13 results
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20ms
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Sources: EU EUDAMED, US FDA
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