23 results
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19ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: 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