11 results · 28ms · Sources: EU EUDAMED, US FDA

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INTERSURGICAL INTER-THERM BREATHING FILTER AND HEAT AND MOISTURE EXCHANGER, INTERSURGICAL INTER-GUARD BREATHING FILTER

FDA 510(k)
FDA Class 2 ·Anesthesiology

MODIFICATION TO: PRONTO DRY

FDA 510(k)
FDA Class 1 ·Microbiology

PROPAQ ENCORE MODELS 202, 204, 206; PROPAQ CS MODELS 242, 244, 246

FDA 510(k)
FDA Class 2 ·Cardiovascular

RX VIATRAC 14 PLUS PERIPHERAL DILATATION CATHETER

FDA Adverse Event
Injury ·ABBOTT VASCULAR-VASCULAR SOLUTIONS·Product code LIT·November 24, 2009

PALL LEUKOCYTE REMOVAL FILTER FOR PLATELETS

FDA Adverse Event
Injury ·PALL MEXICO MANUFACTURING·Product code CAK·May 3, 2013

E SERIES DEFIBRILLATOR

FDA Adverse Event
Malfunction ·ZOLL MEDICAL CORPORATION·Product code MKJ·September 5, 2014

9900

FDA Adverse Event
Malfunction ·GE OEC MEDICAL SYSTEMS (SLC)·Product code JAA·May 2, 2011

MULTIPLE-SEE ATTACHED

FDA Adverse Event
Injury ·ST. JUDE MEDICAL·Product code OAD·March 24, 2009

Optical Access System; 5mm x 100mm and 12mm x 100mm; Model #: CTR03 and CTR73. Indicated for use to establish a port of entry fro endoscopic instruments in patients requiring minimally invasive surgical procedures including thoracic, gynecologic laparoscopy and other abdominal procedures.

FDA Enforcement
Class II ·Terminated·Stryker Sustainability Solutions·July 1, 2015

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

Alaris Syringe Pump, Model No. 8110. Delivers fluids. Expansion of Affected Units: BOM Housing Assembly Service, Part No. 49000226, and Lower Housing/Carriage Block Assembly, Part No. 148188-100.

FDA Enforcement
Class I ·Terminated·CareFusion 303, Inc.·August 26, 2015