13 results
·
36ms
·
Sources: EU EUDAMED, US FDA
TOTAL PARENTERAL NUTRITION SET BAG
FDA 510(k)
FDA Class 2
·General Hospital
Symmetry WILLIAMS
FDA UDI
ASPEN SURGICAL PRODUCTS, INC.·00887482031315·Symmetry® Retractor, Williams Microlumbar, 70 m...
ACUMED
FDA UDI
Acumed LLC·10806378050695·Drill Guide/Trial Assembly 17mm
Millennium
FDA UDI
Avalign Technologies, Inc.·00190776098087·Spinal Discectomy Retractor
NAR
FDA UDI
NORTH AMERICAN RESCUE, LLC·00842209135257·
Millennium
FDA UDI
Avalign Technologies, Inc.·00190776098117·Spinal Discectomy Retractor
CLAROS NANO DENTAL LASER SYSTEM
FDA 510(k)
FDA Class 2
·General, Plastic Surgery
COBRA-OS Kit
FDA 510(k)
FDA Class 2
·Cardiovascular
BURR, OVAL, FLUSHCUT, 12 FLUTE, 5.0MM X 13CM
FDA Adverse Event
Injury
·ARTHREX, INC.·Product code GFF·May 9, 2014
UNKNOWN DEPUY ASR ACETABULAR CUP
FDA Adverse Event
Injury
·DEPUY INTERNATIONAL·Product code KWA·October 23, 2012
FREESTYLE FLASH
FDA Adverse Event
Malfunction
·ABBOTT DIABETES CARE INC., USA·Product code LFR·September 7, 2007
Product Label - ACUSON Sequoia *** Power Input: 100-240V~, 13.0-5.4A, 50-60Hz *** (240)11148775 Model User Manual states - ACUSON Sequoia Diagnostic Ultrasound Systems
FDA Enforcement
Class II
·Ongoing·Siemens Medical Solutions USA, Inc.·April 7, 2021
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