15 results · 21ms · Sources: EU EUDAMED, US FDA

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HARVARD 1 SYRINGE PUMP/HARVARD 1 WITH PCA SYRINGE PUMP

FDA 510(k)
FDA Class 2 ·General Hospital

Baltic Denture System BD Load

FDA UDI
Merz Dental GmbH·D7091033054·Baltic Denture System BDLoad Ln6 PLSEbil2DFl D2...

INSTANT-VIEW Cocaine (150) Urine Cassette Test

FDA UDI
ALFA SCIENTIFIC DESIGNS, INC.·10796918000412·INSTANT-VIEW Cocaine (150) Urine Cassette Test

CosmoLock Pedicle Screw System

FDA UDI
Kalitec Direct LLC·B07311K0330040·Vise Grip, Small, 5.5mm

InTess Lumbar Cage

FDA UDI
Kalitec Direct LLC·B07312K0310540·T-Handle, Primal, 1/4 inch Square, Cannulated

AUTOSTAT II ENA-6 PROFILE ELISA

FDA 510(k)
FDA Class 2 ·Immunology

KONICA DIRECT DIGITIZER REGIUS MODEL 350

FDA 510(k)
FDA Class 2 ·Radiology

RENU WITH MOISTURELOC MULTIPURPOSE SOLUTION

FDA Adverse Event
Injury ·BAUSCH & LOMB INCORPORATED·Product code LPN·February 18, 2020

ECHO POR FMRL LAT NC

FDA Adverse Event
Injury ·ZIMMER BIOMET, INC.·Product code KWY·November 6, 2020

2800

FDA Adverse Event
Malfunction ·GE OEC MEDICAL SYSTEMS (SLC)·Product code JAA·April 1, 2013

TRUFILL DCS ORBIT DETACHABLE COILS COMPLEX

FDA Adverse Event
Malfunction ·CORDIS NEUROVASCULAR, INC.·Product code HCG·March 30, 2011

LIFEPAK 9P DEFIBRILLATOR/MONITOR/PACEMAKER

FDA Adverse Event
Malfunction ·PHYSIO-CONTROL, INC·Product code LDD·April 23, 2008

EMBRYO RPLCMNT CATHETER

FDA Adverse Event
Malfunction ·COOPERSURGICAL, INC.·Product code MQF·September 24, 2019

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

Smiths Medical Medfusion Model 4000 Syringe pump, Item Numbers: a) 4000-0101-249, b) 4000-0101-50, c) 4000-0101-51, d) 4000-0105-249, e) 4000-0105-50, f) 4000-0105-51, g) 4000-0105-78, h) 4000-0106-00, i) 4000-0106-01, j) 4000-0106-231,

FDA Enforcement
Class II ·Ongoing·Smiths Medical ASD Inc.·April 24, 2024