16 results
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21ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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BIJOU Orthodontic Ceramic Bracket
FDA 510(k)
FDA Class 2
·Dental
Simpact Tri-Fin
FDA UDI
Life Spine, Inc.·00190837063054·530mm x 2.4mm Steinmann Pin, Blunt-Blunt 17-4 SS
Trial Liners (Neutral and 10 degree hooded)
FDA UDI
SIGNATURE ORTHOPAEDICS PTY LTD·09348215038533·
OrthoMedFlex, LLC
FDA UDI
ORTHOMEDFLEX LLC·M7161121521670·Trial Liner, 40/60-68E (Neutral)
DATEX-OHMEDA S/5 TONOMETRY MODULE, E TONO AND ACCESSORIES
FDA 510(k)
FDA Class 2
·Anesthesiology
LO-50 LED LIGHT SOURCE
FDA 510(k)
FDA Class 2
·Gastroenterology, Urology
T:SLIM X2 INSULIN PUMP WITH CONTROL-IQ TECHNOLOGY
FDA Adverse Event
Malfunction
·TANDEM DIABETES CARE·Product code QFG·October 12, 2021
DEXCOM G7 CONTINUOUS GLUCOSE MONITORING SYSTEM
FDA Adverse Event
Malfunction
·DEXCOM, INC.·Product code QBJ·June 13, 2025
SENSOR ENLITE MMT-7008A
FDA Adverse Event
Malfunction
·MEDTRONIC PUERTO RICO OPERATIONS CO.·Product code OZO·January 31, 2018
PARADIGM REAL-TIME INSULIN INFUSION PUMP
FDA Adverse Event
Malfunction
·MEDTRONIC PUERTO RICO OPERATIONS CO.·Product code OYC·October 8, 2014
CAPSUREFIXNOVUS
FDA Adverse Event
Malfunction
·MPRI·Product code DTB·June 7, 2013
2600
FDA Adverse Event
Malfunction
·GE OEC MEDICAL SYSTEM (SLC)·Product code JAA·June 23, 2011
A7 ANESTHESIA SYSTEM
FDA Adverse Event
Malfunction
·SHENZHEN MINDRAY BIO-MEDICAL ELECTRONICS CO. LTD.·Product code BSZ·February 15, 2017
ProScreen 10 Panel Cup, Item No. PSCup-10M
FDA Enforcement
Class III
·Terminated·Ameditech Inc·December 30, 2015
Azurion 3 M15; Catalog numbers: (1) 722064, (2) 722222 (3) 722280(OUS ONLY).
FDA Enforcement
Class I
·Ongoing·PHILIPS MEDICAL SYSTEMS NEDERLAND B.V.·February 26, 2025
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