15 results
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21ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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PEEK FUSION IMPLANT
FDA 510(k)
FDA Class 2
·Orthopedic
General Instruments
FDA UDI
ALPHATEC SPINE, INC.·00840180519097·Adjustable Vertebral Body Retractor w/ Light Tr...
ELATION® MB
FDA UDI
DENTSPLY SIRONA ORTHODONTICS INC.·D807K133551621·ELATION® MB Base Rx 018 UL/5-5 CS-BC HK
STILLE Gouges
FDA UDI
Stille AB·07332339206666·GOUGE ORIGINAL STILLE 15 mm 21 cm 8.25 in
MADA MEDICAL PRODUCTS, INC.
FDA UDI
MADA MEDICAL PRODUCTS, INC·00815160020962·A device that is connected to an independent su...
Complete Cervical
FDA UDI
Seaspine Orthopedics Corporation·10889981040895·Screw - Self-Tapping - 3.5x15mm
HUBERPRO SAFETY HUBER INFUSION SET
FDA 510(k)
FDA Class 2
·General Hospital
EQUAL DOSE
FDA 510(k)
FDA Class 2
·Radiology
PARADIGM REAL-TIME REVEL INSULIN INFUSION PUMP
FDA Adverse Event
Malfunction
·MEDTRONIC PUERTO RICO OPERATIONS CO.·Product code OYC·May 29, 2013
UNKNOWN ZIMMER KNEE IMPLANT
FDA Adverse Event
Injury
·ZIMMER INC.·Product code JWH·June 15, 2011
J-VAC RESERVOIR
FDA Adverse Event
Malfunction
·ETHICON, INC.·Product code GCY·August 21, 2008
MIDAS REX MR8
FDA Adverse Event
Malfunction
·MDT POWERED SURGICAL SOLUTIONS·Product code HBC·May 9, 2025
MOTOR MR8 ELECTRIC
FDA Adverse Event
Malfunction
·MDT POWERED SURGICAL SOLUTIONS·Product code HBB·February 24, 2022
GXL acetabular liners, orthopedic hip implant component. Product Line Numbers: a. GXL NEUTRAL LINER, G0 28MM ID, 130-28-50; b. GXL NEUTRAL LINER, G00 22MM ID, 130-22-70; c. NOVATION GXL LIPPED LINER, G0 28MM ID, 132-28-50; d. NOVATION GXL LIPPED LINER, G00 22MM ID, 132-22-70;
FDA Enforcement
Class II
·Ongoing·Exactech, Inc.·September 21, 2022
Azurion 7 M20; System Code: (1)722079, (2)722224, (3)722234, (4)722282 (OUS only);
FDA Enforcement
Class II
·Ongoing·PHILIPS MEDICAL SYSTEMS NEDERLAND B.V.·April 8, 2026