23 results
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24ms
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Sources: EU EUDAMED, US FDA
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Regulation: Us FDA
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GenesisZr UHT700 Zirconia
FDA 510(k)
FDA Class 2
·Dental
EarQ
FDA UDI
Oticon A/S·05707131356727·G40 S, MINIRITE R LI-ION 2.4G C093 EARQ
7450 RV2 MASK
FDA UDI
HANS RUDOLPH, INC.·00874750004300·RV2 MEDIUM MASK BRACE SET
ABSORBENT PAPER POINTS
FDA UDI
DiaDent Group International·08806383554466·"An absorbent paper points is an endodontic pap...
Aria Stem Size 8 Template
FDA UDI
SIGNATURE ORTHOPAEDICS PTY LTD·09348215056193·
ABSORBENT PAPER POINTS
FDA UDI
DiaDent Group International·08806383512428·"An absorbent paper points is an endodontic pap...
ANIMAS INSULIN CARTRIDGE
FDA Adverse Event
Malfunction
·ANIMAS CORPORATION·Product code LZG·March 8, 2012
SMITHWICK CAROTID SHUNT
FDA 510(k)
FDA Class 2
·Cardiovascular
BLAINE SCARCARE PATCH
FDA 510(k)
FDA Class 1
·General, Plastic Surgery
MINIMED QUICK-SET
FDA Adverse Event
Malfunction
·UNOMEDICAL DEVICES S.A. DE C.V.·Product code FPA·May 16, 2025
HAMILTON-C6
FDA Adverse Event
Malfunction
·HAMILTON MEDICAL AG·Product code CBK·February 10, 2025
Fortilink Cages with TiPlus Technology
FDA UDI
Baat Medical Products B.V.·08720246784930·
Fortilink Cages with TiPlus Technology
FDA UDI
Baat Medical Products B.V.·08720246789485·
Fortilink Cages with TiPlus Technology
FDA UDI
Baat Medical Products B.V.·08720246785005·
Fortilink Cages with TiPlus Technology
FDA UDI
Baat Medical Products B.V.·08720246789553·
TENDRIL SDX
FDA Adverse Event
Malfunction
·ST. JUDE MEDICAL, INC., CRMD·Product code NVN·January 13, 2014
ATTAIN ABILITY
FDA Adverse Event
Malfunction
·MEDTRONIC PUERTO RICO, INC.·Product code OJX·August 11, 2011
SYNCHROMED II
FDA Adverse Event
Injury
·MDT PUERTO RICO OPERATIONS CO·Product code LKK·July 2, 2013
Arrow Transradial Artery Access products Arrow Transradial Artery Access products are used for percutaneous introduction of devices into the radial artery for diagnostic and therapeutic purposes.
FDA Enforcement
Class II
·Terminated·Arrow International Inc·December 18, 2013
Xcela PICC with PASV Valve Technology, Intermediate MST-45 Kit, 6F-55cm, UPN H965457440 Rx ONLY The Xcela PICC with PASV, Xcela Hybrid PICC with PASV, BioFlo PICC with PASV and BioFlo Hybrid PICC with PASV are indicated for short or long-term peripheral access to the central venous system for intravenous therapy, including but not limited to, the administration of fluids, medications and nutrients; the sampling of blood; and for power injection of contrast media. Non-valve lumens are indicated for central venous pressure monitoring
FDA Enforcement
Class II
·Terminated·Navilyst Medical, Inc., an AngioDyamics Company·June 22, 2016