6,320 results
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19ms
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Sources: EU EUDAMED, US FDA
REVEAL PLUS INSERTABLE LOOP RECORDER SYSTEM MODEL 9526 IMPLANTABLE RECORDER AND MODEL 6191 PATIENT ACTIVATOR
FDA 510(k)
FDA Class 2
·Cardiovascular
Henry Schein
FDA UDI
HENRY SCHEIN, INC.·00304040013670·Zirlux 16+ C1 98.5X16
InTess C Cervical Cage System
FDA UDI
Kalitec Direct LLC·B07309K01109T0·Cervical Trial, 14 x 11, 9mm, 7 Degree, Tapered
InTess C Cervical Cage System
FDA UDI
Kalitec Direct LLC·B07309K01109N0·Cervical Trial, 14 x 11, 9mm, 0 Degree, No Taper
PRO.DUCT HEALTH MICRO-STYLET, MODEL STY01
FDA 510(k)
FDA Class 2
·General Hospital
MODIFICATION TO CAVERMAP SURGICAL AID
FDA 510(k)
FDA Class 1
·Gastroenterology, Urology
BEAR Implant. Model Number: 1000.
FDA Enforcement
Class II
·Ongoing·Miach Orthopaedics·February 4, 2026
PULSE GEN MODEL 105
FDA Adverse Event
Injury
·CYBERONICS, INC.·Product code LYJ·March 19, 2013
MINICAP
FDA Adverse Event
Injury
·BAXTER HEALTHCARE - CLEVELAND·Product code KDI·March 8, 2011
TENDRIL SDX
FDA Adverse Event
Injury
·ST JUDE MEDICAL CARDIAC RHYTHM MANAGEMENT DIVISION·Product code DTB·March 10, 2008
IMPL TAPERED SCR-V SBM 3. 7MM 3.5MM 8MM
FDA Adverse Event
Malfunction
·ZIMMER DENTAL·Product code DZE·December 19, 2019
IMPL TAPERED SCR-V HA 3.7 MM 3.5MM 13MM
FDA Adverse Event
Injury
·ZIMMER DENTAL·Product code DZE·August 7, 2019
IMPL TAPERED SCR-V SBM 3.7MM 3.5MM 10MM
FDA Adverse Event
Malfunction
·ZIMVIE US CORP LLC·Product code DZE·May 29, 2026
IMPL TAPERED SCR-V SBM 3. 7MM 3.5MM 8MM
FDA Adverse Event
Malfunction
·ZIMMER DENTAL·Product code DZE·October 11, 2022
IMPL TAPERED SCR-V SBM 3.7MM 3.5MM 13MM
FDA Adverse Event
Injury
·ZIMVIE US CORP LLC·Product code DZE·May 20, 2026
IMPL TAPERED SCR-V SBM 4. 7MM 4.5MM 10MM
FDA Adverse Event
Injury
·ZIMVIE US CORP LLC·Product code DZE·May 12, 2026
IMPL TAPERED SCR-V SBM 4. 7MM 4.5MM 8MM
FDA Adverse Event
Injury
·ZIMVIE US CORP LLC·Product code DZE·May 12, 2026
IMPL TAPERED SCR-V SBM 3.7MM 3.5MM 13MM
FDA Adverse Event
Injury
·ZIMVIE US CORP LLC·Product code DZE·March 25, 2026
IMPL TAPERED SCR-V SBM 3. 7MM 3.5MM 8MM
FDA Adverse Event
Injury
·ZIMVIE US CORP LLC·Product code DZE·April 28, 2026
IMPL TAPERED SCR-V SBM 4. 7MM 4.5MM 10MM
FDA Adverse Event
Injury
·ZIMVIE US CORP LLC·Product code DZE·May 7, 2026