12 results · 23ms · Sources: EU EUDAMED, 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