19 results
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38ms
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Sources: EU EUDAMED, US FDA
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Regulation: Us FDA
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Oravan Herbst
FDA 510(k)
FDA Class 2
·Dental
Simpact Tri-Fin
FDA UDI
Life Spine, Inc.·00190837062996·Steinmann Pin Caddy, Long Blunt Pins
Trial Liners (Neutral and 10 degree hooded)
FDA UDI
SIGNATURE ORTHOPAEDICS PTY LTD·09348215038458·
POWERPICC SV CATHETERS
FDA 510(k)
FDA Class 2
·General Hospital
AIDA COMPACT II SYSTEM
FDA 510(k)
FDA Class 2
·Radiology
VALIANT STENT GRAFT
FDA Adverse Event
Death
·MEDTRONIC IRELAND·Product code MIH·March 6, 2018
T:SLIM X2 INSULIN PUMP WITH CONTROL-IQ TECHNOLOGY
FDA Adverse Event
Malfunction
·TANDEM DIABETES CARE·Product code QFG·April 21, 2023
T:SLIM X2 INSULIN PUMP WITH CONTROL-IQ TECHNOLOGY
FDA Adverse Event
Malfunction
·TANDEM DIABETES CARE·Product code QFG·April 3, 2023
UNKNOWN_SPINE_PRODUCT
FDA Adverse Event
Injury
·STRYKER SPINE-US·Product code NKG·November 15, 2024
UNKNOWN_SPINE_PRODUCT
FDA Adverse Event
Injury
·STRYKER SPINE-US·Product code NKG·November 15, 2024
OT VERIO IQ METER
FDA Adverse Event
Malfunction
·LIFESCAN EUROPE, A DIVISION OF CILAG GMBH INTL·Product code NBW·June 8, 2016
VALIANT STENT GRAFT
FDA Adverse Event
Injury
·MEDTRONIC IRELAND·Product code MIH·March 6, 2018
PARADIGM REAL-TIME INSULIN INFUSION PUMP
FDA Adverse Event
Malfunction
·MEDTRONIC PUERTO RICO OPERATIONS CO.·Product code OYC·October 8, 2014
PULSE-GENERATOR, DUAL CHAMBER, IMPLANTABLE
FDA Adverse Event
Injury
·MEDTRONIC MILACA, INC.·Product code LWP·June 7, 2013
SET, ADMINISTRATION, FOR PERITONEAL DIALYSIS, DISPOSABLE
FDA Adverse Event
Injury
·BAXTER HEALTHCARE CORPORATION·Product code KDJ·July 7, 2011
NEUROSTIMULATOR
FDA Adverse Event
Injury
·MEDTRONIC NEUROMODULATION·Product code MHY·April 2, 2012
GORE® VIABAHN® ENDOPROSTHESIS
FDA Adverse Event
Injury
·W.L. GORE & ASSOCIATES·Product code PFV·October 11, 2017
dS Breast 7ch 3.0T
FDA Enforcement
Class II
·Ongoing·Philips North America Llc·December 4, 2024
Continuous CT Fluoroscopy DVI Ceiling Mount CCT Arm DVI Option - Monitor Ingenuity Core, Ingenuity Core 128, Ingenuity CT 728321 - Ingenuity Core 728323 - Ingenuity Core 128 728326/728327 - Ingenuity CT
FDA Enforcement
Class II
·Ongoing·Philips North America Llc·July 7, 2021