16 results
·
28ms
·
Sources: EU EUDAMED, US FDA
KOWA GENESIS-D
FDA 510(k)
FDA Class 2
·Ophthalmic
ACTERA FEMORAL BROACH, SIZE 06
FDA UDI
Conformis, Inc.·00810933031497·ACTERA FEMORAL BROACH, SIZE 06
AU5, AU6
FDA 510(k)
FDA Class 2
·Radiology
SUMMIT OCCIPITO-CERVICO-THORACIC (OCT) SPINAL SYSTEM
FDA 510(k)
FDA Class 2
·Orthopedic
TRUEBALANCE
FDA Adverse Event
Malfunction
·NIPRO DIAGNOSTICS, INC.·Product code NBW·August 13, 2014
QUILL SRS
FDA Adverse Event
Other
·SURGICAL SPECIALTIES CORP. (DBA ANGIOTECH)·Product code NEW·April 30, 2009
QUILL SRS
FDA Adverse Event
Other
·SURGICAL SPECIALTIES CORP. (DBA ANGIOTECH)·Product code NEW·April 30, 2009
QUILL SRS
FDA Adverse Event
Other
·SURGICAL SPECIALTIES CORP. (DBA ANGIOTECH)·Product code NEW·August 24, 2009
DVT CALF GARMENTS STANDARD
FDA Adverse Event
Injury
·ARJOHUNTLEIGH POLSKA SP.Z.O.O.·Product code JOW·April 4, 2013
E SERIES DEFIBRILLATOR
FDA Adverse Event
Malfunction
·ZOLL MEDICAL CORPORATION·Product code MKJ·August 28, 2014
OPTIBOND FL
FDA Adverse Event
Injury
·KERR CORPORATION·Product code KLE·May 6, 2011
QUILL SRS
FDA Adverse Event
Other
·SURGICAL SPECIALTIES CORP. (DBA ANGIOTECH)·Product code NEW·March 12, 2009
WHITE STAR HIGH SPEED VIT CUTTER
FDA Adverse Event
Malfunction
·ABBOTT MEDICAL OPTICS·Product code MLZ·March 24, 2017
WHITE STAR HIGH SPEED VIT CUTTER
FDA Adverse Event
Malfunction
·ABBOTT MEDICAL OPTICS·Product code MLZ·March 24, 2017
QUILL SRS
FDA Adverse Event
Other
·SURGICAL SPECIALTIES CORP. (DBA ANGIOTECH)·Product code NEW·October 31, 2008
CADD-Solis VIP ambulatory Infusion Pumps, Model 2120 (21-2120, 21-2125, and 21-2127) Indicated for the following uses: Intra-arterial, subcutaneous, intraperitoneal, in close proximity to nerves, into an intraoperative site, epidural space or subarachnoid space. Therapies that require a continuous rate of infusion, intermittent bolus, and/or with patient-controlled demand doses.
FDA Enforcement
Class I
·Ongoing·Smiths Medical ASD Inc.·August 14, 2024