10 results
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19ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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BIOFASTIN RC THREADED SUTURE ANCHOR
FDA 510(k)
FDA Class 2
·Orthopedic
LIFESTYLES, CONTEMPO OR PRIVATE LABEL LARGE CONDOM
FDA 510(k)
FDA Class 2
·Obstetrics/Gynecology
POWDERED SYNTHETIC (YELLOW) VINYL PATIENT EXAMINATION GLOVES
FDA 510(k)
FDA Class 1
·General Hospital
SYNERGY
FDA Adverse Event
Malfunction
·MEDTRONIC PUERTO RICO OPERATIONS CO.·Product code LGW·March 4, 2009
UNIVERSAL STEM 115X14MM FLUTED
FDA Adverse Event
Injury
·1219655 DEPUY-RAYNHAM·Product code JWH·March 26, 2013
STENOSCOP
FDA Adverse Event
Malfunction
·GE MEDICAL SYSTEMS (INDIA) PRIVATE LTD (GE PRIVATE)·Product code JAA·February 25, 2011
PD CYCLER 110 VOLT HOME CHOICEPRO AUTOMATED
FDA Adverse Event
Malfunction
·BAXTER HEALTHCARE·Product code FKX·March 28, 2008
REFLECTION CONSTRAINED ACETABULAR LINER
FDA Adverse Event
Injury
·SMITH & NEPHEW, INC.·Product code KWZ·June 8, 2025
Stereotactic Circular Collimator - 3D Line stereotatic Hardware Accessories The device is part of the class of medical devices that are used in radiotherapy for the treatments of head tumors.
FDA Enforcement
Class II
·Terminated·Elekta, Inc.·November 13, 2013
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