301 results
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21ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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BONE SCREW DRILL 3.2 MM DIAMETER
FDA Adverse Event
Injury
·ZIMMER BIOMET, INC.·Product code HWT·August 26, 2020
TRIDENT 10 DEGREE CROSSFIRE INSERT 26 MM ID
FDA Adverse Event
Injury
·STRYKER ORTHOPAEDICS CORK·Product code MEH·May 31, 2012
ALINITY I STAT HIGH SENSITIVITY TROPONIN-I
FDA Adverse Event
Malfunction
·ABBOTT IRELAND DIAGNOSTICS DIVISION·Product code MMI·March 4, 2024
Knee Stem Extensions & Impactor Sleeve: STEM IMPLANT 20MMDX145MM STEM IMPLANT 22MMDX145MM STEM IMPLANT 24MMDX145MM SHARP FLUTED ST 20MMDX75MM SHARP FLUTED ST 22MMDX75MM SHARP FLTD ST 24MMDX75MM SHARP FLUTED ST 20MMDX130MM SHARP FLUTED ST 22MMDX130MM SHARP FLUTED ST 24MMDX130MM CEMENTED STEM EXT 13MM X 145MM IMPACTOR SLEEVE* NGK STEM EXT 12X245MM (200MM) NGK STEM EXT 13X245MM (200MM) NGK STEM EXT 14X245MM (200MM) NGK STEM EXT 15X245MM (200MM) NGK STEM EXT 16X245MM (200MM) NGK STEM EXT 17X245MM (200MM) NGK STEM EXT 18X245MM (200MM) NGK STEM EXT 20X245MM (200MM) NGK STEM EXT 22X245MM (200MM) SMOOTH REV STM 9.5MM X 19 SMOOTH REV STM 11.5MM X 1 SMOOTH REV STM 13.5MM X 1 SMOOTH REV STM 15.5MM X 1 SMOOTH REV STM 17.5MM X 1 REV FEM STM 10.5MM X 200M REV FEM STM 12.5MM X 200M REV FEM STM 14.5MM X 200M REV FEM STM 16.5MM X 200M 18.5X200MM REV STEM REV FEM STM 10.5MM X 250M REV FEM STM 12.5MM X 250M REV FEM STM 14.5MM X 250M REV FEM STM 16.5MM X 250M 12.5X155MM FLUTED OFFST R 14.5X155MM FLUTED OFFST R 16.5X155MM FLUTED OFFST R 18.5X155MM FLUTED OFFST R 20.5X155MM FLUTED OFFST R 12.5X175MM FLUTED REV STM FLUTE REV STEM - 14.5MM X FLUTE REV STEM - 16.5MM X FLUTE REV STEM - 18.5MM X FLUTE REV STEM - 20.5MM X FLUTE REV STEM - 22.5MM X FLUTED REV STM 10.5MM X 1 FLUTED REV STM 11.5MM X 1 FLUTED REV STM 12.5MM X 1 FLUTED REV STM 13.5MM X 1 FLUTED REV STM 14.5MM X 1 FLUTED REV STM 16.5MM X 1 FLUTED REV STM 18.5MM X 1
FDA Recall
Terminated
·Zimmer, Inc.·Product code JWH·July 22, 2014
Knee Stem Extensions & Impactor Sleeve: STEM IMPLANT 20MMDX145MM STEM IMPLANT 22MMDX145MM STEM IMPLANT 24MMDX145MM SHARP FLUTED ST 20MMDX75MM SHARP FLUTED ST 22MMDX75MM SHARP FLTD ST 24MMDX75MM SHARP FLUTED ST 20MMDX130MM SHARP FLUTED ST 22MMDX130MM SHARP FLUTED ST 24MMDX130MM CEMENTED STEM EXT 13MM X 145MM IMPACTOR SLEEVE* NGK STEM EXT 12X245MM (200MM) NGK STEM EXT 13X245MM (200MM) NGK STEM EXT 14X245MM (200MM) NGK STEM EXT 15X245MM (200MM) NGK STEM EXT 16X245MM (200MM) NGK STEM EXT 17X245MM (200MM) NGK STEM EXT 18X245MM (200MM) NGK STEM EXT 20X245MM (200MM) NGK STEM EXT 22X245MM (200MM) SMOOTH REV STM 9.5MM X 19 SMOOTH REV STM 11.5MM X 1 SMOOTH REV STM 13.5MM X 1 SMOOTH REV STM 15.5MM X 1 SMOOTH REV STM 17.5MM X 1 REV FEM STM 10.5MM X 200M REV FEM STM 12.5MM X 200M REV FEM STM 14.5MM X 200M REV FEM STM 16.5MM X 200M 18.5X200MM REV STEM REV FEM STM 10.5MM X 250M REV FEM STM 12.5MM X 250M REV FEM STM 14.5MM X 250M REV FEM STM 16.5MM X 250M 12.5X155MM FLUTED OFFST R 14.5X155MM FLUTED OFFST R 16.5X155MM FLUTED OFFST R 18.5X155MM FLUTED OFFST R 20.5X155MM FLUTED OFFST R 12.5X175MM FLUTED REV STM FLUTE REV STEM - 14.5MM X FLUTE REV STEM - 16.5MM X FLUTE REV STEM - 18.5MM X FLUTE REV STEM - 20.5MM X FLUTE REV STEM - 22.5MM X FLUTED REV STM 10.5MM X 1 FLUTED REV STM 11.5MM X 1 FLUTED REV STM 12.5MM X 1 FLUTED REV STM 13.5MM X 1 FLUTED REV STM 14.5MM X 1 FLUTED REV STM 16.5MM X 1 FLUTED REV STM 18.5MM X 1
FDA Enforcement
Class II
·Terminated·Zimmer, Inc.·September 3, 2014
TRILOGY ACETABULAR SYSTEM LONGEVITY CROSSLINKED POLYETHLENE LINER
FDA Adverse Event
Injury
·ZIMMER, INC.·Product code KWB·June 19, 2009
NGK Stem Ext 24 x 245mm
FDA Recall
Terminated
·Zimmer, Inc.·Product code JWH·November 5, 2013
NGK Stem Ext 24 x 245mm
FDA Enforcement
Class II
·Terminated·Zimmer, Inc.·January 8, 2014
SYNCHROMED II
FDA Adverse Event
Injury
·MDT PUERTO RICO OPERATIONS CO·Product code LKK·April 21, 2014
ERBE VIO 3
FDA Adverse Event
Injury
·ERBE ELEKTROMEDIZIN GMBH·Product code GEI·January 27, 2022
PROXIMATE*HCS HEMORR CIR STAPL
FDA Adverse Event
Injury
·ETHICON ENDO-SURGERY, LLC.·Product code GDW·July 30, 2019
FREESTYLE 3
FDA Adverse Event
Malfunction
·CAIRE INC.·Product code CAW·April 8, 2020
LEAD
FDA Adverse Event
Injury
·MEDTRONIC NEUROMODULATION·Product code MHY·March 20, 2026
Test, Occult Blood, Over The Counter
FDA classification
FDA Class 2
·Test, Occult Blood, Over The Counter
NSK AMERICA CORP.
FDA registration
NSK AMERICA CORP.·21 products·🇺🇸 United States
HARTALEGA NGC SDN BHD
FDA registration
HARTALEGA NGC SDN BHD·7 products·🇲🇾 Malaysia
RGK Octane Sub4
FDA UDI
RGK WHEELCHAIRS LIMITED·50567627059378·The Sub4 is an ultra lightweight and rigid whee...
NUK® Double Electric Breast Pump
FDA UDI
NUK USA LLC·00885131626011·
RGK Octane
FDA UDI
RGK WHEELCHAIRS LIMITED·50567627057596·RGK's Octane is a completely bespoke ultra-ligh...
NUK® Single Electric Breast Pump
FDA UDI
NUK USA LLC·00885131627667·