15 results
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21ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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ORTHODONTIC PLASTIC BRACKETS AND ACCESSORIES
FDA 510(k)
FDA Class 2
·Dental
RZ Medizintechnik GmbH
FDA UDI
RZ-Medizintechnik GmbH·04049197085823·HURD Ligature Needle
210mm,...
AUDIT MICROCV AMMONIAN/ETHANOL LINEARITY SET, MODEL K712M-5
FDA 510(k)
FDA Class 1
·Clinical Chemistry
CELL-CHEX WITH CPPD CRYSTALS
FDA 510(k)
FDA Class 2
·Hematology
TOWEL OR 17X24IN BLUE STERILE 4/PK
FDA Adverse Event
Malfunction
·JIANERKANG MEDICAL DRESSING CO, LTD·Product code NAB·January 25, 2019
BD¿ NEEDLE
FDA Adverse Event
Malfunction
·BECTON DICKINSON, S.A.·Product code FMI·December 14, 2018
PORTABLE OXYGEN GENERATOR (CONCENTRATOR, HOMEFILL)
FDA Adverse Event
Malfunction
·INVACARE FLORIDA OPERATIONS·Product code CAW·October 17, 2014
M2A-MAGNUM MOD HD SZ 50MM
FDA Adverse Event
Injury
·BIOMET ORTHOPEDICS·Product code KWA·June 20, 2013
PRIMA INITIAL DRILL 1.5 X 15MM NON-IRRIGATED
FDA Adverse Event
Malfunction
·KEYSTONE DENTAL·Product code NDP·May 5, 2011
MINIMED QUICK-SET
FDA Adverse Event
Injury
·UNOMEDICAL DEVICES S.A. DE C.V.·Product code FPA·June 4, 2025
Babi.Plus 12.5 cm H2O Pressure Relief Manifold, REF 1030, RX Only, UDI: 04710810093562
FDA Enforcement
Class I
·Terminated·Galemed Corporation·January 1, 2020
TOWEL OR 17X24IN BLUE STERILE 4/PK
FDA Adverse Event
Malfunction
·JIANERKANG MEDICAL DRESSING CO, LTD·Product code NAB·January 25, 2019
TOWEL OR 17X24IN BLUE STERILE 4/PK
FDA Adverse Event
Malfunction
·JIANERKANG MEDICAL DRESSING CO, LTD·Product code NAB·January 25, 2019
Babi.Plus Bubble PAP Valve with 12.5 cm H2O Pressure Relief Manifold, REF 1002, Rx Only, UDI: 24710810093559
FDA Enforcement
Class I
·Terminated·Galemed Corporation·January 1, 2020
ROSA Brain 3.0 Application-Brain
FDA Enforcement
Class II
·Terminated·MEDTECH SAS·February 19, 2020