13 results
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18ms
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Sources: EU EUDAMED, US FDA
MODIFIED IMPLANT FOR XOMED AUDIANT BONE CONDUCTOR
FDA 510(k)
FDA Class 2
·Ear, Nose, Throat
Snowden-Pencer
FDA UDI
STERIS CORPORATION·10885403152825·Snowden-Pencer Plastics DIAMOND-TIP OSTEOTOMES ...
Arthrex®
FDA UDI
ARTHREX, INC.·00888867129313·LO-PRO SCRW,SS 4.0X 56MMCANCLUS
SCHEIN COTTON ROLLS, NON-STERILE
FDA 510(k)
FDA Class 1
·Dental
THERMOCOUPLE SENSORS, ACCESS. FOR ELECTRONIC THERM
FDA 510(k)
FDA Class 2
·General Hospital
8F ANGIO-SEAL VASCULAR CLOSURE DEVICE STS PLUS
FDA Adverse Event
Injury
·ST. JUDE MEDICAL·Product code MGB·October 20, 2010
2520274-2012-04292
FDA Adverse Event
Injury
·SYNTHES·Product code KWP·December 21, 2012
SUR-FIT NATURA 2 PC DURAHESIVE CONVEX MOLDABLE
FDA Adverse Event
Injury
·CONVATEC INC.·Product code EXE·June 9, 2014
Bayonet Forceps 7.-1/8 (181.0mm) 0.75mm Insulated Tips, Sterile Single Use Surgical/Bipolar Forceps, Model #20-1360I, 510 (k) #K884656. The surgical device is package one (s) per plastic Tyvek peel pouch, 10 plastic Tyvek peel pouches per box. Bipolar Forceps and Cords - Olsen Medical Bipolar Forceps and Cords are intended for use in coagulating tissue during surgical procedures.
FDA Enforcement
Class II
·Terminated·PSC Industries Inc·July 18, 2012
Bayonet Forceps 7.-1/8 (181.0mm) 0.75mm Non-Insulated Tips, Sterile Single Use Surgical/Bipolar Forceps, Model #20-1360K 510 (k) #K884656. The surgical device is package one (s) per plastic Tyvek peel pouch, 10 plastic Tyvek peel pouches per box. Bipolar Forceps and Cords - Olsen Medical Bipolar Forceps and Cords are intended for use in coagulating tissue during surgical procedures.
FDA Enforcement
Class II
·Terminated·PSC Industries Inc·July 18, 2012
Bayonet Forceps 7.-1/8 (181.0mm) 0.75mm Insulated Tips, Sterile Single Use Surgical/Bipolar Forceps, Model #20-1360I, 510 (k) #K884656. The surgical device is package one (s) per plastic Tyvek peel pouch, 10 plastic Tyvek peel pouches per box. Bipolar Forceps and Cords - Olsen Medical Bipolar Forceps and Cords are intended for use in coagulating tissue during surgical procedures.
FDA Recall
Terminated
·PSC Industries Inc·Product code GEI·June 1, 2012
Bayonet Forceps 7.-1/8 (181.0mm) 0.75mm Non-Insulated Tips, Sterile Single Use Surgical/Bipolar Forceps, Model #20-1360K 510 (k) #K884656. The surgical device is package one (s) per plastic Tyvek peel pouch, 10 plastic Tyvek peel pouches per box. Bipolar Forceps and Cords - Olsen Medical Bipolar Forceps and Cords are intended for use in coagulating tissue during surgical procedures.
FDA Recall
Terminated
·PSC Industries Inc·Product code GEI·June 1, 2012
Exactech Equinoxe REVERSE SHOULDER, 38mm Humeral Liner: a) +0mm, Item Number 320-38-00, b) +2.5mm, Item Number 320-38-03; Shoulder Arthroplasty
FDA Enforcement
Class II
·Ongoing·Exactech, Inc.·April 10, 2024