23 results
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23ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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COUGAR LS LATERAL CAGE SYSTEM
FDA 510(k)
FDA Class 2
·Orthopedic
Vivid QwikTemp C&B
FDA UDI
PEARSON DENTAL SUPPLIES, INC.·D724N1104540·A2
3.5mm Screw Fastener Tap 200mm
FDA UDI
Osteocentric Technologies, Inc.·00816950028311·3.5mm Screw Fastener Tap 200mm
Marina Medical
FDA UDI
MARINA MEDICAL INSTRUMENTS, INC.·00840306816666·O'Sullivan-O'Connor Blade - Size: 6.5cm x10.25c...
Merit Medical®
FDA UDI
Merit Medical Systems, Inc.·00884450641934·
5.0MM VARIABLE ANGLE LOCKNG SCREW/SLF-TPNG/STRDRV/65MM
FDA Adverse Event
Injury
·SYNTHES MEZZOVICO·Product code JDP·August 28, 2015
SCREW, FIXATION, BONE
FDA Adverse Event
Injury
·SYNTHES USA·Product code HWC·January 26, 2015
SCREW, FIXATION, BONE
FDA Adverse Event
Injury
·SYNTHES USA·Product code HWC·March 2, 2015
Cosmolock
FDA UDI
Kalitec Direct LLC·B07311K1100540·Caddie, 8.5mm Screws
IMPLANT, FIXATION DEVICE CONDYLAR PLATE
FDA Adverse Event
Injury
·SYNTHES (USA)·Product code JDP·February 23, 2017
HYDROCOIL EMBOLIC SYSTEM-HYDROFRAME MODEL 100931HFM-V, 101243HFM-V, 180827HFM-V, 181139HFM-V, 181445HFM-V, 181850HFM-V
FDA 510(k)
FDA Class 2
·Neurology
THE ALBERTA LENS SM2, SULFOCON B
FDA 510(k)
FDA Class 2
·Ophthalmic
DEXCOM G7 CONTINUOUS GLUCOSE MONITORING SYSTEM
FDA Adverse Event
Malfunction
·DEXCOM, INC.·Product code QBJ·May 7, 2025
EG-3630U Ultrasound Video Gastroscope EG-3830UT Ultrasound Video Gastroscope EG-3870UTK Ultrasound Video Gastroscope FG-36UX Ultrasound Fiber Gastroscope Used to provide optical and sonographic visualization of and therapeutic access to the Upper Gastrointestinal Tract.
FDA Enforcement
Class II
·Terminated·Pentax Medical Company·July 30, 2014
IMPLANT, FIXATION DEVICE, CONDYLAR PLATE
FDA Adverse Event
Malfunction
·SYNTHES USA·Product code JDP·June 1, 2015
OT VERIO IQ METER
FDA Adverse Event
Malfunction
·LIFESCAN EUROPE, A DIVISION OF CILAG GMBH INTL·Product code NBW·May 13, 2013
SECURE 3 MED/SURG BED
FDA Adverse Event
Malfunction
·STRYKER MEDICAL·Product code FNL·April 25, 2011
ACCU-CHEK COMFORT CURVE TEST STRIPS
FDA Adverse Event
Malfunction
·ROCHE DIAGNOSTICS·Product code LFR·August 14, 2008
LIFEPAK(R) 20E DEFIBRILLATOR/MONITOR
FDA Adverse Event
Malfunction
·PHYSIO-CONTROL, INC. - 3015876·Product code MKJ·September 25, 2018
4.5MM VA-LCP CURVED CONDYLAR PLATE/6 HOLE/159MM/RIGHT
FDA Adverse Event
Injury
·SYNTHES MEZZOVICO·Product code HRS·July 24, 2015