20 results
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23ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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DEPUY PULSE LUMBAR CAGE SYSTEM
FDA 510(k)
FDA Class 2
·Orthopedic
Merit Medical®
FDA UDI
Merit Medical Systems, Inc.·00884450192900·
RZ Medizintechnik GmbH
FDA UDI
RZ-Medizintechnik GmbH·04049197037938·TC Goldman Fox Gum Scissors
straig...
COLONOSCOPE/SIGMOIDOSCOPE SHEATHES
FDA 510(k)
FDA Class 2
·Gastroenterology, Urology
RPI REPLACEMENT HEATING ELEMENTS
FDA 510(k)
FDA Class 2
·General Hospital
THERMACHOICE CATHETER UNKNOWN PRODUCT
FDA Adverse Event
Injury
·ETHICON INC.·Product code MNB·December 5, 2018
UNKNOWN_NEUROVASCULAR_PRODUCT
FDA Adverse Event
Death
·CONCENTRIC MEDICAL·Product code NRY·December 13, 2012
UNKNOWN_NEUROVASCULAR_PRODUCT
FDA Adverse Event
Death
·CONCENTRIC MEDICAL·Product code NRY·December 13, 2012
UNKNOWN_NEUROVASCULAR_PRODUCT
FDA Adverse Event
Death
·CONCENTRIC MEDICAL·Product code NRY·December 13, 2012
TM ANKLE PROLONG TIBIAL INSERT SZ 6 +2
FDA Adverse Event
Injury
·ZIMMER BIOMET, INC.·Product code HSN·August 14, 2018
TM ANKLE TIBIAL INSERT COMPONENT SIZE 4
FDA Adverse Event
Injury
·ZIMMER BIOMET, INC.·Product code ITW·August 9, 2018
PARADIGM REAL-TIME REVEL INSULIN INFUSION PUMP
FDA Adverse Event
Malfunction
·MEDTRONIC PUERTO RICO OPERATIONS CO.·Product code OYC·May 20, 2013
OCTRODE LEAD
FDA Adverse Event
Injury
·ST. JUDE MEDICAL - NEUROMODULATION·Product code LGW·June 9, 2011
CONTOUR TEST STRIPS (50)
FDA Adverse Event
Malfunction
·BAYER HEALTHCARE, LLC·Product code NBW·August 13, 2008
UNKNOWN_NEUROVASCULAR_PRODUCT
FDA Adverse Event
Death
·CONCENTRIC MEDICAL·Product code NRY·December 13, 2012
TRABECULAR METAL TOTAL ANKLE TIBIAL BASE COMPONENT
FDA Adverse Event
Injury
·ZIMMER BIOMET, INC.·Product code HSN·April 5, 2018
TRABECULAR METAL TOTAL ANKLE TIBIAL INSERT
FDA Adverse Event
Injury
·ZIMMER BIOMET, INC.·Product code HSN·April 5, 2018
TRABECULAR METAL TOTAL ANKLE TALAR COMPONENT
FDA Adverse Event
Injury
·ZIMMER BIOMET, INC.·Product code HSN·April 5, 2018
UNKNOWN_NEUROVASCULAR_PRODUCT
FDA Adverse Event
Death
·CONCENTRIC MEDICAL·Product code NRY·December 18, 2012
Exactech Equinoxe REVERSE SHOULDER,42mm Humeral Liner, a) +0mm, Item number 320-42-00, b) +2.5mm, Item Number 320-42-03; Shoulder Arthroplasty
FDA Enforcement
Class II
·Ongoing·Exactech, Inc.·April 10, 2024