31 results
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33ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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LOCATOR R-Tx
FDA 510(k)
FDA Class 2
·Dental
K-Y BRAND ULTRA GEL PERSONAL LUBRICANT
FDA 510(k)
FDA Class 2
·Obstetrics/Gynecology
UNICOMPARTMENTAL PATELLOFEMORAL PROSTHESIS (UPP) CEMENTED
FDA 510(k)
FDA Class 2
·Orthopedic
Widex
FDA UDI
Widex A/S·05706069735642·Widex BEYOND B-F2 (Winter silver S-220 ) Teleco...
VANGUARD PFR FEMORAL LT SM
FDA Adverse Event
Injury
·BIOMET SPAIN, S.L.·Product code KRR·May 17, 2018
AUVON TENS & EMS DEVICE
FDA Adverse Event
Injury
·SHEN ZHEN AS TEC TECHNOLOGY CO LTD·Product code NUH·January 28, 2025
BAB FLEXIBLE FABRIC BANDAGES
FDA Adverse Event
Injury
·KENVUE BRANDS, LLC·Product code KGX·February 7, 2025
COLLEAGUE 3 VOLUMETRIC INFUSION PUMP
FDA Adverse Event
Malfunction
·BAXTER HEALTHCARE PTE. LTD.·Product code FRN·October 20, 2008
ONETOUCHPING GLUCOSEMGMTSYSTEM
FDA Adverse Event
Malfunction
·ANIMAS CORPORATION·Product code LZG·August 11, 2011
OT VERIO PRO METER
FDA Adverse Event
Malfunction
·LIFESCAN EUROPE, A DIVISION OF CILAG GMBH INTL·Product code NBW·July 2, 2013
NAIL, FIXATION, BONE
FDA Adverse Event
Injury
·SYNTHES (USA)·Product code JDS·September 23, 2014
NAIL, FIXATION, BONE
FDA Adverse Event
Injury
·SYNTHES (USA)·Product code JDS·September 23, 2014
CONTAK RENEWAL 3 HE IS-1/DF-1/IS-1
FDA Adverse Event
Malfunction
·GUIDANT CRM CLONMEL IRELAND·Product code NIK·May 8, 2009
Bullet-Tip PEEK VBR/IBF System, 32mm(l) 13mm(H) Implant 32-13-32 UDI (01)008464680341 08(17)191218(10)200827; T-Plus PEEK VBR/IBF System, 10mm(W) x 27mm(l) x 13mm(H) Implant, 6degree lordotic 30-T-13-6 UDI (01) 00846468032920(17) 200116(10) 202726; and T-Plus PEEK VBR/IBF System, 10mm(W) x 36 mm(l) x 13mm(H) Implant, 6degree lordotic 30-T-1036-13-6 UDI (01)00846468032760(17)200115(10)202582. These products are part of the lnterbody Fusion Vertebral Body Replacement System to ensure stability of the spine and adequate compression of the implant.
FDA Enforcement
Class II
·Terminated·RTI Surgical, Inc. (dba Pioneer Surgical Technology, Inc.)·July 8, 2015
SYNCHROMED II
FDA Adverse Event
Injury
·MEDTRONIC NEUROMODULATION·Product code LKK·February 23, 2009
AUVON TENS UNIT
FDA Adverse Event
Injury
·SHEN ZHEN AS TEC TECHNOLOGY CO LTD·Product code NUH·December 19, 2024
NAIL, FIXATION, BONE
FDA Adverse Event
Injury
·SYNTHES (USA)·Product code JDS·September 23, 2014
ATTUNE SPACER BASE
FDA Adverse Event
Malfunction
·DEPUY IRELAND - 9616671·Product code HWT·July 17, 2023
NAIL, FIXATION, BONE
FDA Adverse Event
Injury
·SYNTHES (USA)·Product code JDS·September 23, 2014
ATTUNE SPACER BASE
FDA Adverse Event
Malfunction
·DEPUY IRELAND - 9616671·Product code HWT·February 19, 2024