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

Get notified when this changes

We'll email you when new records match this search — new devices, new clearances, certificate changes, or withdrawals.

SMARTPREP CENTRIFUGE SYSTEM

FDA 510(k)
FDA Class 1 ·Clinical Chemistry

HARVEST(R) TERUMOBCT, BMAC2-120-01Bone Marrow Procedure Pack, REF 51423, Rx Only, STERILE EO

FDA Enforcement
Class II ·Terminated·Terumo BCT, Inc.·November 22, 2017

HARVEST(R) TERUMOBCT, BMAC-30-07 Bone Marrow Procedure Pack, Private Practice / Clinical Use Only, REF 51416, Rx Only, STERILE EO

FDA Enforcement
Class II ·Terminated·Terumo BCT, Inc.·November 22, 2017

HARVEST(R) TERUMOBCT, BMAC-30-07 Bone Marrow Procedure Pack, Private Practice / Clinical Use Only, REF 51416, Rx Only, STERILE EO

FDA Recall
Terminated ·Terumo BCT, Inc.·Product code JQC·October 20, 2017

HARVEST(R) TERUMOBCT, BMAC2-120-01Bone Marrow Procedure Pack, REF 51423, Rx Only, STERILE EO

FDA Recall
Terminated ·Terumo BCT, Inc.·Product code JQC·October 20, 2017

Monolith

FDA UDI
Nuvasive, Inc.·00887517697998·Monolith Core, Ø14x30mm

PROCARE

FDA UDI
DJO, LLC·00888912038485·WRAPAROUND LIMB HOLDER, 40 PR

ULTRACISION SURGERY REUSABLE DEVICES, HANDPIECES

FDA Adverse Event
Malfunction ·ETHICON ENDO SURGERY, INC.(CINCINNATI)·Product code LFL·June 8, 2006

CARE PAL, MODEL CPW-10X

FDA 510(k)
FDA Class 2 ·Cardiovascular

Pulse Oximeter

FDA 510(k)
FDA Class 2 ·Cardiovascular

SET, ADMINISTRATION, FOR PERITONEAL DIALYSIS, DISPOSABLE

FDA Adverse Event
Injury ·BAXTER HEALTHCARE·Product code KDJ·March 6, 2013

ATTAIN ABILITY

FDA Adverse Event
Malfunction ·MEDTRONIC PUERTO RICO, INC.·Product code OJX·February 15, 2011

CAPSUREFIX MRI SURESCAN

FDA Adverse Event
Injury ·MPRI·Product code NVN·August 8, 2014