13 results
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22ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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K-ETCHANT GEL
FDA 510(k)
FDA Class 2
·Dental
iDMS™ Data Management System
FDA UDI
ACCURAY INCORPORATED·M65810624090·Software, iDMS™ Data Management System, (Versio...
OsteoMed
FDA UDI
OSTEOMED LLC·00845694018715·2.4mm x 9mm Lag Screw
OsteoMed
FDA UDI
OSTEOMED LLC·00845694066822·HPS 2.4 x 9mm Lag Screw Sterile Qty 5
BHR MODULAR HEAD 46MM
FDA Adverse Event
Injury
·SMITH & NEPHEW ORTHOPAEDICS LTD·Product code KWY·January 4, 2018
MAXONE, BLOOD, BLOOD PRODUCTS AND IV FLUID WARMER
FDA 510(k)
FDA Class 2
·General Hospital
LORENZ LACTOSORB LARYNGOTRACHEAL RECONSTRUCTION IMPLANTS
FDA 510(k)
FDA Class 2
·Ear, Nose, Throat
56MM AND R3 ACETABULAR SHELL
FDA Adverse Event
Injury
·SMITH & NEPHEW, INC.·Product code MBL·September 14, 2018
OT PING METER
FDA Adverse Event
Malfunction
·LIFESCAN EUROPE, A DIVISION OF CILAG GMBH INTL·Product code NBW·April 16, 2013
OT VERIO IQ METER
FDA Adverse Event
Malfunction
·LIFESCAN EUROPE, A DIVISION OF CILAG GMBH INTL·Product code NBW·September 5, 2014
840 VENTILATOR
FDA Adverse Event
Malfunction
·PURITAN BENNETT CORP.·Product code CBK·March 18, 2011
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