16 results · 20ms · Sources: EU EUDAMED, US FDA

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LAPAROSCOPIC ACCESS SHEATH SET

FDA 510(k)
FDA Class 2 ·Obstetrics/Gynecology

PURESOM NASAL MASK-SMALL, PURESOM NASAL MASK-MEDIUM, PURESOM NASAL MASK-LARGE, MODELS 11924-01, 11924-02, 11924-03

FDA 510(k)
FDA Class 2 ·Anesthesiology

SERIES II X3 LARGE DIAMETER ACCETABULAR INSERTS

FDA 510(k)
FDA Class 2 ·Orthopedic

ULTRACISION HARMONIC ACE

FDA Adverse Event
Malfunction ·ETHICON ENDO-SURGERY, LLC.·Product code LFL·April 29, 2016

INFUSE BONE GRAFT

FDA Adverse Event
Injury ·MEDTRONIC SOFAMOR DANEK USA, INC·Product code NEK·June 30, 2014

CHARGING SYSTEM

FDA Adverse Event
Injury ·ST. JUDE MEDICAL - NEUROMODULATION·Product code LGW·January 2, 2013

TOTAL ASR FEM IMP SIZE 47

FDA Adverse Event
Injury ·DEPUY INTERNATIONAL, LTD.·Product code KWY·November 17, 2010

LIGACLIP** ENDOSCOPIC CLIP APPLIER

FDA Adverse Event
Malfunction ·ETHICON ENDO-SURGERY, LLC.·Product code FZP·June 14, 2013

LIGACLIP** ENDOSCOPIC CLIP APPLIER

FDA Adverse Event
Malfunction ·ETHICON ENDO-SURGERY, LLC.·Product code FZP·June 8, 2013

PRIMATRIX 6X6

FDA Adverse Event
Injury ·INTEGRA LIFESCIENCES CORPORATION·Product code KGN·December 1, 2023

PRIMATRIX 6X6

FDA Adverse Event
Injury ·INTEGRA LIFESCIENCES CORPORATION·Product code KGN·December 1, 2023

PRIMATRIX 6X6

FDA Adverse Event
Injury ·INTEGRA LIFESCIENCES CORPORATION·Product code KGN·December 1, 2023

Exactech Equinoxe GLENOID,KEELED, CEMENTED, mates with 47, 50, 53 head, beta curvature, Sizes: a) Small, Item Number 314-01-12, b) Medium, Item Number 314-01-13, c) Large, Item Number 314-01-14, Shoulder Arthroplasty

FDA Enforcement
Class II ·Ongoing·Exactech, Inc.·April 10, 2024

smiths medical Pneupac paraPAC plus 300 ventilator kit without PEEP and CPAP, REF P300NUS

FDA Enforcement
Class I ·Ongoing·Smiths Medical ASD Inc.·March 27, 2024

paraPAC 300 ventilator kit without internal PEEP and CPAP, Item Number P300N

FDA Enforcement
Class I ·Ongoing·Smiths Medical ASD Inc.·October 2, 2024

Exactech Equinoxe GLENOID,KEELED, CEMENTED, mates with 47, 50, 53 head, beta curvature, Sizes: a) Small, Item Number 314-02-02, b) Medium, Item Number 314-02-03, c) Large, Item Number 314-02-04, Shoulder Arthroplasty

FDA Enforcement
Class II ·Ongoing·Exactech, Inc.·April 10, 2024