11 results
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25ms
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Sources: EU EUDAMED, US FDA
KEVORKIAN-YOUNGE BIOPSY PUNCH, #90-6610
FDA 510(k)
FDA Class 1
·Obstetrics/Gynecology
Blade Scalpel
FDA UDI
KATENA PRODUCTS, INC.·00841668113462·SCLEROTOME BLADE #57 (BX/5)
ACUMED
FDA UDI
Acumed LLC·10806378097751·FFN Radius Nail Targeting Guide
MICRO-TOUCH NITRATEX STERILE NITRILE POWDER-FREE BLUE EXAMINATION GLOVES (CHEMOTHERAPY USE)
FDA 510(k)
FDA Class 1
·General Hospital
!NSURE FECAL OCCULT BLOOD TEST
FDA 510(k)
FDA Class 2
·Hematology
HEARTSTART ONSITE
FDA Adverse Event
Malfunction
·PHILIPS MEDICAL SYSTEMS·Product code MKJ·February 21, 2014
APEX KNEE SYSTEM
FDA Adverse Event
Malfunction
·OMNLIFE SCIENCE·Product code JWH·October 18, 2012
MULTIDIAGNOST ELEVA
FDA Adverse Event
Malfunction
·PHILIPS MEDICAL SYSTEMS·Product code KPR·August 9, 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