Search FDA 510(k) Devices

5,483 clearances indexed · Search by device name, K-number, manufacturer or product code

Filters: 2023–2023 ×
3,347 results
1993–2016 of 3,347
Cleared Jun 08, 2023
AlloX2 Pro Tissue Expanders
K214124 · LCJ
Sientra, Inc.
General & Plastic Surgery · 525d
Cleared Jun 07, 2023
Intimate Rose Vaginal Dilators
K231430 · HDX
Plus EV Holdings Dba Intimate Rose
Obstetrics & Gynecology · 21d
Cleared Jun 07, 2023
Ambra PACS
K231360 · LLZ
Dicom Grid Dba Ambra Health
Radiology · 28d
Cleared Jun 07, 2023
Fix2Lock(PEEK Self Punching)
K231322 · MBI
Osteonic Co., Ltd.
Orthopedic · 30d
Cleared Jun 07, 2023
C350/C350G LCD Monitor
K231170 · PGY
Nanjing Jusha Display Technology Co.,...
Radiology · 43d
Cleared Jun 07, 2023
Javelot PK-S suture anchor, Javelot PK-S suture anchor (Knotless), Javelot...
K231002 · MBI
Suzhou Endophix Co., Ltd.
Orthopedic · 61d
Cleared Jun 07, 2023
HyperVue™ Imaging System
K230691 · NQQ
Spectrawave, Inc.
Cardiovascular · 86d
Cleared Jun 07, 2023
BD BBL™ Sensi-Disc™ Lefamulin 20µg (LMU-20)
K230651 · JTN
Becton, Dickinson and Company
Microbiology · 90d
Cleared Jun 07, 2023
AETOS Shoulder System
K230572 · KWS
Smith & Nephew, Inc.
Orthopedic · 98d
Cleared Jun 07, 2023
TiLink-L SI Joint Fusion System
K230446 · OUR
SurGenTec, LLC
Orthopedic · 106d
Cleared Jun 07, 2023
Ethos Automated Ultrasound Probe Cleaner Disinfector with AquaCide...
K230381 · PSW
Cs Medical, LLC
General Hospital · 114d
Cleared Jun 07, 2023
Xenco Medical InterAlign Cervical Interbody System
K223059 · OVE
Xenco Medical, LLC
Orthopedic · 250d
Cleared Jun 07, 2023
Infrared Thermometer
K222248 · FLL
Alicn Medical (Shenzhen), Inc.
General Hospital · 316d
Cleared Jun 07, 2023
Fenom Pro
K213611 · MXA
Caire Diagnostics, Inc.
Chemistry · 569d
Cleared Jun 07, 2023
STA R Max 3, STA Compact Max 3
K212183 · JPA
Diagnostica Stago S.A.S
Hematology · 694d
Cleared Jun 06, 2023
A-Line Advanced
K231635 · NJM
Biocetec Co., Ltd.
Dental · 1d
Cleared Jun 06, 2023
Nephron Nitrile Powder-Free Nitrile Examination Gloves (Tested For Use With...
K231349 · LZA
Nephron Nitrile, LLC
General Hospital · 28d
Cleared Jun 06, 2023
AviClear Laser System
K230660 · GEX
Cutera, Inc.
General & Plastic Surgery · 88d
Cleared Jun 06, 2023
Vein360 Reprocessed Visions PV.035 Digital IVUS Catheter
K230584 · OWQ
Vein 360, LLC
Cardiovascular · 96d
Cleared Jun 06, 2023
F3D Interbody System
K230329 · ODP
Corelink, LLC
Orthopedic · 120d
Cleared Jun 06, 2023
Gnesis EMS Plus
K230261 · NGX
Creative Fitness Developments S.L.
Physical Medicine · 126d
Cleared Jun 06, 2023
Pantheris LV Atherectomy Catheter
K230005 · MCW
Avinger, Inc.
Cardiovascular · 154d
Cleared Jun 06, 2023
FEops HEARTguideTM, FEops HEARTguideTM ALPACA
K223855 · QIH
Feops NV
Radiology · 165d
Cleared Jun 06, 2023
Olea S.I.A. Neurovascular V1.0
K223532 · LLZ
Olea Medical
Radiology · 195d