15 results · 29ms · Sources: EU EUDAMED, US FDA

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ATLANTIS SLIT LAMP

FDA 510(k)
FDA Class 2 ·Ophthalmic

NIDO Pedicle Screw System

FDA UDI
Kalitec Direct LLC·B07315K0430210·Sagittal Bender, Double Ended Right

MODIFICATION TO SMITH & NEPHEW TWINFIX TI QUICK T

FDA 510(k)
FDA Class 2 ·Orthopedic

LIGHTLANCE LASER SKIN PERFORATOR

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

BD VACUTAINER® 21 G X 1.5 IN. MULTI SAMPLE BLOOD COLLECTION NEEDLE

FDA Adverse Event
Malfunction ·BECTON, DICKINSON AND COMPANY (BD)·Product code FMI·November 30, 2017

SINAI HSP BALTIMORE MD 1

FDA Adverse Event
Other ·SORIN GROUP USA, INC.·Product code DTZ·July 6, 2011

LAKELAND REG LAKELAND FL 1

FDA Adverse Event
Other ·SORIN GROUP USA, INC.·Product code DWF·May 3, 2010

WA ADVENT TAKOMA PARK MD 1

FDA Adverse Event
Other ·SORIN GROUP USA, INC.·Product code DTZ·November 22, 2011

IOWA METH DES MOINES IA1

FDA Adverse Event
Malfunction ·SORIN GROUP USA, INC.·Product code DTZ·March 7, 2011

COULTER® LH 500 HEMATOLOGY INSTRUMENT

FDA Adverse Event
Malfunction ·BECKMAN COULTER·Product code GKZ·May 3, 2013

PORTABLE OXYGEN GENERATOR (CONCENTRATOR, HOMEFILL)

FDA Adverse Event
Malfunction ·INVACARE FLORIDA OPERATIONS·Product code CAW·September 16, 2014

UNKNOWN

FDA Adverse Event
Malfunction ·MEDTRONIC NEUROMODULATION·Product code LKK·May 5, 2011

METRX SYSTEM

FDA Adverse Event
Malfunction ·MEDTRONIC SOFAMOR DANEK USA, INC·Product code HRX·June 10, 2024

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

cobas 6000 Modular Series system; Part Numbers: 1. 04745914001 cobas c 501 module; 2. 05036453001 cobas 6000 UL c 501 + Core Fix configuration; 3. 05036453692 - cobas 6000 UL + CORE CU; and 4. 05860636001 cobas 6000 c 501 (UL) V

FDA Enforcement
Class II ·Terminated·Roche Diagnostics Corporation·March 14, 2018