12 results
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21ms
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Sources: EU EUDAMED, US FDA
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Regulation: Us FDA
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ReBOSSIS
FDA 510(k)
FDA Class 2
·Orthopedic
Philips
FDA UDI
Sbo Hearing A/S·05714464054848·HEARLINK 3030 MNR T R BL/DG
MSI Precision Specialty Instruments
FDA UDI
Med Saver, Inc.·00194613017989·K-Wire, Single Ended, Trocar Point, Diameter Si...
ASSI
FDA UDI
ACCURATE SURGICAL & SCIENTIFIC INSTRUMENTS CORPORATION·00841645140818·Microdissection Needle TC,
2" 5cm, long angle 4...
AMS INFLATABLE PENILE PROSTHESIS WITH INHIBIZONE
FDA Adverse Event
Injury
·BOSTON SCIENTIFIC CORPORATION·Product code FHW·November 7, 2018
OSTEOTEC SILICONE FINGER IMPLANT
FDA 510(k)
FDA Class 2
·Orthopedic
AUTOPULSE RESUSCITATION SYSTEM, MODEL 100
FDA 510(k)
FDA Class 2
·Cardiovascular
GMK SPHERE TOTAL KNEE SYSTEM
FDA Adverse Event
Injury
·MEDACTA INTERNATIONAL SA·Product code JWH·October 15, 2024
530G INSULIN PUMP
FDA Adverse Event
MEDTRONIC PUERTO RICO OPERATIONS CO.·Product code OZO·November 10, 2014
TENDRIL ST
FDA Adverse Event
Injury
·ST JUDE MEDICAL CARDIAC RHYTHM MANAGEMENT DIVISION·Product code NVN·September 9, 2011
2MM FLUTED BALL, STANDARD
FDA Adverse Event
Malfunction
·DEPUY SYNTHES POWER TOOLS·Product code HBC·July 17, 2013
Model Number L111, ESSENTIO DR SL MRI Pacemaker
FDA Enforcement
Class I
·Ongoing·Boston Scientific Corporation·October 22, 2025