9 results
·
18ms
·
Sources: EU EUDAMED, US FDA
MCCONNELL ORTHOPEDIC POSTERIOR BODY SUPPORT
FDA 510(k)
FDA Class 1
·General, Plastic Surgery
Nasal Speculum
FDA UDI
KATENA PRODUCTS, INC.·00841668108543·NASAL SPECULUM CHILD
COILS, MODELS MCF-B65, MCF-75, MCF-125 AND COOL-B65
FDA 510(k)
FDA Class 2
·Neurology
2 Face / Face Evolution
FDA 510(k)
FDA Class 2
·Neurology
BELIFU
FDA Adverse Event
Injury
·HONG QIANGXING (SHEN ZHEN) ELECTRONICS LIMITED·Product code GZJ·February 10, 2020
7700
FDA Adverse Event
Malfunction
·GE OEC MEDICAL SYSTEMS GMBH·Product code JAA·April 17, 2014
RENAL- DISPOSABLE
FDA Adverse Event
Malfunction
·Product code FKX·October 16, 2010
PARADIGM REAL-TIME INSULIN INFUSION PUMP
FDA Adverse Event
Malfunction
·MEDTRONIC PUERTO RICO OPERATIONS CO.·Product code OYC·December 13, 2012
GXL acetabular liners, orthopedic hip implant component. Product Line Numbers: a. GXL NEUTRAL LINER, G0 28MM ID, 130-28-50; b. GXL NEUTRAL LINER, G00 22MM ID, 130-22-70; c. NOVATION GXL LIPPED LINER, G0 28MM ID, 132-28-50; d. NOVATION GXL LIPPED LINER, G00 22MM ID, 132-22-70;
FDA Enforcement
Class II
·Ongoing·Exactech, Inc.·September 21, 2022