11 results
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28ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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PEAK PLASMABLADE 3.OS TISSUE DISSECTION DEVICE
FDA 510(k)
FDA Class 2
·General, Plastic Surgery
MICROLINE INC. REUSABLE LAPAROSCOPIC CLIP APPLIER WITH IMPLANTABLE TITANIUM CLIPS, MODEL M/L-10
FDA 510(k)
FDA Class 2
·Gastroenterology, Urology
MICROSCOPE-STAINLESS STEEL/FIBER OPTIC: .5-2.6MM MODEL MMD 4500 SERIES AND 2.7-5.0MM MODEL MMD-4700 SERIES
FDA 510(k)
FDA Class 2
·Orthopedic
BD INSULIN SYRINGE WITH THE BD ULTRA-FINE NEEDLE
FDA Adverse Event
Malfunction
·BD MEDICAL - DIABETES CARE·Product code FMF·May 20, 2020
DEXCOM G7 CONTINUOUS GLUCOSE MONITORING SYSTEM
FDA Adverse Event
Malfunction
·DEXCOM, INC.·Product code QBJ·April 21, 2025
DEXCOM G6 CONTINUOUS GLUCOSE MONITORING SYSTEM
FDA Adverse Event
Malfunction
·DEXCOM, INC.·Product code QBJ·April 22, 2024
ENDO SMARTCAP
FDA Adverse Event
MEDIVATORS·Product code KOG·February 2, 2015
ZIMMER M/LL TAPER FEMORAL STEM
FDA Adverse Event
Injury
·ZIMMER INC·Product code LZO·May 1, 2013
M2A 38MM MOD HD -3MM NK
FDA Adverse Event
Injury
·BIOMET ORTHOPEDICS·Product code KWA·September 16, 2014
UNKNOWN DEPUY ACETABULAR CUP
FDA Adverse Event
Injury
·DEPUY ORTHOPAEDICS, INC.·Product code KWA·May 12, 2011
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