14 results
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26ms
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Sources: EU EUDAMED, US FDA
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Regulation: Us FDA
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PRO-LINE CT (BASIC TRAY) MODEL MR28036101
FDA 510(k)
FDA Class 2
·General Hospital
LEONE SPA
FDA UDI
LEONE SPA·08033707065821·EXTRAORAL ELASTICS 1/4" 8 oz
Merit Medical®
FDA UDI
Merit Medical Systems, Inc.·00884450460474·
LINEAR ST
FDA Adverse Event
Injury
·BOSTON SCIENTIFIC NEUROMODULATION·Product code LGW·March 27, 2024
LUXOR RETRACTOR
FDA Adverse Event
Malfunction
·STRYKER SPINE BORDEAUX·Product code GAD·April 27, 2012
GLUCOPRO EVO INFUSION PUMP
FDA 510(k)
FDA Class 2
·General Hospital
DERMAGRIP POWDER FREE GREEN POLYMER COATED EXAMINATION GLOVES CONTAINS 50 MICROGRAMS OR LESS OF TOTAL WATER EXTRACTABLE
FDA 510(k)
FDA Class 1
·General Hospital
LUXOR RETRACTOR
FDA Adverse Event
Injury
·STRYKER SPINE BORDEAUX·Product code GAD·March 30, 2012
ACCESS® 2 IMMUNOASSAY SYSTEM
FDA Adverse Event
Malfunction
·BECKMAN COULTER·Product code JJE·May 6, 2013
RESTORE ULTRA
FDA Adverse Event
Injury
·MEDTRONIC MED REL MEDTRONIC PUERTO RICO·Product code LGW·September 16, 2014
DREAMTOME RX SPHINCTEROTOME
FDA Adverse Event
Malfunction
·BOSTON SCIENTIFIC - SPENCER·Product code KNS·May 18, 2011
NOVOTWIST 8 MM (30G)
FDA Adverse Event
Injury
·NOVO NORDISK A/S, MS HJOERRING·Product code FMI·August 11, 2016
LUXOR RETRACTOR BASE; Catalog Number: 48250030; Manufactured by: STRYKER Spine SAS; Z.I MARTICOT-33610-CESTAS-FRANCE; Distributed in the USA by: Stryker Spine. 2 Pearl Ct. Allendale, NJ 07401. Provides access to the thoracic and lumbar spine from a posterior approach via a small incision.
FDA Enforcement
Class II
·Terminated·Stryker Spine·August 15, 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