13 results
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21ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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PRIZM MEDICAL, INC. MICRO-Z STIMULATION SYSTEM
FDA 510(k)
FDA Class 2
·Physical Medicine
M2376A DEVICELINK SYSTEM, MODEL M2376A
FDA 510(k)
FDA Class 2
·Cardiovascular
MICROSCAN MICROSTREP PLUS PANEL NEW ANTICROBIAL-CLARITHROMYCIN
FDA 510(k)
FDA Class 2
·Microbiology
M2A TPR HI CARBON 41/32MM LNR
FDA Adverse Event
Injury
·BIOMET ORTHOPEDICS·Product code KWY·January 16, 2013
M2A-T M/H RAD 2HL SHL 41/52MM
FDA Adverse Event
Injury
·BIOMET ORTHOPEDICS·Product code KWA·January 16, 2013
THERMOCOOL® SF NAV UNI-DIRECTIONAL CATHETER
FDA Adverse Event
Injury
·BIOSENSE WEBSTER, INC (IRWINDALE)·Product code LPB·March 27, 2013
6461500 INFUSOR PUMP (1 LABEL)
FDA Adverse Event
Malfunction
·BAXTER HEALTHCARE - SINGAPORE·Product code FRN·March 18, 2011
LIFEPAK 20 DEFIBRILLATOR/MONITOR
FDA Adverse Event
Malfunction
·PHYSIO-CONTROL, INC.·Product code LDD·March 26, 2008
SMR SHOULDER
FDA Adverse Event
Injury
·LIMACORPORATE S.P.A.·Product code PHX·October 2, 2025
MEDTRONIC NAVIGATION
FDA Adverse Event
Injury
·MEDTRONIC NAVIGATION, INC·Product code HAW·February 6, 2024
ECHELON ENDOPATH STAPLER
FDA Adverse Event
Injury
·ETHICON ENDO-SURGERY, LLC.·Product code GDW·April 11, 2025
ECHELON ENDOPATH STAPLER
FDA Adverse Event
Injury
·ETHICON ENDO-SURGERY, LLC.·Product code GDW·April 11, 2025
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