13 results · 20ms · Sources: EU EUDAMED, US FDA

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VERSA LITE

FDA 510(k)
FDA Class 2 ·General, Plastic Surgery

Neocis Guidance System

FDA UDI
NEOCIS INC·00810004900134·Vatach PAX Chin Rest

MODIFICATION TO: STERILE COLLES CLASSIC FIXATOR

FDA 510(k)
FDA Class 2 ·Orthopedic

N LATEX CYSTATIN C

FDA 510(k)
FDA Class 2 ·Clinical Chemistry

WAVEWRITER ALPHA

FDA Adverse Event
Injury ·BOSTON SCIENTIFIC NEUROMODULATION·Product code LGW·August 25, 2021

SPECTRA WAVEWRITER

FDA Adverse Event
Injury ·BOSTON SCIENTIFIC NEUROMODULATION·Product code LGW·January 5, 2024

SET SCREW, HEXALOBE (TI-6AI-4V ELI)

FDA Adverse Event
Malfunction ·ALPHATEC SPINE INC·Product code MNI·July 17, 2019

HOMECHOICE AUTOMATED PD SET WITH CASSETTE

FDA Adverse Event
Malfunction ·BAXTER HEALTHCARE - MOUNTAIN HOME·Product code FKX·April 23, 2013

LOGIX SOFTWARE APPLICATION(INCLUDES OE & CM MODULES)

FDA Adverse Event
Injury ·BAXTER HEALTHCARE - BUFFALO GROVE·Product code NEP·May 2, 2011

TENDRIL SDX

FDA Adverse Event
Injury ·ST JUDE MEDICAL CARDIAC RHYTHM MANAGEMENT DIVISION·Product code DTB·July 11, 2008

NORIAN DRILLABLE INJECT 10CC-STERILE

FDA Adverse Event
Malfunction ·WRIGHTS LANE SYNTHES USA PRODUCTS LLC·Product code MQV·February 7, 2018

Boston Scientific/Microvasive Open End Ureteral Catheter (5 Fr x 70 cm) Product Number: 400-201

FDA Recall
Terminated ·Boston Scientific Corporation·Product code GBM·March 17, 2003

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