12 results
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19ms
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Sources: EU EUDAMED, US FDA
TISSUE/POLYP TRAP SYSTEM
FDA 510(k)
FDA Class 2
·General Hospital
COCR BALL HEAD 12/14 32 SIZE S -3.5
FDA Adverse Event
Injury
·MEDACTA INTERNATIONAL SA·Product code JDI·December 1, 2020
LED LAMP OR OTHER
FDA 510(k)
FDA Class 2
·Ophthalmic
PINNACLE METAL-ON-METAL ACETABULAR CUP LINERS
FDA 510(k)
FDA Class 3
·Orthopedic
CUP: MPACT ACETABULAR SHELL Ø50 TWO-HOLES
FDA Adverse Event
Injury
·MEDACTA INTERNATIONAL SA·Product code LPH·January 26, 2022
LINER: MPACT FLAT PE HC LINER Ø32/D
FDA Adverse Event
Injury
·MEDACTA INTERNATIONAL SA·Product code LPH·April 8, 2020
HEARTSTART MRX -EMS DEFIBRILLATOR
FDA Adverse Event
Malfunction
·PHILIPS MEDICAL SYSTEMS·Product code MKJ·November 29, 2012
CORE MICRO DRILL
FDA Adverse Event
Malfunction
·STRYKER INSTRUMENTS KALAMAZOO·Product code HBE·November 12, 2010
TX1 TISSUE REMOVAL SYSTEM - MICROTIP
FDA Adverse Event
Malfunction
·TENEX HEALTH·Product code LFL·February 24, 2014
IPC® HANDPIECE - XPS® STRAIGHTSHOT® M4
FDA Adverse Event
Injury
·MEDTRONIC XOMED INC.·Product code ERL·February 13, 2017
Exactech Equinoxe GLENOID,KEELED, CEMENTED, Mates with 38, 41, 44 head, alpha curvature, Sizes: a), Small, Item Number 314-01-02; b) Medium, Item number 314-01-03; c) Large, Item Number 314-01-04, Shoulder Arthroplasty
FDA Enforcement
Class II
·Ongoing·Exactech, Inc.·April 10, 2024
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