31 results · 33ms · Sources: EU EUDAMED, 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