18 results
·
26ms
·
Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
×
Diamond Digital Sleep Orthotic (DDSO)
FDA 510(k)
FDA Class 2
·Dental
Blade Scalpel
FDA UDI
KATENA PRODUCTS, INC.·00841668113516·MINIATURE BLADE #69 (BX/5)
Blade Scalpel
FDA UDI
KATENA PRODUCTS, INC.·00841668113561·IMPLANT BLADE 6.2MM (BX/5)
SIGMA
FDA UDI
DEPUY ORTHOPAEDICS, INC.·10603295084174·SIGMA HP PARTIAL KNEE-UNI/TROCHLEA SYSTEM HANDLE
SIGMA
FDA UDI
DEPUY ORTHOPAEDICS, INC.·10603295084167·SIGMA HP PARTIAL KNEE-FEMORAL DISTAL CUT BLOCK
DUOFERTILITY
FDA 510(k)
FDA Unclassified
·Unknown
BRENTWOOD IQMARK DIGITAL SPIROMETER (INCLUDES DISPOSABLE PNEUMOTACH MOUTHPIECES AND 3-LITER CALIBRATION SYRINGE
FDA 510(k)
FDA Class 2
·Anesthesiology
SYNCHROMED II
FDA Adverse Event
Injury
·MEDTRONIC NEUROMODULATION·Product code LKK·April 7, 2025
BREATHING CIRCUIT SET
FDA Adverse Event
Malfunction
·HAMILTON MEDICAL AG·Product code BZO·May 5, 2026
ENDURANT STENT GRAFT
FDA Adverse Event
Injury
·MEDTRONIC IRELAND·Product code MIH·May 9, 2025
ENDURANT STENT GRAFT
FDA Adverse Event
Malfunction
·MEDTRONIC IRELAND·Product code MIH·May 9, 2025
PULMONETIC
FDA Adverse Event
Malfunction
·CARDINAL HEALTH 203/PULMONETIC SYSTEMS, INC.·Product code CBK·October 8, 2008
PARADIGM REAL-TIME INSULIN INFUSION PUMP
FDA Adverse Event
Injury
·MEDTRONIC PUERTO RICO OPERATIONS MED-REL·Product code MDS·August 5, 2011
2520274-2013-04029
FDA Adverse Event
Injury
·SYNTHES USA·Product code HWC·July 2, 2013
CHECK-IT
FDA Adverse Event
Malfunction
·LUCIRA HEALTH, INC.·Product code QJR·June 14, 2022
CHECK-IT
FDA Adverse Event
Malfunction
·LUCIRA HEALTH, INC.·Product code QJR·July 5, 2022
BD INTIMA-II Y 24GAX0.75IN PRN/EC SLM
FDA Adverse Event
Malfunction
·BD SUZHOU (MDS)·Product code FOZ·June 5, 2024
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