18 results
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21ms
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Sources: EU EUDAMED, US FDA
TEVADAPTOR, CLOSED DRUG RECONSTITUTION AND TRANSFER SYSTEM
FDA 510(k)
FDA Class 2
·General Hospital
XIENCE PRO¿ S
FDA Adverse Event
Death
·ABBOTT VASCULAR·Product code NIQ·August 19, 2025
RADIONICS RF DISC CATHETER ELECTRODE SYSTEM
FDA 510(k)
FDA Class 2
·Orthopedic
CRIT-LINE MONITOR III TQA (CLM TQA)
FDA 510(k)
FDA Class 2
·Gastroenterology, Urology
XIENCE PRO¿ S
FDA Adverse Event
Malfunction
·ABBOTT VASCULAR·Product code NIQ·August 19, 2025
XIENCE V EVEROLIMUS ELUTING CORONARY STENT SYSTEM
FDA Adverse Event
Injury
·ABBOTT VASCULAR-CARDIAC THERAPIES·Product code NIQ·February 5, 2010
PERCLOSE PROGLIDE 6F SUTURE MEDIATED CLOSURE (SMC) SYSTEM
FDA Adverse Event
Injury
·AV-TEMECULA-CT·Product code MGB·November 19, 2018
PRECISION®
FDA Adverse Event
Injury
·BOSTON SCIENTIFIC NEUROMODULATION·Product code LGW·April 22, 2013
COROX OTW-S 85-BP
FDA Adverse Event
Injury
·BIOTRONIK SE & CO. KG·Product code OJX·August 27, 2014
INRATIO
FDA Adverse Event
Injury
·ALERE SAN DIEGO, INC.·Product code GJS·April 13, 2011
XIENCE V EVEROLIMUS ELUTING CORONARY STENT SYSTEM
FDA Adverse Event
Death
·ABBOTT VASCULAR - CARDIAC THERAPIES·Product code NIQ·April 2, 2010
XIENCE SIERRA¿
FDA Adverse Event
Malfunction
·ABBOTT VASCULAR INC.·Product code NIQ·February 10, 2025
Equinoxe Reverse Shoulder Compression Screw/Locking Cap Kit 4.5 x 22 mm.
FDA Enforcement
Class II
·Terminated·Exactech, Inc.·October 7, 2020
Zeiss brand IOLMaster 500, Model 500, Biomicroscope, Slit-Lamp, AC-Powered, Product is manufactured by Carl Zeiss Meditec AG (Jena), Carl Zeiss Promenade 10, Jena, Germany 07745; and distributed by Carl Zeiss Meditec, Inc., Dublin, CA This device is intended for use primarily by physicians and health care workers and may be only used under the supervision of a physician. This device will not be sold to the general public. The IOLMaster is intended for the biometric determination of ocular measurements of axial length, anterior chamber depth, corneal radius, white-to white (WTW), and for the measurement of pupil size and deviation of the visual axis from the center of the pupil. For patients who are candidates for intraocular lens (IOL) implantation, the device also performs calculations to assist physicians in determining the appropriate IOL power and type for implantation
FDA Enforcement
Class II
·Terminated·Carl Zeiss Meditec, Inc.·November 27, 2013
IOL Master 500: Software versions 7.5 and 7.7; Ophthalmic: IOL Master 500 is intended for biometric determination of ocular measurements of axial length, anterior chamber depth, corneal radius, white-to white (WTW), and for the measurement of pupil size and deviation of the visual axis from the center of the pupil.
FDA Enforcement
Class II
·Terminated·Carl Zeiss Meditec AG·December 9, 2015
Philips Allura Xper Systems (R7.6-R8.1). Labeled as the following: 1. Allura Xper FD10, Model Number: 722010. 2. Allura Xper FD10/10, Model Number: 722011. 3. Allura Xper FD20, Model Number: 722012. 4. Allura Xper FD20 Biplane, Model Number: 722013. 5. Allura Xper FD10 OR Table, Model Number: 722022. 6. Allura Xper FD20 OR Table, Model Number: 722023. 7. Allura Xper FD20 Biplane OR Table, Model Number: 722025.
FDA Enforcement
Class II
·Ongoing·PHILIPS MEDICAL SYSTEMS NEDERLAND B.V.·December 18, 2024
ALLURA Xper FD20; System Code: (1) 722006, (2)722012, (3)722028;
FDA Enforcement
Class II
·Ongoing·PHILIPS MEDICAL SYSTEMS NEDERLAND B.V.·April 8, 2026
Allura Xper FD20; Model Numbers: (1) 722006, (2) 722012, (3) 722028; Associated 510(k)s: K102005, K130638, K130842, K133292, K141979, K162859, K161563;
FDA Enforcement
Class II
·Ongoing·PHILIPS MEDICAL SYSTEMS NEDERLAND B.V.·October 8, 2025