9 results
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21ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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Ambu® aScope 5 Broncho 4.2/2.2 Sampler Set
FDA 510(k)
FDA Class 2
·Ear, Nose, Throat
EXACTECH ACAPELLA ONE CERVICAL SPACER SYSTEM
FDA 510(k)
FDA Class 2
·Orthopedic
UNITY NETWORK PATIENT DATA SERVER
FDA 510(k)
FDA Class 2
·Cardiovascular
G7 NEUTRAL E1 LINER 36MM G
FDA Adverse Event
Injury
·ZIMMER BIOMET, INC.·Product code PBI·June 22, 2018
CERAMIC BIOLOXD OPTION HEAD 36MM
FDA Adverse Event
Injury
·ZIMMER BIOMET, INC.·Product code LZO·June 22, 2018
GE OEC 9800
FDA Adverse Event
Malfunction
·GE OEC MEDICAL SYSTEMS INC.·Product code JAA·November 13, 2008
PARADIGM REAL-TIME INSULIN INFUSION PUMP
FDA Adverse Event
Injury
·MEDTRONIC PUERTO RICO OPERATIONS CO., JUNCOS·Product code MDS·August 24, 2011
M2A 38MM MOD HD -6MM NK
FDA Adverse Event
Injury
·BIOMET ORTHOPEDICS·Product code KWA·July 18, 2013
Exactech Equinoxe REVERSE SHOULDER,38mm Constrained Humeral Liner: a) +0mm, Item Number 320-38-10, b) +2.5mm, Item Number 320-38-13, Shoulder Arthroplasty
FDA Enforcement
Class II
·Ongoing·Exactech, Inc.·April 10, 2024