54 results
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19ms
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Sources: EU EUDAMED, US FDA
Bone Cement
FDA Pre-Market Approval
FDA Class 2
·SURGICAL SIMPLED P BONE CEMENT
Bone Cement
FDA Pre-Market Approval
FDA Class 2
·SURGICAL SIMPLEX BONE CEMENT
Bone Cement
FDA Pre-Market Approval
FDA Class 2
·SURGICAL SIMPLEX(R) P BONE CEMENT
Bone Cement
FDA Pre-Market Approval
FDA Class 2
·SURGICAL SIMPLEX(R) P BONE CEMENT
Bone Cement
FDA Pre-Market Approval
FDA Class 2
·SURGICAL SIMPLEX(R) P BONE CEMENT
Richard-Allan® Needle 3/8 Circle Trocar
FDA UDI
ASPEN SURGICAL PRODUCTS, INC.·00840113217984·Intent to be used with suture material for tiss...
Plateau A
FDA UDI
Life Spine, Inc.·00190837094881·
RePlay
FDA UDI
DIVERSATEK HEALTHCARE, INC.·00816734023174·RePlay Hemostasis Clip, 18 mm
CARDINAL HEALTH
FDA UDI
CARDINAL HEALTH 200, LLC·10885425496600·TRAY,SKIN PREP,DRY,FORCEP,ST
LifeShield Drug Library Management (DLM), LifeShield Infusion Safety Software Suite v2.2 Product No. 17003-02
FDA Recall
Open, Classified
·ICU Medical, Inc.·Product code PHC·November 24, 2025
LifeShield Drug Library Management (DLM), LifeShield Infusion Safety Software Suite v2.2 Product No. 17003-02
FDA Enforcement
Class II
·Ongoing·ICU Medical, Inc.·December 31, 2025
Glaze
FDA UDI
Taub Products·D8370170030·Glaze contains a translucent acrylic and thinne...
RZ Medizintechnik GmbH
FDA UDI
RZ-Medizintechnik GmbH·04049197471862·Micro Hooks, knee bent shaft
6 1/4'...
Inspire
FDA UDI
Inspire Medical Systems, Inc.·00810098650083·The sleep remote is an external device that is ...
RZ Medizintechnik GmbH
FDA UDI
RZ-Medizintechnik GmbH·04049197303231·Shambough Micro Hook
6 1/4'...
ALEUTIAN Interbody Systems
FDA UDI
VB Spine LLC·10888857554467·Nerve Root Retractor Small
Bone Cement
FDA Pre-Market Approval
FDA Class 2
·SURGICAL SIMPLEX P RADEOPAQUE BONE CEMENT
MAMMOTOME ST HOLSTER
FDA Adverse Event
Malfunction
·ETHICON ENDO-SURGERY·Product code KNW·November 21, 2014
NITINOL STAPLE
FDA Adverse Event
Injury
·TRIMED, INC.·Product code JDR·October 18, 2018
NITINOL STAPLE
FDA Adverse Event
Injury
·TRIMED, INC.·Product code JDR·October 18, 2018