47 results
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24ms
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Sources: EU EUDAMED, US FDA
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Regulation: Us FDA
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P pro Crown & Bridge
FDA 510(k)
FDA Class 2
·Dental
ReLine
FDA UDI
Nuvasive, Inc.·00195377047229·RELINE-O Trial, 11mm H TP N L-pop
NanoBone® | granulate
FDA UDI
Biocomposites GmbH·14260418440390·Synthetic biodegradable bone graft substitute c...
OsteoMed
FDA UDI
OSTEOMED LLC·00845694026161·1.2mm Screw Depth Gauge
NeuRx DPS™ Surgical Site Start-up Kit
FDA UDI
Synapse Biomedical, Inc.·00852184003083·
Initia Total Hip System
FDA UDI
KYOCERA MEDICAL CORPORATION·04580810057082·"MXHO LINER 22-50
Size:22-50
Type:Elevated, HO
...
Hayden Medical
FDA UDI
Hayden Medical, Inc.·00840319721582·Cottle Nasal Speculum 6" (15cm), with set screw...
Initia Total Hip System
FDA UDI
KYOCERA CORPORATION·04547898307515·MXHO LINER 22-50
HIP Grasper, Right with Ratchet
FDA UDI
T.A.G MEDICAL PRODUCTS AGRICULTURAL COOPERATIVE ASSOCIATION·10818674029565·
Adaptive Biotechnologies clonoSEQ Assay
FDA 510(k)
FDA Class 2
·Pathology
INVIGRA MALE LATEX CONDOM YELLOW COLORED AND BANANA FLAVORED
FDA 510(k)
FDA Class 2
·Obstetrics/Gynecology
Shockwave Intravascular Lithotripsy System
FDA Pre-Market Approval
FDA Class 3
·Shockwave Intravascular Lithotripsy (IVL) System with Shockwave C2 Coronary Intravascular Lithotripsy (IVL) Catheter
Clarius Ultrasound Scanner
FDA UDI
Clarius Mobile Health Corp·07540205000854·Mobile cart with multi-port battery charger
ANIMAS INSULIN CARTRIDGE
FDA Adverse Event
Malfunction
·ANIMAS CORPORATION·Product code LZG·March 9, 2017
Shockwave Intravascular Lithotripsy System
FDA Pre-Market Approval
FDA Class 3
·Shockwave lntravascular Lithotripsy {IVL) System with Shockwave C2/ C2+/ C2 Aero Coronary IVL Catheter
Shockwave Intravascular Lithotripsy System
FDA Pre-Market Approval
FDA Class 3
·Shockwave Intravascular System with the C2/C2+ Coronary IVL Catheter
Shockwave Intravascular Lithotripsy System
FDA Pre-Market Approval
FDA Class 3
·Shockwave Intravascular Lithotripsy (IVL) Generator, Shockwave Intravascular Lithotripsy (IVL) System with Shockwave C2
Shockwave Intravascular Lithotripsy System
FDA Pre-Market Approval
FDA Class 3
·Shockwave Intravascular Lithotripsy (IVL) System with Shockwave C2 IVL Catheter
Shockwave Intravascular Lithotripsy System
FDA Pre-Market Approval
FDA Class 3
·Shockwave Intravascular Lithotripsy (IVL) System with Shockwave C2+ Coronary Intravascular Lithotripsy (IVL) Catheter
Shockwave Intravascular Lithotripsy System
FDA Pre-Market Approval
FDA Class 3
·Shockwave Intravascular Lithotripsy (IVL) System with Shockwave C2 Coronary Intravascular Lithotripsy (IVL) Catheter