16 results
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22ms
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Sources: EU EUDAMED, US FDA
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Regulation: Us FDA
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ELEOS Limb Salvage System with BioGrip
FDA 510(k)
FDA Class 2
·Orthopedic
MEDI
FDA UDI
MEDI MANUFACTURING, INC.·04049772814732·GENUMEDI EXTRA WIDE SAND SIZE V
Ophthalmic Cannula
FDA UDI
KATENA PRODUCTS, INC.·00841668113868·ROBINS ANTERIOR CHAMBER CANNULA, 30GA
Ophthalmic Cannula
FDA UDI
KATENA PRODUCTS, INC.·00841668114117·SIMCOE CORTEX EXTR 23GA 0.4MM TXT PK/10
Ophthalmic Cannula
FDA UDI
KATENA PRODUCTS, INC.·00841668114186·KRATZ POLISHER 21GA SIDE (PK/10)
C-1805M
FDA 510(k)
FDA Class 1
·Dental
TRAVEL EASE ELECTRIC SCOOTER, MODEL PIONEER
FDA 510(k)
FDA Class 2
·Physical Medicine
SPECIFIC DEVICE NOT REPORTED
FDA Adverse Event
Injury
·EXACTECH, INC.·Product code KWS·July 10, 2025
EQUINOXE REVERSE SHOULDER COMPONENTS
FDA Adverse Event
Injury
·EXACTECH, INC.·Product code KWT·March 7, 2024
CONCERTO CRT-D DR
FDA Adverse Event
Injury
·MEDTRONIC MED REL, INC.·Product code NIK·August 11, 2011
CERVICAL STAND ALONE SYS
FDA Adverse Event
Malfunction
·ORTHOFIX INC.·Product code OVE·July 23, 2014
XMAX MOTOR
FDA Adverse Event
Malfunction
·DEPUY SYNTHES POWER TOOLS·Product code ERL·July 3, 2013
BD ULTRA-FINE PEN NEEDLE
FDA Adverse Event
Malfunction
·BECTON DICKINSON AND CO.·Product code FMI·May 28, 2021
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
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
EMBLEM MRI S-ICD pulse generators, as part of Boston Scientific S-ICD System; Model A219
FDA Enforcement
Class II
·Ongoing·Boston Scientific Corporation·February 3, 2021