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

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Fully Automatic Electronic Blood Pressure Monitor

FDA 510(k)
FDA Class 2 ·Cardiovascular

TALOS® IBF

FDA UDI
MEDITECH SPINE, LLC·B16741514600·

TALOS® IBF

FDA UDI
MEDITECH SPINE, LLC·B1674151460060·

CoRoent

FDA UDI
Nuvasive, Inc.·00887517232274·CoRoent XLW 15°, 14x22x60mm

ProLift Trial

FDA UDI
Life Spine, Inc.·00190837087968·

HNM SPORTS MEDICINE

FDA UDI
HNM STAINLESS, LLC.·00842962101889·ETHOS PRO SMALL JOINT ANCHOR, PEEK, 2.9mm x 10m...

LOCI 8 CALIBRATOR, MODEL KC 646

FDA 510(k)
FDA Class 2 ·Clinical Chemistry

C.CAM-AC

FDA 510(k)
FDA Class 2 ·Radiology

HNM SPORTS MEDICINE

FDA UDI
HNM STAINLESS, LLC.·00842962104095·ETHOS PRO SMALL JOINT ANCHOR, PEEK, 2.9mm x 10m...

DEPTH GAUGE FOR 2.0MM AND 2.4MM SCREWS

FDA Adverse Event
Malfunction ·SYNTHES JENNERSVILLE·Product code HTJ·May 5, 2015

PARADIGM REAL-TIME REVEL INSULIN INFUSION PUMP

FDA Adverse Event
Malfunction ·MEDTRONIC PUERTO RICO OPERATIONS CO.·Product code OYC·October 8, 2014

PLM A+ PLATINUM MODU

FDA Adverse Event
Malfunction ·HSOPIRA COSTA RICA LTD·Product code FRN·May 30, 2013

ACUITY

FDA Adverse Event
Injury ·CPI - DEL CARIBE·Product code OJX·July 6, 2011

DEPTH GAUGE FOR LARGE SCREWS

FDA Adverse Event
Malfunction ·SYNTHES USA·Product code HTJ·May 5, 2015

DEPTH GAUGE FOR 2.0MM AND 2.4MM SCREWS

FDA Adverse Event
Malfunction ·SYNTHES BRANDYWINE·Product code HTJ·May 5, 2015

DEPTH GAUGE FOR 2.0MM AND 2.4MM SCREWS

FDA Adverse Event
Malfunction ·SYNTHES JENNERSVILLE·Product code HTJ·May 5, 2015

DEPTH GAUGE FOR 2.7MM & SMALL SCREWS

FDA Adverse Event
Malfunction ·SYNTHES HAGENDORF·Product code HTJ·May 5, 2015

Visualase Thermal Therapy System, Software: Visualase Software versions 3.1.1 - 3.2, Product #: 9735542

FDA Enforcement
Class II ·Terminated·Medtronic Navigation, Inc.·October 3, 2018

Aespire View. This anesthesia gas machine is intended to provide general inhalation anesthesia and ventilatory support to patients and are to be used only by medical professionals trained and qualified in the administration of general anesthesia.

FDA Enforcement
Class I ·Ongoing·Datex-Ohmeda, Inc.·October 30, 2024