21 results
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25ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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HEMOSPLIT XK, HEMOSPLIT XK CATHETER, 16FR X 42 CM, KIT;16FR X 19 CM, KIT WITH MICROINTRODUCER
FDA 510(k)
FDA Class 2
·Gastroenterology, Urology
Baltic Denture System BDLoad
FDA UDI
Merz Dental GmbH·D7091033294·Baltic Denture System BDLoad BDLoad Sm6 PLSEbm...
MONARCH SPINAL SYSTEMS
FDA 510(k)
FDA Class 2
·Orthopedic
BIOMET LATERAL TROCH PLATE
FDA 510(k)
FDA Class 2
·Orthopedic
NOVATION
FDA Adverse Event
Injury
·EXACTECH, INC.·Product code MEH·March 24, 2026
OASYS BLOCKER
FDA Adverse Event
Injury
·STRYKER SPINE-FRANCE·Product code KWP·November 30, 2015
NOVATION
FDA Adverse Event
Injury
·EXACTECH, INC.·Product code MEH·March 11, 2026
RAD-5 PULSE OXIMETER
FDA Adverse Event
Malfunction
·MASIMO - 40 PARKER·Product code DQA·July 13, 2018
HOURGLASS
FDA Adverse Event
Injury
·MEDTRONIC·Product code MQP·June 16, 2014
NV GXL LINER NEUTRAL, 32MM ID GROUP 1 CUPS
FDA Adverse Event
Injury
·EXACTECH, INC.·Product code MEH·February 26, 2026
NV GXL LINER NEUTRAL, 32MM ID GROUP 1 CUPS
FDA Adverse Event
Injury
·EXACTECH, INC.·Product code JDI·April 21, 2026
NV GXL LINER NEUTRAL, 32MM ID GROUP 1 CUPS
FDA Adverse Event
Injury
·EXACTECH, INC.·Product code JDI·March 16, 2026
NV GXL LINER NEUTRAL, 32MM ID GROUP 1 CUPS
FDA Adverse Event
Injury
·EXACTECH, INC.·Product code JDI·March 16, 2026
ELEMENT-STEM, COLLARLESS W/HA, STD OFFSET, SZ 11
FDA Adverse Event
Injury
·EXACTECH, INC.·Product code MEH·February 26, 2026
GOBED II MED/SURG BED
FDA Adverse Event
Malfunction
·STRYKER MEDICAL-KALAMAZOO·Product code FNL·April 3, 2013
VITROS 3600 IMMUNODIAGNOSTIC SYSTEM
FDA Adverse Event
Malfunction
·ORTHO-CLINICAL DIAGNOSTICS·Product code KHO·March 30, 2011
GDC-10 360 COIL
FDA Adverse Event
Injury
·BOSTON SCIENTIFIC IRELAND, CORK, NEUROVASCULAR DIVISION·Product code HCG·April 22, 2008
NV GXL LINER NEUTRAL, 32MM ID GROUP 1 CUPS
FDA Adverse Event
Injury
·EXACTECH, INC.·Product code MEH·March 19, 2026
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
Smiths Medical Medfusion Model 4000 Syringe pump, Item Numbers: a) 4000-0101-249, b) 4000-0101-50, c) 4000-0101-51, d) 4000-0105-249, e) 4000-0105-50, f) 4000-0105-51, g) 4000-0105-78, h) 4000-0106-00, i) 4000-0106-01, j) 4000-0106-231,
FDA Enforcement
Class II
·Ongoing·Smiths Medical ASD Inc.·April 24, 2024