13 results
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21ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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RTE SNAPCONE
FDA Adverse Event
Malfunction
·BOSTON SCIENTIFIC CORPORATION·Product code FHW·July 11, 2023
AMS SPECTRA CONCEALABLE PENILE PROSTHESIS
FDA 510(k)
FDA Class 2
·Gastroenterology, Urology
REAR TIP EXTENDER
FDA Adverse Event
Malfunction
·BOSTON SCIENTIFIC CORPORATION·Product code N/A·December 30, 2025
RTE SNAPCONE
FDA Adverse Event
Injury
·BOSTON SCIENTIFIC CORPORATION·Product code FHW·February 17, 2021
Amara View
FDA UDI
Respironics, Inc.·00606959009264·Amara View Mask with Headgear, International, M...
KRONNER LOW PROFILE SCOPE HOLDER
FDA 510(k)
FDA Class 2
·Gastroenterology, Urology
POWDERED SYNTHETIC VINYL PATIENT EXAM GLOVE
FDA 510(k)
FDA Class 1
·General Hospital
DEXCOM G7 CONTINUOUS GLUCOSE MONITORING SYSTEM
FDA Adverse Event
Malfunction
·DEXCOM, INC.·Product code QBJ·April 17, 2024
DEXCOM G7 CONTINUOUS GLUCOSE MONITORING SYSTEM
FDA Adverse Event
Malfunction
·DEXCOM, INC.·Product code QBJ·April 17, 2025
OT VERIO IQ METER
FDA Adverse Event
Malfunction
·LIFESCAN EUROPE, A DIVISION OF CILAG GMBH INTL·Product code NBW·May 2, 2013
HD 2.7MM X 30° STUBBY ARTHROSCOPE J-LOCK A/C
FDA Adverse Event
Malfunction
·STRYKER ENDOSCOPY-SAN JOSE·Product code HRX·September 15, 2014
SYNCHROMED EL
FDA Adverse Event
Injury
·RICE CREEK MANUFACTURING·Product code LKK·August 1, 2008
Philips Respironics Amara View Minimal Contact Full-Face Mask
FDA Enforcement
Class I
·Ongoing·Philips Respironics, Inc.·October 12, 2022