Search FDA 510(k) Database

7,034 clearances indexed · Search by device name, K-number, manufacturer or product code

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174,061 results
19321–19344 of 174,061
Cleared Jan 14, 2020
SABLE Expandable Spacer
K192115 · MAX
Globus Medical, Inc.
Orthopedic · 161d
Cleared Jan 14, 2020
Dental Pain Eraser
K192429 · LWM
Synapse Dental
Dental · 131d
Cleared Jan 14, 2020
Streamline TL Spinal Fixation System
K192800 · NKB
Pioneer Surgical Technology, Inc....
Orthopedic · 106d
Cleared Jan 14, 2020
Oragene®•Dx
K192920 · OYJ
DNA Genotek, Inc.
Chemistry · 90d
Cleared Jan 14, 2020
MiiS Horus Eye Anterior Camera
K193188 · HJO
Medimaging Integrated Solution, Inc...
Ophthalmic · 57d
Cleared Jan 14, 2020
XTRAC Momentum Excimer Laser System
K193478 · GEX
Strata Skin Sciences, Inc.
General & Plastic Surgery · 29d
Cleared Jan 13, 2020
Route 92 Medical Sheath System
K191717 · DQY
Route 92 Medical, Inc.
Neurology · 201d
Cleared Jan 13, 2020
Midwest Rhino XE and Air Motor M
K192409 · EFB
Dentsply Sirona
Dental · 131d
Cleared Jan 13, 2020
Erchonia Emerald
K192544 · OLI
Erchonia Corporation
General & Plastic Surgery · 119d
Cleared Jan 13, 2020
nva, nvp, and nvt
K193645 · MAX
Nvision Biomedical Technologies, Inc.
Orthopedic · 14d
Cleared Jan 11, 2020
TENS and EMS Stimulator, TENS Stimulator
K183074 · IPF
Astek Technology , Ltd.
Physical Medicine · 432d
Cleared Jan 10, 2020
Trach- Vac Endotracheal Tube (SFTVPU) Subglottic Suction Tube with Salter...
K190878 · BTR
Salter Labs, Inc.
Anesthesiology · 281d
Cleared Jan 10, 2020
Cybird LED Curing Light
K191221 · EBZ
Dxm Co., Ltd.
Dental · 248d
Cleared Jan 10, 2020
IP Converter
K191678 · GCJ
Sony Electronics, Inc.
General & Plastic Surgery · 200d
Cleared Jan 10, 2020
KardioScreen
K191692 · DPS
Imedrix Inc. (Formerly Piitech Inc.)
Cardiovascular · 199d
Cleared Jan 10, 2020
Nihon Kohden NKV-550 Series Ventilator System
K192307 · CBK
Nihon Kohden Orangemed, Inc.
Anesthesiology · 137d
Cleared Jan 10, 2020
Medline Green Ambidextrous Power-Free Nitrile Examination Gloves with...
K192315 · LZA
Medline Industries, Inc.
General Hospital · 137d
Cleared Jan 10, 2020
FlowMet
K192966 · DPW
Laser Associated Sciences, Inc.
Cardiovascular · 79d
Cleared Jan 10, 2020
OsteoRemedies Hip Spacer System
K192995 · KWL
Osteoremedies, LLC
Orthopedic · 77d
Cleared Jan 10, 2020
CD Horizon™ Fenestrated Screw Set
K193011 · NKB
Medtronic Sofamor Danek USA, Inc.
Orthopedic · 73d
Cleared Jan 10, 2020
Univers Revers Modular Glenoid System (Augemented baseplates)
K193372 · PHX
Arthrex, Inc.
Orthopedic · 36d
Cleared Jan 10, 2020
MotoBAND CP Implant System
K193452 · HRS
Crossroads Extemity Systems, LLC
Orthopedic · 28d
Cleared Jan 10, 2020
CorticaLINK Spinal Fusion Platform
K193465 · NKB
Spine Smith Holdings, LLC
Orthopedic · 25d
Cleared Jan 09, 2020
HyaloGYN Vaginal Moisturizing Suppositories
K191052 · NUC
Fidia Farmaceutici S.P.A.
Obstetrics & Gynecology · 265d