17 results
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21ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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NEWPORT E500 WAVE VENTILATOR
FDA 510(k)
FDA Class 2
·Anesthesiology
E500 VENTILATOR SYSTEM
FDA Adverse Event
Injury
·NEWPORT MEDICAL INSTRUMENTS, INC·Product code CBK·July 11, 2016
Micro Sprint®
FDA UDI
Forestadent Bernhard Förster GmbH·EFOR70610941·Micro Sprint-Brackets Roth .018" 20 Brackets
INTROCAN SAFETY IV CATHETER
FDA 510(k)
FDA Class 2
·Cardiovascular
SAFE TOUCH NATURAL RUBBER POWDERED LATEX EXAMINATION GLOVES
FDA 510(k)
FDA Class 1
·General Hospital
INTROCAN SAFETY®
FDA Adverse Event
Malfunction
·B BRAUN MELSUNGEN AG·Product code DYB·April 11, 2025
INTROCAN SAFETY®
FDA Adverse Event
Malfunction
·B BRAUN MELSUNGEN AG·Product code FOZ·April 8, 2025
INTROCAN SAFETY®
FDA Adverse Event
Injury
·B BRAUN MELSUNGEN AG·Product code FOZ·April 1, 2025
PDS II (POLYDIOXANONE) SUTURE
FDA Adverse Event
Malfunction
·ETHICON, INC.·Product code GAN·April 16, 2013
LIFEVEST WCD 3000 SYSTEM
FDA Adverse Event
Malfunction
·ZOLL LIFECOR CORPORATION·Product code MVK·June 13, 2008
VITROS ECI IMMUNODIAGNOSTIC SYSTEM
FDA Adverse Event
Malfunction
·ORTHO-CLINICAL DIAGNOSTICS·Product code KHO·April 18, 2011
INTROCAN SAFETY®
FDA Adverse Event
Malfunction
·B BRAUN MELSUNGEN AG·Product code FOZ·March 20, 2025
ENCOREANYWHERE
FDA Adverse Event
Malfunction
·RESPIRONICS, INC.·Product code BZD·February 17, 2016
INTROCAN SAFETY®
FDA Adverse Event
Injury
·B BRAUN MELSUNGEN AG·Product code FOZ·April 10, 2025
INTROCAN SAFETY®
FDA Adverse Event
Injury
·B BRAUN MELSUNGEN AG·Product code DYB·March 18, 2026
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 Ambulatory Infusion Pump, Model 2111 & 2112, Version 1.0, Version 2.0 and Version 3.0 & Model 2120, Version 1.0. Provide measured drug therapy to patients in hospital or outpatient settings.
FDA Enforcement
Class II
·Terminated·Smiths Medical ASD, Inc.·June 24, 2015