18 results
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21ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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Bladder Scanner (Model: M3, M3-HD, M4, M4-HD)
FDA 510(k)
FDA Class 2
·Radiology
Dornier MedTech
FDA UDI
DORNIER MEDTECH AMERICA, INC.·04049958003103·270 micron Holmium Laser Fiber Cable, Single Us...
Dornier MedTech
FDA UDI
DORNIER MEDTECH AMERICA, INC.·04049958003127·400 micron Holmium Laser Fiber Cable, Single Us...
OptoMonitor 3
FDA UDI
Opsens Inc·07540184013166·
AGXO
FDA UDI
Oticon A/S·05707131353191·G400 S, MINIRITE 312 2.4G C044 AGXO
LIPOSUCTION CANNULA
FDA UDI
SONTEC INSTRUMENTS, INC.·B0992013160·LIPOSUCTION CANNULA GRATER STYLE
Kirwan
FDA UDI
KIRWAN SURGICAL PRODUCTS LLC·00841019105122·Irrigating Bipolar Coagulation Forceps 7 1/8" (...
ULTRA N-GENEOUS HDL CHOLESTEROL REAGENT 1/REAGENT2; ULTRA N-GENEOUS HDL CHOLESTREOL CALIBRATOR
FDA 510(k)
FDA Class 1
·Clinical Chemistry
UNiD IB3D ALIF
FDA 510(k)
FDA Class 2
·Orthopedic
HAMILTON-C3
FDA Adverse Event
Malfunction
·HAMILTON MEDICAL AG·Product code CBK·February 9, 2024
INSPIRE OXYGENATOR
FDA Adverse Event
Malfunction
·SORIN GROUP ITALIA·Product code DTZ·March 4, 2026
INSPIRE OXYGENATOR
FDA Adverse Event
Malfunction
·SORIN GROUP ITALIA·Product code DTZ·November 20, 2025
PARADIGM REAL-TIME REVEL INSULIN INFUSION PUMP
FDA Adverse Event
Injury
·MEDTRONIC PUERTO RICO OPERATIONS CO.·Product code OYC·October 27, 2014
9800
FDA Adverse Event
Malfunction
·GE OEC MEDICAL SYSTEMS (SLC)·Product code JAA·June 26, 2013
IAB : 8 FR - 40 CC FOS
FDA Adverse Event
Malfunction
·ARROW INTERNATIONAL INC·Product code DSP·August 3, 2011
CHECK-IT
FDA Adverse Event
Malfunction
·LUCIRA HEALTH, INC.·Product code QJR·May 23, 2022
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