12 results
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19ms
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Sources: EU EUDAMED, US FDA
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Regulation: Us FDA
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GRANTON MEDICAL 121-135 C SELF-SEAL STERILIZATION POUCHES
FDA 510(k)
FDA Class 2
·General Hospital
JOBST forMen
FDA UDI
BSN MEDICAL, INC.·04042809845365·FOR MEN 20-30 MM HG KNEE HIGH OPEN TOE EXTRA LA...
WRISTWATCH BPM BLOOD PRESSURE MONITOR, MODEL KP-6120
FDA 510(k)
FDA Class 2
·Cardiovascular
ULTRA THIN MALE LATEX CONDOM WITH SILICONE LUBRICANT
FDA 510(k)
FDA Class 2
·Obstetrics/Gynecology
2027971-2022-052665
FDA Adverse Event
Injury
·NOBEL BIOCARE USA, LLC·Product code DZE·March 21, 2022
COGNIS
FDA Adverse Event
Injury
·GUIDANT CRM CLONMEL IRELAND·Product code LWP·April 11, 2013
SMARTSET MV 40G - EO
FDA Adverse Event
Injury
·DEPUY CMW·Product code LOD·April 7, 2011
VISIAN ICL (IMPLANTABLE COLLAMER LENS)
FDA Adverse Event
Injury
·STAAR SURGICAL·Product code MTA·May 22, 2008
Flush Kit w 3 Way Off Stopcock Product Usage: Flush Kit
FDA Enforcement
Class II
·Terminated·ICU Medical, Inc.·August 8, 2012
High Pressure Stopcock (3-Way, Luer Lock, Off). Product Usage: For IV.
FDA Enforcement
Class II
·Terminated·ICU Medical, Inc.·August 8, 2012
Cardiac Catheterization Waste Management System w/1000mL Waste Bag, 2 Fluid Admin Sets Product Usage: For waste managment.
FDA Enforcement
Class II
·Terminated·ICU Medical, Inc.·August 8, 2012
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