17 results · 29ms · Sources: EU EUDAMED, US FDA

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BD BACTEC Peds Plus/F Culture Vials (plastic)

FDA 510(k)
FDA Class 1 ·Microbiology

BD BACTEC¿ PEDS PLUS¿/ F CULTURE VIALS (PLASTIC)

FDA Adverse Event
Malfunction ·BECTON DICKINSON CARIBE LTD.·Product code MDB·March 10, 2023

OSS™ Orthopedic Salvage System

FDA UDI
Biomet Orthopedics, LLC·00887868267208·

ORTHOPEDIC SALVAGE SYSTEM

FDA UDI
Biomet Orthopedics, LLC·00880304688001·

PREMIER TEMPORARY CEMENT

FDA 510(k)
FDA Class 2 ·Dental

CRYOPATCH SG PULMONARY HUMAN CARDIAC PATCH

FDA 510(k)
FDA Class 2 ·Cardiovascular

BD VACUTAINER SST II ADVANCE TUBES

FDA Adverse Event
Malfunction ·BECTON DICKINSON IND. CIRURGICAS LTDA·Product code JKA·June 22, 2021

INSPIRA SMOOTH SILICONE GEL FILLED BREAST IMPLANT

FDA Adverse Event
Injury ·ALLERGAN (COSTA RICA)·Product code FTR·September 10, 2024

EON MINI

FDA Adverse Event
Injury ·ST JUDE MEDICAL, NEUROMODULATION·Product code GZB·October 6, 2014

COLLEAGUE PRE P1.7

FDA Adverse Event
Malfunction ·BAXTER HEALTHCARE - SINGAPORE·Product code FRN·July 6, 2011

PULSE-GENERATOR, DUAL CHAMBER, IMPLANTABLE

FDA Adverse Event
Malfunction ·MEDTRONIC, INC.·Product code LWP·June 7, 2013

BD TUBE SST PLH 13X100 5.0 PLBL GOLD BR

FDA Adverse Event
Malfunction ·BECTON DICKINSON IND. CIRURGICAS LTDA·Product code JKA·June 1, 2021

TLC-2000 Therapeutic Medical Laser System, used for the temporary relief of knee pain.

FDA Recall
Terminated ·Theralase Inc.·Product code NHN·September 26, 2019

TLC-2000 Therapeutic Medical Laser System, Power Pack component TLC-2002 Used for the temporary relief of knee pain.

FDA Recall
Terminated ·Theralase Inc.·Product code NHN·September 26, 2019

Precise Treatment Table. To be used as part of radiation therapy treatment process.

FDA Enforcement
Class II ·Terminated·Elekta, Inc.·April 17, 2013

All Elekta digital accelerators with electrons and beam modulator, MLCi/MLCi2, Agility or Asymmetric Heads Product Usage: Deliver of radiation to defined target volumes

FDA Enforcement
Class II ·Terminated·Elekta, Inc.·March 12, 2014

ELEKTA LIMITED Elekta Synergy, REF MRT 8501, MRT 8511; Medical Charged-Particle Radiation Therapy System Accelerator, Linear

FDA Enforcement
Class II ·Ongoing·Elekta, Inc.·December 13, 2023