32 results
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21ms
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Sources: EU EUDAMED, US FDA
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Regulation: Us FDA
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NovoStitch Pro Meniscal Repair System
FDA 510(k)
FDA Class 2
·General, Plastic Surgery
DAVINCI XI STAPLER 45
FDA Adverse Event
Malfunction
·INTUITIVE SURGICAL, INC.·Product code GDW·July 3, 2018
IN-OVATION® C
FDA UDI
DENTSPLY SIRONA ORTHODONTICS INC.·D807K100531101·IN-OVATION® C Base Rx 018 U5-5/L3-3 CS HK
MYSTIQUE® MB
FDA UDI
DENTSPLY SIRONA ORTHODONTICS INC.·D807K110531101·MYSTIQUE® MB RT RX 018 U5-5/L3-3 CS HK
IN-OVATION® C
FDA UDI
DENTSPLY SIRONA ORTHODONTICS INC.·D807K100531601·IN-OVATION® C Roncone 018 U5-5/L3-3 CS HK
IN-OVATION® C
FDA UDI
DENTSPLY SIRONA ORTHODONTICS INC.·D807K100531111·IN-OVATION® C Base Rx 018 U5-5/L3-3 CS-BC HK
IN-OVATION® C
FDA UDI
DENTSPLY SIRONA ORTHODONTICS INC.·D807K100531001·IN-OVATION® C Base Rx 018 U5-5/L3-3
IN-OVATION® C
FDA UDI
DENTSPLY SIRONA ORTHODONTICS INC.·D807K100531611·IN-OVATION® C Roncone 018 U5-5/L3-3 CS-BC HK
MYSTIQUE® MB
FDA UDI
DENTSPLY SIRONA ORTHODONTICS INC.·D807K110531111·MYSTIQUE® MB RT RX 018 U 5-5/L3-3 CS-BC HK
KP
FDA UDI
Guilin Kevin Peter Technology Co., Ltd.·06975384334697·5 pieces
RZ Medizintechnik GmbH
FDA UDI
RZ-Medizintechnik GmbH·04049197082587·TC Senning Needleholder
straig...
RZ Medizintechnik GmbH
FDA UDI
RZ-Medizintechnik GmbH·04049197082570·TC Senning Needle Holder
straig...
KP
FDA UDI
Guilin Kevin Peter Technology Co., Ltd.·16975384334694·5 pieces
CONMED LINVATEC MICROFRACTURE INSTRUMENT STERILIZATION TRAY
FDA 510(k)
FDA Class 2
·General Hospital
VISCOPE, MODEL 100P,100S
FDA 510(k)
FDA Class 2
·Cardiovascular
KP
FDA UDI
Guilin Kevin Peter Technology Co., Ltd.·16975384335004·5 pieces
KP
FDA UDI
Guilin Kevin Peter Technology Co., Ltd.·06975384335007·5 pieces
PS TIBIAL INSERTS SZ 2, 9MM
FDA Adverse Event
Injury
·EXACTECH, INC.·Product code JWH·July 11, 2023
NeoBase Succinylacetone Assay Solution, Product Number: 3042-0020; Affected UDI Numbers: (01)06438147295708(17)180531(10)654184 (01)06438147295708(17)180531(10)653414 (01)06438147295708(17)180531(10)653657 (01)06438147295708(17)180630(10)654923 (01)06438147295708(17)180630(10)655680 (01)06438147295708(17)180630(10)655300 (01)06438147295708(17)180630(10)654924 (01)06438147295708(17)180831(10)656025 (01)06438147295708(17)180831(10)657055 (01)06438147295708(17)180831(10)656170 (01)06438147295708(17)180831(10)656320 (01)06438147295708(17)181031(10)657768 (01)06438147295708(17)181031(10)657513 (01)06438147295708(17)181031(10)658006
FDA Recall
Terminated
·PerkinElmer Life and Analytical Sciences, Wallac, OY Mustionkatu 6·Product code NQL·November 2, 2017
PLM A+ PALNTINUM
FDA Adverse Event
Malfunction
·HOSPIRA COSTA RICA LTD.·Product code FRN·October 15, 2014