15 results
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21ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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MINIMED PARADIGM INSULIN PUMP, MODEL 511
FDA 510(k)
FDA Class 2
·General Hospital
DeRoyal
FDA UDI
DEROYAL INDUSTRIES, INC.·00749756836241·ANESTHESIA CIRCUIT
GATIFLOXACIN, 5 UG, BBL SENSI-DISC
FDA 510(k)
FDA Class 2
·Microbiology
GEIGER NEEDLE ADAPTER, MODEL 406
FDA 510(k)
FDA Class 2
·General, Plastic Surgery
CARDIOSAVE HYBRID W/ E/F PLUG
FDA Adverse Event
Malfunction
·DATASCOPE CORP.·Product code DSP·April 17, 2025
IMPLANT HOLDER FOR
FDA Adverse Event
Malfunction
·SYNTHES GMBH·Product code LXH·February 11, 2013
PROSTAR XL SUTURE-MEDIATED CLOSURE
FDA Adverse Event
Injury
·AV-TEMECULA-CT·Product code MGB·February 25, 2011
BREMER SKULL PIN
FDA Adverse Event
Injury
·DEPUY SPINE, INC.·Product code HBL·February 25, 2008
UNO URO/ISC
FDA Adverse Event
Malfunction
·UNOMEDICAL S.R.O.·Product code GBM·September 30, 2022
UNKNOWN EXTERNAL DRAINAGE AND MONITORING SYSTEM
FDA Adverse Event
Injury
·COVIDIEN LLC·Product code GWM·October 18, 2022
UNKNOWN EXTERNAL DRAINAGE AND MONITORING SYSTEM
FDA Adverse Event
Malfunction
·COVIDIEN LLC·Product code GWM·October 18, 2022
Plato 17 Microcatheter: Straight Tip, PL17-160-000 ; 45 degree Tip, PL17-160-045; 90 degree Tip, PL17-160-090
FDA Enforcement
Class II
·Ongoing·Scientia Vascular, Inc.·March 22, 2023
HealthLink***BIOPSY PUNCHES*** Disposable manual instrument for skin biopsy.
FDA Enforcement
Class II
·Terminated·Clorox Healthcare Holdings, LLC (dba HealthLink)·July 10, 2013
Stolen McGRATH MAC Video Laryngoscopes, REF: 301-000-000
FDA Enforcement
Class I
·Ongoing·Covidien·November 8, 2023
CADD-Solis Ambulatory Infusion Pumps, Model 2100. Intended for the following uses: Indicated for the following uses: Intra-arterial, subcutaneous, intraperitoneal, in close proximity to nerves, into an intraoperative site, epidural space or subarachnoid space. Therapies that require a continuous rate of infusion, intermittent bolus, and/or with patient-controlled demand doses.
FDA Enforcement
Class I
·Ongoing·Smiths Medical ASD Inc.·August 14, 2024