34 results
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26ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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POWDERED NITRILE EXAMINATION GLOVES, BLUE AND WHITE
FDA 510(k)
FDA Class 1
·General Hospital
Simpliciti™
FDA UDI
TORNIER, INC.·00846832004881·
Tornier Simpliciti® Shoulder System
FDA UDI
TORNIER, INC.·00846832090471·
GEN-PROBE APTIMA COMBO 2 ASSAY
FDA 510(k)
FDA Class 1
·Microbiology
NEW STETIC ACRYLICS
FDA 510(k)
FDA Class 2
·Dental
G7 SCREW
FDA Adverse Event
Injury
·BIOMET ORTHOPEDICS·Product code PBI·June 2, 2017
AVAN CMNTD SHELL SS 50MM
FDA Adverse Event
Malfunction
·BIOMET UK LTD.·Product code LZO·April 24, 2026
MODULAR CUP SYSTEM, RIMCUP
FDA Adverse Event
Injury
·BIOMET SPAIN, S.L.·Product code PBI·October 2, 2018
RINGLOC MODULAR ACETABULAR SYSTEM (SPIDERCUP, RIMCUP, BATCUP)
FDA Adverse Event
Injury
·BIOMET SPAIN, S.L.·Product code PBI·October 2, 2018
AVAN CMNTD SHELL SS 50MM
FDA Adverse Event
Injury
·BIOMET UK LTD.·Product code LZO·January 21, 2026
RINGLOC MODULAR ACETABULAR SYSTEM (SPIDERCUP, RIMCUP, BATCUP)
FDA Adverse Event
Injury
·BIOMET SPAIN, S.L.·Product code PBI·October 2, 2018
RINGLOC MODULAR ACETABULAR SYSTEM (SPIDERCUP, RIMCUP, BATCUP)
FDA Adverse Event
Injury
·BIOMET SPAIN, S.L.·Product code PBI·October 2, 2018
SYNCHROMED II
FDA Adverse Event
Injury
·MDT PUERTO RICO OPERATIONS CO·Product code LKK·May 21, 2013
PARADIGM REAL-TIME REVEL INSULIN INFUSION PUMP
FDA Adverse Event
Malfunction
·MEDTRONIC MINIMED·Product code OYC·September 26, 2014
ACCESS
FDA Adverse Event
Malfunction
·BAXTER HEALTHCARE - CALI·Product code FPA·June 14, 2011
RINGLOC MODULAR ACETABULAR SYSTEM (SPIDERCUP, RIMCUP, BATCUP)
FDA Adverse Event
Injury
·BIOMET SPAIN, S.L.·Product code PBI·October 2, 2018
CLEARLINK BURETROL SOLUTION SETS
FDA Adverse Event
Malfunction
·BAXTER HEALTHCARE CORPORATION·Product code FPA·June 13, 2023
G7 BONEMASTER LTD ACET SHL 58G
FDA Adverse Event
Malfunction
·ZIMMER BIOMET, INC.·Product code JDI·September 23, 2019
G7 FINNED BM 3 HOLE SHELL 48C
FDA Adverse Event
Malfunction
·ZIMMER BIOMET, INC.·Product code JDI·May 16, 2018
DURAL ALPHA INSERT NEUTR JJ/36
FDA Adverse Event
Malfunction
·ZIMMER GMBH·Product code LZO·February 18, 2026