FDA 510(k) Searchable Database - Search 174,000+ Clearances

Search 174,000+ FDA 510(k) clearances by K-number, device name, manufacturer or product code — with real review time data, denied submission rates and regulatory intelligence no other searchable 510(k) database provides.

175,218 clearances · 1976 to present · Updated monthly from FDA records

Filters: Cleared only ×
174,724 results
14305–14328 of 174,724
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
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
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 Dec 15, 2021
BIT-Motion
K211039 · LLZ
Dde Mri Solutions, Ltd.
Radiology · 252d