19 results
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21ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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CYBERSONICS CYBERWAND DUAL PROBE LITHOTRIPTER
FDA 510(k)
FDA Class 2
·Gastroenterology, Urology
Harvard Ionoglas Fill Extra A3,5
FDA UDI
Harvard Dental International GmbH·EHAR70521351·Esthetic glass ionomer cement for restorations
SOLIDEA
FDA UDI
CALZIFICIO PINELLI SRL·08300496052135·VENERE 70 OPEN TOE, SIZE L, MIELE, GRADUATED CO...
I9011S
FDA UDI
Lenstec Barbados Inc·00844369016858·Push Injector, titanium
NA
FDA UDI
STERILMED, INC.·10888551019927·SAW BLADE RECIPROCATING LARGE BONE
CONMED
FDA UDI
Conmed Corporation·10845854002384·STRYKER RECIPROCATOR BLADE REPLACEMENT, 12.5 X ...
POWDER FREE BROWN LATEX SURGICAL GLOVES WITH PROTEIN CONTENT LABELING CLAIM (50 MICROGRAMS OR LESS)
FDA 510(k)
FDA Class 1
·General, Plastic Surgery
SLEEPSTRIP DISPOSABLE APNEA SCREENER
FDA 510(k)
FDA Class 2
·Anesthesiology
LIFESTENT VALEO BILIARY STENT
FDA Adverse Event
Malfunction
·BARD PERIPHERAL VASCULAR, INC.·Product code FGE·December 29, 2009
ACCU-CHEK ® AVIVA PLUS TEST STRIPS
FDA Adverse Event
Malfunction
·ROCHE DIAGNOSTICS·Product code LFR·May 29, 2013
LIFESTENT VALEO BILIARY STENT
FDA Adverse Event
Malfunction
·BARD PERIPHERAL VASCULAR, INC.·Product code FGE·December 29, 2009
ACCU-CHEK ® AVIVA PLUS TEST STRIPS
FDA Adverse Event
Malfunction
·ROCHE DIAGNOSTICS·Product code LFR·May 29, 2013
LIFESTENT VALEO VASCULAR STENT
FDA Adverse Event
Injury
·BARD PERIPHERAL VASCULAR, INC.·Product code FGE·August 9, 2010
VALEO VASCULAR STENT
FDA Adverse Event
Malfunction
·BARD PERIPHERAL VASCULAR, INC.·Product code FGE·September 3, 2010
ONETOUCHPING GLUCOSEMGMTSYSTEM
FDA Adverse Event
Malfunction
·ANIMAS CORPORATION·Product code LZG·April 11, 2013
HEARTMATE II SYSTEM CONTROLLER
FDA Adverse Event
Malfunction
·THORATEC CORP.·Product code DSQ·March 1, 2011
ONE TOUCH ULTRA TEST STRIPS 100'S
FDA Adverse Event
Malfunction
·LIFESCAN·Product code NBW·May 23, 2008
Pinnacle Destination Guiding Sheath, 7 French, 90 cm, Straight Tip, Tuohy-Borst Valve, Lots ME07 & MF12, 510(k) K052185 Guiding Sheath is used to facilitate the introduction of interventional and diagnostic devices into the human vasculature, including but not limited to the renal arteries for the Renal Guiding Sheath and the carotid arteries for the Carotid Guiding Sheath.
FDA Recall
Terminated
·Terumo Medical Corporation·Product code DYB·June 24, 2010
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