9 results
·
18ms
·
Sources: EU EUDAMED, US FDA
One Step Sterile Lancet for Single Use (3 sizes): 06949517008861 30g 06949517008854 28g 06949517008847 23g The Lancing System is intended for the hygienic collection of capillary blood for testing purposes from the side of a fingertip and from alternative sites, such as the palm, the upper arm, and the forearm.
FDA Recall
Open, Classified
·Home Health US, Incorporated·Product code QRL·July 25, 2025
ECONO STERILE medical procedure kits labeled as: 1) ECONO STERILE D/A NAIL NIPPER 5.75" STER CS5, Model Number 96-2424A; 2) ECONO STERILE TISS NIPPER 14MM CVX 5"CS/25, Model Number 96-2427; 3) ECONO STERILE NAIL NIPPER 4.5" STERILE 25, Model Number 96-2666; 4) ECONO STERILE NAIL NIPPER FLD SPRG 4.5STER25, Model Number 96-2666A; 5) ECONO STERILE NAIL NIPPER 4 1/2" STERILE 50, Model Number 96-2667; 6) ECONO STERILE NAIL NIPPER BRL SPRG 5.5STER25, Model Number 96-2671A; nail procedures
FDA Recall
Open, Classified
·Sklar Instruments·Product code FZT·December 3, 2024
Embrace2- Indicated for use as an adjunct to seizure monitoring of adults and children age 6 and up in home or healthcare facilities during periods of rest. Models: (1) Flamingo Pink EM2-FP-S; (2) Sky Blue EM2-SB-2; (3) Seoul Grey EM2-SG-S; (4) Boston Blue EM2-BB-S; (5) Milan Black EM2-MB-S
FDA Recall
Open, Classified
·EMPATICA SRL Via Enrico Stendhal·Product code POS·July 13, 2023
Stryker Instruments REF 5452-007-000 SN ******* S2 MINI FOOT Pedal - Product Usage: The S2 Mini Drill System has been designed for the light drilling of bones as part of surgical operations such as stapedotomy or ossiculoplasty. The S2 Mini Drill System consists of a foot pedal and a drill, with an integrated micromotor, to drive various burs.
FDA Recall
Open, Classified
·Bien-Air Surgery Sa rue de l' ouest 2b Le Noirmont Switzerland·Product code ERL·September 11, 2020
Bien-Air Surgery REF 1600517-001 SN ******* MULTIFUNCTION PEDAL OSSEODUO - Product Usage: Product Usage: intended to convert electrical energy to mechanically drive attachment, microsaws, shaver blades and burs, burs and perforator tools for cutting and shaping bone including spine and cranium.
FDA Recall
Open, Classified
·Bien-Air Surgery Sa rue de l' ouest 2b Le Noirmont Switzerland·Product code ERL·September 11, 2020
Bien-Air Surgery REF 1600686-001 SN ******* OSSEOSTAP Footcontrol - Product Usage: an active medical device that convert electrical energy into mechanical rotation to a but during Ear, Nose and Throat (ENT) surgery.
FDA Recall
Open, Classified
·Bien-Air Surgery Sa rue de l' ouest 2b Le Noirmont Switzerland·Product code ERL·September 11, 2020
Entellus Medical REF SSA-102 SN ******* Shaver System Foot Pedal - Product Usage: The Entellus Medical Shaver System has been designed for shaping bone and for the resection of soft and hard tissues as part of surgical procedures in the areas of otorhinolaryngology.
FDA Recall
Open, Classified
·Bien-Air Surgery Sa rue de l' ouest 2b Le Noirmont Switzerland·Product code ERL·September 11, 2020
Bien-Air Surgery REF 1600407-001 SN **** FOOTCTRL OSSEODOC - Product Usage: intended to convert electrical energy to mechanically drive handpieces and microsaws used to cut and shape bones.
FDA Recall
Open, Classified
·Bien-Air Surgery Sa rue de l' ouest 2b Le Noirmont Switzerland·Product code ERL·September 11, 2020
REF: 99-709245, Fitbone Trochanteric Nail L245mm, D9mm, Sterile
FDA Recall
Open, Classified
·Orthofix Srl Via Delle Nazioni 9 Bussolengo Italy·Product code HSB·September 24, 2024