10 results
·
26ms
·
Sources: EU EUDAMED, US FDA
H.R. JAKOBI SURG. INSTRUMENTS #11 38/67
FDA 510(k)
FDA Class 1
·General, Plastic Surgery
CARDIO DATA PACEMAKER RECORDER
FDA 510(k)
FDA Class 2
·Cardiovascular
SPHYGMOLOG II MODEL D
FDA 510(k)
FDA Class 2
·Cardiovascular
ONETOUCHPING GLUCOSEMGMTSYSTEM
FDA Adverse Event
Malfunction
·ANIMAS CORPORATION·Product code LZG·May 27, 2014
ACTIVA
FDA Adverse Event
Malfunction
·MDT PUERTO RICO OPERATIONS CO·Product code MHY·November 15, 2012
OT ULTRALINK METER
FDA Adverse Event
Malfunction
·LIFESCAN, INC.·Product code MDS·September 14, 2010
ELLIPSE VR, REF: CD1377-36C Implantable cardioverter defibrillators (ICDs)
FDA Enforcement
Class I
·Terminated·St Jude Medical Inc.·August 14, 2019
Allura Xper FD10 Product Codes: (1)722010, (2) 722026, (3) 722003; 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 FD10 - Catalog numbers: (1) 722003, (2) 722010, (3) 722026,
FDA Enforcement
Class I
·Ongoing·PHILIPS MEDICAL SYSTEMS NEDERLAND B.V.·February 26, 2025
Unify Quadra, Sterile EO, Model #/ Part #: CD3249-40/100036404, 100038435, CD3249-40Q/100036407, 100038436, CD3251-40/100036405, 100038095, 100038226, 100038437, 100038451, 100072563, CD3251-40Q/100036408, 100038214, 100038230, 100038407, 100038442, 100072564, CD3255-40/100038224, CD3255-40Q/100036514
FDA Enforcement
Class II
·Terminated·St Jude Medical Inc.·July 4, 2018