14 results · 25ms · Sources: EU EUDAMED, US FDA

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MAGLIFE C/MAGLIFE C PLUS

FDA 510(k)
FDA Class 2 ·Cardiovascular

GREERTRACK SKIN TESTING SYSTEM, MODEL GT-IT, GT-IC

FDA 510(k)
FDA Class 2 ·General Hospital

HAEMOPHILUS/STREPTOCOCCUS PNEUMONIAE (HP)MIC SUSCEPTIBILITY PLATES

FDA 510(k)
FDA Class 2 ·Microbiology

AMPLATZER AMULET LEFT ATRIAL APPENDAGE OCCLUDER

FDA Adverse Event
Injury ·ABBOTT MEDICAL·Product code NGV·July 24, 2023

HEARTSTART ONSITE

FDA Adverse Event
Malfunction ·PHILIPS MEDICAL SYSTEMS·Product code MKJ·February 27, 2013

ARCTIC FRONT CARDIAC CRYOABLATION CATHETER

FDA Adverse Event
Death ·MEDTRONIC CRYOCATH LP·Product code OAE·March 16, 2011

HINGED TOE IMPLANT

FDA Adverse Event
Other ·WRIGHT MEDICAL·Product code KWD·March 24, 2008

Angled Tip Ureteral Catheter Set, Ureteral Catheter, Global Product No. G14598

FDA Enforcement
Class II ·Terminated·Cook Inc.·February 12, 2020

AMPLATZER AMULET

FDA Adverse Event
Injury ·ABBOTT MEDICAL·Product code NGV·September 6, 2023

EVOLUT FX PLUS VALVE

FDA Adverse Event
Malfunction ·MEDTRONIC HEART VALVES DIVISION·Product code NPT·July 24, 2025

ULTRA FAST-FIX AB ASSEMBLY - CURVED-Absorbable Suture anchors Product Number: 72201494

FDA Enforcement
Class II ·Ongoing·Smith & Nephew, Inc.·October 28, 2020

TRUE METRIX

FDA Adverse Event
Malfunction ·TRIVIDIA HEALTH INC·Product code NBW·August 7, 2023

Accolade TMZF Plus Hip Stem: Catalog # 3020-0537 Accolate d TMZF Hip Stem # 5 Catalog #6020-3535 Accolade 132 Size 3.5 Catalog # 6021-0230 Accolade Plus TMZF Hip Stem #2 Catalog # 6021-0335 Accolade Plus TMZF Hip Stem #3 Catalog #3021-0435 Accolade TMZF Hip Stem #4 Catalog # 6021-0435 Accolade Plus TMZF Hip Stem #4 Catalog #6021-2530 Accolade (127 deg) Size 2.5 Accolade (127 deg) Size 2.5 Catalog # 6021-4535 Accolade (127 DEG) Size 4.5 K994366; k023105; K032300 Manufactured by " Stryker Ireland, Carrigtwohill Industrial Estate Carrington County Cork, Ireland The subject hip stem is a single-use device intended for the reconstruction of the head and neck of the femoral joint. This hip stem is intended for primary reconstruction of the proximal femur or revision total hip arthroplasty.

FDA Recall
Terminated ·Stryker Howmedica Osteonics Corp.·Product code ISL·March 1, 2011

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