39 results
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33ms
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Sources: EU EUDAMED, US FDA
AXSYM CORTISOL ASSAY
FDA 510(k)
FDA Class 2
·Clinical Chemistry
Baltic Denture System BDLoad
FDA UDI
Merz Dental GmbH·D7091033731·Baltic Denture System BDLoad BDLoad ↓ Ln6 PLSEu...
SAFESHEATH MSP INTRODUCER SHEATH KIT WITH INTEGRAL HEMOSTASIS VALVE
FDA 510(k)
FDA Class 2
·Cardiovascular
GIMMI ALPHA SINUSCOPES MODEL # E.8282.01/31/71 + E.8284.01/31/71; GIMMI ALPHA BRONCHOSCOPES MODEL # E.8189.00/01/02/03
FDA 510(k)
FDA Class 2
·Ear, Nose, Throat
HOMECHOICE PRO
FDA Adverse Event
Malfunction
·BAXTER HEALTHCARE - LARGO·Product code FKX·April 3, 2013
CORE IMPACTION DRILL
FDA Adverse Event
Malfunction
·STRYKER INSTRUMENTS KALAMAZOO·Product code DZJ·March 23, 2011
DEXTRUS 4135
FDA Adverse Event
Injury
·BIOTRONIK GMBH AND CO.·Product code DTB·April 25, 2008
VANGUARD - BIOMET 360 TIBIAL TRAY
FDA Adverse Event
Injury
·ZIMMER BIOMET, INC.·Product code JWH·August 2, 2019
SERIES A PATELLA STANARD 31 3 PEG
FDA Adverse Event
Injury
·ZIMMER BIOMET, INC.·Product code HRY·September 23, 2019
VANGUARD BIOMET 360 TIBIAL SM CRUCIATE WING
FDA Adverse Event
Injury
·ZIMMER BIOMET, INC.·Product code JWH·September 23, 2019
VANGUARD 360 DISTAL FEMORAL AUGMENT
FDA Adverse Event
Injury
·ZIMMER BIOMET, INC.·Product code JWH·August 2, 2019
Allura CV20; Product Code: 722031; Associated 510(k) numbers: K102005, K130842, K130638, K133292, K141979, K161563, K162859, K033737, K041949;
FDA Recall
Open, Classified
·PHILIPS MEDICAL SYSTEMS NEDERLAND B.V. Veenpluis 4-6 Best Netherlands·Product code OWB·September 3, 2025
Allura Xper FD20/10; Product Code: 722029; Associated 510(k) numbers: K102005, K130842, K130638, K133292, K141979, K161563, K162859, K033737, K041949;
FDA Recall
Open, Classified
·PHILIPS MEDICAL SYSTEMS NEDERLAND B.V. Veenpluis 4-6 Best Netherlands·Product code OWB·September 3, 2025
Allura Xper FD20/15; Product Code: 722058; Associated 510(k) numbers: K102005, K130842, K130638, K133292, K141979, K161563, K162859, K033737, K041949;
FDA Recall
Open, Classified
·PHILIPS MEDICAL SYSTEMS NEDERLAND B.V. Veenpluis 4-6 Best Netherlands·Product code OWB·September 3, 2025
Allura Xper FD20/20; Product Code: 722038; Associated 510(k) numbers: K102005, K130842, K130638, K133292, K141979, K161563, K162859, K033737, K041949;
FDA Recall
Open, Classified
·PHILIPS MEDICAL SYSTEMS NEDERLAND B.V. Veenpluis 4-6 Best Netherlands·Product code OWB·September 3, 2025
Allura Xper FD20/20 OR Table; Product Code: 722039; Associated 510(k) numbers: K102005, K130842, K130638, K133292, K141979, K161563, K162859, K033737, K041949;
FDA Recall
Open, Classified
·PHILIPS MEDICAL SYSTEMS NEDERLAND B.V. Veenpluis 4-6 Best Netherlands·Product code OWB·September 3, 2025
Allura Xper FD20/15 OR Table; Product Code: 722059; Associated 510(k) numbers: K102005, K130842, K130638, K133292, K141979, K161563, K162859, K033737, K041949;
FDA Recall
Open, Classified
·PHILIPS MEDICAL SYSTEMS NEDERLAND B.V. Veenpluis 4-6 Best Netherlands·Product code OWB·September 3, 2025
Allura Xper FD20/20 OR Table; Product Code: 722039; Associated 510(k) numbers: K102005, K130842, K130638, K133292, K141979, K161563, K162859, K033737, K041949;
FDA Enforcement
Class II
·Ongoing·PHILIPS MEDICAL SYSTEMS NEDERLAND B.V.·October 1, 2025
Allura Xper FD20/15 OR Table; Product Code: 722059; Associated 510(k) numbers: K102005, K130842, K130638, K133292, K141979, K161563, K162859, K033737, K041949;
FDA Enforcement
Class II
·Ongoing·PHILIPS MEDICAL SYSTEMS NEDERLAND B.V.·October 1, 2025
Allura Xper FD20 Biplane Product Codes: (1)722013, (2) 722008; Associated 510(k) numbers: K102005, K130842, K130638, K133292, K141979, K161563, K162859, K033737, K041949;
FDA Recall
Open, Classified
·PHILIPS MEDICAL SYSTEMS NEDERLAND B.V. Veenpluis 4-6 Best Netherlands·Product code OWB·September 3, 2025