21 results
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25ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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E.G. SCAN II ESPHAGOSCOPE SYSTEM
FDA 510(k)
FDA Class 2
·Ear, Nose, Throat
Marina Medical
FDA UDI
MARINA MEDICAL INSTRUMENTS, INC.·00840306819889·Deep Deaver Retractor 3in wide 7in w/Doyen Handle
NA
FDA UDI
Summit Medical, Inc.·00385640002103·
O'REGAN DISPOSABLE ANOSCOPE
FDA 510(k)
FDA Class 2
·Gastroenterology, Urology
STARTROL LED LIGHTING SYSTEMS (X=# OF PODS, Y=# OF LEDS, N=TO MOUNTING STYLE) MODEL X X Y -N-S-W. X=NUMBER OF LIGHT PODS
FDA 510(k)
FDA Class 2
·General, Plastic Surgery
SCISSORS INSERT CEV605G 3PK 350MM
FDA Adverse Event
Malfunction
·MEDTRONIC XOMED INSTRUMENTATION S.A.S. LE PAVILLON·Product code GEI·August 29, 2013
SCISSORS INSERT CEV605G 3PK 350MM
FDA Adverse Event
Malfunction
·MEDTRONIC XOMED INSTRUMENTATION S.A.S. LE PAVILLON·Product code GEI·August 29, 2013
VENTED AUTOFEED CHAMBER
FDA Adverse Event
Malfunction
·FISHER & PAYKEL HEALTHCARE LTD·Product code BTT·April 4, 2013
ELECSYS ANTI-HBS II
FDA Adverse Event
Malfunction
·ROCHE DIAGNOSTICS·Product code LOM·February 18, 2025
MINICAP
FDA Adverse Event
Malfunction
·BAXTER HEALTHCARE - CLEVELAND·Product code KDI·May 20, 2013
VASOVIEW HEMOPRO
FDA Adverse Event
Malfunction
·MAQUET CARDIOVASCULAR LLC·Product code GEI·August 21, 2014
COLLEAGUE PRE P1.7
FDA Adverse Event
Malfunction
·BAXTER HEALTHCARE - SINGAPORE·Product code FRN·June 10, 2011
ADULT INSPIRATORY HEATED BREATHING CIRCUIT
FDA Adverse Event
Malfunction
·FISHER & PAYKEL HEALTHCARE LTD·Product code BTT·November 21, 2012
Titanium Tack Starter Kit, REF 400-270, Rx Only, non-sterile, BIOHORIZONS, BIRMINGHAM, AL 35244. Dental.
FDA Enforcement
Class II
·Terminated·BioHorizons Implant Systems Inc·December 26, 2012
UNKDELTAFILL
FDA Adverse Event
Malfunction
·REFER TO SECTION H10·Product code KRD·October 9, 2018
UNKDELTAFILL
FDA Adverse Event
Malfunction
·REFER TO SECTION H10·Product code KRD·October 9, 2018
UNKDELTAFILL
FDA Adverse Event
Malfunction
·REFER TO SECTION H10·Product code KRD·October 9, 2018
TUBE CEV649-5B DIA 5MM 350MM [MXI/XOM]
FDA Adverse Event
Injury
·XOMED MICROFRANCE ENGINEERING·Product code GEI·October 18, 2013
FORCEPS CEV134 BIPOLAR 350MM MOUIEL
FDA Adverse Event
Malfunction
·MEDTRONIC XOMED INSTRUMENTATION S.A.S.·Product code GEI·August 29, 2013
Logicon Caries Detector Product Usage: Analyze inter-proximal tooth surfaces for decay using digital radiographs. -Initial radiographic assessment of inter-proximal caries (Presently limited to RVG 6100 & 6500 bitewing radiographs in horizontal format) Identify and direct attention to potential interproximal caries sites for possible restoration or other treatment (Focus for further investigation. PRESCAN NOT INTENDED TO BE FINAL ASSESSMENT.) Track interproximal decay progression over time Patient education tool
FDA Enforcement
Class II
·Terminated·GA Industries·May 6, 2015