10 results · 21ms · Sources: EU EUDAMED, US FDA

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AUTOMOATIC BLOOD PRESSURE MONITOR, MODELS: EASY X 800 AND 900 (R/L)

FDA 510(k)
FDA Class 2 ·Cardiovascular

WAVEWRITER ALPHA

FDA Adverse Event
Injury ·BOSTON SCIENTIFIC NEUROMODULATION CORPORATION·Product code LGW·March 13, 2025

MODIFICATION TO CLEARFIL PHOTO BOND

FDA 510(k)
FDA Class 2 ·Dental

STRATO X

FDA 510(k)
FDA Class 2 ·Dental

SOL-MILLENNIUM

FDA Adverse Event
Malfunction ·SOL-MILLENNIUM MEDICAL INC·Product code FMF·May 16, 2025

VERTECEM V+ CEMENT KIT

FDA Adverse Event
Malfunction ·OBERDORF SYNTHES PRODUKTIONS GMBH·Product code NDN·March 14, 2018

HEARTSTART FRX

FDA Adverse Event
Malfunction ·PHILIPS MEDICAL SYSTEMS·Product code MKJ·September 21, 2015

LOCK-CAP ONE-STEP F/MATRIX 5.5 TAN

FDA Adverse Event
Injury ·SYNTHES BRANDYWINE·Product code NKB·May 3, 2013

E SERIES DEFIBRILLATOR

FDA Adverse Event
Malfunction ·ZOLL MEDICAL CORPORATION·Product code MKJ·September 5, 2014

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