Search FDA 510(k) Database

6,521 clearances indexed · Search by device name, K-number, manufacturer or product code

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174,061 results
9457–9480 of 174,061
Cleared Apr 13, 2023
DESS Dental Smart Solutions
K230143 · NHA
Terrats Medical SL
Dental · 85d
Cleared Apr 13, 2023
Trusana™
K230098 · EBI
Myerson, LLC
Dental · 90d
Cleared Apr 13, 2023
ADSEAL Plus
K230010 · KIF
Meta Biomed Co., Ltd.
Dental · 100d
Cleared Apr 13, 2023
Quantum PureFlow Standard Heat Exchangers (HX11W-S2, HX11W-S1M and HX11W-S2M)
K223879 · DTR
Quara S.R.L.
Cardiovascular · 107d
Cleared Apr 13, 2023
FreeStyle Libre 3 Continuous Glucose Monitoring System
K223435 · QBJ
Abbott Diabetes Care, Inc.
Chemistry · 150d
Cleared Apr 13, 2023
Point implant system
K222738 · DZE
Pointnix Co., Ltd.
Dental · 216d
Cleared Apr 13, 2023
Sterile Nitrile Surgical Gloves Powder Free
K222350 · KGO
Jr Engineering & Medical Technologies...
General Hospital · 253d
Cleared Apr 13, 2023
CIRRUS HD-OCT
K222200 · OBO
Carl Zeiss Meditec, Inc.
Ophthalmic · 262d
Cleared Apr 13, 2023
Stratus Infusion Catheter
K222185 · NPG
Intervene, Inc.
Cardiovascular · 265d
Cleared Apr 13, 2023
ALPCO Calprotectin Immunoturbidimetric Assay
K220763 · NXO
ALPCO
Immunology · 393d
Cleared Apr 13, 2023
CerebralGo Plus
K213986 · QIH
Yukun (Beijing) Technology Co., Ltd.
Radiology · 479d
Cleared Apr 13, 2023
AUTION MAX AX-4060 Urinalysis System
K193514 · JIL
Arkray, Inc.
Chemistry · 1211d
Cleared Apr 12, 2023
Omnia Medical Coupler-A™ Anterior Lumbar Plate System
K230424 · KWQ
Omnia Medical, LLC
Orthopedic · 54d
Cleared Apr 12, 2023
Catalys™ Precision Laser System
K223838 · OOE
Amo Manufacturing USA, LLC
Ophthalmic · 111d
Cleared Apr 12, 2023
Task Force CORE
K223332 · DXN
Cnsystems Medizintechnik GmbH
Cardiovascular · 163d
Cleared Apr 12, 2023
Polyfusion IV Administration Sets
K220312 · FPA
Poly Medicure Limited
General Hospital · 434d
Cleared Apr 11, 2023
L12 LED Light Source with AIM
K230754 · OWN
Stryker
General & Plastic Surgery · 25d
Cleared Apr 11, 2023
RCT800
K230753 · OAS
Ray Co., Ltd.
Radiology · 25d
Cleared Apr 11, 2023
Eagle S/Saevo Slim/D700 Slim
K230732 · MUH
Alliage S/A Industrias Medica...
Radiology · 26d
Cleared Apr 11, 2023
POT PTCA Balloon Dilatation Catheter
K230705 · LOX
Brosmed Medical Co., Ltd.
Cardiovascular · 28d
Cleared Apr 11, 2023
ENROUTE® Transcarotid Neuroprotection System
K230402 · NTE
Silk Road Medical
Cardiovascular · 55d
Cleared Apr 11, 2023
Ultrasound System 2300
K223830 · IYN
Bk Medical Aps
Radiology · 111d
Cleared Apr 11, 2023
ZeptoLink IOL Positioning System
K223763 · PUL
Centricity Vision, Inc.
Ophthalmic · 117d
Cleared Apr 11, 2023
Route 92 Medical Full Length 070 Reperfusion System and Aspiration Tubing Set
K223530 · NRY
Route 92 Medical, Inc.
Neurology · 139d