23 results
·
35ms
·
Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
×
EXSALT T7 WOUND DRESSING
FDA 510(k)
FDA Unclassified
·Unknown
N/A
FDA UDI
HANS RUDOLPH, INC.·00874750001507·66 V2 ASSY PETITE 22ID W/HG
Comprehensive® Shoulder System
FDA UDI
Biomet Orthopedics, LLC·00880304591578·
COMPREHENSIVE SHOULDER SYSTEM
FDA UDI
Biomet Orthopedics, LLC·00880304430921·
Plateau Spacer System
FDA UDI
Life Spine, Inc.·00190837045401·Barrel Shaver, 8mm
Comprehensive® Shoulder System
FDA UDI
Biomet Orthopedics, LLC·00887868343858·
Plateau Spacer System
FDA UDI
Life Spine, Inc.·00190837045418·Barrel Sizer, 8mm
SCREW,FIXATION,BONE
FDA Adverse Event
Injury
·SYNTHES MONUMENT·Product code HWC·June 9, 2017
MODIFICATION TO HEARTWAVE ALTERNANS PROCESSING SYSTEM, MODEL APS
FDA 510(k)
FDA Class 2
·Cardiovascular
VENOFER PUMP
FDA 510(k)
FDA Class 2
·Gastroenterology, Urology
INFINION 16
FDA Adverse Event
Injury
·BOSTON SCIENTIFIC NEUROMODULATION·Product code LGW·August 3, 2021
IMPAX CV OUTBOUND (RESULTS MGMT 2.08)
FDA Adverse Event
Malfunction
·AGFA HEALTHCARE CORP·Product code LLZ·February 28, 2014
ASR XL TAP SLV ADAP 12/14+8
FDA Adverse Event
Injury
·DEPUY INTERNATIONAL·Product code KWA·May 15, 2013
IN TOUCH ZU
FDA Adverse Event
Malfunction
·STRYKER MEDICAL·Product code FNL·May 24, 2011
SCREW, FIXATION, BONE
FDA Adverse Event
Injury
·SYNTHES SELZACH·Product code HWC·June 2, 2015
DRILL BIT ¿1.1 L56/39 F/CORE HOLE
FDA Adverse Event
Injury
·SYNTHES SELZACH·Product code HTW·January 17, 2017
1.1MM DRILL BIT/MQC FOR THREADED HOLE/56MM
FDA Adverse Event
Malfunction
·SYNTHES SELZACH·Product code HTW·July 6, 2017
DRILL BIT ¿1.1 L56/39 F/CORE HOLE
FDA Adverse Event
Injury
·SYNTHES SELZACH·Product code HTW·May 18, 2017
SCREW, FIXATION, BONE
FDA Adverse Event
Injury
·SYNTHES SELZACH·Product code HWC·June 3, 2015
EMBLEM S-ICD Model A209
FDA Enforcement
Class I
·Terminated·Boston Scientific Corporation·February 17, 2021