11 results
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27ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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RELIEVA ULTIRRA Sinus Balloon Catheter
FDA 510(k)
FDA Class 1
·Ear, Nose, Throat
VIDAS® MEASLES IGG
FDA Adverse Event
Malfunction
·BIOMERIEUX SA·Product code LJB·April 17, 2019
RZ Medizintechnik GmbH
FDA UDI
RZ-Medizintechnik GmbH·04049197530286·RZ Tebbet Breast Retractor
190x25...
ELITECH CLINICAL SYSTEMS GLUCOSE PAP SL ELITECH CLINICAL SYSTEMS ELICAL 2, ELITECH CLINICAL SYSTEMS ELITROL 1 AND 2
FDA 510(k)
FDA Class 2
·Clinical Chemistry
LOI SYSTEM
FDA 510(k)
FDA Class 2
·General, Plastic Surgery
I-STAT TROPONIN (CTNI) CARTRIDGE
FDA Adverse Event
Malfunction
·ABBOTT POINT OF CARE·Product code MMI·September 24, 2019
AEQUALIS STEM FOR FRACTURE D.6.5 HA-COATED
FDA Adverse Event
Injury
·TORNIER S.A.S.·Product code KWS·January 5, 2026
BRAVO
FDA Adverse Event
Malfunction
·GIVEN IMAGING LTD.·Product code FFT·June 21, 2013
LIGAMAX-5MM ENDO CLIP APPLIER
FDA Adverse Event
Malfunction
·ETHICON ENDO SURGERY, INC. (CINCINNATI)·Product code GDO·October 9, 2008
COLLEAGUE PRE P1.7
FDA Adverse Event
Malfunction
·BAXTER HEALTHCARE - SINGAPORE·Product code FRN·August 4, 2011
St. Jude Medical CONFIRM Rx Insertable Cardiac Monitor, Sterile EO, Model #: DM3500 The Confirm Rx ICM is indicated for the monitoring and diagnostic evaluation of patients who experience unexplained symptoms such as: dizziness, palpitations, chest pain, syncope, and shortness of breath, as well as patients who are at risk for cardiac arrhythmias. It is also indicated for patients who have been previously diagnosed with atrial fibrillation or who are susceptible to developing atrial fibrillation.
FDA Enforcement
Class II
·Terminated·St Jude Medical Inc.·July 11, 2018