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

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HEPAFAT SCAN

FDA 510(k)
FDA Class 2 ·Radiology

MSI Precision Specialty Instruments

FDA UDI
Med Saver, Inc.·00194613017699·K-Wire, Double Ended, Trocar Point, Diameter Si...

Yellowstone

FDA UDI
SUMMIT SPINE LLC·B587X1220350·12mm H x 20mm W x 35mm L x 0 degrees XLIF

75V - Class A BMD 21 - 3 Shelf Cabinet

FDA UDI
Certified Safety Manufacturing, Inc.·00766588620350·75V - Class A BMD 21 - 3 Shelf Cabinet

TALOS® IBF

FDA UDI
MEDITECH SPINE, LLC·B16741220350·

Yellowstone

FDA UDI
SUMMIT SPINE LLC·B587X122035120·12mm H x 20mm W x 35mm L x 12 degrees XLIF

Yellowstone

FDA UDI
SUMMIT SPINE LLC·B587L122035120·12mm H x 20mm W x 35mm L XLIF Trial 12 degree L...

Yellowstone

FDA UDI
SUMMIT SPINE LLC·B587X12203580·12mm H x 20mm W x 35mm L x 8 degrees XLIF

TALOS® IBF

FDA UDI
MEDITECH SPINE, LLC·B1674122035060·

SLEEK OTW PTA CATHETERS

FDA 510(k)
FDA Class 2 ·Cardiovascular

OSTEOMEDICS RESORBABLE SMALL FIXATION SYSTEM, OSTEOSORB

FDA 510(k)
FDA Class 2 ·Dental

HAHN TAPERED IMPLANT Ø4.3 X 10 MM

FDA Adverse Event
Injury ·PRISMATIK DENTALCRAFT, INC.·Product code DZE·January 12, 2024

ABSORB BIORESORBABLE VASCULAR SCAFFOLD SYSTEM

FDA Adverse Event
Malfunction ·AV-TEMECULA-CT·Product code PNY·February 21, 2019

ALLEGRETTO WAVE EYE-Q

FDA Adverse Event
Injury ·WAVELIGHT GMBH·Product code LZS·May 16, 2013

ASR UNI FEMORAL IMPL SIZE 49

FDA Adverse Event
Injury ·DEPUY INTL. LTD.·Product code KWA·June 9, 2011

LIGAMAX-5MM ENDO CLIP APPLIER

FDA Adverse Event
Malfunction ·ETHICON ENDO-SURGERY, LLC·Product code FZP·August 14, 2008

ABSORB BIORESORBABLE VASCULAR SCAFFOLD SYSTEM

FDA Adverse Event
Death ·AV-TEMECULA-CT·Product code PNY·February 21, 2019

SLEEK OTW PTA CATHETER

FDA Adverse Event
Injury ·CLEARSTREAM TECHNOLOGIES LTD.·Product code DQY·December 13, 2023

SOMATOM Edge Plus-Computed tomography system Model 1026700

FDA Enforcement
Class II ·Ongoing·Siemens Medical Solutions USA, Inc·January 19, 2022

SOMATOM Edge Plus with software syngo.CT VB20 Model #10267000

FDA Enforcement
Class II ·Terminated·Siemens Medical Solutions USA, Inc·December 1, 2021