18 results
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37ms
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Sources: EU EUDAMED, US FDA
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Regulation: Us FDA
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\RESENIUS ACCESS FLOW RESERVING CONNECTORS, FRESENIUS STANDALONE ACCCES FLOW RESERVING CONNECTOR
FDA 510(k)
FDA Class 2
·Gastroenterology, Urology
Anaerotest for microbiology Specification: Performance Test Anerobic: white within 4-6 hours; aerobic: blue with 20 minutes Merck KgaA 64271 Darmstadt, Germany 1.19034.0002 17.08.06 1 unit UPC 4 022536 667928
FDA Recall
Terminated
·EMD Chemicals Inc·Product code J·August 17, 2006
REPROCESSED POWERED ARTHROSCOPIC ACCESSORIES
FDA 510(k)
FDA Class 2
·Orthopedic
LIQUICHEK BLOOD GAS PLUS CO-OXIMETER CONTROL, MODELS 637, 638, 639 (RADIOMETER)
FDA 510(k)
FDA Class 1
·Clinical Chemistry
RED DCI-DC3 SENSOR
FDA Adverse Event
Malfunction
·MASIMO CORPORATION·Product code DQA·September 15, 2015
RD SET GE - 12
FDA Adverse Event
Malfunction
·Product code DQA·August 13, 2021
RD SET DCI
FDA Adverse Event
Malfunction
·MASIMO - 40 PARKER·Product code DQA·February 17, 2017
BD PHASEAL¿ SECONDARY SET C61
FDA Adverse Event
Malfunction
·BECTON DICKINSON·Product code FPA·December 19, 2022
MAXI MOVE
FDA Adverse Event
Malfunction
·ARJO HOSPITAL EQUIPMENT AB·Product code FSA·March 21, 2013
STERLING ES PTA BALLOON DILATATION CATHETER
FDA Adverse Event
Malfunction
·BOSTON SCIENTIFIC - MAPLE GROVE·Product code LIT·March 17, 2011
ACRYSOF
FDA Adverse Event
Other
·ALCON RESEARCH, LTD. / HUNTINGTON·Product code HQL·March 20, 2008
UNKNOWN
FDA Adverse Event
Malfunction
·COOK INC·Product code DQX·July 26, 2024
KIT, RADICAL-7 HANDHELD
FDA Adverse Event
Malfunction
·MASIMO - 40 PARKER·Product code DQA·May 10, 2019
KIT, RADICAL-7 HANDHELD
FDA Adverse Event
Malfunction
·MASIMO - 40 PARKER·Product code DQA·May 10, 2019
KIT, RADICAL-7 HANDHELD
FDA Adverse Event
Malfunction
·MASIMO - 40 PARKER·Product code DQA·May 10, 2019
RD SET NEO CS-3
FDA Adverse Event
Malfunction
·MASIMO - 52 DISCOVERY·Product code DQA·January 29, 2021
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
Allura Exper FD Series. System codes 722003 722010 722022 722005 722011 722019 722001 722002 722006 722012 722008 722013 722020 722025 722015 722023 722038 889006 889016 889009 722005 The device is an X-Ray Generator.
FDA Enforcement
Class II
·Terminated·Philips North America, LLC·March 25, 2020