26 results
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20ms
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Sources: EU EUDAMED, US FDA
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Regulation: Us FDA
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Humeral Eccentric Reverse Metaphysis
FDA 510(k)
FDA Class 2
·Orthopedic
SHOULDER SYSTEM
FDA Adverse Event
Injury
·MEDACTA INTERNATIONAL SA·Product code PHX·December 27, 2024
VERSALOOP™ 2.5mm Reusable Awl
FDA UDI
T.A.G MEDICAL PRODUCTS AGRICULTURAL COOPERATIVE ASSOCIATION·10818674024928·
Hayden Medical
FDA UDI
Hayden Medical, Inc.·00840319706824·Cottle Osteotome 7" (17.5cm), 4mm wide, rounded...
DeBakey Vessel Probe 19cm 6.0mm
FDA UDI
Geister Medizintechnik GmbH·04057034047941·DeBakey Vessel Probe 19cm 6.0mm
InTess Lumbar Cage
FDA UDI
Kalitec Direct LLC·B07312K0102070·Shaver, Open 7mm
neoWave LS
FDA UDI
XENIX MEDICAL LLC·00818345023901·PADDLE SPREADER, 7MM
DeBakey Vascular Dilator 19cm 6.0mm
FDA UDI
Geister Medizintechnik GmbH·04057034047958·DeBakey Vascular Dilator 19cm 6.0mm
Dilator, Vascular, acc. DeBakey 19cm 6.0mm
FDA UDI
Geister Medizintechnik GmbH·04057034047965·Dilator, Vascular, acc. DeBakey
19cm 6...
Dilator, Vascular, acc. DeBakey 19cm 6.0mm #Custom-made product#
FDA UDI
Geister Medizintechnik GmbH·04057034292327·Dilator, Vascular, acc. DeBakey
19cm 6...
Coral
FDA UDI
Seaspine Orthopedics Corporation·10889981027650·Pedicle Hook Medium. The Coral Spinal System co...
Stainless Steel
FDA UDI
Seaspine Orthopedics Corporation·10889981028329·Pedicle Hook Medium. The Stainless Steel Spinal...
ALOKA PROUSOUND F75 DIAGNOSTIC ULTRASOUND SYSTEM
FDA 510(k)
FDA Class 2
·Radiology
PORTABLE INSTENSIVE CARE UNIT
FDA 510(k)
FDA Class 3
·Cardiovascular
INSPIRA SMOOTH SILICONE GEL FILLED BREAST IMPLANT
FDA Adverse Event
Injury
·ALLERGAN (COSTA RICA)·Product code FTR·December 13, 2024
PUMP MMT-722NAS PRDGM INS V2.2 SK EN
FDA Adverse Event
Injury
·MEDTRONIC PUERTO RICO OPERATIONA MED-REL·Product code LZG·October 22, 2008
SENSORMEDICS
FDA Adverse Event
Malfunction
·CAREFUSION·Product code LSZ·July 11, 2011
HEART START XL
FDA Adverse Event
Malfunction
·PHILIPS MEDICAL SYSTEMS·Product code MKJ·June 27, 2013
EVOLUT FX DCS
FDA Adverse Event
Injury
·MEDTRONIC HEART VALVES DIVISION·Product code NPT·May 31, 2023
VERICIS, Merge Cardio, Model/Catalog Number: Version 11.x, Software Version: 11.0.2, 11.0.3, 11.0.4, 11.1, 11.1.1; The VERICIS is an integrated cardiovascular information system classified as a picture archiving and communications system.
FDA Enforcement
Class II
·Ongoing·Merge Healthcare, Inc.·March 26, 2025