16 results
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21ms
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Sources: EU EUDAMED, US FDA
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Regulation: Us FDA
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FIBER-METAL POST
FDA 510(k)
FDA Class 1
·Dental
ORTHOPEDIC MANUAL SURGICAL INSTRUMENT
FDA UDI
FX SOLUTIONS·03701037312315·CANNULATED 3,5MM HEX. SCREWDRIVER BIT / HUDSON
TMA - Archwire
FDA UDI
ORMCO CORPORATION·00889989026436·ARCH ALXLOOP TMA 17X25 L/U 44MM PK/5
CAPTURED CANCELLOUS SCREW, FULLY THREADED 6.5mm x 75mm
FDA UDI
ADVANCED ORTHOPAEDIC SOLUTIONS, INC.·00848665020809·
Medallion®
FDA UDI
Merit Medical Systems, Inc.·00884450024331·
Canaveral®
FDA UDI
FLOSPINE LLC·B183120600750·6.0mm Curved Rod, Ti Alloy 75mm
TEKNIQUE
FDA 510(k)
FDA Class 2
·Physical Medicine
MODIFICATION TO OSI MEDICAL DOLPHIN STAND-ALONE PULSE OXIMETER
FDA 510(k)
FDA Class 2
·Cardiovascular
CADIERE FORCEPS INSTRUMENT
FDA Adverse Event
Malfunction
·INTUITIVE SURGICAL, INC.·Product code GCJ·December 21, 2007
M SERIES
FDA Adverse Event
Malfunction
·ZOLL MEDICAL CORPORATION·Product code MKJ·March 19, 2013
ACCU-CHEK COMFORT CURVE TEST STRIPS
FDA Adverse Event
Malfunction
·ROCHE DIAGNOSTICS·Product code LFR·June 12, 2008
COGNIS
FDA Adverse Event
Injury
·GUIDANT CRM CLONMEL IRELAND·Product code NIK·April 15, 2011
BD MULTITEST¿ 6-COLOR TBNK REAGENT W/BD TRUCOUNT¿ TUBES
FDA Adverse Event
Malfunction
·BECTON, DICKINSON AND COMPANY, BD BIOSCIENCES·Product code GKZ·May 20, 2022
BD MULTITEST¿ 6-COLOR TBNK
FDA Adverse Event
Malfunction
·BECTON DICKINSON CARIBE LTD.·Product code GKZ·January 31, 2024
BD MULTITEST¿ 6-COLOR TBNK
FDA Adverse Event
Malfunction
·BECTON DICKINSON CARIBE LTD.·Product code GKZ·January 31, 2024
Aurora 2 Series, Aurora 7 lighthead; Models: AUR7 (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