38 results
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23ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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Prelude
FDA 510(k)
FDA Class 2
·Radiology
BI-METRIC X-SERIES HIP SYSTEM
FDA UDI
Biomet Orthopedics, LLC·00880304182578·
CoRoent
FDA UDI
Nuvasive, Inc.·00887517567406·CoRoent Ant TLIF PEEK, 8x10x30mm 8°
Maestro™ Total Wrist
FDA UDI
Biomet Orthopedics, LLC·00887868239632·
MAESTRO TOTAL WRIST
FDA UDI
Biomet Orthopedics, LLC·00880304480971·
BI-METRIC X-SERIES HIP SYSTEM
FDA UDI
Biomet Orthopedics, LLC·00880304182271·
BI-METRIC X-SERIES HIP SYSTEM
FDA UDI
Biomet Orthopedics, LLC·00880304182875·
InFix®
FDA UDI
BIOMET SPINE LLC·00889024331150·
N.A.
FDA UDI
DENTAURUM GmbH & Co.KG·J011180308000·Super hard metal burs, with cross toothing cut,...
PROSTHETIC SYSTEM
FDA 510(k)
FDA Class 2
·Dental
BIO-SCAFFOLD BIOSCAFF ALVELAC RESOBABLE SCAFFOLD
FDA 510(k)
FDA Class 2
·Dental
T:SLIM X2 INSULIN PUMP WITH CONTROL-IQ TECHNOLOGY
FDA Adverse Event
Malfunction
·TANDEM DIABETES CARE·Product code QFG·August 23, 2023
M2A 1 PC SHELL 38MMX54MM
FDA Adverse Event
Injury
·BIOMET ORTHOPEDICS·Product code KWA·August 18, 2017
M2A 38MM MOD HD+9MM NK NO SKRT
FDA Adverse Event
Injury
·BIOMET ORTHOPEDICS·Product code KWA·August 15, 2017
GMK-SPHERE TIBIAL INSERT FIXED SPHERE FLEX SIZE 4/17 MM
FDA Adverse Event
Injury
·MEDACTA INTERNATIONAL SA·Product code JWH·November 18, 2019
STEALTHSTATION S7 NAVIGATION
FDA Adverse Event
Malfunction
·MEDTRONIC NAVIGATION, INC·Product code HAW·August 14, 2020
SURETRAK® II UNIVERSAL TRACKER, MEDIUM CLAMP
FDA Adverse Event
Malfunction
·MEDTRONIC NAVIGATION, INC.·Product code HAW·June 20, 2013
COLLEAGUE PRE P1.7
FDA Adverse Event
Malfunction
·BAXTER HEALTHCARE - SINGAPORE·Product code FRN·July 27, 2011
PORTABLE OXYGEN GENERATOR (CONCENTRATOR, HOMEFILL)
FDA Adverse Event
Malfunction
·INVACARE FLORIDA OPERATIONS·Product code CAW·October 17, 2014
TRANSCEND 365 MINICPAP SYSTEM
FDA Adverse Event
Injury
·SOMNETICS INTERNATIONAL, INC.·Product code BZD·October 6, 2021