14 results · 21ms · Sources: EU EUDAMED, US FDA

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Toro-L Interbody Fusion System

FDA 510(k)
FDA Class 2 ·Orthopedic

Streck Cell Preservative

FDA UDI
STRECK, INC.·30844509000847·An easy-to-use liquid preservative that maintai...

POSEY BED

FDA 510(k)
FDA Class 1 ·General Hospital

SPARC SLING SYSTEM

FDA 510(k)
FDA Class 2 ·General, Plastic Surgery

RESTORE ULTRA

FDA Adverse Event
Injury ·MEDTRONIC MED REL MEDTRONIC PUERTO RICO·Product code LGW·March 8, 2013

PRIMEADVANCED

FDA Adverse Event
Malfunction ·MEDTRONIC MED REL MEDTRONIC PUERTO RICO·Product code LGW·October 3, 2012

PRIMEADVANCED

FDA Adverse Event
Injury ·MEDTRONIC MED REL MEDTRONIC PUERTO RICO·Product code LGW·October 27, 2014

RESTORE ULTRA

FDA Adverse Event
Malfunction ·MDT PUERTO RICO OPERATIONS CO·Product code LGW·December 29, 2011

PRISM HIV O PLUS

FDA Adverse Event
Malfunction ·ABBOTT LABORATORIES·Product code MZF·October 30, 2014

ASR ACETABULAR CUPS 46

FDA Adverse Event
Injury ·DEPUY INTERNATIONAL, LTD.·Product code KWA·August 12, 2011

AVAULTA PLUS BIOSYNTHETIC SUPPORT SYSTEM - ANTERIOR

FDA Adverse Event
Injury ·C.R. BARD, INC. (COVINGTON)·Product code FTL·July 2, 2013

Sure T, contact, contact detach, neria, neria detach, neria multi and thalaset Used in combination with infusion pumps for continuous subcutaneous infusion of medication.

FDA Enforcement
Class II ·Terminated·Unomedical As·July 1, 2015

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