12 results · 26ms · Sources: EU EUDAMED, US FDA

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MODEL 561 C-ARM PROCEDURES STRETCHER

FDA 510(k)
FDA Class 2 ·General Hospital

Instrument Case

FDA UDI
KATENA PRODUCTS, INC.·00841668111062·INSTRUMENT CASE MEDIUM ALUMINUM

AESCULAP TITANIUM BONE PLATES

FDA 510(k)
FDA Class 2 ·Orthopedic

D.I.C. TRACHEOSTOMY TUBES & LARYNGECTOMY TUBES

FDA 510(k)
FDA Class 2 ·Anesthesiology

BD FACSCALIBUR¿ FLOW CYTOMETER

FDA Adverse Event
Malfunction ·BECTON, DICKINSON AND COMPANY, BD BIOSCIENCES·Product code GKZ·January 31, 2023

PROLIFT PELVIC FLOOR REPAIR

FDA Adverse Event
Injury ·ETHICON, INC.·Product code FTL·January 22, 2013

PRECISION

FDA Adverse Event
Injury ·BOSTON SCIENTIFIC NEUROMODULATION·Product code LGW·December 9, 2010

UNKNOWN M2A HIP

FDA Adverse Event
Injury ·BIOMET ORTHOPEDICS·Product code KWA·July 9, 2014

BD FACSCALIBUR FLOW CYTOMETER

FDA Adverse Event
Malfunction ·BECTON, DICKINSON AND COMPANY, BD BIOSCIENCES·Product code GKZ·March 31, 2023

BD FACSCALIBUR¿ FLOW CYTOMETER

FDA Adverse Event
Malfunction ·BECTON, DICKINSON AND COMPANY, BD BIOSCIENCES·Product code GKZ·March 31, 2023

BD FACSCALIBUR¿ FLOW CYTOMETER

FDA Adverse Event
Malfunction ·BECTON, DICKINSON AND COMPANY, BD BIOSCIENCES·Product code GKZ·July 24, 2023

PORTEX Bivona Tracheostomy Silicone Tube, labeled as: a) NEONATAL TRACHEOSTOMY TUBE 2.5mm TTS FLEXTEND V FLANGE , Product Code/List Number/Item Code 67NFP25; b) NEONATAL TRACHEOSTOMY TUBE 3.0mm TTS FLEXTEND V FLANGE , Product Code/List Number/Item Code 67NFP30; c) NEONATAL TRACHEOSTOMY TUBE 3.5mm TTS FLEXTEND V FLANGE , Product Code/List Number/Item Code 67NFP35; d) NEONATAL TRACHEOSTOMY TUBE 4.0mm TTS FLEXTEND V FLANGE , Product Code/List Number/Item Code 67NFP40

FDA Enforcement
Class I ·Ongoing·Smiths Medical ASD Inc.·September 4, 2024