11 results
·
28ms
·
Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
×
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