15 results · 23ms · Sources: EU EUDAMED, US FDA

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SMART CO2 (SMART US 20D / ULTRASPEED, SMART CLINIC AND PERIOPULSE) SURGICAL LASER

FDA 510(k)
FDA Class 2 ·General, Plastic Surgery

ICS MEDICAL CHARTR OAE WITH TYMP

FDA 510(k)
FDA Class 2 ·Ear, Nose, Throat

MICROSCAN MICROSTREP PLUS PANEL NEW ANTICROBIAL-CLARITHROMYCIN

FDA 510(k)
FDA Class 2 ·Microbiology

PRECISION MONTAGE MRI

FDA Adverse Event
Injury ·BOSTON SCIENTIFIC NEUROMODULATION CORPORATION·Product code LGW·December 19, 2024

BD DURASAFE¿ COMBINED ANESTHESIA KIT

FDA Adverse Event
Malfunction ·BECTON DICKINSON INDUSTRIAS CIRURGICAS, LTDA.·Product code CAZ·October 10, 2017

XIENCE V EVEROLIMUS ELUTING CORONARY STENT SYSTEM

FDA Adverse Event
Injury ·AV-TEMECULA-CT·Product code NIQ·April 26, 2013

O-ARM 1000 IMAGING SYSTEM

FDA Adverse Event
Malfunction ·MEDTRONIC NAVIGATION, INC.·Product code IZL·April 21, 2011

MBT CEM KEEL TIB TRAY SZ2.5

FDA Adverse Event
Injury ·DEPUY-CORK, A DIVISION OF DEPUY ORTHOPAEDICS·Product code NJL·July 23, 2008

PROSTHESIS, KNEE, FEMOROTIBIAL, CONSTRAINED, CEMENTED, METAL/POLYMER

FDA Adverse Event
Injury ·SMITH & NEPHEW, INC.·Product code KRO·October 15, 2025

PROSTHESIS, KNEE, FEMOROTIBIAL, CONSTRAINED, CEMENTED, METAL/POLYMER

FDA Adverse Event
Injury ·SMITH & NEPHEW, INC.·Product code KRO·April 23, 2026

LGN PRSFT STEM 10MMX220MM STRT

FDA Adverse Event
Injury ·SMITH & NEPHEW, INC.·Product code JWH·October 19, 2017

BD DURASAFE¿ COMBINED ANESTHESIA KIT

FDA Adverse Event
Injury ·BECTON DICKINSON INDUSTRIAS CIRURGICAS, LTDA.·Product code CAZ·August 18, 2017

LEGION HK HINGE KNEE SYSTEM

FDA Adverse Event
Injury ·SMITH & NEPHEW, INC.·Product code KRO·March 15, 2025

IOL Master 500: Software versions 7.5 and 7.7; Ophthalmic: IOL Master 500 is intended for biometric determination of ocular measurements of axial length, anterior chamber depth, corneal radius, white-to white (WTW), and for the measurement of pupil size and deviation of the visual axis from the center of the pupil.

FDA Enforcement
Class II ·Terminated·Carl Zeiss Meditec AG·December 9, 2015

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