10 results
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21ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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SR-IVOCAP
FDA 510(k)
FDA Class 2
·Dental
LEONE SPA
FDA UDI
LEONE SPA·08033707085072·WEB I MOL BANDS G8424-16+G2820-00 LR 30
LIGHT-TOUCH LAPAROSCOPIC MODEL 905200 FIBEROPTIC
FDA 510(k)
FDA Class 2
·General, Plastic Surgery
PATIENT EXAMINATION GLOVES (LATEX)
FDA 510(k)
FDA Class 1
·General Hospital
CONTRA DRILL 1.5X15.5MM STP
FDA Adverse Event
Malfunction
·BIOMET MICROFIXATION·Product code HBE·June 29, 2021
2.0MM SYSTEM TWIST DRILL CONTRA 1.5MM X 30.5MM W/ 15.5MM STOP
FDA Adverse Event
Malfunction
·BIOMET MICROFIXATION·Product code HBE·November 24, 2020
SPECTRUM INFUSION PUMP
FDA Adverse Event
Malfunction
·BAXTER HEALTHCARE CORPORATION·Product code FRN·January 22, 2014
ESPRIT VENTILATOR
FDA Adverse Event
Malfunction
·RESPIRONICS CALIFORNIA, INC.·Product code CBK·November 10, 2010
9800
FDA Adverse Event
Malfunction
·GE OEC MEDICAL SYSTEMS (SLC)·Product code JAA·December 10, 2012
Copeland HA Resurfacing Head, MB/HA EAS Head; Item Nos. 11-114641 11-114642 11-114643 11-114644 11-114644S 11-114645 11-114646 11-114647 11-114648 11-114661 11-114662 11-114663 11-114664 11-114664S 11-114665 11-114666 11-114667 11-114668 11-114632 11-114633 Product Usage: Partial Shoulder Replacement.
FDA Enforcement
Class II
·Terminated·Zimmer Biomet, Inc.·December 4, 2019