19 results
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29ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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DRSplus
FDA 510(k)
FDA Class 2
·Ophthalmic
ECHO BI-METRIC HIP SYSTEM
FDA UDI
Biomet Orthopedics, LLC·00880304462922·
Sonic
FDA UDI
Sonic Innovations, Inc.·05711583032634·ET40, KIT 312 NFM PB L BE ENCHANT 40
Echo® Bi-Metric® Hip System
FDA UDI
Biomet Orthopedics, LLC·00887868260599·
Orthos
FDA UDI
ORMCO CORPORATION·00889989030235·ORTHOS CM TMA ARCH 021X025 LOSM PK10
APEX Knee System
FDA UDI
Omni Life Science, Inc.·00841690198444·AK3 Ultra Insert Trial Size 1, 13mm
De Soutter Medical
FDA UDI
DE SOUTTER MEDICAL LIMITED·05051471123076·K-WIRE - DOUBLE TROCAR 1.1mm DIA x 75mm
Best Medical International
FDA UDI
BEST MEDICAL INTERNATIONAL, INC.·00841365112799·
GE VENUE 40 COMPACT DIAGNOSTIC ULTRASOUND
FDA 510(k)
FDA Class 2
·Radiology
STA - FREE PS CALIBRATOR
FDA 510(k)
FDA Class 2
·Clinical Chemistry
Best Medical International
FDA UDI
BEST MEDICAL INTERNATIONAL, INC.·00841365114748·
G7 PPS ACETABULAR SHELL
FDA Adverse Event
Injury
·BIOMET ORTHOPEDICS·Product code LZO·July 27, 2017
ECHO BI-METRIC HIP SYSTEM LATERALIZED FEMORAL STEM
FDA Adverse Event
Injury
·BIOMET ORTHOPEDICS·Product code KWA·July 27, 2017
ANT-CER 1 LVL PLATE ASSY, 24MM
FDA Adverse Event
Injury
·ABBOTT SPINE·Product code KWQ·October 7, 2008
QUATTRODE
FDA Adverse Event
Injury
·ST. JUDE MEDICAL - NEUROMODULATION·Product code GZB·June 20, 2013
HEARTMATE II LVAS
FDA Adverse Event
Injury
·THORATEC CORPORATION·Product code DSQ·August 4, 2011
ESOPHYX Z
FDA Adverse Event
Injury
·ENDOGASTRIC SOLUTIONS, INC.·Product code ODE·June 22, 2017
G7 SCREW 6.5MM X 35MM
FDA Adverse Event
Injury
·ZIMMER BIOMET, INC.·Product code PBI·June 3, 2021
Quanta System Sterile Optical Laser Fiber, single use
FDA Enforcement
Class II
·Terminated·Quanta System, S.p.A.·June 16, 2021