Search FDA 510(k) Database

6,626 clearances indexed · Search by device name, K-number, manufacturer or product code

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174,061 results
11113–11136 of 174,061
Cleared Oct 07, 2022
IdentiTi™ Porous Ti Interbody System, IdentiTi™ NanoTec™ Interbody System,...
K222028 · MAX
Alphatec Spine
Orthopedic · 88d
Cleared Oct 07, 2022
Cold Sore Device (Model: QPZ-01)
K222205 · OKJ
Light Tree Ventures Europe B.V.
General & Plastic Surgery · 74d
Cleared Oct 07, 2022
PURE Laser
K222369 · GEX
Endymed Medical, Ltd.
General & Plastic Surgery · 63d
Cleared Oct 07, 2022
Nuvola
K222418 · NXC
Gruppo Europeo Ortodonzia Srl
Dental · 58d
Cleared Oct 07, 2022
Protect-It Custom Fit Dental Guard
K222424 · OBR
Doc Brands, Inc.
Dental · 57d
Cleared Oct 07, 2022
CUVIS-spine
K222698 · OLO
Curexo, Inc.
Orthopedic · 30d
Cleared Oct 07, 2022
Nitrile Patient Examination Gloves Blue Tested For Use With Chemotherapy...
K222714 · LZA
Guangdong Kingfa Sci. & Tech.Co., Ltd.
General Hospital · 29d
Cleared Oct 06, 2022
ArtFx Corpectomy Cages (Espinax and Distractania Corpectomy Cages)
K211892 · MQP
Arftx Medical, LLC
Orthopedic · 472d
Cleared Oct 06, 2022
A&D Medical UM-212BLE Blood Pressure Monitor
K212168 · DXN
A&D Company, Ltd.
Cardiovascular · 451d
Cleared Oct 06, 2022
NuCath Wedge Pressure Catheter
K213666 · DQO
Pfm Medical, Inc.
Cardiovascular · 318d
Cleared Oct 06, 2022
Gemini Sterilization Wrap
K220365 · FRG
Medline Industries, LP
General Hospital · 240d
Cleared Oct 06, 2022
iCare IC200
K220852 · HKY
Icare Finland OY
Ophthalmic · 197d
Cleared Oct 06, 2022
Genius AI Detection 2.0
K221449 · QDQ
Hologic, Inc.
Radiology · 141d
Cleared Oct 06, 2022
InfaTherm Disposable Infant Warming Mattress
K221653 · IMD
International Biomedical
Physical Medicine · 121d
Cleared Oct 06, 2022
ProSomnus EVO [PH] Sleep and Snore Device, ProSomnus EVO [PH] Sleep and Snore...
K221889 · LRK
Prosomnus Sleep Technologies
Dental · 99d
Cleared Oct 06, 2022
Garion Image-Intensified Fluoroscopic X-Ray System, Mobile
K222080 · OWB
Sg Healthcare Co, Ltd.
Radiology · 83d
Cleared Oct 06, 2022
PRIMA TT Glenoid
K222427 · MBF
Lima Corporate S.P.A.
Orthopedic · 56d
Cleared Oct 06, 2022
b-ONER MOBIO Total Knee System
K222431 · JWH
B-One Ortho, Corp.
Orthopedic · 56d
Cleared Oct 06, 2022
Perfit FS Dental Zirconia Fully Sintered Block
K222686 · EIH
Vatech Acucera, Inc.
Dental · 30d
Cleared Oct 06, 2022
Tibial baseplate, Tibial insert
K222700 · JWH
United Orthopedic Corporation
Orthopedic · 29d
Cleared Oct 05, 2022
Coag-Sense Prothrombin (PT) / INR Monitoring System for Patient Self-Testing
K212779 · GJS
Coagusense, Inc.
Hematology · 399d
Cleared Oct 05, 2022
Surtron 80 D, Surtron 160, Surtron 200, Surtron Flash 160 HF, Surtron 400 HP
K220138 · GEI
Led Spa
General & Plastic Surgery · 260d
Cleared Oct 05, 2022
ClearCorrect System
K220140 · NXC
Clearcorrect, LLC
Dental · 260d
Cleared Oct 05, 2022
Colibrí System
K220546 · LON
Copan Wasp Srl
Microbiology · 222d