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
121–144 of 17,825
Search insights Median review: 89d Cleared: 100% Top manufacturer: Baxter Healthcare Corp Lead specialty: General Hospital
Cleared Mar 03, 2026
Surgical Face Mask (Ear mount)
K252534 · FXX
Zhejiang Hangkang Medical Equipment...
General Hospital · 203d
Cleared Feb 26, 2026
Enbio PRO
K260254 · FLE
Enbio Group AG
General Hospital · 30d
Cleared Feb 26, 2026
PUREVUE™ Quick Connect Cannula System Tray
K253791 · KCT
DePuy Mitek, Inc.
General Hospital · 90d
Cleared Feb 26, 2026
Copioumed AAMI 3 Surgical Gown
K251860 · FYA
Copioumed International, Inc.
General Hospital · 254d
Cleared Feb 23, 2026
Profoject™ Insulin Syringes
K253068 · FMF
CMT Health PTE., Ltd.
General Hospital · 154d
Cleared Feb 20, 2026
LF Process Indicator Tape for Steam Sterilization
K260181 · JOJ
Intertape Polymer Group
General Hospital · 30d
Cleared Feb 19, 2026
Disposable Surgical Mask (Non-Sterile) (EFX3PLBLKMSK300)
K253398 · FXX
Efofex, Inc.
General Hospital · 142d
Cleared Feb 19, 2026
Profoject™ Low Dead Space Syringe /Profoject™ Tuberculin Syringe
K252814 · QNQ
CMT Health PTE., Ltd.
General Hospital · 168d
Cleared Feb 18, 2026
PA3X Detachable Safety Sleeve Syringe (with needle) (SC-23ED / SD-23ED)
K252098 · MEG
Methyl Co., Ltd.
General Hospital · 230d
Cleared Feb 13, 2026
MEDRAD MRXperion MR Injection System and MR Injection System Syringe Kit
K252891 · DXT
Bayer Medical Care, Inc.
General Hospital · 155d
Cleared Feb 13, 2026
Babyleo TN500
K251619 · FMZ
Dr?gerwerk AG & Co KGaA
General Hospital · 262d
Cleared Feb 12, 2026
PuraCath Firefly Needleless Connector IT (9005)
K251375 · FPA
Puracath Medical, Inc.
General Hospital · 286d
Cleared Feb 11, 2026
SteriHub™ Disinfecting Device and Protective Cover
K251592 · QBP
1World Vista Medical
General Hospital · 264d
Cleared Feb 06, 2026
Stainless Steel Surgical Kits
K251614 · KCT
Dentsply Sirona, Inc.
General Hospital · 255d
Cleared Feb 04, 2026
Henan Yadu Level 4 Surgical Gowns (Reinforced)
K252301 · FYA
Yadu Medical (Henan) Co., Ltd.
General Hospital · 195d
Cleared Jan 30, 2026
Medblue Skin Prick Test Applicator (AS103, AS108, AS109, AS110, AS111, AS113,...
K250983 · SCL
Asistan Medikal
General Hospital · 305d
Cleared Jan 29, 2026
UV Smart D60
K251354 · SCS
UV Smart Technologies B.V.
General Hospital · 274d
Cleared Jan 28, 2026
FreedomEdge Infusion System
K252015 · FRN
Koru Medical Systems, Inc.
General Hospital · 215d
Cleared Jan 28, 2026
Sterilization Pouch/Roll
K251347 · FRG
Sterivic Medical Co., Ltd.
General Hospital · 273d
Cleared Jan 23, 2026
Syntex Exam Gloves
K253160 · LZA
Basic Medical Technology, Inc.
General Hospital · 119d
Cleared Jan 22, 2026
Getinge GSS67N Series Steam Sterilizer
K252307 · FLE
Maquet GmbH (A Getinge Group Company)
General Hospital · 182d
Cleared Jan 15, 2026
SnugLit(TM) Wearable Phototherapy System (SNGL-01-US)
K251308 · LBI
Thera B Medical Products
General Hospital · 262d
Cleared Jan 14, 2026
Cardinal Health Nitrile Examination Gloves Extended Cuff
K252313 · LZC
Cardinalhealth
General Hospital · 173d
Cleared Jan 13, 2026
Non-sterile Powder Free Nitrile Examination Glove, Dual Color (White-Green),...
K252549 · LZA
Kossan International Sdn Bhd
General Hospital · 153d