14 results
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20ms
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Sources: EU EUDAMED, US FDA
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Regulation: Us FDA
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TopLock Anchor System
FDA 510(k)
FDA Class 2
·Orthopedic
EarQ
FDA UDI
Oticon A/S·05707131341327·G20, BTE 13 PP 2.4G 105 C093 EARQ
Contrast Line
FDA UDI
ARGON MEDICAL DEVICES, INC.·00886333207558·Contrast Line 72"(183cm) Male/Female Polyuretha...
POLARIS CONTACT LENS CASE
FDA 510(k)
FDA Class 2
·Ophthalmic
CHARTER GUIDEWIRE MODEL 45-281, 45-282, 45-283
FDA 510(k)
FDA Class 2
·Cardiovascular
COMP RVRS 25MM BSPLT HA+ADPTR
FDA Adverse Event
Injury
·ZIMMER BIOMET, INC.·Product code KWS·March 8, 2021
HEARTMATE 3 LEFT VENTRICULAR ASSIST SYSTEM
FDA Adverse Event
Malfunction
·THORATEC CORPORATION·Product code DSQ·July 30, 2018
TOTALCARE
FDA Adverse Event
Malfunction
·HILL-ROM RITTER·Product code FNL·October 7, 2008
GYNECARE TVT RETROPUBIC SYSTEM
FDA Adverse Event
Injury
·ETHICON INC.·Product code OTN·June 27, 2013
PARADIGM REAL-TIME REVEL INSULIN INFUSION PUMP
FDA Adverse Event
MEDTRONIC PUERTO RICO OPERATIONS MED-REL·Product code MDS·July 26, 2011
FREESTYLE LIBRE 14 DAY
FDA Adverse Event
Injury
·ABBOTT DIABETES CARE INC·Product code PZE·September 5, 2023
FREE STYLE LIBRE 2
FDA Adverse Event
Injury
·ABBOTT DIABETES CARE INC.·Product code QLG·June 10, 2022
Azurion 5 M20; Catalog numbers: (1) 722228, (2) 722232 (OUS ONLY), (3) 722281 (OUS ONLY).
FDA Enforcement
Class I
·Ongoing·PHILIPS MEDICAL SYSTEMS NEDERLAND B.V.·February 26, 2025
Exactech Equinoxe GLENOID,KEELED, CEMENTED, mates with 47, 50, 53 head, beta curvature, Sizes: a) Small, Item Number 314-01-12, b) Medium, Item Number 314-01-13, c) Large, Item Number 314-01-14, Shoulder Arthroplasty
FDA Enforcement
Class II
·Ongoing·Exactech, Inc.·April 10, 2024