25 results
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23ms
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Sources: EU EUDAMED, US FDA
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Regulation: Us FDA
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S128 Anterior Lumbar Interbody Fusion (ALIF) System
FDA 510(k)
FDA Class 2
·Orthopedic
RESTORIS
FDA UDI
MAKO SURGICAL CORP.·00848486000547·MCK Femoral Component
COMPREHENSIVE REVERSE SHOULDER
FDA UDI
Biomet Orthopedics, LLC·00880304475557·
LOCATOR F-Tx
FDA UDI
Zest Anchors, LLC·00840481121234·LOCATOR F-Tx Abutment for 3.3mm Platform Intern...
LOCATOR R-Tx
FDA UDI
Zest Anchors, LLC·00840481121296·LOCATOR R-Tx Abutment for 3.3mm Platform Intern...
ASCENSION TOTAL PLATE SYSTEM
FDA 510(k)
FDA Class 2
·Orthopedic
MODIFICATION TO:PILOT SPINAL SYSTEM
FDA 510(k)
FDA Class 2
·Orthopedic
MONOJECT
FDA Adverse Event
Malfunction
·JIANGSU CAINA MEDICAL CO., LTD·Product code PNR·April 14, 2024
CARDINAL HEALTH
FDA Adverse Event
Malfunction
·JIANGSU CAINA MEDICAL CO., LTD.·Product code PNR·April 12, 2024
CARDINAL
FDA Adverse Event
Malfunction
·JIANGSU CAINA MEDICAL CO., LTD.·Product code PNR·April 12, 2024
PORTABLE OXYGEN GENERATOR (CONCENTRATOR, HOMEFILL)
FDA Adverse Event
Malfunction
·INVACARE FLORIDA OPERATIONS·Product code CAW·October 17, 2014
PRECISION®
FDA Adverse Event
Injury
·BOSTON SCIENTIFIC NEUROMODULATION·Product code LGW·July 27, 2011
VICRYL PLUS ANTIBACTERIAL (POLYGLACTIN 910) SUTURE
FDA Adverse Event
Injury
·ETHICON INC.·Product code GAM·June 20, 2013
MODIFIED NOVY CORNUAL CANNULATION SET
FDA Adverse Event
Malfunction
·COOK INC·Product code MOV·March 14, 2024
Nitinol Staple, Elastic Staple Large-Asymmetrical, Sterile R, Model #: a) ES-18x15x17; b) ES-18x17x19
FDA Enforcement
Class II
·Terminated·TriMed Inc.·June 27, 2018
CARDINAL HEALTH
FDA Adverse Event
Malfunction
·JIANGSU CAINA MEDICAL CO., LTD.·Product code PNR·April 12, 2024
MODIFIED NOVY CORNUAL CANNULATION SET
FDA Adverse Event
Malfunction
·COOK INC·Product code MOV·January 10, 2024
MODIFIED NOVY CORNUAL CANNULATION SET
FDA Adverse Event
Malfunction
·COOK INC·Product code MOV·November 22, 2024
COMPREHENSIVE REVERSE SHOULDER
FDA Adverse Event
Injury
·ZIMMER BIOMET, INC.·Product code PAO·January 4, 2018
COMPREHENSIVE REVERSE SHOULDER HUMERAL BEARING
FDA Adverse Event
Injury
·ZIMMER BIOMET, INC.·Product code PAO·January 4, 2018