31 results
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21ms
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Sources: EU EUDAMED, US FDA
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Regulation: Us FDA
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HORIZON CARDIOLOGY ECG MANAGEMENT
FDA 510(k)
FDA Class 2
·Cardiovascular
DD tempMED
FDA UDI
Dental Direkt GmbH·EDDIK113151·DD tempMED are pre-colored dental milling blank...
DD tempMED
FDA UDI
Dental Direkt GmbH·EDDIK115151·DD tempMED are pre-colored dental milling blank...
N/A
FDA UDI
HANS RUDOLPH, INC.·00874750003150·75 V2 LARGE 22OD STRGHT W/HG
Plateau Spacer System
FDA UDI
Life Spine, Inc.·00190837045227·Straight Sizer, 12mm
Complete Cervical
FDA UDI
Seaspine Orthopedics Corporation·10889981040611·Screw - Self-Tapping - 3.5x15mm
Segmental Plating System
FDA UDI
ALPHATEC SPINE, INC.·00190376545400·SPS VA Self-Tap Screw, 3.5 x 15 mm
Proximity
FDA UDI
ALPHATEC SPINE, INC.·00190376694474·PROXIMITY VA SELF-TAP SCREW, 3.5 x 15mm
INFINITY EXPLORER
FDA 510(k)
FDA Class 2
·Cardiovascular
EQUAL DOSE
FDA 510(k)
FDA Class 2
·Radiology
PENCAN®
FDA Adverse Event
Injury
·B BRAUN MELSUNGEN AG·Product code BSP·May 6, 2025
EVOLUTION® COLONIC CONTROLLED-RELEASE STENT - UNCOVERED
FDA Adverse Event
Malfunction
·COOK IRELAND LTD·Product code MQR·April 12, 2018
GYNECARE MORCELLEX* TISSUE MORCELLATOR
FDA Adverse Event
Malfunction
·ETHICON, INC.·Product code HET·May 15, 2013
IMPAX CV OUTBOUND (RESULTS MANAGEMENT 2.08)
FDA Adverse Event
Malfunction
·AGFA HEALTHCARE CORP.·Product code LLZ·February 28, 2014
DEPUY
FDA Adverse Event
Death
·JOHNSON AND JOHNSON·Product code LPH·May 28, 2011
TEMPOROMANDIBULAR JOINT REPLACEMENT SYSTEM
FDA Adverse Event
Injury
·BIOMET MICROFIXATION·Product code JEY·May 31, 2019
EVOLUTION® COLONIC CONTROLLED-RELEASE STENT - UNCOVERED
FDA Adverse Event
Injury
·COOK IRELAND LTD·Product code MQR·August 17, 2017
EVOLUTION BILIARY CONTROLLED-RELEASE STENT - FULLY COVERED
FDA Adverse Event
Malfunction
·COOK IRELAND LTD·Product code FAD·March 12, 2015
PENCAN®
FDA Adverse Event
Injury
·B BRAUN MELSUNGEN AG·Product code BSP·April 10, 2025
WALTER LORENZ TOTAL TEMPOROMANDIBULAR JOINT REPLACEMENT SYSTEM
FDA Adverse Event
Injury
·BIOMET MICROFIXATION·Product code LZD·August 29, 2017