11 results · 20ms · Sources: EU EUDAMED, US FDA

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HL888HM

FDA 510(k)
FDA Class 2 ·Cardiovascular

TRAY MATERIAL

FDA UDI
AMERICAN TOOTH INDUSTRIES·D772ATI0304990·TRAY MATERIAL/25 LBS. POWDER

REMVIEW SLEEP RECORDER, MODEL 320

FDA 510(k)
FDA Class 2 ·Neurology

ADVANTA SUPER SOFT GRAFT

FDA 510(k)
FDA Class 2 ·Cardiovascular

BURR ATTACHMENT-SHORT FOR PEN DRIVE

FDA Adverse Event
Malfunction ·SYNTHES GMBH·Product code HWE·April 2, 2013

9600

FDA Adverse Event
Malfunction ·GE OEC MEDICAL SYSTEMS (SLC)·Product code JAA·March 9, 2011

M SERIES

FDA Adverse Event
Malfunction ·ZOLL MEDICAL CORP·Product code MKJ·April 16, 2008

LIFEWISE BLOOD PRESSURE MONITOR

FDA Adverse Event
Injury ·RADIOSHACK·Product code DXN·October 20, 2004

Aurora Series, Aurora 7 lighthead; Models: LED7 (including TV models). The Aurora Series is intended to illuminate the surgical field and ensure visibility of the surgical site.

FDA Enforcement
Class II ·Ongoing·DKK Dai-Ichi Shomei Co., Ltd.·August 21, 2024

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

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