15 results
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23ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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Longeviti PorousFit implant
FDA 510(k)
FDA Class 2
·General, Plastic Surgery
MEDI
FDA UDI
MEDI MANUFACTURING, INC.·00636257073438·PROTECT PATELLA TRACKING BRACE, LT, XL
24M - Duke Energy FA/BBP
FDA UDI
Certified Safety Manufacturing, Inc.·00766588015149·24M - Duke Energy FA/BBP
ALEUTIAN® Interbody Systems
FDA UDI
VB Spine LLC·10888857308084·Parallel Rasp Size; 18x45x19 mm
INSTRUMENTS FOR ONE TIME USE - DISPOSABLE
FDA 510(k)
FDA Class 1
·General, Plastic Surgery
SBV2, MULTICHARGER MODEL MC10V2
FDA 510(k)
FDA Class 2
·Neurology
SYRINGE 5ML SALINE FILL CHINA SP
FDA Adverse Event
Malfunction
·BECTON DICKINSON·Product code NGT·August 14, 2025
PRECISION XTRA
FDA Adverse Event
Malfunction
·Product code NBW·August 15, 2011
ACRYSOF TORIC
FDA Adverse Event
Other
·ALCON RESEARCH, LTD./HUNTINGDON·Product code MJP·October 17, 2008
ANIMAS INSULIN INFUSION PUMP
FDA Adverse Event
Injury
·ANIMAS CORPORATION·Product code LZG·July 8, 2013
NSK
FDA Adverse Event
Injury
·NAKANISHI INC.·Product code KMW·April 25, 2022
NSK
FDA Adverse Event
Injury
·NAKANISHI INC.·Product code KMW·July 7, 2022
Dragonfly OpStar Imaging Catheter, REF 1014651/1014652, 0.068 in, 0.014 in, 135 cm, STERILE EO
FDA Enforcement
Class I
·Ongoing·Abbott Vascular·May 25, 2022
ACUSON S 1000, ACUSON S 2000, or ACUSON S 3000 ultrasound systems with software version C3, C3, C3, or C1. Model numbers: 10041461, 10440017 S 2000 system 10441730 S 3000 system 10441701 S 1000 system Radiology: The ultrasound imaging systems are intended for the following applications: Fetal, Abdominal, Intraoperative, Pediatric, Small Parts, Transcranial, OB/GYN, Cardiac, Pelvic, Neonatal/Adult Cephalic, Vascular, Musculoskeletal, Superficial Musculoskeletal, and Peripheral Vascular applications.
FDA Enforcement
Class II
·Terminated·Siemens Medical Solutions USA, Inc.·August 5, 2015
Veradius Unity with Software Release 2.1- Amobile, diagnostic X-ray imaging and viewing system. . Model Number: 718132
FDA Enforcement
Class II
·Ongoing·Philips North America Llc·December 15, 2021