19 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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DIAGNODENT 2190 WITH PERIODONTAL PROBE
FDA 510(k)
FDA Class 2
·Dental
ADVANCE®
FDA UDI
Microport Orthopedics Inc.·M684K00600801·
THUNDERBOLT
FDA UDI
Choice Spine, LP·00840996190343·THUNDERBOLT,X-TAB SCREW,6.0X60X080
JADE PLUS PTA Balloon Dilatation Catheter / JADE PLUS 35 OTW
FDA UDI
OrbusNeich Medical (ShenZhen) Co., Ltd.·06934955933646·Percutaneous Transluminal Angioplasty Balloon C...
THUNDERBOLT
FDA UDI
Choice Spine, LP·00840996190947·THUNDERBOLT,X-TAB SCREW,7.0X60X080
THUNDERBOLT
FDA UDI
Choice Spine, LP·00840996189743·THUNDERBOLT,X-TAB SCREW,5.0X60X080
JADE PLUS PTA Balloon Dilatation Catheter / JADE PLUS 35 OTW
FDA UDI
OrbusNeich Medical (ShenZhen) Co., Ltd.·06934955933035·Percutaneous Transluminal Angioplasty Balloon C...
JADE PLUS PTA Balloon Dilatation Catheter / JADE PLUS 35 OTW
FDA UDI
OrbusNeich Medical (ShenZhen) Co., Ltd.·06934955934254·Percutaneous Transluminal Angioplasty Balloon C...
Canaveral®
FDA UDI
FLOSPINE LLC·B183120600800·6.0mm Curved Rod, Ti Alloy 80mm
INSTANT-VIEW MORPHINE (2000) URINE CASSETTE TEST
FDA 510(k)
FDA Class 2
·Clinical Toxicology
ASNIS III CANNULATED SCREW SYSTEM
FDA 510(k)
FDA Class 2
·Orthopedic
HIGH SPEED ROTARY ATTACHMENT
FDA Adverse Event
Malfunction
·MAKO SURGICAL CORP.·Product code OLO·October 15, 2019
PALINDROME SAPPHIRE 23/40KT VT
FDA Adverse Event
Malfunction
·COVIDIEN·Product code MSD·March 20, 2013
VITALITY 2
FDA Adverse Event
Injury
·GUIDANT CRM CLONMEL IRELAND·Product code LWS·April 15, 2011
ACCU-CHEK COMFORT CURVE TEST STRIPS
FDA Adverse Event
Malfunction
·ROCHE DIAGNOSTICS·Product code LFR·June 12, 2008
INTROSYTE AUTOGUARD 26G INTRO ONLY
FDA Adverse Event
Malfunction
·BD INFUSION THERAPY SYSTEMS INC. S.A. DE C.V.·Product code DYB·April 24, 2023
PALLAS M/MAXIMIS 80mm Curved Rod. Part of MAXIMIS Pedicle Screw Spinal Fixation System. Valorem Surgical, Chicago, IL. Product labeled as Pallas M Spinal Fixation System through 2015. Intended for posterior pedicle screw fixation of the non-cervical spine.
FDA Enforcement
Class II
·Terminated·Valorem Surgical LLC·August 16, 2017
PALLAS M/MAXIMIS 80mm Straight Rod. Part of MAXIMIS Pedicle Screw Spinal Fixation System. Valorem Surgical, Chicago, IL. Product labeled as Pallas M Spinal Fixation System through 2015. Intended for posterior pedicle screw fixation of the non-cervical spine.
FDA Enforcement
Class II
·Terminated·Valorem Surgical LLC·August 16, 2017
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