2,703 results
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23ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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Epic Anterior Thoracolumbar Plate System, Gallery Laminoplasty Fixation System, Concero Facet Screw System, Alpine XC Adjustable Fusion System, Aspen MIS Fusion System, L-Plate MIS Fusion System
FDA 510(k)
FDA Class 2
·Orthopedic
CVS HEALTH
FDA UDI
WOONSOCKET PRESCRIPTION CENTER, INCORPORATED·00050428335758·ULTRA THIN PAD WINGS REGULAR UNSCENTED
Corneal Trephine
FDA UDI
KATENA PRODUCTS, INC.·00841668112786·BARRON VACUUM PUNCH 8.25MM
Sklar®
FDA UDI
SKLAR CORPORATION·10649111117244·SENNING NH DEL 6.75"
TMS SYSTEM
FDA UDI
BIOMET MICROFIXATION, INC·00841036085377·
Innomed, Inc.
FDA UDI
INNOMED, INC.·00840277129789·Trephine for 2.7mm Screw
ECT Cotton Bite Block- size Large, ECT Cotton Bite Block -size Medium
FDA 510(k)
FDA Class 2
·Neurology
STRYKER POWERED WHEELED STRETCHER
FDA 510(k)
FDA Class 2
·Physical Medicine
MINIMED 770G US SYSTEM BLE CONNECT 3.0 MG/DL
FDA Adverse Event
Malfunction
·MEDTRONIC PUERTO RICO OPERATIONS CO.·Product code OZP·August 25, 2023
MINIMED 780G OUS SYSTEM BLE CONNECT 3.0 MMOL/L
FDA Adverse Event
Malfunction
·MEDTRONIC PUERTO RICO OPERATIONS CO.·Product code OZP·August 28, 2023
PUMP MMT-1780KPK 670G PATHWAY BLACK MG
FDA Adverse Event
Malfunction
·MEDTRONIC PUERTO RICO OPERATIONS CO.·Product code OZP·January 9, 2024
ARIA RADIATION THERAPY MANAGEMENT
FDA Adverse Event
Injury
·VARIAN MEDICAL SYSTEMS·Product code IYI·July 28, 2023
MINIMED 780G US SYSTEM BLE CONNECT 3.0 MG/DL
FDA Adverse Event
Malfunction
·MEDTRONIC PUERTO RICO OPERATIONS CO.·Product code OZP·December 26, 2023
PUMP MMT-1714K 630G BLACK MMOL CANADA
FDA Adverse Event
Malfunction
·MEDTRONIC PUERTO RICO OPERATIONS CO.·Product code OZO·August 11, 2023
670G INSULIN PUMP MMT-1780KL
FDA Adverse Event
Malfunction
·MEDTRONIC PUERTO RICO OPERATIONS CO.·Product code OZP·February 3, 2023
ARROWGARD BLUE PLUS MULTI-LUMEN CATHETER
FDA Adverse Event
Malfunction
·ARROW·Product code DQO·June 25, 2013
PARADIGM REAL-TIME REVEL INSULIN INFUSION PUMP
FDA Adverse Event
Injury
·MEDTRONIC PUERTO RICO OPERATIONS MED-REL·Product code MDS·August 2, 2011
CONCERTO NYLON HELICAL DETACHABLE COIL
FDA Adverse Event
Malfunction
·EV3 NEUROVASCULAR·Product code HCG·August 14, 2014
Quidel Triage Cardiac Panel: REF: 97000HS, 97021HS (Troponin I), 97022HS (CK-MB and Troponin I), 97000HSEU, 97000HSEUJP, 97000HZ01, 97000QIL. Lots T13664 - T14045.
FDA Enforcement
Class I
·Ongoing·QUIDEL CARDIOVASCULAR INC·July 12, 2023
640G INSULIN PUMP MMT-1711K
FDA Adverse Event
Malfunction
·MEDTRONIC PUERTO RICO OPERATIONS CO.·Product code OYC·July 13, 2023