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
865–888 of 17,791
Search insights Median review: 89d Cleared: 100% Top manufacturer: Baxter Healthcare Corp Lead specialty: General Hospital
Cleared Jan 22, 2023
Synthetic Polymer Glove - Polyethylene (Black)
K222531 · LZA
Ur Industry Sdn Bhd
General Hospital · 153d
Cleared Jan 20, 2023
FlowArt® Needle-Free Split Septum Valve
K222889 · FPA
Asset Medikal Tasarim San Tic As.
General Hospital · 119d
Cleared Jan 20, 2023
Digital Thermometer, Model: DT007, DT008
K214077 · FLL
Guangzhou Berrcom Medical Device Co.,...
General Hospital · 389d
Cleared Jan 20, 2023
Insupen Pen needle, Insupen ORIGINAL Pen Needle, Insupen ADVANCED pen needle
K203792 · FMI
Pikdare Spa
General Hospital · 753d
Cleared Jan 19, 2023
Disposable Nitrile Examination Glove
K223250 · LZA
Yangzhou Saraguard Medical Supplies...
General Hospital · 90d
Cleared Jan 13, 2023
Nitrile Exam Gloves (Chemotherapy Drug Tested)
K223748 · LZA
Us Medical Glove Company, LLC
General Hospital · 30d
Cleared Jan 13, 2023
Non-Sterile Powder Free Nitrile Examination Gloves
K223221 · LZA
Dynacare Sdn Bhd
General Hospital · 88d
Cleared Jan 13, 2023
Ideal Med Pro 3-Ply Disposable Face Mask
K221682 · FXX
Jsn Holdings, LLC
General Hospital · 217d
Cleared Jan 11, 2023
Iconic Blue Nitrile Glove - Tested for use with Chemotherapy Drugs & Fentanyl...
K222181 · LZA
Iconic Medicare Sdn Bhd
General Hospital · 173d
Cleared Jan 06, 2023
Disposable Surgical Face Mask
K203380 · FXX
Shandong Pop Jeans Intelligent...
General Hospital · 780d
Cleared Jan 05, 2023
Safety Push Button Blood Collection Set
K222834 · JKA
Jiangsu Caina Medical Co.,Ltd
General Hospital · 107d
Cleared Jan 04, 2023
Disposable Isolation Gowns (S,M,L,XL,XXL,XXXL)
K223411 · FYC
Xiamen Probtain Medical Techology...
General Hospital · 56d
Cleared Jan 04, 2023
Nitrile Powder Free Examination Glove Tested for Use with Chemotherapy Drugs...
K222907 · LZA
Rmkh Glove (Cambodia) Co., Ltd.
General Hospital · 100d
Cleared Jan 04, 2023
Surgical Face Mask
K222483 · FXX
Hubei Woozon Healthcare Co., Ltd.
General Hospital · 140d
Cleared Jan 04, 2023
Steriking LT-Blueline Pouches with Tyvek
K221379 · FRG
Wipak OY
General Hospital · 237d
Cleared Jan 03, 2023
Medical Disposable Face Masks
K222809 · FXX
Anqing Mayfield Medical Limited
General Hospital · 109d
Cleared Dec 30, 2022
Aesculap AICON Container
K214041 · KCT
Aesculap, Inc.
General Hospital · 372d
Cleared Dec 29, 2022
SafeR Syringe and SafeR Sting
K221981 · MEG
Roncadelle Operations Srl
General Hospital · 177d
Cleared Dec 28, 2022
BD AutoShield Duo™ Pen Needle
K223286 · FMI
Becton, Dickinson and Company
General Hospital · 64d
Cleared Dec 22, 2022
SteriKing LT-Blueline Pouches with Tyvek
K221377 · FRG
Wipak OY
General Hospital · 224d
Cleared Dec 21, 2022
Comfort Gown, Safewear Gown
K213893 · FYA
Xuchang Zhengde Environstar Medical...
General Hospital · 372d
Cleared Dec 20, 2022
Kangaroo OMNI™ Enteral Feeding Pump (385400 )
K221603 · LZH
Cardinal Health, LLC
General Hospital · 201d
Cleared Dec 20, 2022
Infrared Thermometer, models AOJ-20A, AOJ-20B, AOJ-20C, AOJ-20D, AOJ-20E,...
K221039 · FLL
Shenzhen AOJ Medical Technology Co.,...
General Hospital · 257d
Cleared Dec 16, 2022
Sterile Hypodermic Needles for Single Use
K223334 · FMI
Zhejiang Kindly Medical Devices Co.,...
General Hospital · 45d