12 results
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21ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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ZIMMER 3.1MM DENTAL IMPLANT;2.9MM ANGLED ABUTMENT;STRAIGHT HEX, 2.9MM CONTOUR ABUTEMENT
FDA 510(k)
FDA Class 2
·Dental
IMP,TSV,4.1MM,DUAL SEL,HA
FDA Adverse Event
Injury
·ZIMMER DENTAL·Product code DZE·February 5, 2024
IMPL TAPERED SCR-V SBM 3.7MM 3.5MM 10MM
FDA Adverse Event
Injury
·ZIMMER DENTAL·Product code DZE·February 5, 2024
AIRSTRIP OB
FDA 510(k)
FDA Class 2
·Obstetrics/Gynecology
EXTRACTOR PRO RX RETRIEVAL BALLONS, EXTRACTOR PRO XL RETRIEVAL BALLONS, EXTRACTOR PRO DL RETRIEVAL BALLONS MODEL M005470
FDA 510(k)
FDA Class 2
·Gastroenterology, Urology
PARADIGM REAL-TIME REVEL INSULIN INFUSION PUMP
FDA Adverse Event
Malfunction
·MEDTRONIC PUERTO RICO OPERATIONS CO.·Product code OYC·October 4, 2014
DA VINCI SURGICAL SYSTEM
FDA Adverse Event
Death
·INTUITIVE SURGICAL, INC.·Product code NAY·May 21, 2013
TINA-QUANT HEMOGLOBIN A1C GEN.2
FDA Adverse Event
Malfunction
·ROCHE DIAGNOSTICS·Product code LCP·June 28, 2011
UNKNOWN IMPLANTABLE NEUROSTIMULATOR
FDA Adverse Event
Injury
·MEDTRONIC NEUROMODULATION·Product code MHY·June 10, 2014
NGAGE NITINOL STONE EXTRACTOR
FDA Adverse Event
Malfunction
·COOK INC·Product code FFL·February 12, 2018
NGAGE NITINOL STONE EXTRACTOR
FDA Adverse Event
Malfunction
·COOK INC·Product code FFL·February 12, 2018
BZO Strip Dip Card (300ng/ml)*, Item No. 100170
FDA Enforcement
Class III
·Terminated·Ameditech Inc·December 30, 2015