23 results · 19ms · Sources: EU EUDAMED, US FDA

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PROPHY PASTE

FDA 510(k)
FDA Class 1 ·Dental

Map-iT

FDA UDI
ACCESS POINT TECHNOLOGIES, INC.·00818087020015·Fixed Curve Decapolar Catheter, Multi-Purpose A...

Printed Lower ROC Pack for Herbst LL4 12mm

FDA UDI
SPECIALTY APPLIANCES, LLC·D8199015800·

ERA 2.2MM IMP 0DEG MICRO HEAD 10X1MM, Ti

FDA UDI
STERNGOLD DENTAL LLC·00841549108495·Designed for both transitional and long-term de...

Sklar®

FDA UDI
SKLAR CORPORATION·10649111276002·SIMS SCISS CVD S/S 8"

N/A

FDA UDI
MEDTRONIC SOFAMOR DANEK, INC.·00673978079738·DISTRACTOR 901-580 22/14MM SGL BARREL OS

ARCOMXL POLYETHYLENE LINERS AND 38/40MM FEMORAL HEADS

FDA Adverse Event
Injury ·BIOMET ORTHOPEDICS·Product code KWA·August 31, 2017

E-POLY HIWALL LINER

FDA Adverse Event
Injury ·BIOMET ORTHOPEDICS·Product code JDI·August 31, 2017

MALLORY/HEAD TOTAL HIP SYSTEM; HA MALLORY/HEAD TOTAL HIP SYSTEM; BI-METRIC FEMOR

FDA Adverse Event
Injury ·BIOMET ORTHOPEDICS·Product code LPH·August 31, 2017

RINGLOC + HYBRID ACETABULAR SYSTEM

FDA Adverse Event
Injury ·BIOMET ORTHOPEDICS·Product code KWA·August 31, 2017

GROSS FEMORAL COMPONENT

FDA 510(k)
FDA Class 2 ·Orthopedic

PICA WHOLE BODY MRI SYSTEM

FDA 510(k)
FDA Class 2 ·Radiology

STEM: AMISTEM H HA COATED STD STEM SIZE 2

FDA Adverse Event
Injury ·MEDACTA INTERNATIONAL SA·Product code LZO·August 29, 2019

TAPERLOC POR FEMORAL LAT STEM 7.5X135

FDA Adverse Event
Injury ·BIOMET ORTHOPEDICS·Product code LPH·June 30, 2014

HS III PROXIMAL SEAL SYTEM 3.8MM

FDA Adverse Event
Malfunction ·MAQUET CARDIOVASCULAR, LLC·Product code DXC·January 4, 2013

AOSEPT CLEAR CARE CLEANING AND DISINFECTANT

FDA Adverse Event
Injury ·CIBA VISION CANADA, INC.·Product code LPN·November 12, 2010

CPS SM SPDL WITH PINS 600LBF

FDA Adverse Event
Injury ·ZIMMER BIOMET, INC.·Product code KRO·February 26, 2021

Medtronic Sofamor Danek USA, CD Horizon Spinal System Agile Dynamic Stabilization Device, REF 7901580, 15mm, 5.5mm dia x 80mm, size: 15mm x 80mm, for spinal fixation.

FDA Recall
Terminated ·Medtronic Sofamor Danek USA Inc·Product code NQP·November 12, 2007

CPS ANCHOR PLUG 14MM

FDA Adverse Event
Injury ·ZIMMER BIOMET, INC.·Product code KRO·February 26, 2021

Affixus¿ Hip Fracture Nail Left 130¿ 11 mm x 380 mm, Item Number: 814611380

FDA Enforcement
Class II ·Terminated·Zimmer Biomet, Inc.·September 19, 2018