14 results
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36ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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DOUBLE ENDED FILTERED TRANSFER NEEDLE
FDA 510(k)
FDA Class 2
·General Hospital
LF
FDA UDI
Liebel-Flarsheim Company LLC·10746190002192·Y-Tubing with Single Check Valve
Oph.Forceps
FDA UDI
KATENA PRODUCTS, INC.·00841668117439·McPherson Tying Fcps, Angled
NAR
FDA UDI
NORTH AMERICAN RESCUE, LLC·00842209114757·
STAT DL 9.5 FR. 40 CC. IAB
FDA Adverse Event
Malfunction
·DATASCOPE CORP.·Product code DSP·September 16, 1998
STAT DL 9.5 FR. 34 CC. IAB
FDA Adverse Event
Malfunction
·DATASCOPE CORP.·Product code DSP·September 16, 1998
FRESENIUS COMBILINES LOW VOLUME BLOOD TUBING SET, MODELS 03-2291 (POST PUMP) AND 03-2292 (PRE-PUMP)
FDA 510(k)
FDA Class 2
·Gastroenterology, Urology
CASPIAN SPINAL SYSTEM, SCREWS, RODS, HOOKS, ROD CONNECTORS
FDA 510(k)
FDA Class 2
·Orthopedic
PARADIGM REAL-TIME REVEL INSULIN INFUSION PUMP
FDA Adverse Event
Malfunction
·MEDTRONIC PUERTO RICO OPERATIONS CO.·Product code OYC·May 8, 2014
CONSTELLATION VISION SYSTEM
FDA Adverse Event
Malfunction
·ALCON - IRVINE TECHNOLOGY CENTER·Product code HQC·October 17, 2012
FREESTYLE FLASH
FDA Adverse Event
Malfunction
·ABBOTT DIABETES CARE INC, USA·Product code LFR·September 11, 2007
UNSPECIFIED BD PHASEAL¿ INJECTOR
FDA Adverse Event
Malfunction
·BECTON DICKINSON·Product code ONB·January 7, 2019
ADAC ARGUS Gamma Camera Systems & ADAC CIRRUS Gamma Camera Systems. Distributed by Philips Medical Systems, Cleveland, OH
FDA Enforcement
Class II
·Terminated·Philips Medical Systems (Cleveland) Inc·January 29, 2014
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