19 results
·
20ms
·
Sources: EU EUDAMED, US FDA
PACEART HOME TRAK PLUS EASI EVENT RECORDER SYSTEM
FDA 510(k)
FDA Class 2
·Cardiovascular
Polystar Selection EDITION
FDA UDI
Merz Dental GmbH·D7091982090·posteriors; shade C3; size L; upper jaw
9131 DEFIBRILLATION ELECTRODES
FDA 510(k)
FDA Class 3
·Cardiovascular
AposTherapy System
FDA 510(k)
FDA Class 1
·Physical Medicine
TSRH SPINAL SYSTEM
FDA Adverse Event
Malfunction
·WARSAW ORTHOPEDIC, INC.·Product code KWP·March 31, 2015
TSRH SPINAL SYSTEM
FDA Adverse Event
Injury
·WARSAW ORTHOPEDICS·Product code KWP·November 23, 2016
TSRH SPINAL SYSTEM
FDA Adverse Event
Malfunction
·WARSAW ORTHOPEDICS·Product code KWP·May 16, 2017
ENDOPATH ETS
FDA Adverse Event
Malfunction
·ETHICON ENDO-SURGERY·Product code KOG·April 20, 1998
9800
FDA Adverse Event
Malfunction
·GE OEC MEDICAL SYSTEMS (SLC)·Product code JAA·February 8, 2013
STARCLOSE SE VASCULAR CLOSURE SYSTEM
FDA Adverse Event
Injury
·AV-TEMECULA-CT·Product code MGB·February 8, 2011
PARADIGM REAL-TIME REVEL INSULIN INFUSION PUMP
FDA Adverse Event
Malfunction
·MEDTRONIC MINIMED·Product code OYC·August 5, 2014
TSRH SPINAL SYSTEM
FDA Adverse Event
Injury
·WARSAW ORTHOPEDICS·Product code KWP·February 23, 2016
TSRH SPINAL SYSTEM
FDA Adverse Event
Injury
·WARSAW ORTHOPEDICS·Product code KWP·February 23, 2016
TSRH SPINAL SYSTEM
FDA Adverse Event
Injury
·WARSAW ORTHOPEDICS·Product code KWP·February 23, 2016
TSRH SPINAL SYSTEM
FDA Adverse Event
Injury
·WARSAW ORTHOPEDICS·Product code KWP·February 23, 2016
TSRH SPINAL SYSTEM
FDA Adverse Event
Malfunction
·WARSAW ORTHOPEDICS·Product code KWP·August 21, 2020
CD HORIZON SPINAL SYSTEM
FDA Adverse Event
Injury
·WARSAW ORTHOPEDICS·Product code KWP·December 4, 2012
Daig Livewire Steerable, Product Number 401932; REPROCESSED ELECTROPHYSIOLOGY CATHETER
FDA Enforcement
Class II
·Ongoing·Stryker Sustainability Solutions·May 20, 2026
Exactech Equinoxe REVERSE SHOULDER,38mm Constrained Humeral Liner: a) +0mm, Item Number 320-38-10, b) +2.5mm, Item Number 320-38-13, Shoulder Arthroplasty
FDA Enforcement
Class II
·Ongoing·Exactech, Inc.·April 10, 2024