17 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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MEMOMETAL FIXOS SCREWS
FDA 510(k)
FDA Class 2
·Orthopedic
MAS PLIF
FDA UDI
Nuvasive, Inc.·00887517413659·MAS PLIF Fixation Guide
Micro pipette, plastic EDTA
FDA UDI
Boule Medical AB·07350040790687·Accessory for the MPA use in Medonic M-series, ...
ComfortGel Blue
FDA UDI
Respironics, Inc.·00606959004283·ComfortGel Blue Nasal Mask w/Headgear, Small, USA
ORTHOPEDIC MANUAL SURGICAL INSTRUMENT
FDA UDI
FX SOLUTIONS·03701037318904·RESURFACING GLENOID REAMER Ø39mm/FX
Paltop
FDA UDI
PALTOP ADVANCED DENTAL SOLUTIONS LTD·07290108691719·Final Drill for Ø4.2mm Implant
Paltop
FDA UDI
PALTOP ADVANCED DENTAL SOLUTIONS LTD·07290114694711·Final Drill for Ø4.2mm Implant
INVIGRA MALE LATEX CONDOM YELLOW COLORED AND BANANA FLAVORED
FDA 510(k)
FDA Class 2
·Obstetrics/Gynecology
QUICKTEK BLOOD GLUCOSE SYSTEM, QUICKTEK BLOOD GLUCOSE METER, QUICKTEK BLOOD GLUCOSE STRIPS, QUICKTEK CONTROL SOLUTION
FDA 510(k)
FDA Class 2
·Clinical Chemistry
POWER CORD, TGS SYSTEM V2, 20' LG
FDA Adverse Event
Malfunction
·MAKO SURGICAL CORP.·Product code OLO·October 8, 2019
3D TOP Ceiling Stand, model no. 3070039 3074486 3070013 3070021 Product Usage: The ceiling stand is used to hold the X-ray tube and / or the detector and is moveable on a ceiling rail system in three axis. The tube and / or detector can be rotated above a horizontal and a vertical axle. The ceiling stand can be used within a stationary diagnostic X-ray system as well.
FDA Enforcement
Class II
·Terminated·Siemens Medical Solutions USA, Inc·August 29, 2018
CONTOUR NEXT
FDA Adverse Event
Malfunction
·ASCENSIA DIABETES CARE US INC.·Product code JJX·April 22, 2013
MONOPOLAR CURVED SCISSORS INSTRUMENT
FDA Adverse Event
Malfunction
·INTUITIVE SURGICAL, INC.·Product code GEI·July 3, 2008
HI-TORQUE BALANCE MIDDLEWEIGHT UNIVERSAL II GUIDE WIRE
FDA Adverse Event
Injury
·AV-TEMECULA-CT·Product code DQX·April 26, 2011
3D TOP Ceiling Stand, model no. 3070039 3074486 3070013 3070021 Product Usage: The ceiling stand is used to hold the X-ray tube and / or the detector and is moveable on a ceiling rail system in three axis. The tube and / or detector can be rotated above a horizontal and a vertical axle. The ceiling stand can be used within a stationary diagnostic X-ray system as well.
FDA Recall
Terminated
·Siemens Medical Solutions USA, Inc·Product code IYB·June 29, 2018
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