12 results · 25ms · Sources: EU EUDAMED, US FDA

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MASTERGRAFT PUTTY BONE VOID FILLER

FDA 510(k)
FDA Class 2 ·Orthopedic

EBI OSTEOSTIM GRANULES-RESORBABLE BONE GRAFT SUBSTITUTE

FDA 510(k)
FDA Class 2 ·Orthopedic

ACCUSET SENSOR, MODEL 2000

FDA 510(k)
FDA Class 2 ·Gastroenterology, Urology

INFUSION PUMP

FDA Adverse Event
Injury ·MEDTRONIC NEUROMODULATION·Product code LKK·April 10, 2013

EXPRESS2 MONORAIL CORONARY STENT DELIVERY SYSTEM

FDA Adverse Event
Injury ·BOSTON SCIENTIFIC CORPORATION·Product code MAF·May 16, 2008

CAPSUREFIX NOVUS

FDA Adverse Event
Malfunction ·MEDTRONIC PUERTO RICO, INC.·Product code DTB·April 12, 2011

PROSTHESIS, KNEE, PATELLO/FEMORAL, SEMI-CONSTRAINED, CEMENTED, METAL/POLYMER

FDA Adverse Event
Injury ·SMITH & NEPHEW, INC.·Product code KRR·October 15, 2025

PROSTHESIS, KNEE, PATELLO/FEMORAL, SEMI-CONSTRAINED, CEMENTED, METAL/POLYMER

FDA Adverse Event
Injury ·SMITH & NEPHEW, INC.·Product code KRR·October 20, 2025

PROSTHESIS, KNEE, PATELLO/FEMORAL, SEMI-CONSTRAINED, CEMENTED, METAL/POLYMER

FDA Adverse Event
Injury ·SMITH & NEPHEW, INC.·Product code KRR·October 15, 2025

C-QUR MOSAIC

FDA Adverse Event
Injury ·ATRIUM MEDICAL CORPORATION·Product code FTL·October 9, 2015

Quadra Assura, Sterile EO, Model #/ Part #: CD3265-40/100042335, 100059846; CD3265-40Q/100042336, 100059847; CD3267-40/100042956, 100043569, 100059961, 100078810; CD3267-40Q/100043132, 100043539, 100059917, 100059956, 100078904; CD3365-40C/100080435, 100080436; CD3365-40Q/100080426, 100080427; CD3367-40/100078813, 100079497, 100096097; CD3367-40C/100078597, 100079174, 100079450, 100079490, 100105524; CD3367-40Q/100078851, 100079212, 100079504, 100096098; CD3367-40QC/100078656, 100079193, 100079498, 100079524, 100105513, 100105514, 100138185, 100138213; CD3385-40C/100080778; CD3385-40QC/100080780, 100105489

FDA Enforcement
Class II ·Terminated·St Jude Medical Inc.·July 4, 2018

OEC 6800 Miniview, Image-intensified fluoroscopic x-ray system used during diagnostic, surgical and interventional procedures. Designed to provide the physician with general fluoroscopic visualization of the patient including but not limited to surgical orthopedic and extremity imagine. The device is not intended for whole-body pediatric imaging.

FDA Enforcement
Class I ·Terminated·GE OEC Medical Systems, Inc·August 1, 2012