19 results
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22ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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PIPELINE II ACCESS SYSTEM
FDA 510(k)
FDA Class 2
·Neurology
Spider Limited Wrist Fusion System
FDA UDI
Smith & Nephew, Inc.·00885556834701·SPIDER TITANIUM 2.8/14MM BONE SCREW
Integra® Spider™ Limted Wrist Fusion System
FDA UDI
Ascension Orthopedics, Inc.·10381780064718·The Integra Spider Limited Wrist Fusion titaniu...
COLLAGEN NERVE CUFF
FDA 510(k)
FDA Class 2
·Neurology
DISPOSBABLE POWDERED VINYL SYNTHETIC EXAM GLOVES, WHITE COLOR
FDA 510(k)
FDA Class 1
·General Hospital
LINEAR ST
FDA Adverse Event
Malfunction
·BOSTON SCIENTIFIC NEUROMODULATION·Product code LGW·August 28, 2020
ISPAN GAS TANK REGULATOR
FDA Adverse Event
Injury
·ALCON - FORT WORTH / ALCON LABS. INC.·Product code LPO·April 11, 2013
PARADIGM REAL-TIME INSULIN INFUSION PUMP
FDA Adverse Event
Death
·MEDTRONIC MINIMED·Product code MDS·April 12, 2011
PALINDROME SAPPHIRE 23/40KT VT
FDA Adverse Event
Malfunction
·TYCO HEALTHCARE/KENDALL·Product code MPB·June 18, 2008
VASOPRESS DIGITAL MINI PUMP
FDA Adverse Event
Malfunction
·ZIMMER SURGICAL, INC.·Product code JOW·January 6, 2020
VASOPRESS DIGITAL MINI PUMP
FDA Adverse Event
Malfunction
·COMPRESSION THERAPY CONCEPTS, INC.·Product code JOW·February 18, 2020
ANGIODYNAMICS / SMART PORT
FDA Adverse Event
Malfunction
·ANGIODYNAMICS·Product code LJT·August 21, 2017
VASOPRESS DIGITAL MINI PUMP
FDA Adverse Event
Malfunction
·COMPRESSION THERAPY CONCEPTS, INC.·Product code JOW·September 17, 2019
VASOPRESS DIGITAL MINI PUMP
FDA Adverse Event
Malfunction
·ZIMMER SURGICAL, INC.·Product code JOW·November 19, 2019
VASOPRESS DIGITAL MINI PUMP
FDA Adverse Event
Malfunction
·ZIMMER SURGICAL, INC.·Product code JOW·November 19, 2019
VASOPRESS DIGITAL MINI PUMP
FDA Adverse Event
Malfunction
·ZIMMER SURGICAL, INC.·Product code JOW·December 10, 2019
Infusion Set, Comfort, 23" Hosp 10; Comfort 13mm, 23", STD 5/5; Comfort 13mm, 23" Hosp 10; Infusion Set, Comfort, 43", Hosp 10; Infusion Set, Comfort, 31", Hosp 10; Comfort 13mm, 31". Hosp 10; Infusion Set, Comfort, 23", STD 5/6; Comfort 13mm, 43" Hosp 10; Infusion Set, Comfort 43", STD 5/5; Infusion Set, Comfort Short, 13mm x 23"; Infusion Set, Comfort Short, 13mm x 32"; Infusion Set, Comfort, 17mm x 32"' Infusion Set, Comfort Short, 13mm x 43"; Infusion Set, Comfort, 17mm x 43" The products are used in combination with insulin infusion pumps for continuous subcutaneous infusion of insulin
FDA Enforcement
Class II
·Terminated·Unomedical As·November 9, 2016
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