14 results · 28ms · Sources: EU EUDAMED, US FDA

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DATEX-OHMEDA S/5 COMPACT CRITICAL CARE MONITOR WITH L-CICU05 AND L-CICU05A SOFTWARE

FDA 510(k)
FDA Class 2 ·Cardiovascular

PMMA disc

FDA UDI
Dentsply International Inc.·D00180710200·

BioQuick®

FDA UDI
Forestadent Bernhard Förster GmbH·EFOR70710201·BioQuick-Brackets Roth .018" 5 cases Starter-as...

General Instrument

FDA UDI
ORTHOPEDIATRICS CORP.·00841132127193·Screw Extractor

TALOS® IBF

FDA UDI
MEDITECH SPINE, LLC·B16720030710200·

Cosmolock

FDA UDI
Kalitec Direct LLC·B07311K0170200·Handheld Fascia Dilator

DENVER PLEURAL EFFUSION SHUNT WITH EXTERNAL PUMP CHAMBER

FDA 510(k)
FDA Class 2 ·Gastroenterology, Urology

8100 VITAL SIGNS MONITOR

FDA 510(k)
FDA Class 2 ·Cardiovascular

WAVEWRITER ALPHA?

FDA Adverse Event
Injury ·BOSTON SCIENTIFIC NEUROMODULATION CORPORATION·Product code LGW·March 16, 2026

TRANSTAR STRETCHER

FDA Adverse Event
Malfunction ·HILL-ROM, INC.·Product code FPO·April 8, 2013

BD SAF-T-INTIMA CLOSED IV CATHETER SYSTEM

FDA Adverse Event
Other ·BECTON DICKINSON INFUSION THERAPY SYSTEMS·Product code FOZ·April 19, 2011

ONE TOUCH ULTRALINK METER

FDA Adverse Event
Malfunction ·LIFESCAN, INC.·Product code NBW·July 2, 2008

BVI CustomEyes Procedure Packs containing Sol-M Luer Lock and Luer Slip 1ml syringes, Part Number: 58001014;

FDA Enforcement
Class II ·Ongoing·Beaver Visitec International, Inc.·September 4, 2024

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