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