12 results
·
19ms
·
Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
×
MAGNETOM Amira
FDA 510(k)
FDA Class 2
·Radiology
Ophthalmic Cannula
FDA UDI
KATENA PRODUCTS, INC.·00841668109076·RANDOLPH CYCLODIALYSIS CANNULA DELICATE
JOBST Elvarex
FDA UDI
BSN-Jobst GmbH·04019702453324·E2/AG/CT-KC/OH-WOV/BLU
BAK®
FDA UDI
BIOMET SPINE LLC·00887868259951·
T:SLIM X2 INSULIN PUMP WITH INTEROPERABLE TECHNOLOGY (WITH T:CONNECT MOBILE APP)
FDA Adverse Event
Injury
·TANDEM DIABETES CARE·Product code QFG·August 15, 2024
COMFORTGEL FULL FACE MASK
FDA 510(k)
FDA Class 2
·Anesthesiology
PORTABLE X-RAY SYSTEM
FDA 510(k)
FDA Class 2
·Dental
STEALTHSTATION® I7¿ INTEGRATED NAVIGATION SYSTEM
FDA Adverse Event
Malfunction
·MEDTRONIC NAVIGATION, INC.·Product code HAW·June 17, 2013
CVC SET: 3-LUMEN 7 FR X 30 CM
FDA Adverse Event
Malfunction
·ARROW INTERNATIONAL INC.·Product code FOZ·August 7, 2014
COLLEAGUE PRE P1.7
FDA Adverse Event
Malfunction
·BAXTER HEALTHCARE - SINGAPORE·Product code FRN·July 23, 2011
The Spacelabs Healthcare Xhibit Telemetry Receiver (XTR), Model 96280 is used to transmit patient(s) physiological measurements and data to a monitor.
FDA Enforcement
Class II
·Terminated·Spacelabs Healthcare Inc·April 27, 2016
various polyethylene implants Knees Revision Tibial Tray Systems Oxford Partial Knee Orthopedic Salvage System Vanguard Complete Knee System Vanguard SSK Revision System Biomet Patella Maxim Complete Knee System Biomet Series A Patella Vanguard 360 Revision System Vanguard Deep Dish Rotating Platform Biomet CP Bearings Product Usage: For use in total knee arthroplasty. Limb salvage joint reconstruction. Partial knee replacement.
FDA Enforcement
Class II
·Terminated·Zimmer Biomet, Inc.·April 26, 2017