92 results
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24ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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Bose SoundControl Hearing Aids
FDA 510(k)
FDA Class 2
·Ear, Nose, Throat
EASYPOINT NEEDLE
FDA Adverse Event
Injury
·RETRACTABLE TECHNOLOGIES, INC.·Product code FMI·February 9, 2023
EASYPOINT NEEDLE
FDA Adverse Event
Injury
·RETRACTABLE TECHNOLOGIES, INC.·Product code FMI·February 9, 2023
NA
FDA UDI
Smith & Nephew, Inc.·03596010543615·DYONICS 25 PATIENT TUBE SET MUST
...
EVOS Lumbar Interbody System
FDA UDI
Cutting Edge Spine, LLC·00841193114392·HA PEEK EVOS Straight, ,8mmx11mmx 30mm , FLAT ...
PMT® Halo Systems
FDA UDI
PMT CORPORATION·00650551110330·HALO, 1203-5 VEST PED00, COOLMAX LINER, 1211-1 ...
Zavation
FDA UDI
Zavation LLC·00842166132603·Ti3Z CIF 13mmx15mmx8mm -10 deg
Biliary Drainage Tube
FDA UDI
OLYMPUS MEDICAL SYSTEMS CORP.·04953170046957·
TRILLIANT SURGICAL K-WIRES
FDA 510(k)
FDA Class 2
·Orthopedic
MICROWARE BONE PLATES AND BONE SCREW
FDA 510(k)
FDA Class 2
·Orthopedic
GMK TOTAL KNEE SYSTEM
FDA Adverse Event
Injury
·MEDACTA INTERNATIONAL SA·Product code JWH·October 22, 2025
OT PING METER
FDA Adverse Event
Malfunction
·LIFESCAN INC.·Product code NBW·August 13, 2011
LUMAX 640 VR-T DX PROMRI
FDA Adverse Event
Malfunction
·BIOTRONIK SE & CO. KG·Product code LWS·October 29, 2014
ENDOTAK RELIANCE
FDA Adverse Event
Malfunction
·CPI - DEL CARIBE·Product code NVY·July 8, 2013
GMK TOTAL KNEE SYSTEM
FDA Adverse Event
Injury
·MEDACTA INTERNATIONAL SA·Product code JWH·May 22, 2026
GMK SPHERE TOTAL KNEE SYSTEM
FDA Adverse Event
Injury
·MEDACTA INTERNATIONAL SA·Product code JWH·November 7, 2024
DYONICS 25 Fluid Management System Bag for enclosure of wireless remote control included with Disposable Patient Tubeset. Catalog # 7211008. Bag is used for remote control in a sterile field.
FDA Recall
Terminated
·Smith & Nephew, Inc. Endoscopy Division·Product code HRX·August 7, 2008
GMK PRIMARY TOTAL KNEE SYSTEM
FDA Adverse Event
Injury
·MEDACTA INTERNATIONAL SA·Product code JWH·March 21, 2025
GMK TOTAL KNEE SYSTEM
FDA Adverse Event
Injury
·MEDACTA INTERNATIONAL SA·Product code JWH·March 3, 2026
GMK SPHERE TOTAL KNEE SYSTEM
FDA Adverse Event
Injury
·MEDACTA INTERNATIONAL SA·Product code JWH·July 17, 2025