16 results
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24ms
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Sources: EU EUDAMED, US FDA
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Regulation: Us FDA
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TruShot with Y-Knot All-Suture Anchor
FDA 510(k)
FDA Class 2
·Orthopedic
OsteoMed
FDA UDI
OSTEOMED LLC·00842528127957·2.4 X 46mm Cannulated Headed Screw, T7
TOMOTHERAPY TREATMENT SYSTEM
FDA 510(k)
FDA Class 2
·Radiology
BIOMET METAL-ON-METAL HIP SYSTEMS- EXPANDED CONTRAINDICATIONS
FDA 510(k)
FDA Class 3
·Orthopedic
ASPHERE M SPEC 12/14 36 +5
FDA Adverse Event
Injury
·DEPUY ORTHOPAEDICS INC US·Product code KWA·June 21, 2013
PARADIGM REAL-TIME REVEL INSULIN INFUSION PUMP
FDA Adverse Event
Injury
·MEDTRONIC PUERTO RICO OPERATIONS MED-REL·Product code MDS·July 19, 2011
SYNCHRON LX I 725 CLINICAL SYSTEM
FDA Adverse Event
Other
·BECKMAN COULTER, INC.·Product code MMI·September 12, 2008
AVAN TAP CORT SCR SS 4.5X26MM
FDA Adverse Event
Injury
·BIOMET UK LTD.·Product code LZO·December 29, 2025
AVAN TAP CORT SCR SS 4.5X58MM
FDA Adverse Event
Injury
·BIOMET UK LTD.·Product code LZO·December 29, 2025
AVAN TAP CORT SCR SS 4.5X48MM
FDA Adverse Event
Injury
·BIOMET UK LTD.·Product code LZO·December 29, 2025
AVAN TAP CORT SCR SS 4.5X56MM
FDA Adverse Event
Injury
·BIOMET UK LTD.·Product code LZO·December 29, 2025
AVAN TAP CORT SCR SS 4.5X60MM
FDA Adverse Event
Injury
·BIOMET UK LTD.·Product code LZO·December 29, 2025
AVAN TAP CORT SCR SS 4.5X20MM
FDA Adverse Event
Injury
·BIOMET UK LTD.·Product code LZO·December 29, 2025
AVAN TAP CORT SCR SS 4.5X52MM
FDA Adverse Event
Injury
·BIOMET UK LTD.·Product code LZO·December 29, 2025
M2A ACETABULAR COMPONENT
FDA Adverse Event
Injury
·ZIMMER BIOMET, INC.·Product code KWA·May 23, 2018
cobas 6000 analyzer series Operators Manual Roche cobas; Filter label: Filter (N) Mat. No 03149773001, Contents 1, 768-320 Filter (N) Product Usage: Fully automated immunoassay analyzer intended for the in-vitro quantitative/qualitative determination of analytes in body fluids.
FDA Enforcement
Class II
·Terminated·Roche Diagnostics Operations, Inc.·June 25, 2014