13 results
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22ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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SOMNODENT HERBST; CLASSIC, FLEX
FDA 510(k)
FDA Class 2
·Dental
PN841
FDA UDI
Respironics, Inc.·00606959041615·PN841 Mask, Child Med, Leak 3, Japan
BENCO
FDA UDI
BENCO DENTAL SUPPLY CO.·00366975052759·
RZ Medizintechnik GmbH
FDA UDI
RZ-Medizintechnik GmbH·04049197047692·Glanz atraumatic forceps
150mm,...
QUANTA SYSTEM S.P.A.
FDA Adverse Event
Malfunction
·QUANTA SYSTEM, S.P.A.·Product code GEX·December 21, 2012
MAMMOSITE RADIATION THERAPY SYSTEM (RTS) TRAY, MAMMOSITE HDR AFTERLOADER ACCESSORIES TRAY
FDA 510(k)
FDA Class 2
·Radiology
QUANTA DIODE LASER SYSTEM
FDA 510(k)
FDA Class 2
·General, Plastic Surgery
DEXCOM G7 CONTINUOUS GLUCOSE MONITORING SYSTEM
FDA Adverse Event
Malfunction
·DEXCOM, INC.·Product code QBJ·May 28, 2025
INTRALASE FS2
FDA Adverse Event
Injury
·ABBOTT MEDICAL OPTICS·Product code HNO·May 24, 2013
PARADIGM REAL-TIME INSULIN INFUSION PUMP
FDA Adverse Event
Malfunction
·MEDTRONIC PUERTO RICO OPERATIONS CO.·Product code OYC·September 30, 2014
UNKNOWN ZIMMER KNEE
FDA Adverse Event
Injury
·ZIMMER, INC.·Product code JWH·June 14, 2011
QUADRA-H CEMENTLESS, HA COATED STD STEM SIZE 0 LOT. 102677
FDA Adverse Event
Injury
·MEDACTA INTERNATIONAL SA·Product code JDI·April 26, 2018
Eversense CGM SENSOR (FG-4200-00-301)-Continuous Glucose Monitor
FDA Enforcement
Class II
·Terminated·Senseonics, Inc.·November 6, 2019