15 results · 20ms · 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.

ELECTRODE/EXTENSION CABLES, MODELS ATAR

FDA 510(k)
FDA Class 2 ·Physical Medicine

TALOS® IBF

FDA UDI
MEDITECH SPINE, LLC·B16710709260·

ZEUS-P

FDA UDI
SPINAL ELEMENTS·00840916153199·Zeus-P Trial, 7 x 9 x 26mm

Yellowstone

FDA UDI
SUMMIT SPINE LLC·B587P07092670·7mm PLIF Implant 9mm Wide 26mm Length, 7 deg Lo...

TALOS® IBF

FDA UDI
MEDITECH SPINE, LLC·B1671000709260·

FULL FACE MASK

FDA Adverse Event
Malfunction ·FISHER & PAYKEL HEALTHCARE, LTD.·Product code MNT·March 14, 2008

EASYELECTROLYTE ANALYZER AND RAPIDLYTE ANALYZER

FDA 510(k)
FDA Class 2 ·Clinical Chemistry

R-SI-LINE METAL-BITE

FDA 510(k)
FDA Class 2 ·Dental

GPSIII 30ML PLATELET CONCENTRATION KIT WITH ACD-A

FDA Adverse Event
Malfunction ·ZIMMER BIOMET, INC.·Product code KSS·August 22, 2018

PINNACLE PELVIC FLOOR REPAIR KITS

FDA Adverse Event
Injury ·BOSTON SCIENTIFIC - MARLBOROUGH·Product code FTL·April 22, 2013

UNKNOWN TRIATHLON PRIMARY TIBIA

FDA Adverse Event
Injury ·STRYKER ORTHOPAEDICS MAHWAH·Product code JWH·April 19, 2011

MOSAIC AORTIC BIOPROSTHETIC HEART VALVE

FDA Adverse Event
Injury ·MEDTRONIC HEART VALVES, INC.·Product code LWR·July 8, 2008

RESTORE

FDA Adverse Event
Malfunction ·MEDTRONIC MED REL MEDTRONIC PUERTO RICO·Product code LGW·November 5, 2013

DEBAKEY, SP, ERG TA

FDA Adverse Event
Injury ·CAREFUSION, INC·Product code GCJ·March 10, 2023

CADD-Solis VIP ambulatory Infusion Pumps, Model 2120 (21-2120, 21-2125, and 21-2127) Indicated for the following uses: Intra-arterial, subcutaneous, intraperitoneal, in close proximity to nerves, into an intraoperative site, epidural space or subarachnoid space. Therapies that require a continuous rate of infusion, intermittent bolus, and/or with patient-controlled demand doses.

FDA Enforcement
Class I ·Ongoing·Smiths Medical ASD Inc.·August 14, 2024