14 results
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35ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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DERMAGRIP POWDER FREE BLACK NITRILE PATIENT EXAMINATION GLOVES, NON-STERILE
FDA 510(k)
FDA Class 1
·General Hospital
AGXO
FDA UDI
Oticon A/S·05707131257826·H150, BTE 13 WL 100 TC AGXO
Integra®
FDA UDI
INTEGRA PAIN MANAGEMENT·10381780260424·MYELOGRAM TRAY, STYLE 1
SEQURE SNARE SYSTEM
FDA 510(k)
FDA Class 2
·Cardiovascular
MEDTRONIC MINIMED PARADIGM COUNTACH INFUSION SET, MODEL MMT 310
FDA 510(k)
FDA Class 2
·General Hospital
LINEAR? ST
FDA Adverse Event
Injury
·BOSTON SCIENTIFIC NEUROMODULATION CORPORATION·Product code LGW·November 22, 2025
UNKNOWN PATHINDER NXT OR INSTINCT JAVA IMPLANT
FDA Adverse Event
Malfunction
·ZIMMER BIOMET SPINE INC.·Product code NKB·September 24, 2022
AMPHIRION DEEP OTW
FDA Adverse Event
Malfunction
·INVATEC SPA·Product code DQY·May 29, 2013
ESPRIT VENTILATOR
FDA Adverse Event
Malfunction
·RESPIRONICS CALIFORNIA, INC.·Product code CBK·October 1, 2014
ZENITH RENU AAA ANCILLARY GRAFT CONVERTER
FDA Adverse Event
Injury
·COOK, INC.·Product code MIH·June 8, 2011
ROD, UNKNOWN SIZE
FDA Adverse Event
Injury
·ZIMMER BIOMET SPINE INC.·Product code NKB·May 9, 2019
PEDICLE SCREW, UNKNOWN SIZE
FDA Adverse Event
Injury
·ZIMMER BIOMET SPINE INC.·Product code NKB·May 9, 2019
PEDICLE SCREW, UNKNOWN SIZE
FDA Adverse Event
Injury
·ZIMMER BIOMET SPINE INC.·Product code NKB·May 9, 2019
Exactech Equinoxe GLENOID,KEELED, CEMENTED,47, 50, 53 head, beta curvature, Sizes: a) Small, Item Number 314-02-12, b) Medium, Item Number 314-02-13, c) Large, Item Number 314-02-14, d) Extra Large, Item Number 314-02-15, Shoulder Arthroplasty
FDA Enforcement
Class II
·Ongoing·Exactech, Inc.·April 10, 2024