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
49–72 of 17,825
Search insights Median review: 89d Cleared: 100% Top manufacturer: Baxter Healthcare Corp Lead specialty: General Hospital
Cleared Jul 28, 2026
Latex Powder Free Surgical Gloves Tested for Use with Chemotherapy Drugs and...
K260558 · KGO
Hartalega NGC Sdn. Bhd.
General Hospital · 159d
Cleared Jul 28, 2026
Giraffe™ OmniBed™ Carestation (CS1)
K260326 · FMZ
Datex-Ohmeda, Inc.
General Hospital · 179d
Cleared Jul 24, 2026
RemunityPRO+ Pump for Remodulin® (treprostinil) Injection
K253703 · FRN
Deka R&D Corp
General Hospital · 242d
Cleared Jul 21, 2026
PUREZERO* MARIN* Nitrile Powder-Free Exam Gloves
K262014 · LZA
O&M Halyard, Inc.
General Hospital · 36d
Cleared Jul 20, 2026
Nitrile Powder Free Examination Gloves Tested for Use with Chemotherapy Drugs...
K254285 · LZA
Hartalega NGC Sdn. Bhd.
General Hospital · 201d
Cleared Jul 15, 2026
Profoject™ Pen Needles (Model A
K260739 · FMI
CMT Health PTE., Ltd.
General Hospital · 131d
Cleared Jul 13, 2026
Ultra-Fine™ SAFETY Insulin Syringe
K260208 · FMF
embecta Medical II, LLC
General Hospital · 171d
Cleared Jul 10, 2026
NYES Tuff Cuff L3 Disposable Gowns
K261949 · FYA
New York Embroidery Studio
General Hospital · 29d
Cleared Jul 10, 2026
ClearSafe Closed System
K261041 · FOZ
MedSource Labs, LLC
General Hospital · 101d
Cleared Jul 09, 2026
MedSource QuickSafe™ Safety IV Catheter
K260539 · FOZ
MedSource Labs, LLC
General Hospital · 142d
Cleared Jul 02, 2026
HALYARD* ARMOR-FLEX* Sterilization Wrap with ASSURE-DRY* Technology
K261897 · FRG
O&M Halyard, Inc.
General Hospital · 27d
Cleared Jun 24, 2026
AMSCO 700 Steam Sterilizer
K261055 · FLE
STERIS Corporation
General Hospital · 85d
Cleared Jun 24, 2026
Biodegradable Powder Free Nitrile Examination Glove, Blue Color, Tested for...
K252117 · LZA
Sw Technologies, Inc.
General Hospital · 352d
Cleared Jun 18, 2026
Powder Free Nitrile Examination Gloves Non-Sterile Black
K253824 · LZA
Kanglongda Vietnam Protection...
General Hospital · 199d
Cleared Jun 18, 2026
SteriBest® Sterilization Tray System
K253187 · KCT
Mastel Surgical
General Hospital · 265d
Cleared Jun 18, 2026
Sol-Glide Safety Needle
K253110 · FMF
Sol-Millennium Medical, Inc.
General Hospital · 267d
Cleared Jun 18, 2026
InstaTRU Instant Biological Indicator for Steam (IBI-05)
K251559 · QVB
True Indicating, LLC
General Hospital · 393d
Cleared Jun 17, 2026
FLEXI-PORT™ Power Injectable Implantable Port
K260916 · LJT
Portal Access, Inc.
General Hospital · 90d
Cleared Jun 17, 2026
Nitrile Powder Free Examination Gloves Tested for Use with Chemotherapy Drugs...
K260867 · LZA
Hartalega NGC Sdn. Bhd.
General Hospital · 92d
Cleared Jun 12, 2026
Profoject™ Safety Needle
K260514 · FMF
CMT Health PTE., Ltd.
General Hospital · 115d
Cleared Jun 12, 2026
MEDRAD® Imaging Bulk Package Transfer Spike
K253688 · PQH
Bayer Medical Care, Inc.
General Hospital · 203d
Cleared Jun 12, 2026
ADRx™ Admixture Device
K252987 · LHI
Epic Medical Pte. , Ltd.
General Hospital · 267d
Cleared Jun 10, 2026
Profoject™ Safety Pen Needles
K260855 · FMI
CMT Health PTE., Ltd.
General Hospital · 86d
Cleared Jun 05, 2026
Vial Adapter
K260301 · LHI
Hangzhou Qiantang Longyue...
General Hospital · 126d