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

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VERTEFIX VERTEBROPLASTY PROCEDURE SET

FDA 510(k)
FDA Class 2 ·Orthopedic

JOBST forMen

FDA UDI
BSN MEDICAL, INC.·04042809867725·FOR MEN 30-40 MM HG THIGH MICRO DOT BAND OPEN T...

LIPASE-ESTERASE, ENZYMATIC, PHOTOMETRIC, LIPASE

FDA Adverse Event
Malfunction ·BECKMAN COULTER INC.·Product code CHI·March 4, 2011

SYNCHRON VANCOMYCIN REAGENT

FDA Adverse Event
BECKMAN COULTER INC.·Product code LEH·June 10, 2011

MONSOON CRITICAL CARE JET VENTILATOR AND ACCESSORIES

FDA 510(k)
FDA Class 2 ·Anesthesiology

COM-MED O.R. TOWEL - NON-STERILE, BLUE, GREEN, WHITE

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

PRECISION? MONTAGE? MRI

FDA Adverse Event
Injury ·BOSTON SCIENTIFIC NEUROMODULATION CORPORATION·Product code LGW·March 28, 2025

SYNCHRON LX 20 PRO CLINICAL SYSTEMS

FDA Adverse Event
Malfunction ·BECKMAN COULTER INC.·Product code JJE·June 8, 2011

INFUSE BONE GRAFT DEVICE (RHBMP-2)

FDA Adverse Event
Injury ·MEDTRONIC INC·Product code NEK·April 4, 2013

SPRINT QUATTRO SECURE

FDA Adverse Event
Death ·MEDTRONIC PUERTO RICO, INC.·Product code LWS·April 6, 2011

VITALITY 2 VR

FDA Adverse Event
Malfunction ·CARDIAC PACEMAKERS, INC·Product code LWS·May 8, 2008

NCB, DF PLATE, RIGHT, 13 HOLES, 324 MM

FDA Adverse Event
Injury ·ZIMMER GMBH·Product code HRS·June 11, 2018

PKG, OP-VIOPSY FORCEPS, SPOON JAW, P/N 0250080246. Laparoscopic Manual Instruments are intended for cutting, holding, grasping and manipulating of tissue, organs, organ areas and surgical auxiliaries such as suturing material. Some instruments have radio frequency (RF) ports which allow them to be used for electrosurgery. Laparoscopic surgical manual instruments are designed to be used endoscopically through cannulae to perform cutting, grasping, dissecting, retracting, and manipulating functions. This device does not sustain or support life.

FDA Enforcement
Class II ·Terminated·Stryker Endoscopy·December 24, 2014

The Spirit Plus Bed, Model 5600 Spirit Plus /with high rail siderail option

FDA Enforcement
Class II ·Terminated·Stryker Medical Division of Stryker Corporation·November 21, 2018

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

Boston Scientific COGNIS CRT-D, Cardiac Resynchronization Therapy Defibrillator, models N118, N119. The following models are not available in the US: models N106, N107, P106, P107. Sterilized using ethylene oxide. Boston Scientific, 4100 Hamline Avenue North, St. Paul, MN 55112-5798 USA. Indicated for patients who are at risk for sudden cardiac death due to ventricular arrhythmias and may require pacing support.

FDA Enforcement
Class II ·Terminated·Boston Scientific CRM Corp·October 23, 2013