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
913–936 of 17,825
Search insights Median review: 89d Cleared: 100% Top manufacturer: Baxter Healthcare Corp Lead specialty: General Hospital
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
Cleared Dec 16, 2022
Tuttnauer Pre-vacuum Steam Sterilizer models 3870HSG and 3870HSG-WS
K222608 · FLE
Tuttnauer , Ltd.
General Hospital · 109d
Cleared Dec 16, 2022
Surgical Mask
K213601 · FXX
Wuhan Zonsen Medical Products Co., Ltd.
General Hospital · 396d
Cleared Dec 15, 2022
Powder Free Polyurethane Examination Gloves, Blue color, Tested for use with...
K222892 · LZA
Grand Work Plastic Products Co., Ltd.
General Hospital · 83d
Cleared Dec 15, 2022
PM Excellence SEQUR 100 Surgical Face Mask
K220520 · FXX
Pm Excellence, LLC
General Hospital · 295d
Cleared Dec 14, 2022
Nitrile Patient Examination Glove
K222527 · LZA
Pingan Medical Products Co., Ltd.
General Hospital · 114d
Cleared Dec 14, 2022
Infrared Thermometer (Model: Y20001, Y20002)
K221800 · FLL
Zhangzhou Easepal Medical Science and...
General Hospital · 176d
Cleared Dec 13, 2022
Surgical Face Mask
K222651 · FXX
Xiantao Sanda Industrial Co., Ltd.
General Hospital · 103d
Cleared Dec 13, 2022
CCBIO ASCPO Needle
K214004 · FMI
Cc Biotechnology Corporation
General Hospital · 357d
Cleared Dec 11, 2022
Disposable Nitrile Examination Glove (Tested for use with Chemotherapy Drug)
K222733 · LZA
Inner Mongolia Boming Medical...
General Hospital · 93d
Cleared Dec 09, 2022
Medline Sure-Snap Safety Needle, Medline Sure-Snap Safety Syringe
K213054 · FMF
Medline Industries, Inc.
General Hospital · 443d
Cleared Dec 08, 2022
Warrior Blood and Fluid Warmer, Warrior EXTREME Blood and Fluid Warmer,...
K211800 · LGZ
Quality IN Flow , Ltd.
General Hospital · 546d
Cleared Dec 07, 2022
Disposable Nitrile Examination Glove
K223281 · LZA
Anhui Kindguard Medical Supplies...
General Hospital · 43d
Cleared Dec 07, 2022
3-Ply Disposable Medical Mask
K223045 · FXX
Wealth Lead Industrial Limited
General Hospital · 69d
Cleared Dec 07, 2022
Filter CareStar Plus, Filter SafeStar Plus, Filter/HME TwinStar Plus
K221836 · CAH
Dr?gerwerk AG & Co KGaA
General Hospital · 167d