20 results
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23ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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REMINGTON I-LIGHT HAIR REMOVAL SYSTEM
FDA Adverse Event
Injury
·SHASER INC·Product code ONF·May 21, 2021
LUMENA FH HAIR REMOVAL SYSTEM
FDA 510(k)
FDA Class 2
·General, Plastic Surgery
RZ Medizintechnik GmbH
FDA UDI
RZ-Medizintechnik GmbH·04049197056601·SCHNIDT-SAWTELL Tonsil Seizing Forceps
185mm,...
CERVICAL PLATE VARIABLE SELF-DRILLING SCREW DIAM. 4X16MM (2X)
FDA Adverse Event
Malfunction
·MEDACTA INTERNATIONAL SA·Product code KWQ·November 10, 2016
CERVICAL PLATE FIXED SELF-TAPPING SCREW DIAM. 4X14MM (2X)
FDA Adverse Event
Injury
·MEDACTA INTERNATIONAL SA·Product code KWQ·September 13, 2018
AFFIITY CP CENTRIFUGAL BLOOD PUMP
FDA 510(k)
FDA Class 2
·Cardiovascular
VITALAB DIRECT BILIRUBIN REAGENT
FDA 510(k)
FDA Class 2
·Clinical Chemistry
MAXZERO
FDA Adverse Event
Malfunction
·BECTON DICKINSON·Product code FPA·March 17, 2026
MECTA C VARIABLE SELF-DRILLING SCREW DIAM. 4X18MM (2X)
FDA Adverse Event
Malfunction
·MEDACTA INTERNATIONAL SA·Product code KWQ·June 24, 2022
CERVICAL PLATE VARIABLE SELF-TAPPING SCREW DIAM. 4X14MM (2X)
FDA Adverse Event
Injury
·MEDACTA INTERNATIONAL SA·Product code KWQ·June 8, 2018
PULSE GEN MODEL 103
FDA Adverse Event
Injury
·CYBERONICS INC·Product code LYJ·May 31, 2013
HEARTSTART MRX- EMS DEFIBRILLATOR
FDA Adverse Event
Malfunction
·PHILIPS HEALTHCARE·Product code MKJ·June 16, 2011
ITREL 3
FDA Adverse Event
Malfunction
·MEDTRONIC SWISS MANUFACTURING FACILITY·Product code LGW·August 28, 2008
BD MAXZERO¿ MULTI-FUSE PRESSURE RATED EXTENSION SET
FDA Adverse Event
Malfunction
·SISTEMAS MEDICOS ALARIS, S.A. DE C.V.·Product code FPA·March 21, 2023
BD MAXZERO¿ EXTENSION SET
FDA Adverse Event
Malfunction
·SISTEMAS MEDICOS ALARIS, S.A. DE C.V.·Product code FPA·June 10, 2022
CERVICAL PLATE FIXED SELF-TAPPING SCREW DIAM. 4X18MM (2X)
FDA Adverse Event
Malfunction
·MEDACTA INTERNATIONAL SA·Product code KWQ·September 15, 2021
MAXZERO NEEDLELESS CONNECTOR
FDA Adverse Event
Malfunction
·CFN MEXICO 215 SA DE CV·Product code FPA·May 12, 2020
BD MAXZERO¿ MULTI-FUSE EXTENSION SET WITH NEEDLELESS CONNECTOR
FDA Adverse Event
Malfunction
·SISTEMAS MEDICOS ALARIS, S.A. DE C.V.·Product code FPA·May 19, 2023
BD MAXZERO¿ MULTI-FUSE EXTENSION SET WITH NEEDLELESS CONNECTOR
FDA Adverse Event
Malfunction
·SISTEMAS MEDICOS ALARIS, S.A. DE C.V.·Product code FPA·May 18, 2023
Microtek Medical, Inc. ORS Fluid Warming and Slush Drapes, Model #'s ORS-100, ORS-110, ORS-130, ORS-300, ORS-301, ORS-320, ORS-321, ORS-325, ORS-330, ORS-331 and ORS-2200. The ORS Fluid Warming and Slush Drapes are individually wrapped and placed in poly-Tyvek pouches with a label insert, then packaged as 24 per case in a labeled corrugated shipper box. Intended for use during various surgeries where warm irrigation, slush and/or cold solution are required.
FDA Enforcement
Class II
·Terminated·Ecolab Inc·September 30, 2015