabi AG
General Hospital · 413d
Cleared Mar 01, 2022
Agilia SP Infusion System, Agilia SP MC WIFI Infusion Pump, Agilia Link,...
K210074 · FRN
Fresenius Kabi AG
General Hospital · 413d
Cleared Mar 01, 2022
Agilia VP Infusion System, Agilia VP MC WIFI Infusion Pump, Volumat Lines...
K210073 · FRN
Fresenius Kabi AG
General Hospital · 413d
Cleared Feb 28, 2022
Disposable Nitrile Examination Gloves
K212833 · LZA
Chifeng Huawei Medical...
General Hospital · 174d
Cleared Feb 25, 2022
Ear Thermometer, Model ET005, ET008, ET009
K213084 · FLL
Guangzhou Berrcom Medical Device Co.,...
General Hospital · 155d
Cleared Feb 24, 2022
ROKI Surgical Mask
K214094 · FXX
Roki Co., Ltd.
General Hospital · 58d