12 results
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23ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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DGH 55 HANDHELD PACHYMETER (PACHMATE)
FDA 510(k)
FDA Class 2
·Radiology
Baltic Denture System BDLoad
FDA UDI
Merz Dental GmbH·D7091033385·Baltic Denture System BDLoad BDLoad ↓ Sw7 PLSEu...
NEXGEN COMPLETE KNEE SOLUTION ROTATNG HINGE KNEE
FDA 510(k)
FDA Class 2
·Orthopedic
TWILITE, TWILITE WHITE
FDA 510(k)
FDA Class 2
·General, Plastic Surgery
TENDRIL ST
FDA Adverse Event
Death
·ST JUDE MEDICAL CARDIAC RHYTHM MANAGEMENT DIVISION·Product code NVN·April 3, 2013
SIDNE SMART 40L CORE INSUFFLATOR
FDA Adverse Event
Malfunction
·STRYKER ENDOSCOPY SAN JOSE·Product code HIF·March 22, 2011
DEPUY HAND INNOVATIONS
FDA Adverse Event
Malfunction
·Product code HRS·April 23, 2008
HEARTMATE 3 LVAS IMPLANT KIT
FDA Adverse Event
Malfunction
·THORATEC CORPORATION·Product code DSQ·January 17, 2024
Smith & Nephew FOOTPRINT ULTRA PK SUTURE ANCHOR 4.5 Part Number: 72202901
FDA Enforcement
Class II
·Ongoing·Smith & Nephew, Inc.·April 29, 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
Smiths Medical Medfusion Model 4000 Syringe pump, Item Numbers: a) 4000-0101-249, b) 4000-0101-50, c) 4000-0101-51, d) 4000-0105-249, e) 4000-0105-50, f) 4000-0105-51, g) 4000-0105-78, h) 4000-0106-00, i) 4000-0106-01, j) 4000-0106-231,
FDA Enforcement
Class II
·Ongoing·Smiths Medical ASD Inc.·April 24, 2024
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