12 results
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18ms
·
Sources: EU EUDAMED, US FDA
BIO-CONSOLE, MODEL 560
FDA 510(k)
FDA Class 2
·Cardiovascular
CARDINAL HEALTH
FDA UDI
Cardinal Health 200, LLC·10885425965793·LACERATION TRAY
BREAST IMMOBILIZATION DEVICE MR-BY 160
FDA 510(k)
FDA Class 2
·Radiology
RANDOX PHENOBARBITAL
FDA 510(k)
FDA Class 2
·Clinical Toxicology
PROFEMUR(R) MODULAR FEMORAL NECK
FDA Adverse Event
Injury
·WRIGHT MEDICAL TECHNOLOGY, INC·Product code LWJ·April 10, 2013
PENTA SURGICAL LEAD
FDA Adverse Event
Injury
·ST JUDE MEDICAL - NEUROMODULATION DIVISION·Product code LGW·April 7, 2011
CALAXO SCREW
FDA Adverse Event
Other
·SMITH & NEPHEW INC., ENDOSCOPY DIV.·Product code HWC·May 22, 2008
BLUNT TIP SCREW, 4X42MM
FDA Adverse Event
Injury
·ZIMMER SWITZERLAND MANFACTURING GMBH·Product code HSB·March 30, 2022
BLUNT TIP SCREW, 4X42MM
FDA Adverse Event
Injury
·ZIMMER SWITZERLAND MANFACTURING GMBH·Product code HSB·March 30, 2022
AC TenderLink 13/30 10 pcs; AC TenderLink I 13/60 10 pcs; AC TenderLink I 13/80 10 pcs; AC TenderLink I 17/110 10 pcs; AC TenderLink I 17/30 10 pcs; AC TenderLink I 17/60 10 pcs; AC TenderLink I 17/80 10 pcs; AC TenderLink I 13/110 10 pcs 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
Baxter Auto Syringe Micro-Volume Extension Set with 0.22 Micron Filter, catalog 1M8527 and 1M8527Y; Baxter Healthcare Corporation, Deerfield, IL 60015
FDA Recall
Terminated
·Baxter Healthcare Corp. Rt·Product code FPA·October 17, 2002
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