10 results · 20ms · Sources: EU EUDAMED, US FDA

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E3-80 PORTABLE ECG RECORDER & ANALYZER

FDA 510(k)
FDA Class 2 ·Cardiovascular

GUIDEWIRE INTRODUCER SAFETY NEEDLE

FDA 510(k)
FDA Class 2 ·Cardiovascular

MODIFICATION TO ONYX, FINGER CLIP PULSE OXIMETER, MODEL 9500

FDA 510(k)
FDA Class 2 ·Cardiovascular

PRECISION? MONTAGE? MRI

FDA Adverse Event
Injury ·BOSTON SCIENTIFIC NEUROMODULATION CORPORATION·Product code LGW·May 30, 2025

HEARTSTART ADULT MULTIFUNCTION PADS PLUS

FDA Adverse Event
Malfunction ·PHILIPS MEDICAL SYSTEMS·Product code MKJ·April 8, 2013

LIGAMAX-5MM

FDA Adverse Event
Malfunction ·ETHICON ENDO-SURGERY, LLC.·Product code FZP·April 27, 2011

LASIK

FDA Adverse Event
Injury ·Product code LZS·July 7, 2008

NIBP CUFFS

FDA Adverse Event
Injury ·PHILIPS MEDIZIN SYSTEME BÖBLINGEN GMBH·Product code OED·August 8, 2025

STERRAD 100NX STERILIZER 1-DR

FDA Adverse Event
Malfunction ·ADVANCED STERILIZATION PRODUCTS·Product code MLR·January 6, 2021

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