17 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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IDRIVE ULTRA STERILIZATION TRAY
FDA 510(k)
FDA Class 2
·General Hospital
LEONE SPA
FDA UDI
LEONE SPA·08033707010807·CALIBRA 1ST MOLAR BANDS n.UL 32
Scanner, TxCell Z130/532
FDA UDI
IRIDEX CORPORATION·00813125016364·
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.·D807K100532601·IN-OVATION® C Roncone 022/U5-5 L3-3 CS HK
IN-OVATION® C
FDA UDI
DENTSPLY SIRONA ORTHODONTICS INC.·D807K100532001·IN-OVATION® C Base Rx 022 U5-5/L3-3
IN-OVATION® C
FDA UDI
DENTSPLY SIRONA ORTHODONTICS INC.·D807K100532611·IN-OVATION® C Roncone 022/U5-5 L3-3 CS-BC HK
MYSTIQUE® MB
FDA UDI
DENTSPLY SIRONA ORTHODONTICS INC.·D807K110532101·MYSTIQUE® MB RT RX 022 U 5-5/L3-3 CS HK
IN-OVATION® C
FDA UDI
DENTSPLY SIRONA ORTHODONTICS INC.·D807K100532111·IN-OVATION® C Base Rx 022 U5-5/L3-3 CS-BC HK
IN-OVATION® C
FDA UDI
DENTSPLY SIRONA ORTHODONTICS INC.·D807K100532101·IN-OVATION® C Base Rx 022 U5-5/L3-3 CS HK
K133532
FDA Adverse Event
Malfunction
·CAREFUSION SD·Product code FRN·February 2, 2021
VERSALOK PEEK ANCHOR WITH ORTHOCORD SUTURE, MODELS 210818, 210819
FDA 510(k)
FDA Class 2
·Orthopedic
CPCA2000 COUNTERPULSATION SYSTEM
FDA 510(k)
FDA Class 2
·Cardiovascular
PINNACLE MTL INS NEUT36IDX52OD
FDA Adverse Event
Injury
·DEPUY ORTHOPAEDICS INC US·Product code KWA·May 24, 2013
PARADIGM REAL-TIME INSULIN INFUSION PUMP
FDA Adverse Event
Malfunction
·MEDTRONIC PUERTO RICO OPERATIONS CO.·Product code OYC·September 30, 2014
CAPSUREFIX
FDA Adverse Event
Malfunction
·MEDTRONIC PUERTO RICO, INC.·Product code DTB·June 16, 2011
Endotec Prothesis Ankle, Titanium Alloy, Sterilized, BP Ankle System. BP Ankle System, F-P Type III Ankle Bearing Component: 2x5mm F-P Type III Ankle Bearing Catalog: 05-13-0532, 2x7mm F-P Type III Ankle Bearing Catalog: 05-13-0732, 8x3mm F-P Type III Ankle Bearing Catalog: 05-13-0533, 8x1mm F-P Type III Ankle Bearing Catalog: 05-13-0731. BP Ankle System, F-P Type III Tibial Ankle Component: Size 1 F-P Type III Tibial Component Catalog: 05-12-0031, Size 2 F-P Type III Tibial Component Catalog: 05-12-0032, Size 3 F-P Type III Tibial Component Catalog: 05-12-0033. BP Ankle System, F-P Type III Talar Component: Size 1 F-P Type III Talar Component Catalog: 05-01-0031, Size 2 F-P Type III Talar Component Catalog: 05-01-0032, Size 3 F-P Type III Talar Component Catalog: 05-01-0033.
FDA Recall
Terminated
·Endotec, Inc.·Product code JWH·June 5, 2009