15 results
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21ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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CODMAN CERTAS PROGRAMMABLE VALVE SYSTEM
FDA 510(k)
FDA Class 2
·Neurology
Oticon
FDA UDI
Oticon A/S·05707131234827·K50, ITC P DIR L BE KIT
Fixion Nailing System
FDA UDI
CARBOFIX ORTHOPEDICS LTD·07290109330877·An interlocking intramedullary nail intended fo...
Fixion Nailing System
FDA UDI
CARBOFIX ORTHOPEDICS LTD·07290109330181·The nail is intended for use in the fixation of...
N/A
FDA UDI
HANS RUDOLPH, INC.·00874750003266·65 V2 MEDIUM 22OD ELBOW W/HG
CapSure® Spine System
FDA UDI
Spine Wave, Inc.·10840642104806·PS2 Screw 5.5mm x 25mm
CAPIOX RX HARDSHELL RESERVOIR
FDA 510(k)
FDA Class 2
·Cardiovascular
ZOLL AEDPRO WITH 2010 AHA GUIDELINES SOFTWARE UPDATE
FDA 510(k)
FDA Class 3
·Cardiovascular
HAHN TAPERED IMPLANT Ø3.5 X 10 MM
FDA Adverse Event
Injury
·PRISMATIK DENTALCRAFT, INC.·Product code DZE·October 15, 2025
IMPAX CV OUTBOUND (RESULTS MANAGEMENT 2.08)
FDA Adverse Event
Malfunction
·AGFA HEALTHCARE CORP.·Product code LLZ·February 28, 2014
UNIV FEM SLEEVE CEM 20MM
FDA Adverse Event
Injury
·1818910 DEPUY ORTHOPAEDICS, INC.·Product code JWH·May 15, 2013
SM104 MSERIES W5TH WHL
FDA Adverse Event
Malfunction
·STRYKER MEDICAL·Product code FPO·May 24, 2011
GOOSENECK SNARE
FDA Adverse Event
Injury
·COVIDIEN·Product code DQY·December 24, 2021
HAHN TAPERED IMPLANT 3.5 X 10 MM
FDA Adverse Event
Injury
·PRISMATIK DENTALCRAFT, INC.·Product code DZE·November 11, 2022
Model Number L131, ESSENTIO DR EL MRI Pacemaker
FDA Enforcement
Class I
·Ongoing·Boston Scientific Corporation·October 22, 2025