13 results · 25ms · Sources: EU EUDAMED, US FDA

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MAK OSS KNEE FEMORAL COMPONENTS

FDA 510(k)
FDA Class 2 ·Orthopedic

THERMOMETER MODELS ST8132C, ST8132F, ST8142C, ST8142F, ST8532C, ST8532F, ST8542C, AND ST8542F

FDA 510(k)
FDA Class 2 ·General Hospital

IMMOBILIZATION SYSTEM FOR ENT

FDA 510(k)
FDA Class 2 ·Radiology

WAVEWRITER ALPHA PRIME

FDA Adverse Event
Injury ·BOSTON SCIENTIFIC NEUROMODULATION CORPORATION·Product code LGW·March 14, 2025

PRISMAFLEX

FDA Adverse Event
Injury ·GAMBRO LUNDIA AB·Product code KDI·May 6, 2010

PRISMAFLEX

FDA Adverse Event
Injury ·GAMBRO LUNDIA AB·Product code KDI·November 5, 2010

PRISMAFLEX

FDA Adverse Event
Injury ·GAMBRO LUNDIA AB·Product code KDI·November 25, 2010

FLOGARD

FDA Adverse Event
Malfunction ·SHARP CORPORATION OSAKA JAPAN·Product code FRN·April 29, 2013

ACCESS

FDA Adverse Event
Malfunction ·BAXTER HEALTHCARE - AIBONITO·Product code BRZ·May 10, 2011

UNK ANGIOGUARD

FDA Adverse Event
Malfunction ·CORDIS CORPORATION·Product code NTE·July 24, 2008

AS COLUMBUS REV F FEMUR ZEMENTIERT F5L

FDA Adverse Event
Injury ·AESCULAP AG·Product code JWH·November 6, 2019

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