9 results · 28ms · Sources: EU EUDAMED, US FDA

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ANESTHESIA BREATHING BAGS SIZES 1/2, 1,2,3 LITER

FDA 510(k)
FDA Class 1 ·Anesthesiology

THREADED TITANIUM METAL BACKED ACETABULAR CUP

FDA 510(k)
FDA Class 2 ·Orthopedic

PERCUTANEOUS NEPHROSTOMY SETS (OTTO)

FDA 510(k)
FDA Class 1 ·General, Plastic Surgery

SERVO-U

FDA Adverse Event
Malfunction ·MAQUET CRITICAL CARE AB·Product code CBK·October 12, 2023

MOTORIZED 3-WHEELED VEHICLE FOR OUTSIDE TRANSPORT

FDA Adverse Event
C.T.M. SHANGHAI·Product code INI·June 25, 2014

PRECISION

FDA Adverse Event
Injury ·BOSTON SCIENTIFIC NEUROMODULATION·Product code LGW·November 4, 2010

RESTORE ULTRA

FDA Adverse Event
Malfunction ·MEDTRONIC MED REL MEDTRONIC PUERTO RICO·Product code LGW·January 3, 2013

UNKNOWN IMPLANTABLE NEUROSTIMULATOR

FDA Adverse Event
Injury ·MEDTRONIC NEUROMODULATION·Product code MHY·November 27, 2013

PORTEX Bivona Tracheostomy Silicone Tube, labeled as: a) 3.0MM FLEXTEND PEDIATRIC STANDARD STRAIGHT TRACH TUBE , Product Code/List Number/Item Code 60PFSS30; b) 3.5MM FLEXTEND PEDIATRIC STANDARD STRAIGHT TRACH TUBE , Product Code/List Number/Item Code 60PFSS35; c) 4.0MM FLEXTEND PEDIATRIC STANDARD STRAIGHT TRACH TUBE TRACH TUBE , Product Code/List Number/Item Code 60PFSS40; d) 4.5MM FLEXTEND PEDIATRIC STANDARD STRAIGHT TRACH TUBE , Product Code/List Number/Item Code 60PFSS45; e) 5.0MM FLEXTEND PEDIATRIC STANDARD STRAIGHT TRACH TUBE , Product Code/List Number/Item Code 60PFSS50; f) 5.5MM FLEXTEND PEDIATRIC STANDARD STRAIGHT TRACH TUBE , Product Code/List Number/Item Code 60PFSS55

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