21 results · 20ms · Sources: EU EUDAMED, US FDA

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PEEK SA Anterior Lumbar Interbody Fusion (ALIF) System

FDA 510(k)
FDA Class 2 ·Orthopedic

Dornier MedTech

FDA UDI
DORNIER MEDTECH AMERICA, INC.·00810116022380·600 micron core/1040 micron OD Luer Lock Diode ...

Zavation

FDA UDI
Zavation LLC·00197157002848·CIF 14x18, 8 deg, -08

Lumbar IBFD

FDA UDI
KEOS·B084KPS12308080·

Lumbar IBFD

FDA UDI
KEOS·B084KPS22308080·

STRAUMANN HEALING ABUTMENTS, HEALING CAPS, CLOSURE SCREWS

FDA 510(k)
FDA Class 2 ·Dental

HANSON MEDICAL CALF IMPLANT

FDA 510(k)
FDA Class 2 ·Ear, Nose, Throat

PLUM A+ PUMP MEDNET WIRELESS

FDA Adverse Event
Malfunction ·HOSPIRA, INC.·Product code FRN·November 6, 2008

AVAULTA PLUS SYNTHETIC SUPPORT SYSTEM

FDA Adverse Event
Injury ·C.R. BARD, INC.·Product code FTL·August 23, 2011

OT VERIO IQ METER

FDA Adverse Event
Malfunction ·LIFESCAN EUROPE, A DIVISION OF CILAG GMBH INTL·Product code NBW·July 17, 2013

24 G X 0.56 IN. BD INSYTE-N¿ AUTOGUARD¿ SHIELDED IV CATHETER

FDA Adverse Event
Malfunction ·BECTON DICKINSON INFUSION THERAPY SYSTEMS INC.·Product code FOZ·November 1, 2017

BD SYRINGE 1ML S/T W/NDL 25X5/8 RB

FDA Adverse Event
Malfunction ·BECTON DICKINSON MEDICAL SYSTEMS·Product code FMF·December 3, 2023

Transseptal Needle, Trocar. RPN TSNC-18-71.0, TSNC-19-56.0. GPN G02364, G02365. Product consists of a transseptal needle and obturator.

FDA Enforcement
Class II ·Terminated·Cook Inc.·November 24, 2021

BIOMET StageOne Knee Tibial Cement Spacer Mold, 65 MM, Silicone, Sterile, Item 433165.

FDA Enforcement
Class II ·Terminated·Biomet, Inc.·April 15, 2020

BIOMET StageOne, Hip Cement Spacer Mold w/Reinforcement, 13 X 145 MM, 57 MM, Silicone, Sterile, Item 431213.

FDA Enforcement
Class II ·Terminated·Biomet, Inc.·April 15, 2020

BIOMET StageOne Knee Femoral Cement Spacer Mold, 65 MM, Silicone, Sterile, Item 432165.

FDA Enforcement
Class II ·Terminated·Biomet, Inc.·April 15, 2020

BIOMET StageOne, Hip Cement Spacer Mold w/Reinforcement, 9 X 125 MM, 51 MM, Silicone, Sterile, Item 431209.

FDA Enforcement
Class II ·Terminated·Biomet, Inc.·April 15, 2020

BIOMET StageOne Knee Tibial Cement Spacer Mold, 70 MM, Silicone, Sterile, Item 433170.

FDA Enforcement
Class II ·Terminated·Biomet, Inc.·April 15, 2020

BIOMET StageOne Knee Tibial Cement Spacer Mold, 75 MM, Silicone, Sterile, Item 433175.

FDA Enforcement
Class II ·Terminated·Biomet, Inc.·April 15, 2020

BIOMET StageOne Knee Femoral Cement Spacer Mold, 60 MM, Silicone, Sterile, Item 432160.

FDA Enforcement
Class II ·Terminated·Biomet, Inc.·April 15, 2020