16 results · 22ms · Sources: EU EUDAMED, US FDA

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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