9 results
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25ms
·
Sources: EU EUDAMED, US FDA
MODIFIED THORACENTESIS CATHETER
FDA 510(k)
FDA Class 2
·General Hospital
ERA® Micro 17° DO Small Post Female SS
FDA UDI
STERNGOLD DENTAL LLC·00841549102011·This part contains: 1 female 1.3mm post diamete...
MSI
FDA UDI
Modern Surgical Instruments LLC·00810130203185·Lumbar K Style Curette 9 1/2” (241mm) Square Ha...
SYNTHES RIA SYSTEM (EXPANDED INDICATIONS)
FDA 510(k)
FDA Class 1
·Orthopedic
SYNERGY 4.0 MM, 4.5 MM VLS SCREWS
FDA 510(k)
FDA Class 2
·Orthopedic
LIGACLIP CLIP APPLIER
FDA Adverse Event
Malfunction
·ETHICON ENDO-SURGERY, LLC.·Product code GDO·May 15, 2014
FREESTYLE FLASH
FDA Adverse Event
Malfunction
·ABBOTT DIABETES CARE INC, USA·Product code LFR·October 30, 2007
PROTECTA XT CRT-D
FDA Adverse Event
Injury
·MEDTRONIC MED REL MEDTRONIC PUERTO RICO·Product code NIK·October 31, 2012
OPTETRAK Comprehensive Knee System including OPTETRAK Logic RBK PS Tibial Components (Product Line: 02-012-38-XXXX). NOTE: Information reflects Exactech recall expansion initiated on 02/07/2022.
FDA Enforcement
Class II
·Ongoing·Exactech, Inc.·October 13, 2021