10 results
·
26ms
·
Sources: EU EUDAMED, US FDA
AUTOPHOR 128
FDA 510(k)
FDA Class 2
·Hematology
CH-200M
FDA UDI
SHIMADZU CORPORATION·04540217062782·
INSTANT-VIEW PHENCYCLIDINE (PCP) URINE CASSETTE TEST
FDA 510(k)
FDA Unclassified
·Unknown
VERTICOR K-WIRE SYSTEM
FDA 510(k)
FDA Class 2
·Orthopedic
Accessories, Soft Lens Products
FDA Pre-Market Approval
FDA Class 2
·HYDRON(TM) SALINE SYSTEM (135 & 250MG)
Accessories, Soft Lens Products
FDA Pre-Market Approval
FDA Class 2
·HYDRON(TM) SALINE SYSTEM (135 & 250MG)
FRESENIUS 2008K
FDA Adverse Event
Death
·FRESENIUS MEDICAL CARE NORTH AMERICA·Product code KDI·April 25, 2014
HARMONIC ACE 23 CM
FDA Adverse Event
Malfunction
·ETHICON ENDO SURGERY, INC. (CINCINNATI)·Product code LFL·November 12, 2007
PROVENT PROFESSIONAL SLEEP APNEA THERAPY
FDA Adverse Event
Injury
·VENTUS MEDICAL·Product code OHP·October 24, 2012
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