10 results
·
19ms
·
Sources: EU EUDAMED, US FDA
ISPIRA RESUSCITATION UNIT
FDA 510(k)
FDA Class 2
·Anesthesiology
GALILEO® CRT²™ LAG SCREW, RIGHT, 10.5mm x 85mm
FDA UDI
ADVANCED ORTHOPAEDIC SOLUTIONS, INC.·00848665036688·
De Soutter Medical
FDA UDI
DE SOUTTER MEDICAL LIMITED·05051471118805·K-WIRE - DOUBLE TROCAR 0.8mm DIA x 125mm
SOMNO STAR & SERIES SLEEP SYSTEM
FDA 510(k)
FDA Class 2
·Neurology
ULTRASOUND SCANNER, TYPE 1101
FDA 510(k)
FDA Class 2
·Radiology
UNKNOWN_NEUROVASCULAR_PRODUCT
FDA Adverse Event
Injury
·CONCENTRIC MEDICAL·Product code NRY·December 14, 2012
GREENLIGHT XPS LASER SYSTEM
FDA Adverse Event
Malfunction
·AMERICAN MEDICAL SYSTEMS, INNOVATION CENTER - SILICON VALLEY·Product code GEX·April 27, 2011
RESERVOIR 3ML
FDA Adverse Event
Injury
·MEDTRONIC PUERTO RICO OPERATIONS CO.·Product code FRN·May 3, 2013
MATRISTEM MICROMATRIX
FDA Adverse Event
Injury
·ACELL INC.·Product code KGN·August 21, 2014
GXL acetabular liners, orthopedic hip implant component. Product Line Numbers: a. NOVATION CONSTRAINED LINER 28MM ID GROUP 1, REF 134-28-41 b. NOVATION CONSTRAINED LINER 32MM ID GROUP 2, REF 134-32-42 c. NOVATION CONSTRAINED LINER 36MM ID GROUP 3, REF 134-36-43 d. NOVATION CONSTRAINED LINER 36MM ID GROUP 4, REF 134-36-44 e. NOVATION CONSTRAINED LINER 36MM ID GROUP 5, REF 134-36-45
FDA Enforcement
Class II
·Ongoing·Exactech, Inc.·September 21, 2022