18 results
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22ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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V.A.C. GRANUFOAM SILVER PROTECTION DRESSING
FDA 510(k)
FDA Class 2
·General, Plastic Surgery
SOLIDEA
FDA UDI
CALZIFICIO PINELLI SRL·08300496050261·RED WELLNESS 70 LEGGINGS, SIZE XXL, PAVONE, GRA...
Merit Medical®
FDA UDI
Merit Medical Systems, Inc.·00884450143025·
Merit Medical®
FDA UDI
Merit Medical Systems, Inc.·00884450207277·
Merit Medical®
FDA UDI
Merit Medical Systems, Inc.·00884450146460·
ENDOPATH ETS FLEX
FDA Adverse Event
Malfunction
·ETHICON ENDO-SURGERY, INC.·Product code KOG·November 26, 1997
CARDIOMEDICS ECP SYSTEM
FDA 510(k)
FDA Class 2
·Cardiovascular
HARDYDISK, PIPERACILLIN/TAZOBACTAM, 110MCG
FDA 510(k)
FDA Class 2
·Microbiology
MANUAL ORTHOPEDIC SURGICAL INSTRUMENT
FDA Adverse Event
Injury
·MEDTRONIC SOFAMOR DANEK USA, INC.·Product code LXH·March 31, 2010
PROMUS EVEROLIMUS ELUTING CORONARY STENT SYSTEM
FDA Adverse Event
Injury
·ABBOTT VASCULAR-CARDIAC THERAPIES·Product code NIQ·July 10, 2009
SPINAL VERTEBRAL BODY REPLACEMENT DEVICE
FDA Adverse Event
Injury
·MEDTRONIC SOFAMOR DANEK·Product code MQP·July 3, 2018
2-L HUB CONNECT ASSY REPLACEMENT SET
FDA Adverse Event
Malfunction
·ARROW INTL., INC.·Product code NFK·April 5, 2013
NUCLEUS 24 CHANNEL COCHLEAR IMPLANT SYSTEM
FDA Adverse Event
Injury
·COCHLEAR LTD.·Product code MCM·May 22, 2008
ACUITY
FDA Adverse Event
Injury
·CPI - DEL CARIBE·Product code OJX·April 12, 2011
Custom Inflation Kit, REF: K05-00052M, K05-00053H, K05-00109G, K05-00137K, K05-00296L, K05-00399D, K05-00404C, K05-00410G, K05-00438G, K05-00502F, K05-00564L, K05-00587D, K05-00612Q, K05-00704F, K05-00724F, K05-00793B, K05-00798, K05-00890D, K05-00890D, K05-00944D, K05-00956D, K05-01018C, K05-01051, K05-01104G, K05-01140D, K05-01194G, K05-01274D, K05-01304A, K05-01756B, K05-01820B, K05-01853A, K05-01855L, K05-01895A, K05-01933A, K05-02161, K05-02431A, K05-02487A, K05-02489C, K05-02495B, K05-02554, K05-02573, K05-02575, K05-02595, K05-02595, K05-02657A, K05-02810, K05-02887, K05-03069A, K05-03095B, K05-03112, K05-03124, K05-03150, K05-50037G
FDA Enforcement
Class II
·Ongoing·Merit Medical Systems, Inc.·October 23, 2024
Custom Inflation Kit, REF: K05-00052M, K05-00053H, K05-00109G, K05-00137K, K05-00296L, K05-00399D, K05-00404C, K05-00410G, K05-00438G, K05-00502F, K05-00564L, K05-00587D, K05-00612Q, K05-00704F, K05-00724F, K05-00793B, K05-00798, K05-00890D, K05-00890D, K05-00944D, K05-00956D, K05-01018C, K05-01051, K05-01104G, K05-01140D, K05-01194G, K05-01274D, K05-01304A, K05-01756B, K05-01820B, K05-01853A, K05-01855L, K05-01895A, K05-01933A, K05-02161, K05-02431A, K05-02487A, K05-02489C, K05-02495B, K05-02554, K05-02573, K05-02575, K05-02595, K05-02595, K05-02657A, K05-02810, K05-02887, K05-03069A, K05-03095B, K05-03112, K05-03124, K05-03150, K05-50037G
FDA Recall
Open, Classified
·Merit Medical Systems, Inc.·Product code OEQ·August 19, 2024
Aurora Series, Aurora 7 lighthead; Models: LED7 (including TV models). The Aurora Series is intended to illuminate the surgical field and ensure visibility of the surgical site.
FDA Enforcement
Class II
·Ongoing·DKK Dai-Ichi Shomei Co., Ltd.·August 21, 2024
Belmont Rapid Infuser, a Fluid Management System, Model FMS2000.
FDA Enforcement
Class II
·Terminated·Belmont Instrument Corporation·October 24, 2012