12 results
·
22ms
·
Sources: EU EUDAMED, US FDA
GUIDANT VASOVIEW ENDOSCOPIC VESSEL HARVESTING SYSTEM
FDA 510(k)
FDA Class 2
·Gastroenterology, Urology
Latitude™ EV
FDA UDI
TORNIER, INC.·00846832002870·Humeral Stem - Coated
MEDI
FDA UDI
MEDI MANUFACTURING, INC.·04051526827844·***DISC*LEVAMED ANKLE SUPPORT BLACK II
Ultracryl
FDA UDI
Ortho Organizers, Inc.·00190707000424·ULTRACRYL II LIQUID
OSCILLOMITT, MODELS CM 1050, CM 1040, CM 1030, CM 1020, CM 1010
FDA 510(k)
FDA Class 2
·Cardiovascular
LASER PACK I, LASER PACK II, PHACO PACK I, PHACO PACK II
FDA 510(k)
FDA Class 2
·Ophthalmic
BABLOG 8000+
FDA Adverse Event
Death
·DRAEGER MEDICAL GMBH·Product code CBK·March 20, 2013
9600
FDA Adverse Event
Malfunction
·GE OEC MEDICAL SYSTEMS (SLC)·Product code JAA·March 9, 2011
SILICONE ADVANCED OPTIC-VIOLET SHIELD
FDA Adverse Event
Malfunction
·BAUSCH & LOMB·Product code HQL·April 17, 2008
Stryker MA204 Bed Model (FL25E) Beds are intended for medical purposes in both general patient care as well as critical care environments. Each uses built-in electric motors and controls which can be operated by the patient, or caregiver, to adjust the height and/or surface contour of the bed.The devices listed above also include movable and latchable side rails which can be lowered or raised to help prevent patient fall and subsequent injury. The Beds include an optional Scale (Models: FL20E, FL25E, FL28C, FL28EX) as well as an optional Bed Exit (1 Zone) or Chaperone
FDA Enforcement
Class II
·Terminated·Stryker Medical Division of Stryker Corporation·July 4, 2012
Azurion 7 M12; Catalog numbers: (1) 722078, (2) 722223, (3) 722233 (OUS ONLY).
FDA Enforcement
Class I
·Ongoing·PHILIPS MEDICAL SYSTEMS NEDERLAND B.V.·February 26, 2025
Unify Assura, Sterile EO, Model #/ Part #: CD3257-40/100042333, 100059944; CD3257-40Q/100042334, 100059936; CD3261-40/100048460, 100048546, 100059897, 100059954, 100059996, 100078828; CD3261-40Q/100048568, 100048581, 100059898, 100059955, 100059997, 100078853; CD3357-40C/100080408, 100080424, 100083511; CD3357-40Q/100080419, 100080463, 100083504; CD3361-40/100078842, 100079211, 100083506, 100096893; CD3361-40C/100078604, 100079159, 100079160, 100079338, 100083429, 100083514, 100117625; CD3361-40Q/100078805, 100079222, 100079456, 100083523, 100098067; CD3361-40QC/100078654, 100079202, 100079221, 100083475, 100083515, 100117558; CD3389-40C/100080778; CD3389-40QC/100080780, 100105489
FDA Enforcement
Class II
·Terminated·St Jude Medical Inc.·July 4, 2018