22 results
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20ms
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Sources: EU EUDAMED, US FDA
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Regulation: Us FDA
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CT PULMONARY ANALYSIS
FDA 510(k)
FDA Class 2
·Radiology
INTERACTIVE SBM 3.7MMDX13MML 3.0MM PLAT
FDA Adverse Event
Injury
·IMPLANT DIRECT SYBRON MANUFACT·Product code DZE·October 29, 2025
IN-OVATION® C
FDA UDI
DENTSPLY SIRONA ORTHODONTICS INC.·D807K100552821·IN-OVATION® C EURO 022 U 5-5/L 3-3 CS-BC HK
IN-OVATION® C
FDA UDI
DENTSPLY SIRONA ORTHODONTICS INC.·D807K100552811·IN-OVATION® C EURO 022 U5-5/L3-3 CS HK
ELATION® MB
FDA UDI
DENTSPLY SIRONA ORTHODONTICS INC.·D807K133552621·ELATION® MB Base Rx 022 UL/5-5 CS-BC HK
LINK Instruments - Rasps, compressors and broaches
FDA UDI
WALDEMAR LINK GmbH & Co. KG·04026575426287·Orthopaedic broach - SPII Model Lubinus Hip Stem
LINK Instruments - Rasps, compressors and broaches
FDA UDI
WALDEMAR LINK GmbH & Co. KG·04026575426270·Orthopaedic broach - SPII Model Lubinus Hip Stem
LINK Instruments - Rasps, compressors and broaches
FDA UDI
WALDEMAR LINK GmbH & Co. KG·04026575426294·Orthopaedic broach - SPII Model Lubinus Hip Stem
RZ Medizintechnik GmbH
FDA UDI
RZ-Medizintechnik GmbH·04049197047562·Adson-Brown Forceps
7x7 te...
LINK Instruments - Rasps, compressors and broaches
FDA UDI
WALDEMAR LINK GmbH & Co. KG·04026575426263·Orthopaedic broach - SPII Model Lubinus Hip Stem
RZ Medizintechnik GmbH
FDA UDI
RZ-Medizintechnik GmbH·04049197382243·Adson-Brown Forceps
7x7 te...
LINK Instruments - Rasps, compressors and broaches
FDA UDI
WALDEMAR LINK GmbH & Co. KG·04026575426300·Orthopaedic broach - SPII Model Lubinus Hip Stem
LINK Instruments - Rasps, compressors and broaches
FDA UDI
WALDEMAR LINK GmbH & Co. KG·04026575426317·Orthopaedic broach - SPII Model Lubinus Hip Stem
LINK Instruments - Rasps, compressors and broaches
FDA UDI
WALDEMAR LINK GmbH & Co. KG·04026575426256·Orthopaedic broach - SPII Model Lubinus Hip Stem
IMAGELESS KNEE MODULE FOR THE STEALTHSTATION SYSTEM
FDA 510(k)
FDA Class 2
·Neurology
RAYSTATION VERSION 1.0
FDA 510(k)
FDA Class 2
·Radiology
POWERED WHEELCHAIR
FDA Adverse Event
Malfunction
·INVACARE SUZHOU·Product code ITI·May 24, 2013
PARADIGM REAL-TIME REVEL INSULIN INFUSION PUMP
FDA Adverse Event
Malfunction
·Product code OYC·September 30, 2014
ADAPTA DR
FDA Adverse Event
Malfunction
·MEDTRONIC MED REL, INC.·Product code NVZ·June 16, 2011
MODIFIED NOVY CORNUAL CANNULATION SET
FDA Adverse Event
Malfunction
·COOK INC·Product code MOV·March 14, 2024