22 results · 24ms · Sources: EU EUDAMED, US FDA

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CALCIUM GEN. 2

FDA 510(k)
FDA Class 2 ·Clinical Chemistry

CD HORIZON® Spinal System

FDA UDI
MEDTRONIC SOFAMOR DANEK, INC.·00885074250779·CROSSLINK 8113521 X10 FOR 3.5ROD L 21

N/A

FDA UDI
HANS RUDOLPH, INC.·00874750003211·75 V2 MEDIUM 22ID STRGT W/HG

Plateau Spacer System

FDA UDI
Life Spine, Inc.·00190837045265·Straight Osteotome

Proximity

FDA UDI
ALPHATEC SPINE, INC.·00190376694535·PROXIMITY VA SELF-TAP SCREW, 3.5 x 21mm

Segmental Plating System

FDA UDI
ALPHATEC SPINE, INC.·00190376545462·SPS VA Self-Tap Screw, 3.5 x 21 mm

EVERON CENTRAL DISPLAY STATION (CDS)

FDA 510(k)
FDA Class 2 ·Cardiovascular

GEMINI IMAGING SYSTEM

FDA 510(k)
FDA Class 2 ·Radiology

HAHN TAPERED IMPLANT Ø3.0 X 11.5 MM

FDA Adverse Event
Injury ·PRISMATIK DENTALCRAFT, INC.·Product code DZE·December 4, 2023

HAHN TAPERED IMPLANT Ø3.0 X 11.5 MM

FDA Adverse Event
Injury ·PRISMATIK DENTALCRAFT, INC.·Product code DZE·June 27, 2024

HAHN TAPERED IMPLANT Ø3.0 X 11.5 MM

FDA Adverse Event
Injury ·PRISMATIK DENTALCRAFT, INC.·Product code DZE·March 20, 2023

HAHN TAPERED IMPLANT Ø3.0 X 11.5 MM

FDA Adverse Event
Injury ·PRISMATIK DENTALCRAFT, INC.·Product code DZE·March 6, 2023

TEMPOROMANDIBULAR JOINT REPLACEMENT SYSTEM

FDA Adverse Event
Injury ·BIOMET MICROFIXATION·Product code JEY·May 31, 2019

FLOGARD

FDA Adverse Event
Malfunction ·BAXTER HEALTHCARE - SINGAPORE·Product code FRN·May 15, 2013

GRANUFLO

FDA Adverse Event
Death ·FRESENIUS MEDICAL CARE NORTH AMERICA·Product code KPO·September 11, 2014

SECURE II MED/SURG BED

FDA Adverse Event
Malfunction ·STRYKER MEDICAL·Product code FNL·May 24, 2011

UNKNOWN SCREW

FDA Adverse Event
Injury ·BIOMET ORTHOPEDICS·Product code PAO·February 4, 2015

WALTER LORENZ TOTAL TEMPOROMANDIBULAR JOINT REPLACEMENT SYSTEM

FDA Adverse Event
Injury ·BIOMET MICROFIXATION·Product code LZD·August 29, 2017

BIOMET MICROFIXATION MANDIBULAR FRACTURE/ RECONSTRUCTION DEVICES

FDA Adverse Event
Injury ·BIOMET MICROFIXATION·Product code HWC·June 3, 2016

EMBLEM S-ICD Model A209

FDA Enforcement
Class I ·Terminated·Boston Scientific Corporation·February 17, 2021