19 results · 21ms · Sources: EU EUDAMED, 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