23 results
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23ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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NEXTSTITCH CARDIOVASCULAR VALVE SUTURE
FDA 510(k)
FDA Class 2
·General, Plastic Surgery
Custom Procedure Kit
FDA UDI
MEDIVATORS INC.·40677964012707·The ENDO CARRY-ON Procedure Kit contains all of...
LoFric®
FDA UDI
Wellspect AB·07333387033730·Single Use Urinary Catheter LoFric Nelaton 16" ...
artVeneer life
FDA UDI
Merz Dental GmbH·D7092001440·artVeneer life upper anteriors, BIM, D2
LoFric®
FDA UDI
Wellspect AB·07392532131844·Single Use Urinary Catheter LoFric Nelaton 16" ...
ODYSSEY®
FDA UDI
Microport Orthopedics Inc.·M684K00124401·
DIAMOND
FDA UDI
SPINAL ELEMENTS·00840916162078·4MM CERVICAL PLATE TAP
PedFuse®
FDA UDI
SPINEFRONTIER, INC.·00190361008477·PedFuse Respond, CNL, 7.0mm x 40mm
HARDYDISK CEFTRIAXONE 30MCG
FDA 510(k)
FDA Class 2
·Microbiology
IDS5 IMAGE DISPLAY SYSTEM
FDA 510(k)
FDA Class 2
·Radiology
TUFF IMPLANT
FDA Adverse Event
Injury
·NORIS MEDICAL LTD·Product code DZE·April 19, 2026
KINETRA
FDA Adverse Event
Malfunction
·MEDTRONIC MED REL MEDTRONIC PUERTO RICO·Product code MHY·October 11, 2012
CHARGING SYSTEM
FDA Adverse Event
Injury
·ST. JUDE MEDICAL - NEUROMODULATION·Product code LGW·March 5, 2013
ACCU-CHEK ® COMFORT CURVE TEST STRIPS
FDA Adverse Event
Malfunction
·ROCHE DIAGNOSTICS·Product code LFR·February 25, 2011
NOVAPLUS ALCOHOL PREP PAD
FDA Adverse Event
Malfunction
·TRIAD/NOVATION·Product code LKB·February 19, 2008
ACTIVA
FDA Adverse Event
Injury
·MEDTRONIC PUERTO RICO VILLALBA·Product code PJS·February 11, 2026
PriMatrix; Dermal Repair Scaffold; Rx Only; Sizes 0.2x26.5 cm (3 pack), 10x12cm, 10x25 cm, 20x25 cm, 4x4 cm, 6x6 cm, 8x12 cm, and 8x8 cm.
FDA Enforcement
Class II
·Ongoing·TEI Biosciences, Inc.·July 12, 2023
Li-Ion battery used in the Oxus Portable Oxygen Concentrator (POC), RS-00400. Also branded as Reliability Plus byDrive. The Portable Oxygen Concentrator is intended to deliver concentrated oxygen for adult patients with chronic pulmonary diseases.
FDA Enforcement
Class II
·Terminated·Oxus America, Inc.·February 13, 2013
PriMatrix¿ is an acellular dermal tissue matrix derived from fetal bovine dermis. The device is supplied sterile in a variety of sizes to be trimmed by the surgeon to meet the individual patient's needs.
FDA Enforcement
Class II
·Terminated·TEI Biosciences·January 24, 2018
Boston Scientific/Cameron Health SQ-RX Model 1010 subcutaneous pulse generators. The S-ICD System is intended to provide therapy for the treatment of life-threatening ventricular tachyarrhythmias.
FDA Enforcement
Class II
·Terminated·Boston Scientific CRM Corp·March 27, 2013