10 results · 27ms · Sources: EU EUDAMED, US FDA

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MICROLIFE UPPER ARM AUTOMATIC DIGITAL BLOOD PRESSURE MONITOR, MODEL WATCHBP HOME (BP3MX1-1)

FDA 510(k)
FDA Class 2 ·Cardiovascular

VULCAN TAC PROBES, MODEL 911XXX

FDA 510(k)
FDA Class 2 ·Orthopedic

FUJI VII CAPSULE

FDA 510(k)
FDA Class 2 ·Dental

LAVA C.O.S. POWDER

FDA Adverse Event
Injury ·3M ESPE DENTAL PRODUCTS·Product code NOF·March 16, 2012

SPECTRA WAVEWRITER

FDA Adverse Event
Injury ·BOSTON SCIENTIFIC NEUROMODULATION·Product code LGW·November 8, 2023

COAGUCHEK ® XS SYSTEM

FDA Adverse Event
Malfunction ·ROCHE DIAGNOSTICS·Product code GJS·April 23, 2013

HI-TORQUE BALANCE MIDDLEWEIGHT UNIVERSAL II GUIDE WIRE

FDA Adverse Event
Malfunction ·AV-TEMECULA-CT·Product code DQX·April 29, 2011

DURATA STS OPTIM ACTIVE FIXATION LEAD

FDA Adverse Event
Injury ·ST JUDE MEDICAL CARDIAC RHYTHM MANAGEMENT DIVISION·Product code LWS·July 11, 2008

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

Exactech Equinoxe REVERSE SHOULDER,38mm Constrained Humeral Liner: a) +0mm, Item Number 320-38-10, b) +2.5mm, Item Number 320-38-13, Shoulder Arthroplasty

FDA Enforcement
Class II ·Ongoing·Exactech, Inc.·April 10, 2024