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