13 results · 27ms · Sources: EU EUDAMED, US FDA

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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