22 results
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24ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: 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