27 results
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25ms
·
Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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Arrowhead Mini-Rail Fixator
FDA 510(k)
FDA Class 2
·Orthopedic
Millennium
FDA UDI
Avalign Technologies, Inc.·00190776116057·Pass Thru Bracket
Pinehurst Anterior Cervical Plate System
FDA UDI
SIGNATURE ORTHOPAEDICS PTY LTD·09348215030674·
Aquila Anterior Cervical Plate System
FDA UDI
SIGNATURE ORTHOPAEDICS PTY LTD·09348215125738·
MAGNETOM Verio Dot Upgrade. Model Number: 10684334.
FDA Enforcement
Class I
·Ongoing·Siemens Medical Solutions USA, Inc·October 8, 2025
ACCUSOFT, ACCUSOFT XL
FDA 510(k)
FDA Class 2
·Radiology
KIMBERLY-CLARK PURPLE NITRILE XTRA* STERILE POWDER-FREE EXAM GLOVE (CHEMOTHERAPY GLOVE) - 12 STERILE PAIRS
FDA 510(k)
FDA Class 1
·General Hospital
KYPHON XPEDE BONE CEMENT
FDA Adverse Event
Injury
·MEDTRONIC SOFAMOR DANEK USA, INC·Product code NDN·December 21, 2018
KYPHON XPEDE BONE CEMENT
FDA Adverse Event
Malfunction
·MEDTRONIC SOFAMOR DANEK USA, INC·Product code NDN·May 29, 2019
KYPHON XPEDE BONE CEMENT
FDA Adverse Event
Malfunction
·MDT KYPHON NEUCHATEL MFG·Product code NDN·February 28, 2019
KYPHON XPEDE BONE CEMENT
FDA Adverse Event
Malfunction
·MDT KYPHON NEUCHATEL MFG·Product code NDN·February 28, 2019
1030489-2019-01511
FDA Adverse Event
Death
·MEDTRONIC SOFAMOR DANEK USA, INC.·Product code NDN·December 31, 2019
SYSTEM, PERITONEAL, AUTOMATIC DELIVERY
FDA Adverse Event
Malfunction
·BAXTER HEALTHCARE CORPORATION·Product code FKX·October 10, 2014
KINECTIV TECHNOLOGY MODULAR NECK
FDA Adverse Event
Injury
·ZIMMER, INC.·Product code LPH·July 12, 2011
STENOSCOP
FDA Adverse Event
Malfunction
·GE OEC MEDICAL SYSTEMS (SLC)·Product code JAA·June 6, 2013
1030489-2019-01423
FDA Adverse Event
Injury
·MEDTRONIC SOFAMOR DANEK·Product code NDN·December 13, 2019
CER BIOLOXD MOD HD 38MM STD NK
FDA Adverse Event
Injury
·ZIMMER BIOMET, INC.·Product code LZO·August 26, 2020
CER BIOLOXD MOD HD 38MM -6 NK
FDA Adverse Event
Injury
·BIOMET UK LTD.·Product code LPH·April 8, 2020
M2A 1 PC SHELL 38MMX54MM
FDA Adverse Event
Injury
·ZIMMER BIOMET, INC.·Product code KWY·May 18, 2020
M2A-38 CUP NON FLARED SZ 52MM
FDA Adverse Event
Injury
·ZIMMER BIOMET, INC.·Product code KWA·April 8, 2020