18 results · 22ms · Sources: EU EUDAMED, US FDA

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extriCARE 1000 Negative Pressure Wound Therapy System

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

HLS NOETOS SYSTEM

FDA 510(k)
FDA Class 2 ·Orthopedic

VERTEX RECONSTRUCTION SYSTEM, VERTEXT SELECT RECONSTRUCTION SYSTEM

FDA 510(k)
FDA Class 2 ·Orthopedic

VERTEX RECONSTRUCTION SYSTEM

FDA Adverse Event
Injury ·MEDTRONIC SOFAMOR DANEK·Product code KWP·February 17, 2014

VERTEX RECONSTRUCTION SYSTEM

FDA Adverse Event
Malfunction ·WARSAW ORTHOPEDICS·Product code KWP·January 15, 2016

VERTEX RECONSTRUCTION SYSTEM

FDA Adverse Event
Injury ·MEDTRONIC SOFAMOR DANEK·Product code KWP·February 17, 2014

VERTEX RECONSTRUCTION SYSTEM

FDA Adverse Event
Injury ·MEDTRONIC SOFAMOR DANEK·Product code KWP·February 17, 2014

VERTEX RECONSTRUCTION SYSTEM

FDA Adverse Event
Injury ·MEDTRONIC SOFAMOR DANEK·Product code KWP·February 17, 2014

COLLEAGUE

FDA Adverse Event
Malfunction ·BAXTER HEALTHCARE - SINGAPORE·Product code FRN·August 17, 2011

PREMILENE 3/0 (2) 90CM 2XHR30 (M) .RCP

FDA Adverse Event
Malfunction ·B, BRAUN SURGICAL SA·Product code GAW·October 6, 2014

ANIMAS INSULIN INFUSION PUMP

FDA Adverse Event
Injury ·ANIMAS CORPORATION·Product code LZG·July 9, 2013

VERTEX RECONSTRUCTION SYSTEM

FDA Adverse Event
Injury ·MEDTRONIC SOFAMOR DANEK·Product code KWP·February 17, 2014

VERTEX RECONSTRUCTION SYSTEM

FDA Adverse Event
Injury ·MEDTRONIC SOFAMOR DANEK·Product code KWP·February 17, 2014

VERTEX RECONSTRUCTION SYSTEM

FDA Adverse Event
Injury ·MEDTRONIC SOFAMOR DANEK·Product code KWP·November 15, 2013

VERTEX RECONSTRUCTION SYSTEM

FDA Adverse Event
Injury ·MEDTRONIC SOFAMOR DANEK·Product code KWP·February 17, 2014

VERTEX RECONSTRUCTION SYSTEM

FDA Adverse Event
Malfunction ·MEDTRONIC SOFAMOR DANEK·Product code KWP·November 15, 2013

HealthLink***BIOPSY PUNCHES*** Disposable manual instrument for skin biopsy.

FDA Enforcement
Class II ·Terminated·Clorox Healthcare Holdings, LLC (dba HealthLink)·July 10, 2013

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