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
505–528 of 17,825
Search insights Median review: 89d Cleared: 100% Top manufacturer: Baxter Healthcare Corp Lead specialty: General Hospital
Cleared Apr 22, 2024
Black Pearl Nitrile Examination Glove
K232319 · LZA
Ug Global Resources Sdn. Bhd.
General Hospital · 263d
Cleared Apr 19, 2024
ulricheasyINJECT Max 2M (XD 10140)
K233737 · IZQ
Ulrich GmbH & Co. KG
General Hospital · 149d
Cleared Apr 19, 2024
AccuCath Ace™ Intravascular Catheter
K233106 · FOZ
Bard Access Systems, Inc. (C.R. Bard,...
General Hospital · 205d
Cleared Apr 18, 2024
Disposable Medical Face Mask (M643BE)
K240258 · FXX
Makrite Industries, Inc.
General Hospital · 78d
Cleared Apr 17, 2024
Celerity Chemical Indicator for enspire 3000 CLCSPS
K240032 · JOJ
STERIS Corporation
General Hospital · 104d
Cleared Apr 16, 2024
nextaro® v, 20/20
K240748 · LHI
Sfm Medical Devices GmbH
General Hospital · 28d
Cleared Apr 12, 2024
Medical electronic thermometer (FC01, FC02)
K240109 · FLL
Zhuzhou Goldenhot Medical Technology...
General Hospital · 87d
Cleared Apr 12, 2024
Disposable Extension Set
K222766 · FPA
Shandong Ande Healthcare Apparatus...
General Hospital · 577d
Cleared Apr 10, 2024
CELERITY HP Indicator Tape
K240760 · JOJ
Steris
General Hospital · 21d
Cleared Apr 10, 2024
8Q10 Surclear Smoke Plume Evacuation System
K233789 · FYD
Surnic Corporation
General Hospital · 134d
Cleared Apr 08, 2024
Powder Free Nitrile Examination Glove 3.5, Blue Color, Non-Sterile, and...
K240021 · LZA
Yue Kang Anhui Medical Products Co.,...
General Hospital · 96d
Cleared Apr 05, 2024
Wireless Smart Thermometer
K233192 · FLL
Famidoc Technology Company Limited
General Hospital · 190d
Cleared Apr 05, 2024
Terragene® Chemdye® Multivariable Chemical Indicator (CD40), Terragene®...
K232103 · QKM
Terragene S.A.
General Hospital · 266d
Cleared Apr 05, 2024
ACTIV™ Cap
K223914 · QBP
Cleansite Medical, Inc.
General Hospital · 463d
Cleared Apr 04, 2024
Powder Free Green Nitrile Examination Gloves (XS/S/M/L/XL)
K240361 · LZA
Hebei Titans Hongsen Medical...
General Hospital · 58d
Cleared Apr 04, 2024
Midmark Smart M9® Sterilizer, Midmark Smart M11® Sterilizer
K233026 · FLE
Midmark Corporation
General Hospital · 195d
Cleared Apr 03, 2024
Digital Thermometer
K230889 · FLL
Wenzhou Yosun Medical Technology Co.,Ltd
General Hospital · 369d
Cleared Apr 02, 2024
Aloe Vera Nitrile Examination Gloves (Green) Tested for Use with Chemotherapy...
K240080 · LZA
Syntex Healthcare Products Co., Ltd.
General Hospital · 82d
Cleared Apr 02, 2024
R&G Surgical Mask
K232112 · FXX
R&G Seguridad E Higiene Industrial...
General Hospital · 263d
Cleared Apr 01, 2024
Nitrile Disposable Examination Gloves, Tested for Use with Chemotherapy Drugs...
K233990 · LZA
Shandong Xingyu Gloves Co., Ltd.
General Hospital · 105d
Cleared Mar 29, 2024
Disposable Surgical Gown
K233068 · FYA
Nanning Tecbod Biological Technology...
General Hospital · 185d
Cleared Mar 29, 2024
Dose IQ Safety Software
K230665 · PHC
Baxter Healthcare Corporation
General Hospital · 385d
Cleared Mar 29, 2024
Novum IQ Large Volume Pump
K211122 · FRN
Baxter Healthcare Corporation
General Hospital · 1079d
Cleared Mar 28, 2024
ProSeal™ Injector Plus (Model no. 421050)
K240171 · ONB
Epic Medical Pte. , Ltd.
General Hospital · 66d