14 results
·
22ms
·
Sources: EU EUDAMED, US FDA
PDI PARALLEL SIDED POST KIT
FDA 510(k)
FDA Class 1
·Dental
EBERLE
FDA UDI
Eberle GmbH & Co. KG·04050052023362·Drill chuck adapter, high-power, 0.7-7.4 mm
Cosmolock Pedicle Screw System
FDA UDI
Kalitec Direct LLC·B07311K0130190·T-Handle, Head Persuader, 5.5mm
WARMTOUCH COMPACT WARMING UNIT
FDA Adverse Event
Malfunction
·COVIDIEN/FORMERLY TYCO·Product code DWJ·December 23, 2010
DATACAPTOR
FDA 510(k)
FDA Class 2
·Cardiovascular
PROFEMUR XM WINGLESS DISTAL CENTRALIZER, PERFECTA DISTAL CENTRALIZER
FDA 510(k)
FDA Class 3
·Orthopedic
WARM TOUCH II COMPACT WARMING UNIT
FDA Adverse Event
Malfunction
·COVIDIEN, FORMERLY TYCO HEALTHCARE·Product code DWJ·September 24, 2010
M SERIES HEATED HUMIDIFIER
FDA Adverse Event
Injury
·RESPIRONICS INC.·Product code BZD·June 11, 2014
TOTAL HIP BALL 28MM +8
FDA Adverse Event
Injury
·DEPUY ORTHOPAEDICS, INC.·Product code JDI·January 14, 2013
OMNIPOD INSULIN PUMP
FDA Adverse Event
Malfunction
·INSULET CORPORATION·Product code LZG·November 19, 2010
ULTRACISION HARMONIC ACE
FDA Adverse Event
Malfunction
·ETHICON ENDO-SURGERY, LLC.·Product code LFL·October 5, 2015
ULTRACISION HARMONIC ACE
FDA Adverse Event
Malfunction
·ETHICON ENDO-SURGERY, LLC.·Product code LFL·November 9, 2015
HARMONIC ACE 36CM W ERG HANDLE
FDA Adverse Event
Malfunction
·ETHICON ENDO-SURGERY, LLC.·Product code LFL·January 30, 2018
Exactech Equinoxe CAGE GLENOID, CEMENTED, beta curvature, Mates with: a) 47, 50, 53 head, Medium, Item Number 314-13-13, b) 47, 50, 53 head, Large, Item Number 314-13-14, c) 47, 50, 53 head, Extra Large, Item Number 314-13-15; Shoulder Arthroplasty
FDA Enforcement
Class II
·Ongoing·Exactech, Inc.·April 10, 2024