16 results
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27ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: 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