54 results · 19ms · Sources: EU EUDAMED, US FDA

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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