15 results · 27ms · Sources: EU EUDAMED, US FDA

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LUBRICANO-ULTRASOUND

FDA 510(k)
FDA Class 2 ·Radiology

Caplugs/Evergreen

FDA UDI
CAPlugs·00810044206876·EXTRACT COLUMN W/MED FILTERS

DYNAPULSE 5000A MINI ABP BLOOD PRESSURE MONITORING SYSTEM

FDA 510(k)
FDA Class 2 ·Cardiovascular

QPS (QUANTITATIVE PERFUSION SPECT), QGS (QUANTITATIVE GATED SPECT)

FDA 510(k)
FDA Class 2 ·Radiology

INFINION? CX

FDA Adverse Event
Injury ·BOSTON SCIENTIFIC NEUROMODULATION CORPORATION·Product code LGW·April 9, 2025

PASS LP

FDA Adverse Event
Injury ·MEDICREA TECHNOLOGIES·Product code MNI·April 17, 2013

PASS LP

FDA Adverse Event
Injury ·MEDICREA·Product code MNI·April 17, 2013

ACCU-CHEK ® MOBILE TEST STRIPS

FDA Adverse Event
Malfunction ·ROCHE DIAGNOSTICS·Product code LFR·April 29, 2013

CODAN SECONDARY SET

FDA Adverse Event
Malfunction ·CODAN US CORP·Product code FPA·April 13, 2011

LIFESHIELD MICROBORE SET

FDA Adverse Event
Malfunction ·HOSPIRA LTD.·Product code FPK·July 28, 2008

PASS LP - LIAPASS

FDA Adverse Event
Injury ·MEDICREA TECHNOLOGIES·Product code MNI·March 29, 2013

5.0MM TROCAR

FDA Adverse Event
Malfunction ·SYNTHES HAGENDORF·Product code FZX·December 30, 2016

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

CADD-Solis VIP ambulatory Infusion Pumps, Model 2120 (21-2120, 21-2125, and 21-2127) Indicated for the following uses: Intra-arterial, subcutaneous, intraperitoneal, in close proximity to nerves, into an intraoperative site, epidural space or subarachnoid space. Therapies that require a continuous rate of infusion, intermittent bolus, and/or with patient-controlled demand doses.

FDA Enforcement
Class I ·Ongoing·Smiths Medical ASD Inc.·August 14, 2024