10 results
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29ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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Checkpoint Guardian Intraoperative Lead, Medium, Checkpoint Guardian Intraoperative Lead, Large
FDA 510(k)
FDA Class 2
·Ear, Nose, Throat
IMAGE-X SYSTEM
FDA 510(k)
FDA Class 2
·Dental
VANISHPOINT BLOOD COLLECTION SET
FDA 510(k)
FDA Class 2
·Clinical Chemistry
KANGAROO
FDA Adverse Event
Malfunction
·CARDINAL HEALTH 200, LLC·Product code KNT·October 16, 2024
MOTORIZED 3-WHEELED VEHICLE FOR OUTSIDE TRANSPORT
FDA Adverse Event
Malfunction
·C.T.M. TAIWAN·Product code INI·October 30, 2014
OT PING METER
FDA Adverse Event
Malfunction
·LIFESCAN INC.·Product code NBW·August 15, 2011
CAPSURE FIX
FDA Adverse Event
Malfunction
·MEDTRONIC, INC.·Product code DTB·July 8, 2013
LPS Diaphyseal Sleeves Product Usage: The LPS Diaphyseal Sleeves are used with the LPS System which is an end-stage revision knee product that allows surgeons to reconstruct severe soft tissue and bony defects.
FDA Enforcement
Class I
·Terminated·DePuy Orthopaedics, Inc.·February 27, 2013
ACUSON S 1000, ACUSON S 2000, or ACUSON S 3000 ultrasound systems with software version C3, C3, C3, or C1. Model numbers: 10041461, 10440017 S 2000 system 10441730 S 3000 system 10441701 S 1000 system Radiology: The ultrasound imaging systems are intended for the following applications: Fetal, Abdominal, Intraoperative, Pediatric, Small Parts, Transcranial, OB/GYN, Cardiac, Pelvic, Neonatal/Adult Cephalic, Vascular, Musculoskeletal, Superficial Musculoskeletal, and Peripheral Vascular applications.
FDA Enforcement
Class II
·Terminated·Siemens Medical Solutions USA, Inc.·August 5, 2015
DRX Revolution Mobile X-Ray System
FDA Enforcement
Class II
·Ongoing·Carestream Health, Inc.·December 13, 2023