14 results
·
21ms
·
Sources: EU EUDAMED, US FDA
OHMEDA RM121 RESPIROMETER
FDA 510(k)
FDA Class 2
·Anesthesiology
ASCENT CLSD BOX PS FMRL LG R
FDA Adverse Event
Injury
·BIOMET ORTHOPEDICS·Product code JWH·July 25, 2017
18X150 ASCENT FML POROUS STEM
FDA Adverse Event
Injury
·BIOMET ORTHOPEDICS·Product code JWH·May 3, 2017
PRO Pen Microneedling System (6883)
FDA 510(k)
FDA Class 2
·General, Plastic Surgery
AZLOCILLIN 75MCG SENSI-DISC
FDA 510(k)
FDA Class 2
·Microbiology
PHOENIX 3.5MM INSERTER SHORT
FDA Adverse Event
Injury
·BIOMET TRAUMA·Product code HXX·August 8, 2017
ARTICULEZE M HEAD 36MM +8.5
FDA Adverse Event
Injury
·DEPUY ORTHOPAEDICS, INC. 1818910·Product code JDI·August 16, 2013
INTERSTIM II
FDA Adverse Event
Injury
·MEDTRONIC MED REL MEDTRONIC PUERTO RICO·Product code EZW·June 2, 2014
PORTEX 9.0MM VOCALAID TRACHEOSTOMY TUBE
FDA Adverse Event
Malfunction
·SMITHS MEDICAL MD, INC.·Product code CAZ·October 25, 2012
PUMP MMT-522CAL PRDGM INS V2.2 CL EN PR
FDA Adverse Event
Malfunction
·MEDTRONIC PUERTO RICO OPERATIONS MED-REL·Product code MDS·September 10, 2010
PINNACLE MTL INS NEUT36IDX52OD
FDA Adverse Event
Injury
·DEPUY ORTHOPAEDICS, INC. 1818910·Product code KWA·August 16, 2013
PHOENIX 3.5MM INSERTER CONNECTOR SHORT
FDA Adverse Event
Injury
·BIOMET TRAUMA·Product code LXH·August 8, 2017
Exactech Equinoxe REVERSE SHOULDER, 38mm Humeral Liner: a) +0mm, Item Number 320-38-00, b) +2.5mm, Item Number 320-38-03; Shoulder Arthroplasty
FDA Enforcement
Class II
·Ongoing·Exactech, Inc.·April 10, 2024
Unify Quadra, Sterile EO, Model #/ Part #: CD3249-40/100036404, 100038435, CD3249-40Q/100036407, 100038436, CD3251-40/100036405, 100038095, 100038226, 100038437, 100038451, 100072563, CD3251-40Q/100036408, 100038214, 100038230, 100038407, 100038442, 100072564, CD3255-40/100038224, CD3255-40Q/100036514
FDA Enforcement
Class II
·Terminated·St Jude Medical Inc.·July 4, 2018