16 results · 19ms · Sources: EU EUDAMED, US FDA

Get notified when this changes

We'll email you when new records match this search — new devices, new clearances, certificate changes, or withdrawals.

BECKMAN COULTER DNASE B CALIBRATOR

FDA 510(k)
FDA Class 2 ·Clinical Chemistry

Endo Carry-on Procedure Kit

FDA UDI
MEDIVATORS INC.·00677964151767·Endo Carry-on Procedure Kit contains Intercept ...

TLIF

FDA UDI
Nuvasive, Inc.·00887517062598·TLIF Inserter, 9x25mm Angled

Zirlux

FDA UDI
HENRY SCHEIN, INC.·H65890106960·Zirlux Titanium Screw compatible with: Strauman...

MACROPOREMX MANDIBULAR FIXATION SYSTEM

FDA 510(k)
FDA Class 2 ·Dental

MULTI CARE THERAPEUTIC VIBRATOR

FDA 510(k)
FDA Class 2 ·Obstetrics/Gynecology

BAXANO IO-FLEX SYSTEM

FDA Adverse Event
Other ·BAXANO, INC.·Product code HAE·July 2, 2012

BAXANO IO-FLEX SYSTEM

FDA Adverse Event
Other ·BAXANO, INC.·Product code HAE·July 2, 2012

BAXANO IO-FLEX SYSTEM

FDA Adverse Event
Other ·BAXANO, INC.·Product code HAE·July 2, 2012

ULTRACISION HARMONIC ACE

FDA Adverse Event
Malfunction ·ETHICON ENDO-SURGERY, LLC.·Product code LFL·March 19, 2013

OMNIFIT PLUS CEMENTED HIP STEMOBSOLETE

FDA Adverse Event
Injury ·STRYKER ORTHOPAEDICS MAHWAH·Product code JDI·February 25, 2011

RIATA ST ACTIVE FIXATION LEAD

FDA Adverse Event
Injury ·ST JUDE MEDICAL CARDIAC RHYTHM MANAGEMENT DIVISION·Product code LWS·March 10, 2008

HISTOLOCK RESECTION DEVICE

FDA Adverse Event
Malfunction ·UNITED STATES ENDOSCOPY GROUP, INC.·Product code FDI·May 27, 2021

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