10 results
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23ms
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Sources: EU EUDAMED, US FDA
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Regulation: Us FDA
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KEVORKIAN-YOUNGE BIOPSY CURETTE #90-6611
FDA 510(k)
FDA Class 1
·Obstetrics/Gynecology
ACUMED
FDA UDI
Acumed LLC·10806378097768·FFN 6.1mm Drill
4CIS SOLAR SPINE SYSTEM AND 4CIS APOLLON SPINE SYSTEM
FDA 510(k)
FDA Class 2
·Orthopedic
P3T ABDOMEN
FDA 510(k)
FDA Class 2
·Radiology
HEARTSTART FRX
FDA Adverse Event
Malfunction
·PHILIPS MEDICAL SYSTEMS·Product code MKJ·February 21, 2014
LAP-BAND ADJUSTABLE GASTRIC BANDING SYSTEM (UNK SIZE)
FDA Adverse Event
Malfunction
·ALLERGAN·Product code LTI·October 18, 2012
NVPRM PB CLV OL100IN
FDA Adverse Event
Malfunction
·HOSPIRA LTD.·Product code FPA·August 6, 2010
ACUSON Sequoia Ultrasound Imaging System with Software Version VA25A/B
FDA Enforcement
Class II
·Ongoing·Siemens Medical Solutions USA, Inc.·February 9, 2022
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