18 results
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22ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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EndoArmor + Surgical Gown
FDA 510(k)
FDA Class 2
·General, Plastic Surgery
NorthStar
FDA UDI
Seaspine Orthopedics Corporation·10889981197537·Smooth Shank Poly. Screw, 3.5mm x 48mm
PROXIS FLOW-CONTROL DEVICE, MODELS EPS 101, IC 101
FDA 510(k)
FDA Class 2
·Cardiovascular
PADPRO SYSTEM DEFIBRILLATOR ELECTRODE ADAPTERS
FDA 510(k)
FDA Class 3
·Cardiovascular
BD INSTRUMENT MAX CLINICAL
FDA Adverse Event
Malfunction
·BECTON, DICKINSON & CO.·Product code OOI·September 21, 2020
GMK SPHERE CEMENTLESS
FDA Adverse Event
Injury
·MEDACTA INTERNATIONAL SA·Product code MBH·May 25, 2026
GMK SPHERE TOTAL KNEE SYSTEM
FDA Adverse Event
Injury
·MEDACTA INTERNATIONAL SA·Product code JWH·November 21, 2024
GMK 3D METAL TIBIAL TRAY
FDA Adverse Event
Injury
·MEDACTA INTERNATIONAL SA·Product code JWH·May 12, 2025
GMK SPHERIKA CEMENTLESS
FDA Adverse Event
Injury
·MEDACTA INTERNATIONAL SA·Product code MBH·March 16, 2026
T-SLING
FDA Adverse Event
Injury
·HERNIAMESH S.R.L.·Product code FTL·October 20, 2014
ENTRUST AT
FDA Adverse Event
Malfunction
·MEDTRONIC MED REL, INC.·Product code LWS·August 11, 2011
PUMP, INFUSION, IMPLANTED, PROGRAMMABLE
FDA Adverse Event
Malfunction
·MEDTRONIC NEUROMODULATION·Product code LKK·July 3, 2013
GMK SPHERIKA CEMENTLESS
FDA Adverse Event
Injury
·MEDACTA INTERNATIONAL SA·Product code MBH·December 19, 2025
GMK SPHERIKA CEMENTLESS
FDA Adverse Event
Injury
·MEDACTA INTERNATIONAL SA·Product code MBH·December 24, 2025
BioGX SARS-CoV-2 Reagents for BD MAX System-IVD PCR test intended for the qualitative detection of nucleic acid from the SARS-CoV-2 in nasopharyngeal specimens Catalog Number: 444213
FDA Enforcement
Class II
·Terminated·Becton Dickinson & Co.·April 21, 2021
GMK 3D METAL TIBIAL TRAY
FDA Adverse Event
Injury
·MEDACTA INTERNATIONAL SA·Product code JWH·July 11, 2025
GMK 3D METAL TIBIAL TRAY
FDA Adverse Event
Injury
·MEDACTA INTERNATIONAL SA·Product code JWH·September 29, 2025
Stryker MA204 Bed Model (FL25E) Beds are intended for medical purposes in both general patient care as well as critical care environments. Each uses built-in electric motors and controls which can be operated by the patient, or caregiver, to adjust the height and/or surface contour of the bed.The devices listed above also include movable and latchable side rails which can be lowered or raised to help prevent patient fall and subsequent injury. The Beds include an optional Scale (Models: FL20E, FL25E, FL28C, FL28EX) as well as an optional Bed Exit (1 Zone) or Chaperone
FDA Enforcement
Class II
·Terminated·Stryker Medical Division of Stryker Corporation·July 4, 2012