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
16081–16104 of 175,820
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Sep 29, 2021
Cochlear Baha 6 System, Cochlear Baha Fitting Software 6, Cochlear Baha Baha...
K212136 · LXB
Cochlear Americas
Ear, Nose, Throat · 83d
Cleared Sep 29, 2021
DR Safety Syringe, Sterile Hypodermic needle for Single use
K212226 · MEG
Zhuhai DR Medical Instruments Co., Ltd.
General Hospital · 75d
Cleared Sep 29, 2021
TheraFace Microcurrent
K212238 · NFO
Theragun, Inc.
Neurology · 72d
Cleared Sep 29, 2021
Da Vinci SP Surgical System
K212747 · NAY
Intuitive Surgical, Inc.
General & Plastic Surgery · 30d
Cleared Sep 28, 2021
Electrically Powered Wheelchair -Model HP358E
K201855 · ITI
Kunshan Hi-Fortune Health Products...
Physical Medicine · 449d
Cleared Sep 28, 2021
ThermArt (Model IR-EFT)
K202481 · FLL
Comper Chuangxiang (Beijing)...
General Hospital · 396d
Cleared Sep 28, 2021
Advisor Pro Platform
K210561 · QCC
DreaMed Diabetes, Ltd.
Chemistry · 215d
Cleared Sep 28, 2021
Surgical Face Mask (Model: CM2006, CM2008, A88)
K210878 · FXX
Shenzhen Realtone Medical Appliance...
General Hospital · 188d
Cleared Sep 28, 2021
SIDDHARTH-II
K210894 · IYE
Panacea Medical Technologies Pvt. , Ltd.
Radiology · 187d
Cleared Sep 28, 2021
EzDent Web
K211700 · LLZ
Ewoosoft Co., Ltd.
Radiology · 117d
Cleared Sep 28, 2021
Panther OIS
K211760 · IYE
Prowess, Inc.
Radiology · 112d
Cleared Sep 28, 2021
Disposable surgical mask
K211794 · FXX
Shanghai No.9 Knitting Mill Co., Ltd.
General Hospital · 110d
Cleared Sep 28, 2021
SubtlePET
K211964 · KPS
Subtle Medical, Inc.
Radiology · 96d
Cleared Sep 28, 2021
SoftSpot
K212045 · QQO
Pediametrix, Inc.
Neurology · 90d
Cleared Sep 28, 2021
Persona® Personalized Knee System
K212129 · JWH
Zimmer Switzerland Manufacturing GmbH
Orthopedic · 82d
Cleared Sep 28, 2021
Dermatac™ Drape and V.A.C. Granufoam Dressings Featuring SensaT.R.A.C....
K212320 · OMP
3M Healthcare Business Group
General & Plastic Surgery · 64d
Cleared Sep 27, 2021
B Dispensing Line
K203674 · LHI
Aea Srl
General Hospital · 285d
Cleared Sep 27, 2021
Disposable Vinyl Examination Gloves
K211236 · LYZ
Tangshan Hongyun Healthcare Products...
General Hospital · 154d
Cleared Sep 27, 2021
Amplatzer Steerable Delivery Sheath
K212026 · DQY
Abbott Medical
Cardiovascular · 90d
Cleared Sep 27, 2021
Dark Star Navigation Instrument System
K212028 · OLO
Republic Spine, LLC
Orthopedic · 90d
Cleared Sep 27, 2021
Imaging Plate Scanner, i-Scan
K212080 · MUH
Guilin Woodpecker Medical Instrument...
Radiology · 87d
Cleared Sep 27, 2021
POWERSEAL Curved Jaw Sealer and Divider, Double Action
K212643 · GEI
Olympus Surgical Technologies America
General & Plastic Surgery · 38d
Cleared Sep 27, 2021
Amplatzer Talisman Delivery Sheath
K212738 · DQY
Abbott Medical
Cardiovascular · 28d
Cleared Sep 27, 2021
Ultrasonic Surgical Aspirator System, Model: XD880B
K212750 · LFL
Smtp Technology Co., Ltd.
General & Plastic Surgery · 28d