16 results
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20ms
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Sources: EU EUDAMED, US FDA
STONY BROOK SURGICAL INNOVAIONS STERNA-WIRE (STERNAL SUTURES)
FDA 510(k)
FDA Class 2
·General, Plastic Surgery
SureFlex
FDA UDI
AMERICAN MEDICAL SYSTEMS·00878953000145·200 µm Lithotripsy Fiber
Diamond D
FDA UDI
Keystone Industries·H66810130591·Denture Acrylic SC Lrp Pwd
FOSTER GRANT
FDA UDI
FGX INTERNATIONAL INC.·00193033454206·
ENGPLUS
FDA 510(k)
FDA Class 2
·Neurology
LASER 4SPSC340
FDA 510(k)
FDA Class 2
·Physical Medicine
G7 PPS LTD ACET SHELL 48C
FDA Adverse Event
Injury
·ZIMMER BIOMET, INC.·Product code PBI·October 15, 2020
INSPIRA SMOOTH SILICONE GEL FILLED BREAST IMPLANT
FDA Adverse Event
Injury
·ALLERGAN (COSTA RICA)·Product code FTR·November 21, 2024
9800
FDA Adverse Event
Malfunction
·GE OEC MEDICAL SYSTEMS (SLC)·Product code JAA·March 1, 2013
PORTABLE OXYGEN GENERATOR (CONCENTRATOR, HOMEFILL)
FDA Adverse Event
Other
·INVACARE·Product code CAW·March 1, 2011
12MM PRESS FIT FLUTED STEM
FDA Adverse Event
Injury
·STRYKER ORTHOPAEDICS-MAHWAH·Product code KRO·August 15, 2014
G7 VIT E NEUTRAL LNR 32MM C
FDA Adverse Event
Injury
·ZIMMER BIOMET, INC.·Product code LPH·October 15, 2020
AVENIR CMPL HA HO COL SIZE 4
FDA Adverse Event
Injury
·ZIMMER BIOMET, INC.·Product code LZO·October 15, 2020
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
Ellipse Implantable Cardioverter Defibrillators (ICDs), Model No. CD1275, CD1311, CD2275, CD2311, CD1411, CD2411 Ellipse ST Implantable Cardioverter Defibrillators (ICDs), Model No. CD1273, CD1309, CD1409, CD2273, CD2309, CD2409.
FDA Enforcement
Class II
·Terminated·St Jude Medical Cardiac Rhythm Management Division·September 10, 2014
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