8 results
·
25ms
·
Sources: EU EUDAMED, US FDA
STERILE SALINE SOLUTION
FDA 510(k)
FDA Class 1
·Anesthesiology
LIGHT CURED RESIN BONDED CERAMIC
FDA 510(k)
FDA Class 2
·Dental
MALE-MALE LUER LOCK CONNECTOR W/ROTA
FDA 510(k)
FDA Class 2
·Cardiovascular
5QT.CNT.W/COUNTR BLNC DR RED20
FDA Adverse Event
Other
·COVIDIEN·Product code MMK·May 23, 2014
PORTEX 8.5 SOFT SEAL CUFF TRACHEAL TUBE
FDA Adverse Event
Malfunction
·SMITHS MEDICAL INTERNATIONAL, LTD·Product code BTR·October 25, 2012
ACCU-CHEK D-TRONPLUS
FDA Adverse Event
Malfunction
·ROCHE INSULIN DELIVERY SYSTEMS, INC.·Product code LZG·September 10, 2010
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