14 results
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22ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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Capnostream 35 Portable Respiratory Monitor
FDA 510(k)
FDA Class 2
·Anesthesiology
Oticon
FDA UDI
Oticon A/S·05707131286697·RIA2 PRO, RITE 312 WL DBL
ESI
FDA UDI
FTT MEDICAL, INC.·B3961502720·ARMSTRONG TRI-SLOT TAPERED ANOSCOPE. ACMI FITTING.
CRYOMEDICAL INSTRUMENTS CRYO-PAC SYSTEMS
FDA 510(k)
FDA Class 2
·Neurology
INTELLIVUE CLINICAL INFORMATION PORTFOLIO
FDA 510(k)
FDA Class 2
·Cardiovascular
DEXCOM G7 15 DAY CONTINUOUS GLUCOSE MONITORING SYSTEM
FDA Adverse Event
Malfunction
·Product code QBJ·May 12, 2026
RADIFOCUS OPTITORQUE
FDA Adverse Event
Malfunction
·TERUMO CORPORATION, ASHITAKA·Product code DQX·June 13, 2022
RESTORE ULTRA
FDA Adverse Event
Malfunction
·MEDTRONIC MED REL MEDTRONIC PUERTO RICO·Product code LGW·June 6, 2013
SECURE II MED/SURG BED
FDA Adverse Event
Malfunction
·STRYKER MEDICAL·Product code FNL·June 10, 2011
TENDRIL SDX LEAD
FDA Adverse Event
Injury
·ST. JUDE MEDICAL, INC.(CRM-SYLMAR)·Product code NVN·October 14, 2015
COCR HEAD 28/ 0 M 12/14
FDA Adverse Event
Injury
·ZIMMER SWITZERLAND MANUFACTURING GMBH·Product code LPH·June 20, 2023
BIPOLAR INSERT, MODULAR¸ 42/28
FDA Adverse Event
Injury
·ZIMMER SWITZERLAND MANUFACTURING GMBH·Product code LPH·June 20, 2023
OPTITORQUE ANGIOGRAPHIC CATHETER
FDA Adverse Event
Malfunction
·Product code DQO·January 20, 2021
Exactech Equinoxe GLENOID, POSTERIOR AUGMENT,PEGGED, CEMENTED, 8o, RIGHT, Mates with: a) 38, 41, 44, 47 head, Small, Item Number 314-02-32, b) 41, 44, 47, 50 head, Medium, Item Number 314-02-33, c) 44, 47, 50, 53 head, Large, Item Number 314-02-34, d) 44, 47, 50, 53 head, Extra Large, Item Number 314-02-35; Shoulder Arthroplasty
FDA Enforcement
Class II
·Ongoing·Exactech, Inc.·April 10, 2024