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
15409–15432 of 175,820
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Dec 16, 2021
Blue Nitrile Powder Free Patient Examination Glove, Non-Sterile, Tested For...
K212898 · LZA
Rimba Glove Snd Bhd
General Hospital · 97d
Cleared Dec 16, 2021
6MP Color LCD Monitor CL-S600
K212985 · PGY
Jvckenwood Corporation
Radiology · 90d
Cleared Dec 16, 2021
IPL hair removal machine
K213020 · OHT
Shenzhen Borria Technology Co., Ltd.
General & Plastic Surgery · 87d
Cleared Dec 16, 2021
UltiCare Disposable Pen Needles
K213407 · FMI
Ultimed Incorporated
General Hospital · 58d
Cleared Dec 16, 2021
NightOwl
K213463 · MNR
Ectosense NV
Anesthesiology · 50d
Cleared Dec 16, 2021
VBrain
K213628 · QKB
Vysioneer, Inc.
Radiology · 29d
Cleared Dec 16, 2021
Ponto 5 SuperPower
K213733 · LXB
Oticon Medical AB
Ear, Nose, Throat · 20d
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 CT 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 CT 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