21 results
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24ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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ONDEMAND3D
FDA 510(k)
FDA Class 2
·Radiology
N/A
FDA UDI
HANS RUDOLPH, INC.·00874750003433·65 V2 EX SMALL 22ID STR W/HG
PP needle guide for Mammotome
FDA UDI
Noras MRI products GmbH·04251269202292·
Plateau C
FDA UDI
Life Spine, Inc.·00190837093440·
Stablecut®
FDA UDI
ZIMMER ORTHOPAEDIC SURGICAL PRODUCTS, INC.·00889024493971·
Stablecut®
FDA UDI
ZIMMER ORTHOPAEDIC SURGICAL PRODUCTS, INC.·00889024647541·
Stablecut®
FDA UDI
ZIMMER ORTHOPAEDIC SURGICAL PRODUCTS, INC.·00846795002313·
CRESCENT (R) SPINAL SYSTEM TITANIUM
FDA 510(k)
FDA Class 2
·Orthopedic
BOND-1 C & B
FDA 510(k)
FDA Class 2
·Dental
SCREW, UNKNOWN TYPE
FDA Adverse Event
Malfunction
·ZIMMER BIOMET SPINE INC.·Product code KWP·June 17, 2019
SCREW, UNKNOWN TYPE
FDA Adverse Event
Malfunction
·ZIMMER BIOMET SPINE INC.·Product code KWP·June 17, 2019
BAXANO IO-FLEX SYSTEM
FDA Adverse Event
Other
·BAXANO, INC.·Product code HAE·July 2, 2012
BAXANO IO-FLEX SYSTEM
FDA Adverse Event
Other
·BAXANO, INC.·Product code HAE·July 2, 2012
BAXANO IO-FLEX SYSTEM
FDA Adverse Event
Other
·BAXANO, INC.·Product code HAE·July 2, 2012
AC-POWERED ADJUSTABLE HOSPITAL BED, INCLUDING RAILS
FDA Adverse Event
Malfunction
·INVACARE FLORIDA OPERATIONS·Product code FNL·May 15, 2013
*
FDA Adverse Event
Malfunction
·SMITHS HEALTHCARE MANUFACTURING S.A. DE C.V.·Product code JOH·June 6, 2008
UNKNOWN ZIMMER KNEE
FDA Adverse Event
Injury
·ZIMMER, INC.·Product code JWH·June 1, 2011
WALLFLEX? BILIARY TRANSHEPATIC
FDA Adverse Event
Injury
·BOSTON SCIENTIFIC - GALWAY·Product code FGE·August 21, 2012
Stolen McGRATH MAC Video Laryngoscopes, REF: 301-000-000
FDA Enforcement
Class I
·Ongoing·Covidien·November 8, 2023
INLIVEN CRT-P, Model Numbers: a) V284 b) V285 c) W274 d) W275 (added 7/15/2021)
FDA Enforcement
Class I
·Ongoing·Boston Scientific Corporation·July 21, 2021