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
745–768 of 17,825
Search insights Median review: 89d Cleared: 100% Top manufacturer: Baxter Healthcare Corp Lead specialty: General Hospital
Cleared Jul 17, 2023
Durio Surgical Face Mask, Models 501 (3-ply, blue) and 545 (4-ply,blue)
K230395 · FXX
Durio Ppe Sdn Bhd
General Hospital · 153d
Cleared Jul 13, 2023
Praxiject™ 0.9% NaCl
K231754 · NGT
Medxl, Inc.
General Hospital · 28d
Cleared Jul 11, 2023
Anthogyr Surgical Cassettes
K230680 · KCT
Anthogyr
General Hospital · 120d
Cleared Jul 07, 2023
Complement Kit Cases
K230804 · KCT
JJGC Ind?stria e Com?rcio de...
General Hospital · 106d
Cleared Jul 07, 2023
Blood Collection Set, Blood Collection Set with Holder, Safety Blood...
K230080 · JKA
Yangzhou Medline Industry, Co., Ltd.
General Hospital · 177d
Cleared Jul 04, 2023
MemorialTM Gloves
K231740 · LZA
Us Glove Supply
General Hospital · 20d
Cleared Jul 03, 2023
Cardinal Health Surgical Mask With Anti-fog Hydrogel (Level 3 )
K230569 · FXX
Cardinalhealth
General Hospital · 124d
Cleared Jun 30, 2023
enspire 3000 Cleaning and Liquid Chemical Sterile Processing System
K230930 · FEB
STERIS Corporation
General Hospital · 88d
Cleared Jun 30, 2023
Unistik® ShieldLock, Unistik VacuFlip
K223854 · JKA
Owen Mumford, Ltd.
General Hospital · 189d
Cleared Jun 28, 2023
e-Celsius Medical System
K210924 · FLL
Bodycap
General Hospital · 821d
Cleared Jun 27, 2023
NobelZygoma PureSet™ Tray
K231219 · KCT
Nobel Biocare Services AG
General Hospital · 60d
Cleared Jun 23, 2023
Mais Central Venous Catheter
K221827 · FOZ
Saudi Mais Co. For Medical Products
General Hospital · 365d
Cleared Jun 23, 2023
Surflo Winged Infusion Set
K221411 · FPA
Terumo Medical Products Hangzhou Co.,...
General Hospital · 403d
Cleared Jun 21, 2023
Sturdy Autoclave Super Microm
K231489 · FLE
Sturdy Industrial Co., Ltd.
General Hospital · 29d
Cleared Jun 21, 2023
Monoject Magellan Insulin Safety Syringe 1mL, 31G x 6mm (8881893110)
K223376 · MEG
Cardinal Health200, LLC
General Hospital · 229d
Cleared Jun 20, 2023
NC° Thermometer (Gen 3), Model Number: NCTG3
K223522 · FLL
Xiamen Intretech, Inc.
General Hospital · 209d
Cleared Jun 16, 2023
Surgical Gown
K222999 · FYA
Hubei Woozon Healthcare Co., Ltd.
General Hospital · 261d
Cleared Jun 16, 2023
Maxcon Reusable Sharps Container, 17 Gallon Sharps Container MA1421
K222906 · MMK
Ningbo Maxcon Medical Technology Co.,...
General Hospital · 266d
Cleared Jun 16, 2023
Volumat Polyethylene I.V. Administration Set
K221121 · FPA
Fresenius Kabi
General Hospital · 424d
Not Cleared Jun 16, 2023
Neoasis
DEN220048 · QWX
Invictus Medical, Inc.
General Hospital · 326d
Cleared Jun 15, 2023
UTC 3mL Medication Cartridge
K230718 · MRZ
Gilero, LLC
General Hospital · 92d
Cleared Jun 15, 2023
Celerity 5 HP Biological Indicator
K223717 · FRC
STERIS Corporation
General Hospital · 185d
Cleared Jun 15, 2023
Celerity Incubator
K223715 · FRC
STERIS Corporation
General Hospital · 195d
Cleared Jun 15, 2023
TNI Clear-Guard™ 3 angled breathing filter (1545020)
K223258 · CAH
Intersurgical , Ltd.
General Hospital · 237d