15 results
·
23ms
·
Sources: EU EUDAMED, US FDA
Twist Drills
FDA 510(k)
FDA Class 2
·Neurology
Navagio
FDA UDI
Kalitec Direct LLC·B07330K0132080·Trial, TLIF, 27L OB CRV 7Deg, 8mm
ITOTAL IPOLY XE 32MM X 8MM CEMENTED OVAL PATELLA IMPLANT
FDA UDI
Conformis, Inc.·M572POV0213208011·
SYRINGE 50ML LL TIP 1ML
FDA Adverse Event
Malfunction
·BECTON DICKINSON·Product code FMF·January 6, 2025
GAL-1A BLOOD GLUCOSE MONITORING SYSTEM
FDA 510(k)
FDA Class 2
·Clinical Chemistry
DIGITAL RETINAL CAMERA
FDA 510(k)
FDA Class 2
·Ophthalmic
SYRINGE 50-60ML L/L NO NEEDLE
FDA Adverse Event
Malfunction
·BECTON DICKINSON & COMPANY·Product code FMF·December 12, 2024
SYRINGE 50-60ML L/L NO NEEDLE
FDA Adverse Event
Malfunction
·BECTON DICKINSON & COMPANY·Product code FMF·December 12, 2024
ENSITE CLASSIC SYSTEM
FDA Adverse Event
Injury
·ST. JUDE MEDICAL·Product code DQK·February 9, 2010
PARADIGM REAL-TIME REVEL INSULIN INFUSION PUMP
FDA Adverse Event
Malfunction
·MEDTRONIC PUERTO RICO OPERATIONS CO.·Product code OYC·October 13, 2014
ASR ACETABULAR CUPS 52
FDA Adverse Event
Injury
·DEPUY INTERNATIONAL, LTD.·Product code KWA·August 12, 2011
VITALITY
FDA Adverse Event
Injury
·GUIDANT CRM CLONMEL IRELAND·Product code LWS·July 9, 2013
SYRINGE 50ML LL TIP 1ML
FDA Adverse Event
Malfunction
·BECTON DICKINSON·Product code FMF·January 7, 2025
ANIMAS VIBE
FDA Adverse Event
Malfunction
·ANIMAS LLC·Product code OYC·June 19, 2018
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