13 results
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27ms
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Sources: EU EUDAMED, US FDA
FEATHERLITE AQUA TOCODYNAMOMETER
FDA 510(k)
FDA Class 2
·Obstetrics/Gynecology
REMEL
FDA UDI
REMEL, INC.·00848838007262·HI Broth w/6.5% NaCl,BCP (5ml) 100/PK
Mini-Sprint®
FDA UDI
Forestadent Bernhard Förster GmbH·EFOR70610441·Mini Sprint-Brackets 5-5 McLaugh/Benn/Trev. .01...
TEXTURED POWDER-FREE LATEX EXAMINATION GLOVES WITH CONTAINS 50 MICROGRAMS OR LESS OF TOTAL WATER EXTRACTABLE PROTEIN PER
FDA 510(k)
FDA Class 1
·General Hospital
ACME SPINE SYSTEM - SERIES 6000, 7000, MONOAXIAL AND POLYAXIAL SCREW SYSTEM
FDA 510(k)
FDA Class 2
·Orthopedic
E500 VENTILATOR SYSTEM
FDA Adverse Event
Injury
·NEWPORT MEDICAL INSTRUMENTS, INC·Product code CBK·July 11, 2016
MALLINCKRODT
FDA Adverse Event
Malfunction
·COVIDIEN/ FORMERLY TYCOHEA·Product code BTS·April 9, 2013
IPUMP PAIN MANAGEMENT SYSTEM US VERSION
FDA Adverse Event
Malfunction
·BAXTER HEALTHCARE CORPORATION PTE. LTD.·Product code FRN·June 12, 2008
SEVEN CONTINOUS GLUCOSE MONITORING SENSOR
FDA Adverse Event
Other
·DEXCOM, INC.·Product code MDS·April 4, 2011
ENCOREANYWHERE
FDA Adverse Event
Malfunction
·RESPIRONICS, INC.·Product code BZD·February 17, 2016
NON-VENTED HOSPITAL FULL FACE MASK
FDA Adverse Event
Malfunction
·FISHER & PAYKEL HEALTHCARE LTD·Product code MNT·April 26, 2017
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