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

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ABC SYRINGE INFUSION PUMP, MODEL 4100

FDA 510(k)
FDA Class 2 ·General Hospital

ZYNERGY BALLOONPACE BALLOON GUIDED PACING AND MONITORING CATHETER

FDA 510(k)
FDA Class 2 ·Cardiovascular

REPROCESSED AUTOSUTURE UNIPOLAR LAPAROSCOPIC/ENDOSCOPIC INSTRUMENTS

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

WAVEWRITER ALPHA?

FDA Adverse Event
Injury ·BOSTON SCIENTIFIC NEUROMODULATION CORPORATION·Product code LGW·June 25, 2025

IMMULITE 2000

FDA Adverse Event
Malfunction ·SIEMENS HEALTHCARE DIAGNOSTICS, INC.·Product code CFP·January 23, 2012

IMMULITE 2000

FDA Adverse Event
Malfunction ·SIEMENS HEALTHCARE DIAGNOSTICS, INC.·Product code CFP·February 2, 2012

KOH-EFFICIENT, RUMI 3.5CM

FDA Adverse Event
Malfunction ·COOPERSURGICAL, INC.·Product code KOH·April 19, 2013

CONTOUR USB

FDA Adverse Event
Malfunction ·BAYER HEALTHCARE, LLC·Product code NBW·April 25, 2011

VERSA DR

FDA Adverse Event
Injury ·MEDTRONIC MED REL, INC.·Product code DXY·July 10, 2008

IMMULITE 2000 INSULIN

FDA Adverse Event
Malfunction ·SIEMENS HEALTHCARE DIAGNOSTICS·Product code CFP·January 27, 2012

IMMULITE 2000 INSULIN

FDA Adverse Event
Malfunction ·SIEMENS HEALTHCARE DIAGNOSTICS·Product code CFP·February 1, 2012

Abbott IMx AFP Calibrators, list 2271-01; a box of 6 bottles (4 mL each) with AFP (human), nonreactive for anti-HIV-1/HIV-2 and HCV and nonreactive for HBsAg, inbuffered calf serum at the following concentrations: A - 0, B - 15, C - 50, D - 100, E - 200 and F - 350; Abbott Diagnostics, a Division of Abbott Laboratories, Abbott park, IL 60064

FDA Recall
Terminated ·Abbott Laboratories HPD/ADD·Product code LOJ·March 4, 2003

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