19 results
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21ms
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Sources: EU EUDAMED, US FDA
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Regulation: Us FDA
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Single Use Arthroscopic Electrode (with Pencil)
FDA 510(k)
FDA Class 2
·Orthopedic
RESTORIS
FDA UDI
MAKO SURGICAL CORP.·00848486003982·MCK ONLAY INSERT TRIAL (SIZE 3 X 10mm)
RESTORIS
FDA UDI
MAKO SURGICAL CORP.·00848486004002·MCK ONLAY INSERT TRIAL (SIZE 3 X 12mm)
RESTORIS
FDA UDI
MAKO SURGICAL CORP.·00848486003975·MCK ONLAY INSERT TRIAL (SIZE 3 X 9mm)
RESTORIS
FDA UDI
MAKO SURGICAL CORP.·00848486003968·MCK ONLAY INSERT TRIAL (SIZE 3 X 8mm)
RZ Medizintechnik GmbH
FDA UDI
RZ-Medizintechnik GmbH·04049197072168·FINSEN retractor
70mm, ...
n/a
FDA UDI
Ortho Development Corporation·00822409091645·I/M Tibial Cut Guide Scaffolding
STATIONARY X-RAY SYSTEM (DETECTOR) MODEL: ALTAS
FDA 510(k)
FDA Class 2
·Radiology
BD AUTOSHIELD DUO PEN NEEDLE
FDA 510(k)
FDA Class 2
·General Hospital
BD INSYTE¿ AUTOGUARD¿ SHIELDED IV CATHETER
FDA Adverse Event
Malfunction
·BECTON DICKINSON INFUSION THERAPY SYSTEMS INC.·Product code FOZ·September 21, 2018
PARADIGM REAL-TIME INSULIN INFUSION PUMP
FDA Adverse Event
Injury
·MEDTRONIC PUERTO RICO OPERATIONS MED-REL·Product code MDS·July 12, 2011
SET, ADMINISTRATION, FOR PERITONEAL DIALYSIS, DISPOSABLE
FDA Adverse Event
Injury
·BAXTER HEALTHCARE·Product code KDJ·June 14, 2013
RESTORE PRIME ADVANCED
FDA Adverse Event
Malfunction
·MEDTRONIC PUERTO RICO OPERATIONS CO·Product code LGW·September 16, 2008
BD INSULIN PEN NEEDLE
FDA Adverse Event
Injury
·BECTON DICKINSON AND CO.·Product code FMI·November 9, 2015
T-HANDLE INSERTER
FDA Adverse Event
Malfunction
·EIT EMERGING IMPLANT TECHNOLOGIES GMBH·Product code MAX·April 29, 2021
BD INSYTE¿ AUTOGUARD¿ SHIELDED IV CATHETER
FDA Adverse Event
Malfunction
·BECTON DICKINSON INFUSION THERAPY SYSTEMS INC.·Product code FOZ·December 10, 2018
T-HANDLE
FDA Adverse Event
Malfunction
·EIT EMERGING IMPLANT TECHNOLOGIES GMBH·Product code LXH·May 2, 2023
IMPLANT INSERTER SH CONNECTION
FDA Adverse Event
Malfunction
·EIT EMERGING IMPLANT TECHNOLOGIES GMBH·Product code MAX·May 2, 2023
AquaC UNO H [120V, 60Hz, 1000VA, Fresenius US-Version: 24-10VA-1 Vivonic Part Number: G02000970-US
FDA Enforcement
Class II
·Ongoing·Fresenius Medical Care Holdings, Inc.·August 3, 2022