11 results
·
18ms
·
Sources: EU EUDAMED, US FDA
TRACH-COLLAR
FDA 510(k)
FDA Class 2
·Ear, Nose, Throat
SpheRx
FDA UDI
Nuvasive, Inc.·00887517121721·SpheRx® PPS Screw Tulip, 5.5mm Rod
n.a.
FDA UDI
Karl Storz GmbH & Co. KG·04048551198988·Indirect Laryngeal Biopsy Forceps
Symmetry Bunnell
FDA UDI
ASPEN SURGICAL PRODUCTS, INC.·00887482126547·Symmetry® Stripper, Bunnell Tendon, Round, 2.0 ...
BOSS Instruments
FDA UDI
BOSS INSTRUMENTS, LTD., INC.·00888515203402·Curette Excavator, DE, 1.5x2.0mm, 5 1/2" w/holes
Cumulus Remover
FDA 510(k)
FDA Class 2
·Obstetrics/Gynecology
PROGENIX PLUS
FDA 510(k)
FDA Class 2
·Orthopedic
8800
FDA Adverse Event
Malfunction
·GE OEC MEDICAL SYSTEMS (SLC)·Product code JAA·October 5, 2012
U BY KOTEX CLICK
FDA Adverse Event
Malfunction
·AVENT S. DE R.L. DE C.V.·Product code HEB·April 30, 2014
HARMONIC ACE 36 CM
FDA Adverse Event
Malfunction
·ETHICON ENDO-SURGERY, INC (CINCINNATI)·Product code LFL·January 30, 2008
OPTETRAK Comprehensive Knee System including OPTETRAK RBK PS Tibial Components. NOTE: Information reflects Exactech recall expansion initiated on 02/07/2022.
FDA Enforcement
Class II
·Ongoing·Exactech, Inc.·October 13, 2021