16 results
·
22ms
·
Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
×
HARMONIC 700 Shears
FDA 510(k)
FDA Unclassified
·Unknown
ACCESS ACCUTNI REAGENT, ACCESS ACCUTNI CALIBRATOR, UNICEL DXI 800 ACCESS IMMUNOASSAY SYSTEM
FDA 510(k)
FDA Class 2
·Clinical Chemistry
Dual Cure Resin Cement
FDA 510(k)
FDA Class 2
·Dental
OXF UNI TIB TRAY SZ B RM PMA
FDA Adverse Event
Injury
·BIOMET UK LTD.·Product code NRA·September 15, 2019
REALIZE ADJ GASTRIC BAND STR
FDA Adverse Event
Malfunction
·OBTECH MEDICAL SARL_·Product code LTI·August 24, 2011
GLENOID REAMER / PLANAR - 32MM
FDA Adverse Event
Malfunction
·STRYKER ORTHOPAEDICS-MAHWAH·Product code KWS·November 3, 2014
INFINITI VISION SYSTEM OZIL
FDA Adverse Event
Injury
·ALCON - IRVINE TECHNOLOGY CENTER·Product code HQC·July 9, 2013
VNGD XP CR INTLK TIB TRAY 75MM
FDA Adverse Event
Injury
·ZIMMER BIOMET, INC.·Product code MBH·July 7, 2025
ACCESS ACCUTNI REAGENT
FDA Adverse Event
Injury
·BECKMAN COULTER·Product code MMI·September 15, 2016
RESORBABLE INTERFERENCE SCREW
FDA Adverse Event
Malfunction
·S.B.M. SAS·Product code MAI·May 20, 2025
PROLENE POLYPROPYLENE MESH UNKNOWN PRODUCT
FDA Adverse Event
Injury
·ETHICON INC.·Product code FTL·August 15, 2019
VYPRO MESH UNKNOWN PRODUCT
FDA Adverse Event
Injury
·ETHICON INC.·Product code FTL·August 15, 2019
VICRYL POLYGLACTIN 910 SUTURE UNKNOWN PRODUCT
FDA Adverse Event
Injury
·ETHICON INC.·Product code GAM·August 15, 2019
OXF ANAT BRG RT MD SIZE 4 PMA
FDA Adverse Event
Injury
·BIOMET UK LTD.·Product code NRA·September 15, 2019
Unify, Sterile EO, Model #/ Part #: CD3231-40/100029240, 100030104, 100041904; CD3231-40Q/100029281, 100030124, 100041905; CD3235-40/100029256, 100029293, 100029307, 100031111, 100037047, 100048897, 100070009; CD3235-40Q/100029257, 100029294, 100029308, 100031059, 100037048, 100070010; CD3281-40Q/100056770; CD3297-40/100056933
FDA Enforcement
Class II
·Terminated·St Jude Medical Inc.·July 4, 2018
Model Number L111, ESSENTIO DR SL MRI Pacemaker
FDA Enforcement
Class I
·Ongoing·Boston Scientific Corporation·October 22, 2025