21 results
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26ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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ADMIRE
FDA 510(k)
FDA Class 2
·Radiology
CoRoent
FDA UDI
Nuvasive, Inc.·00887517575487·CoRoent Ant TLIF Ti, 15x13x36mm 0°
Ophthalmic Speculum
FDA UDI
KATENA PRODUCTS, INC.·00841668100301·INFANT WIRE SPECULUM 3MM/5MM BLADES
Sklar®
FDA UDI
SKLAR CORPORATION·10649111059056·SKLHN PLAST SCIS STR 4 3/4"
AEROLIFE ULTRASONIC NEBULIZER, MODEL P2C
FDA 510(k)
FDA Class 2
·Anesthesiology
DIMENSION VISTA DIGITOXIN CALIBRATOR - DGTX CAL
FDA 510(k)
FDA Class 2
·Clinical Chemistry
DEXCOM G7 CONTINUOUS GLUCOSE MONITORING SYSTEM
FDA Adverse Event
Malfunction
·DEXCOM, INC.·Product code QBJ·June 27, 2024
DEXCOM G7 CONTINUOUS GLUCOSE MONITORING SYSTEM
FDA Adverse Event
Malfunction
·DEXCOM, INC.·Product code QBJ·July 3, 2024
CART 9733856 S7 STAFF ASSEMBLED 110V
FDA Adverse Event
Malfunction
·MEDTRONIC NAVIGATION, INC·Product code HAW·June 18, 2019
CART 9733856 S7 STAFF ASSEMBLED 110V
FDA Adverse Event
Malfunction
·MEDTRONIC NAVIGATION, INC·Product code HAW·June 6, 2019
STEALTHSTATION S7 SYSTEM
FDA Adverse Event
Malfunction
·MEDTRONIC NAVIGATION, INC. (LOUISVILLE)·Product code HAW·February 12, 2018
OMNIPOD INSULIN PUMP
FDA Adverse Event
Other
·INSULET CORPORATION·Product code LZG·February 13, 2009
MCGHAN 153 3600CC
FDA Adverse Event
Injury
·ALLERGAN·Product code FTR·November 18, 2019
CART 9734056 S7 STAFF SHRT 100-120V INTL
FDA Adverse Event
Malfunction
·MEDTRONIC NAVIGATION, INC·Product code HAW·June 18, 2019
STEALTHSTATION® S7
FDA Adverse Event
Malfunction
·MEDTRONIC NAVIGATION, INC·Product code HAW·March 18, 2019
SPRINT QUATTRO SECURE
FDA Adverse Event
Injury
·MPRI·Product code LWS·June 8, 2013
LAMITRODE 44C 60-CM LENGTH PADDLE LEAD
FDA Adverse Event
Injury
·ST. JUDE MEDICAL - NEUROMODULATION·Product code LGW·June 30, 2011
PRONTO SHORT EXTRACTION CATHETER
FDA Adverse Event
Injury
·VASCULAR SOLUTIONS, INC.·Product code DXE·September 5, 2008
FREESTYLE PRECISION NEO H
FDA Adverse Event
Injury
·ABBOTT DIABETES CARE INC.·Product code NBW·May 25, 2016
Comprehensive Reverse Shoulder System Humeral Tray Model 115340
FDA Enforcement
Class I
·Terminated·Zimmer Biomet, Inc.·February 22, 2017