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
793–816 of 17,825
Search insights Median review: 89d Cleared: 100% Top manufacturer: Baxter Healthcare Corp Lead specialty: General Hospital
Cleared May 26, 2023
Gammex® PI Plus Glove-in-Glove™ System Tested For Use with Chemotherapy Drugs
K213289 · KGO
Ansell Healthcare Products, LLC
General Hospital · 602d
Cleared May 25, 2023
STERLINK plus Sterilizer with STERLOAD Cassette, Tyvek Roll with CI for...
K231169 · MLR
Plasmapp Co,., Ltd.
General Hospital · 30d
Cleared May 25, 2023
Nipro SafeTouch Needle
K222852 · FMI
Nipro Medical Corporation
General Hospital · 246d
Cleared May 23, 2023
Green Non Sterile Powder Free Nitrile Examination Gloves
K230564 · LZA
Central Medicare Sdn Bhd
General Hospital · 83d
Cleared May 22, 2023
MixJect® Transfer Device
K230464 · LHI
West Pharma Services Il, Ltd.
General Hospital · 90d
Cleared May 19, 2023
SafeBreak® Vascular
K223486 · QOI
Lineus Medical
General Hospital · 179d
Cleared May 19, 2023
Disposable Medical Mask
K222545 · FXX
Guangzhou Fuzelong Hygiene Material...
General Hospital · 270d
Cleared May 18, 2023
I.V. Administration Set, I.V. Extension Set
K223645 · FPA
Bq Plus Medical Co., Ltd.
General Hospital · 163d
Cleared May 18, 2023
3M™ Ioban™ CHG Chlorhexidine Gluconate Incise Drape (contains 2% w/w CHG)
K222578 · KKX
3M Company
General Hospital · 266d
Cleared May 17, 2023
Biodegradable Nitrile Powder Free Examination Glove Tested for Use with...
K223437 · LZA
Hartalega NGC Sdn. Bhd.
General Hospital · 184d
Cleared May 15, 2023
Nitrile Examination Gloves Powder Free Tested For Use With Chemotherapy Drugs...
K230121 · LZA
Careglove Global Sdn. Bhd.
General Hospital · 118d
Cleared May 13, 2023
Sterile Polyisoprene Powder Free Surgical Glove, Tested for Use with...
K230217 · KGO
Grand Work Plastic Products Co., Ltd.
General Hospital · 107d
Cleared May 12, 2023
BD Secondary Infusion Set
K223101 · FPA
Care Fusion
General Hospital · 224d
Cleared May 10, 2023
Digital Thermometer (Model QT001)
K223044 · FLL
Shen Zhen Rong Feng Technology Co., Ltd.
General Hospital · 223d
Cleared May 09, 2023
Tyvek Roll with CI for STERLINK Sterilizer
K223025 · FRG
Plasmapp Co,., Ltd.
General Hospital · 222d
Cleared May 09, 2023
Terragene Bionava SCBI (BT96), Terragene Bionova Reader Incubators...
K223023 · FRC
Plasmapp Co,., Ltd.
General Hospital · 222d
Cleared May 09, 2023
STERLINK™ FPS-15s Plus sterilizer with STERPACK™ plus cassette
K223015 · MLR
Plasmapp Co,., Ltd.
General Hospital · 222d
Cleared May 09, 2023
Sterile Syringe for Single Use (with Needle), Sterile Hypodermic Needle for...
K212857 · FMF
Jiangsu Zhiyu Medical Instrument Co,...
General Hospital · 608d
Cleared May 08, 2023
Disposible Nitrile Gloves
K223280 · LZA
Holik Asia Group Co.,Ltd
General Hospital · 196d
Cleared May 05, 2023
Polyguard and Polyshield Safety IV Catheters
K230616 · FOZ
Poly Medicure Limited
General Hospital · 60d
Cleared May 05, 2023
Lexa MINI (RIS-303, RIS-305)
K223858 · FLE
W&H Sterilization S.R.L.
General Hospital · 133d
Cleared May 04, 2023
Orchid Safety Release Valve
K230266 · QOI
Linear Health Sciences, LLC
General Hospital · 93d
Cleared May 04, 2023
Sol-Guard Auto-disable Syringe
K220713 · FMF
Sol-Millennium Medical, Inc.
General Hospital · 419d
Cleared May 01, 2023
RIA Safeguard
K222416 · FRF
Ria Tech Co., Ltd.
General Hospital · 264d