21 results
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43ms
·
Sources: EU EUDAMED, US FDA
CONVALESCENT RECLINER
FDA 510(k)
FDA Class 2
·Physical Medicine
MEDI
FDA UDI
MEDI MANUFACTURING, INC.·04049772814541·GENUMEDI SAND SIZE III
G/L .070 ESI Male
FDA UDI
STERNGOLD DENTAL LLC·00841549100611·Intracoronal precision slide attachment
DeRoyal
FDA UDI
DEROYAL INDUSTRIES, INC.·00749756016674·ARM SLING
Merit Medical®
FDA UDI
Merit Medical Systems, Inc.·00884450169636·
COAXIAL ACCORDION STONE MANAGEMENT DEVICE, MODEL: COAC12005 - COA20015
FDA 510(k)
FDA Class 2
·Gastroenterology, Urology
THE O'NEIL STERILE FIELD URINARY CATHETER KIT
FDA 510(k)
FDA Class 2
·Gastroenterology, Urology
PCA EMPTY STERILE
FDA Adverse Event
Malfunction
·HOSPIRA INC.·Product code MEA·February 21, 2014
AFFINITY OXY NT 511
FDA Adverse Event
Malfunction
·PERFUSION SYSTEMS·Product code DTZ·October 24, 2012
ASKU
FDA Adverse Event
Injury
·MEDTRONIC MILACA INC.·Product code DTE·August 17, 2010
RetractaBed , Clinical Contour, Med - Mizer Inc..... Model SS 801, 802, 803, 803A: 80 " bed with 1, 2, or 3, motors and autocontour 120 V, ...Max Safe Working Load 450 LBS. Acute/Longterm Care AC Powered Adjustable Bed for geriatric care.
FDA Recall
Terminated
·Med-Mizer, Inc.·Product code FNK·April 18, 2014
RetractaBed , Clinical Contour, Med - Mizer Inc..... Model SS 801, 802, 803, 803A: 80 " bed with 1, 2, or 3, motors and autocontour 120 V, ...Max Safe Working Load 450 LBS. Acute/Longterm Care AC Powered Adjustable Bed for geriatric care.
FDA Enforcement
Class II
·Terminated·Med-Mizer, Inc.·May 14, 2014
Stereotactic Circular Collimator - 3D Line stereotatic Hardware Accessories The device is part of the class of medical devices that are used in radiotherapy for the treatments of head tumors.
FDA Enforcement
Class II
·Terminated·Elekta, Inc.·November 13, 2013
HA FlexTrak-Patient transport functionality to transport the patient from the preparation area to the MR system, Product Number: 989710006411
FDA Enforcement
Class II
·Ongoing·Philips North America Llc·June 12, 2024
ALLURA Xper FD10; System Code: (1) 722003, (2)722010, (3)722026;
FDA Enforcement
Class II
·Ongoing·PHILIPS MEDICAL SYSTEMS NEDERLAND B.V.·April 8, 2026
Allura Xper FD10 - Catalog numbers: (1) 722003, (2) 722010, (3) 722026,
FDA Enforcement
Class I
·Ongoing·PHILIPS MEDICAL SYSTEMS NEDERLAND B.V.·February 26, 2025
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
Philips Allura Xper Systems (R7.6-R8.1). Labeled as the following: 1. Allura Xper FD10, Model Number: 722010. 2. Allura Xper FD10/10, Model Number: 722011. 3. Allura Xper FD20, Model Number: 722012. 4. Allura Xper FD20 Biplane, Model Number: 722013. 5. Allura Xper FD10 OR Table, Model Number: 722022. 6. Allura Xper FD20 OR Table, Model Number: 722023. 7. Allura Xper FD20 Biplane OR Table, Model Number: 722025.
FDA Enforcement
Class II
·Ongoing·PHILIPS MEDICAL SYSTEMS NEDERLAND B.V.·December 18, 2024
Exactech Equinoxe GLENOID,KEELED, CEMENTED,47, 50, 53 head, beta curvature, Sizes: a) Small, Item Number 314-02-12, b) Medium, Item Number 314-02-13, c) Large, Item Number 314-02-14, d) Extra Large, Item Number 314-02-15, Shoulder Arthroplasty
FDA Enforcement
Class II
·Ongoing·Exactech, Inc.·April 10, 2024
DRX Revolution Mobile X-Ray System
FDA Enforcement
Class II
·Ongoing·Carestream Health, Inc.·December 13, 2023