16 results · 27ms · Sources: EU EUDAMED, US FDA

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D-SPECT Scanner, D-SPECT L Scanner

FDA 510(k)
FDA Class 2 ·Radiology

OsteoMed

FDA UDI
OSTEOMED LLC·00842528103890·Ratcheting Driver Handle, Large AO

OsteoMed

FDA UDI
OSTEOMED LLC·00845694047333·PrimaLIF LLIF PEEK Implant, 17mm X 22mm X 40mm,...

EXPERIENCE®

FDA UDI
Gc Orthodontics America Inc.·D78816174000101·EXL 018/U&L4&5 UNIV 10T 0A

ALBOSURE POLYESTER VASCULAR PATCH

FDA 510(k)
FDA Class 2 ·Cardiovascular

AMERIWATER MRO PORTABLE REVERSE OSMOSIS SYSTEM - SINGLE PATIENT, 1 TO 3 STATION

FDA 510(k)
FDA Class 2 ·Gastroenterology, Urology

PENUMBRA SYSTEM ACE 68 REPERFUSION CATHETER

FDA Adverse Event
Malfunction ·PENUMBRA, INC.·Product code NRY·December 14, 2017

PENUMBRA SYSTEM ACE 68 HI-FLOW KIT

FDA Adverse Event
Malfunction ·PENUMBRA, INC.·Product code NRY·December 8, 2017

ATTAIN ABILITY STRAIGHT

FDA Adverse Event
Malfunction ·MPRI·Product code OJX·October 10, 2014

SYSTEM, PERITONEAL, AUTOMATIC DELIVERY

FDA Adverse Event
Malfunction ·BAXTER HEALTHCARE·Product code FKX·June 11, 2013

MICROCLAVE

FDA Adverse Event
Malfunction ·ICU MEDICAL, INC·Product code FPA·July 11, 2011

PENUMBRA SYSTEM ACE 68 HI-FLOW KIT

FDA Adverse Event
Malfunction ·PENUMBRA, INC.·Product code NRY·October 10, 2017

PENUMBRA SYSTEM REPERFUSION CATHETER

FDA Adverse Event
Injury ·PENUMBRA, INC.·Product code NRY·March 4, 2022

PENUMBRA SYSTEM REPERFUSION CATHETER

FDA Adverse Event
Injury ·PENUMBRA, INC.·Product code NRY·March 4, 2022

DOUBLE MOBILITY HC LINER 28/DMF

FDA Adverse Event
Injury ·MEDACTA INTERNATIONAL SA·Product code MEH·December 1, 2016

OPTETRAK Comprehensive Knee System including OPTETRAK Logic RBK PS Tibial Components (Product Line: 02-012-38-XXXX). NOTE: Information reflects Exactech recall expansion initiated on 02/07/2022.

FDA Enforcement
Class II ·Ongoing·Exactech, Inc.·October 13, 2021