11 results · 28ms · 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.

NOVATION 12/14 CEMENTED FEMORAL STEMS

FDA 510(k)
FDA Class 2 ·Orthopedic

Caplugs/Evergreen

FDA UDI
CAPlugs·00810044206777·7" CHROM COLUMN COAR FILTER

CARDIO MONITOR CENTER VISION; MODEL S-CV7-00

FDA 510(k)
FDA Class 2 ·Cardiovascular

CARDIOBLATE SURGICAL ABLATION PEN, MODEL 60811C; CARDIOBLATE SURGICAL ABLATION GENERATOR, MODEL 60880

FDA 510(k)
FDA Class 2 ·General, Plastic Surgery

DEXCOM G6 CONTINUOUS GLUCOSE MONITORING SYSTEM

FDA Adverse Event
Malfunction ·DEXCOM, INC.·Product code QBJ·April 9, 2024

ELECTROSURGICAL COAGULATION FOR AESTHETIC

FDA Adverse Event
Injury ·F CARE SYSTEMS USA LLC·Product code ONQ·November 22, 2013

VITROS 5600 INTEGRATED SYSTEM

FDA Adverse Event
Malfunction ·ORTHO-CLINICAL DIAGNOSTICS·Product code JJE·April 29, 2013

OT PING METER

FDA Adverse Event
Malfunction ·LIFESCAN INC.·Product code NBW·May 10, 2011

APEX PUSH MONORAIL

FDA Adverse Event
Malfunction ·BOSTON SCIENTIFIC·Product code LOX·July 28, 2008

On-Board Imager - Exact Arm Elbow Motor Shaft (kVD, kVS, and MV) with ''Type 01" elbow motors. Product Usage: The On-Board Imager device is an x-ray device used for evaluation of correct patient position in relation to isocenter and verification of treatment fields in relation to anatomical and fiducial landmarks.

FDA Enforcement
Class II ·Terminated·Varian Medical Systems, Inc.·April 30, 2014

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