Search FDA 510(k) Database

6,787 clearances indexed · Search by device name, K-number, manufacturer or product code

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174,061 results
13657–13680 of 174,061
Cleared Dec 16, 2021
ArchForm Orthodontic Software System
K213916 · PNN
Archform, Inc.
Dental · 1d
Cleared Dec 15, 2021
FREEDOM Integrated Syringe Infusion System
K200176 · FRN
Repro-Med Systems, Inc. Dba Koru...
General Hospital · 691d
Cleared Dec 15, 2021
Helianthus
K202822 · MUE
Metaltronica Spa
Radiology · 447d
Cleared Dec 15, 2021
Innomed NPWT Silicone Foam Dressing
K202823 · OMP
Zhejiang Longterm Medical Technology...
General & Plastic Surgery · 447d
Cleared Dec 15, 2021
Psychemedics Homogeneous Enzyme Immunoassay for Amphetamines in Hair
K210212 · LAF
Psychemedics Corporation
Toxicology · 322d
Cleared Dec 15, 2021
Transcutaneous Electrical Nerve Stimulator
K210223 · NUH
Top-Rank Health Care Co., Ltd.
Neurology · 321d
Cleared Dec 15, 2021
ProTEC-USA EZDoff Gown
K210405 · QPC
Cadillac Products, Inc.
General Hospital · 308d
Cleared Dec 15, 2021
reVive Light Therapy Essentials
K210965 · OHS
Led Technologies, Inc.
General & Plastic Surgery · 259d
Cleared Dec 15, 2021
BIT-Motion
K211039 · LLZ
Dde Mri Solutions, Ltd.
Radiology · 252d
Cleared Dec 15, 2021
Will3D
K211114 · LLZ
Hdx Will Corp.
Radiology · 245d
Cleared Dec 15, 2021
Sensititre YeastOne Susceptibility System with Voriconazole in the dilution...
K211539 · NGZ
Thermo Fisher Scientific
Microbiology · 211d
Cleared Dec 15, 2021
HealthPPT
K211803 · QFM
Zebra Medical Vision, Ltd.
Radiology · 187d
Cleared Dec 15, 2021
Revolution Peripheral Atherectomy System
K212351 · MCW
Rex Medical, L.P.
Cardiovascular · 139d
Cleared Dec 15, 2021
Surgical Face Mask (Non-sterile)
K212398 · FXX
Hubei Kimsoul Industrial Co., Ltd.
General Hospital · 135d
Cleared Dec 15, 2021
Posterior Fusion Plate/HA Posterior Fusion Plate, Minuteman G3 MIS Fusion...
K212781 · PEK
Spinal Simplicity, LLC
Orthopedic · 105d
Cleared Dec 15, 2021
Merit Siege Vascular Plug
K212817 · KRD
Merit Medical System, Inc.
Cardiovascular · 103d
Cleared Dec 15, 2021
Surgical Gown, Reinforced Surgical Gown
K212861 · FYA
Wuhan Zonsen Medical Products Co., Ltd.
General Hospital · 98d
Cleared Dec 15, 2021
SIMPACT Sacroiliac Joint Fixation System
K212903 · OUR
Life Spine, Inc.
Orthopedic · 93d
Cleared Dec 15, 2021
Disposable Nitrile Examination Gloves (Tested for Use with Chemotherapy Drugs)
K212919 · LZA
Jiujiang Taixin Technology Co., Ltd.
General Hospital · 92d
Cleared Dec 15, 2021
Disposable Surgical Mask
K212944 · FXX
Heilongjiang Yinjia Medical Equipment...
General Hospital · 93d
Cleared Dec 15, 2021
Cellusheet, Cellufil
K213092 · KGN
Human Biosciences, Inc.
General & Plastic Surgery · 82d
Cleared Dec 15, 2021
RT-Mind-AI
K213155 · QKB
Medmind Technology Co., Ltd.
Radiology · 78d
Cleared Dec 15, 2021
Insignia™ Anterior Cervical Plate System
K213443 · KWQ
Alphatec Spine, Inc.
Orthopedic · 51d
Cleared Dec 15, 2021
Chocolate PTA Balloon Catheter
K213631 · LIT
Medtronic, Inc.
Cardiovascular · 28d