17 results
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21ms
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Sources: EU EUDAMED, US FDA
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Regulation: Us FDA
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Q-SWITCHED ND:YAG OPHTALMIC LASER (WITH SLIT LAMP), MODEL OPTIMIS II
FDA 510(k)
FDA Class 2
·Ophthalmic
BD SYRINGE 0.5ML 31GA 8MM
FDA Adverse Event
Malfunction
·BD MEDICAL - DIABETES CARE·Product code FMF·June 19, 2019
ZAVATION
FDA UDI
Zavation LLC·00842166154810·WHITNEY 4deg 36mmx13mm
ZAVATION
FDA UDI
Zavation LLC·00842166157033·HA+ ALIF 4deg 36mmx13
Zavation
FDA UDI
Zavation LLC·00842166180482·ALIF Sizer 4eg 36mm x 13mm
Zavation
FDA UDI
Zavation LLC·00842166121430·ALIF 4deg 36mm x 13mm
SOFT PLUG ABSORBABLE PLUG-SA
FDA 510(k)
FDA Unclassified
·Unknown
3.0.T SIGNA VH/I (T/R) BODY IMAGING COIL
FDA 510(k)
FDA Class 2
·Radiology
BD SYRINGE 0.5ML 31GA 8MM 10BAG 500 PL/WG
FDA Adverse Event
Malfunction
·BD MEDICAL - DIABETES CARE·Product code FMF·March 8, 2019
VITALITY 2
FDA Adverse Event
Malfunction
·GUIDANT CRM CLONMEL IRELAND·Product code LWS·April 9, 2013
CMS MAIN FRAME
FDA Adverse Event
Death
·PHILIPS MEDICAL SYSTEMS·Product code DRT·March 15, 2011
LD CV EZTRK 2 BP IS1 4543 90CM US
FDA Adverse Event
Injury
·CARDIAC PACEMAKERS, INC·Product code LWP·May 8, 2008
FEMORAL STEM PRESS-FIT COLLARLESS 12/14 NECK TAPER STANDARD BODY
FDA Adverse Event
Injury
·ZIMMER BIOMET, INC.·Product code JDI·October 13, 2022
FEMORAL STEM PRESS-FIT COLLARLESS 12/14 NECK TAPER STANDARD BODY
FDA Adverse Event
Injury
·ZIMMER BIOMET, INC.·Product code JDI·October 13, 2022
uNion Cervical Plate System Product Usage: The uNion Cervical Plate System is intended for anterior fixation of the cervical spine (C2 to Ti). The system is to be used to provide stabilization of the anterior cervical spine as an adjunct to fusion for the treatment of degenerative disc disease (defined as neck pain of discogenic origin with the degeneration of the disc confirmed by history and radiographic studies), spondylolisthesis, trauma (i.e., fractures or dislocations), tumors, spinal stenosis, deformity (i.e., kyphosis, lordosis or scoliosis), pseudarthrosis or failed previous fusion.
FDA Enforcement
Class II
·Terminated·Ulrich Medical USA Inc·May 3, 2017
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
Fortify Assura, Sterile EO, Model #/ Part #: CD1257-40/100042322, 100059623; CD1257-40Q/100042341, 100059535; CD1259-40/100041914, 100042338, 100059536, 100059646, 100081567; CD1259-40Q/100041931, 100042339, 100059537, 100059620, 100059626, 100078685; CD1263-40/100042948; CD1263-40Q/100042949; CD1357-40C/100080365, 100080377, 100083441; CD1357-40Q/100080389, 100080390, 100083388; CD1359-40/100078740, 100083267, 100096839; CD1359-40C/100078500, 100078969, 100079372, 100079373, 100083442, 100083443, 100117545; CD1359-40Q/100078804, 100079155, 100079413, 100083445, 100096884; CD1359-40QC/100078603, 100079145, 100079146, 100079239, 100083405, 100083444, 100117632, 100127000, 100127065; CD1363-40C/100080349; CD1363-40Q/100080317; CD1391-40C/100080756; CD1391-40QC/100080783; CD2257-40/100042337, 100059839; CD2257-40Q/100042342, 100059842; CD2259-40/100041893, 100042308, 100059794, 100059907, 100082567; CD2259-40Q/100041894, 100042309, 100059845, 100059873, 100078610; CD2263-40/100042950; CD2263-40Q/100043201; CD2357-40C/100080404, 100080413, 100083490; CD2357-40Q/100080319, 100080412, 100083492; CD2359-40/100078750, 100083466; CD2359-40C/100078651, 100079201, 100079240, 100079442, 100083501, 100083502, 100117546; CD2359-40Q/100078841, 100079109, 100083472; CD2359-40QC/100078652, 100079156, 100079157, 100079337, 100083407, 100083465, 100117580, 100127092, 100127103; CD2363-40C/100080416; CD2363-40Q/100080407; CD2391-40C/100080784; CD2391-40QC/100080744
FDA Enforcement
Class II
·Terminated·St Jude Medical Inc.·July 4, 2018