13 results
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34ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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Keffort (MC-100, MC-100A)
FDA 510(k)
FDA Class 2
·Gastroenterology, Urology
CHESAPEAKE® Stabilization System
FDA UDI
VB Spine LLC·10888857082113·3-Screw Titanium Implant, Size 13x18x13 mm
NORDIX INC RECHARGEABLE BATTERY PART NUMBER 2116
FDA 510(k)
FDA Class 1
·General, Plastic Surgery
MEDRAD MARK 7 ARTERION (PEDESTAL SYSTEM), (TABLE MOUNT SYSTEM), MEDRAD MARK 7 ARTERION ARTERION SYRINGE
FDA 510(k)
FDA Class 2
·Cardiovascular
ANIMAS INSULIN INFUSION PUMP
FDA Adverse Event
Malfunction
·ANIMAS CORPORATION·Product code LZG·August 16, 2011
AAP CORTICAL STANDARD SCREW
FDA Adverse Event
Malfunction
·AAP IMPLANTATE AG·Product code HWC·September 4, 2014
ENDOTAK RELIANCE
FDA Adverse Event
Injury
·CPI - DEL CARIBE·Product code LWS·July 9, 2013
BD PHOENIX¿ PMIC/ID-107
FDA Adverse Event
Malfunction
·BECTON DICKINSON & CO. (SPARKS)·Product code LON·November 18, 2024
CURRENT HEALTH MONITORING SYSTEM GEN 2 (G2)
FDA Adverse Event
Death
·CURRENT HEALTH LTD·Product code MSX·September 9, 2024
CA090, DIRECT DRIVE LCA 3/BX
FDA Adverse Event
Malfunction
·APPLIED MEDICAL·Product code FZP·October 21, 2015
CustMbite, Model Number CBT-SRS-UL
FDA Enforcement
Class II
·Ongoing·Dental Choice Holding Llc·August 10, 2022
18L6 HD transducer on the ACUSON S Family ultrasound systems with software versions VD10A or VD10C; Model numbers: 18L6 HD transducer 10041227 & 10789400 S1000 10441701 S2000 10041461 S2000 (Refurb) - 10440017 S3000 10441730 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.·May 3, 2017
DRX Revolution Mobile X-Ray System
FDA Enforcement
Class II
·Ongoing·Carestream Health, Inc.·December 13, 2023