FDA 510(k) Searchable Database - Search 176,325+ Clearances

Search 176,325+ 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.

176,325 clearances · 1976 to present · Updated monthly from FDA records · Free access · No registration required

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175,820 results
15385–15408 of 175,820
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Dec 17, 2021
Single Use Electrosurgical Knife with Fluid Pump System
K211172 · GEI
Micro-Tech (Nanjing) Co., Ltd.
General & Plastic Surgery · 242d
Cleared Dec 17, 2021
Hycare Med+ Nitrile Examination Gloves
K211209 · LZA
Hycare International Co., Ltd.
General Hospital · 238d
Cleared Dec 17, 2021
Cordless Prophy System, Model: i-Polish
K211531 · EKX
Guilin Woodpecker Medical Instrument...
Dental · 214d
Cleared Dec 17, 2021
Surgical Face Mask
K212059 · FXX
Zhongshan Saifute Labor Protective...
General Hospital · 169d
Cleared Dec 17, 2021
EMBOGUARD Balloon Guide Catheter
K212340 · QJP
Neuravi Limited
Neurology · 142d
Cleared Dec 17, 2021
Avenger Radial Head System
K212872 · KWI
In2bones USA, LLC
Orthopedic · 99d
Cleared Dec 17, 2021
Physica system
K213381 · JWH
Lima Corporate S.P.A.
Orthopedic · 65d
Cleared Dec 17, 2021
InkSpace Imaging Pediatric Body Array
K213397 · MOS
Inkspace Imaging, Inc.
Radiology · 60d
Cleared Dec 17, 2021
RF Vapor System
K213627 · KNS
Aqua Medical, Inc.
Gastroenterology & Urology · 30d
Cleared Dec 17, 2021
Arthrex Knotless Mini TightRopes
K213644 · HTN
Arthrex, Inc.
Orthopedic · 29d
Cleared Dec 17, 2021
Revolution Apex, Revolution Apex Elite, Revolution Apex Plus, Revolution Apex...
K213715 · JAK
Ge Medical Systems, LLC
Radiology · 23d
Cleared Dec 16, 2021
Activmotion S DTO
K202803 · HRS
Newclip Technics
Orthopedic · 449d
Cleared Dec 16, 2021
Voyant Fine Fusion Device (EB230)
K202818 · GEI
Applied Medical
General & Plastic Surgery · 448d
Cleared Dec 16, 2021
Surgical Gown, Model: surgical gown-hp-3
K210355 · FYA
Weihai Dishang Medical Technology...
General Hospital · 311d
Cleared Dec 16, 2021
Profound Matrix
K211217 · GEI
Candela Corporation
General & Plastic Surgery · 237d
Cleared Dec 16, 2021
Theia NPWT Foam Wound Dressing Kit
K211277 · OMP
Clear Choice Therapeutics, Inc.
General & Plastic Surgery · 233d
Cleared Dec 16, 2021
LM Surgical Mask Level 3, LM Surgical Mask Level 2,
K211378 · FXX
Liberty Mask, LLC
General Hospital · 226d
Cleared Dec 16, 2021
Balanced Knee System Uni
K211471 · HSX
Ortho Development Corporation
Orthopedic · 219d
Cleared Dec 16, 2021
Connected OR Hub with Device and Voice Control
K212055 · GCJ
Stryker Corporation
General & Plastic Surgery · 168d
Cleared Dec 16, 2021
MIVI Q Distal Access Catheter
K212402 · QJP
Mivi Neuroscience, Inc.
Neurology · 136d
Cleared Dec 16, 2021
Brainlab Elements, Brainlab Elements Contouring, Brainlab Elements...
K212420 · LLZ
Brainlab AG
Radiology · 134d
Cleared Dec 16, 2021
Koios DS
K212616 · POK
Koios Medical, Inc.
Radiology · 120d
Cleared Dec 16, 2021
Tango, Tango Reflex, Ultra Q, Ultra Q Reflex, Solo
K212630 · HQF
Ellex Medical Pty, Ltd.
Ophthalmic · 119d
Cleared Dec 16, 2021
AT
K212645 · LZA
At Glove Engineering Sdn. Bhd
General Hospital · 118d