13 results
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22ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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SURGI-WRAP MAST BIORESORBABLE SHEET
FDA 510(k)
FDA Class 2
·General, Plastic Surgery
SNAZZY2
FDA 510(k)
FDA Class 2
·Physical Medicine
BAIR HUGGER TEMPERATURE MANAGEMENT SYSTEM
FDA 510(k)
FDA Class 2
·Cardiovascular
PLATE, FIXATION, BONE
FDA Adverse Event
Injury
·WRIGHTS LANE SYNTHES USA PRODUCTS LLC·Product code HRS·July 25, 2018
AN UNSPECIFIED CLOSED SYSTEM ART LINE TRANSUDUCER
FDA Adverse Event
Malfunction
·ICU MEDICAL DE MEXICO, S. DE R.L. DE C.V.·Product code DRS·March 18, 2025
UNSPECIFIED SAFESET TRANSPAC SETS
FDA Adverse Event
Malfunction
·ICU MEDICAL DE MEXICO, S. DE R.L. DE C.V.·Product code DRS·January 2, 2025
UNSPECIFIED CENTRAL LINE TRANSDUCER SET
FDA Adverse Event
Malfunction
·ICU MEDICAL DE MEXICO, S. DE R.L. DE C.V.·Product code DRS·November 5, 2024
AN UNSPECIFIED CLOSED SYSTEM ART LINE SYRINGE
FDA Adverse Event
Malfunction
·ICU MEDICAL DE MEXICO, S. DE R.L. DE C.V.·Product code DRS·March 18, 2025
TRILOGY 100
FDA Adverse Event
Malfunction
·RESPIRONICS INC.·Product code CBK·April 10, 2013
E-POLY 40MM +3 HIWALL LINER SZ24
FDA Adverse Event
Injury
·BIOMET ORTHOPEDICS·Product code MAY·September 4, 2014
SYNCHROMED EL
FDA Adverse Event
Malfunction
·RICE CREEK MFG.·Product code LKK·June 13, 2008
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