19 results
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22ms
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Sources: EU EUDAMED, US FDA
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Regulation: Us FDA
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ROCKET IPC INSERTION PACK, ROCKET IPC MINI INSERTION SET, ROCKET IPC DRESSING PACK AND BOTTLE SET, ROCKET IPC DRAINAGE B
FDA 510(k)
FDA Class 2
·Cardiovascular
n.a.
FDA UDI
Karl Storz GmbH & Co. KG·04048551054147·FARRIOR Ear Speculum, Ø 6 mm
DANmed
FDA UDI
DANNORITZER Medizintechnik GmbH & Co. KG·04251351102240·LAP-Instrument, Ø5mm, l=330mm, flushp.
Atraum...
DANmed
FDA UDI
DANNORITZER Medizintechnik GmbH & Co. KG·04251351112195·LAP-Instrument, Ø5mm, l=330mm, detach.
Atraum...
DANmed
FDA UDI
DANNORITZER Medizintechnik GmbH & Co. KG·04251351108464·LAP-Instrument, Ø5mm, l=330mm, flushp.
Atraum...
DANmed
FDA UDI
DANNORITZER Medizintechnik GmbH & Co. KG·04251351114793·LAP-Instrument, Ø5mm, l=330mm, detach.
Atraum...
DANmed
FDA UDI
DANNORITZER Medizintechnik GmbH & Co. KG·04251351104428·LAP-Instrument, Ø5mm, l=330mm, detach.
Atraum...
DANmed
FDA UDI
DANNORITZER Medizintechnik GmbH & Co. KG·04251351117046·LAP-Insert only, Ø5mm, l=330mm
Atraum...
DANmed
FDA UDI
DANNORITZER Medizintechnik GmbH & Co. KG·04251351110337·LAP-Instrument, Ø5mm, l=330mm, detach.
Atraum...
ALLGRAD WASH (HERPES BUFFERED WASHING MEDIUM)
FDA 510(k)
FDA Class 2
·Obstetrics/Gynecology
TRABECULAR METAL FUSION DEVICE MODEL 06-101-XXXXX, 06-102-XXXXX AND 08-100-XXXXX
FDA 510(k)
FDA Class 2
·Orthopedic
DEXCOM G7 CONTINUOUS GLUCOSE MONITORING SYSTEM
FDA Adverse Event
Malfunction
·DEXCOM, INC.·Product code QBJ·May 20, 2025
DEXCOM G6 CONTINUOUS GLUCOSE MONITORING SYSTEM
FDA Adverse Event
Malfunction
·DEXCOM, INC.·Product code QBJ·May 22, 2024
PARADIGM REAL-TIME REVEL INSULIN INFUSION PUMP
FDA Adverse Event
Malfunction
·MEDTRONIC PUERTO RICO OPERATIONS CO.·Product code OYC·May 21, 2013
PARADIGM REAL-TIME REVEL INSULIN INFUSION PUMP
FDA Adverse Event
Malfunction
·MEDTRONIC MINIMED·Product code OYC·September 26, 2014
LIGAMAX-5MM
FDA Adverse Event
Malfunction
·ETHICON ENDO-SURGERY, LLC.·Product code FZP·June 14, 2011
V.A.C. FREEDOM THERAPY SYSTEM
FDA Adverse Event
Injury
·KINETIC CONCEPTS, INC.·Product code OMP·February 15, 2021
ASPRIRE Cristalle Mammography System (cleared under K212873) installed with the ASPIRE Cristalle Digital Breast Tomosynthesis (DBT) Option (approved under P160031).
FDA Enforcement
Class II
·Ongoing·FUJIFILM Healthcare Americas Corporation·August 6, 2025
Stolen McGRATH MAC Video Laryngoscopes, REF: 301-000-000
FDA Enforcement
Class I
·Ongoing·Covidien·November 8, 2023