14 results
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28ms
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Sources: EU EUDAMED, US FDA
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