263 results
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15ms
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Sources: EU EUDAMED, US FDA
Covidien Sonicision Reusable Generator-converts electrical power from the battery pack to ultrasonic energy to drive the active blade. Product Number: SCGAA
FDA Enforcement
Class II
·Terminated·Covidien Llc·August 18, 2021
Polysorb Braided Absorbable Suture 2/0 30 VIOLET GS-21, Item Code CL811 - Product Usage: Indicated for use in soft tissue approximation or ligation and ophthalmic surgery, but not in cardiovascular or neural tissue.
FDA Enforcement
Class II
·Terminated·Covidien LLC·February 26, 2020
Polysorb Braided Absorbable Suture 1 30 VIOLET GS-22, Item Code CL885 - Product Usage: Indicated for use in soft tissue approximation or ligation and ophthalmic surgery, but not in cardiovascular or neural tissue.
FDA Enforcement
Class II
·Terminated·Covidien LLC·February 26, 2020
Polysorb Braided Absorbable Suture 13-0 VIOLET 30" GS-23, Item Code CL892 - Product Usage: Indicated for use in soft tissue approximation or ligation and ophthalmic surgery, but not in cardiovascular or neural tissue.
FDA Enforcement
Class II
·Terminated·Covidien LLC·February 26, 2020
Polysorb Braided Absorbable Suture 1 36 VIOLET GS-21, Item Code CL925 - Product Usage: Indicated for use in soft tissue approximation or ligation and ophthalmic surgery, but not in cardiovascular or neural tissue.
FDA Enforcement
Class II
·Terminated·Covidien LLC·February 26, 2020
Polysorb Braided Absorbable Suture 2-0 UNDYED 36" GS-21, Item Code CL953 - Product Usage: Indicated for use in soft tissue approximation or ligation and ophthalmic surgery, but not in cardiovascular or neural tissue.
FDA Enforcement
Class II
·Terminated·Covidien LLC·February 26, 2020
8Fr SAFE GRAD CAT W/Valve (Argyle Suction Catheter Kits with Chimney Valve), Model Number 36826
FDA Enforcement
Class II
·Terminated·COVIDIEN LLC·December 26, 2018
Covidien Precision Specimen Container- 4 oz (118 mL), Plastic Screw Top Cap, OR Packaged, Sterile Item Code: 17099
FDA Enforcement
Class II
·Terminated·Covidien LLC·December 21, 2016
Dermacea Gauze Fluff Roll, 6 Ply, 4 x 4-1/8 yd (10.2 cm x 3.7 m), REF 441106 Product Usage: Used as both primary and secondary dressing for bandaging heads, limbs and difficult-to-dress wounds.
FDA Enforcement
Class II
·Terminated·COVIDIEN LLC·October 10, 2018
Rechargeable Li-ion battery used with Puritan Bennett TM 980 Series Ventilator System including Pediatric-Adult Ventilator, Neonatal Ventilator, Universal Ventilator; Battery Product Number: 10086042; UDI: 20884521700861 The rechargeable lithium-ion batteries are intended to provide a backup power source to the ventilator in case AC power is lost.
FDA Enforcement
Class II
·Terminated·Covidien LLC·April 4, 2018
HALO Flex Energy Generators Manufactured by B¿RRX Medical (now Covidien) 540 Oakmead Parkway Sunnyvale, CA 95085. The HALO Flex Energy Generator is indicated for use for the coagulation of soft tissue. The HALO Flex System is indicated for use in the coagulation of bleeding and non-bleeding sites in the gastrointestinal tract including but not limited to, the esophagus, including Barrett's Esophagus.
FDA Enforcement
Class II
·Terminated·Covidien LLC·September 26, 2012
Palindrome Precision SI Chronic Catheter Kit 14.5 Fr x 55cm Item Code: 8888145066CP
FDA Enforcement
Class II
·Terminated·Covidien LLC·July 8, 2015
Palindrome SI Chronic Catheter Kit w/VenaTrac Stylet 14.5 Fr x 28cm Item Code: 8888145064C
FDA Enforcement
Class II
·Terminated·Covidien LLC·July 8, 2015
Palindrome SI Chronic Catheter Sport Pack w/VenaTrac Stylet 14.5 Fr x 28cm Item Code: 8888128458
FDA Enforcement
Class II
·Terminated·Covidien LLC·July 8, 2015
Palindrome Precision SI Chronic Catheter Kit 14.5 Fr x 55cm Item Code: 8888145066CP
FDA Enforcement
Class II
·Terminated·Covidien LLC·July 8, 2015
Palindrome HSI Chronic Catheter Kit w/VenaTrac Stylet 14.5 Fr x 28cm Item Code:8888145049C
FDA Enforcement
Class II
·Terminated·Covidien LLC·July 8, 2015
Palindrome Precision SI Chronic Catheter Kit w/VenaTrac Stylet 14.5 Fr x 33cm Item Code: 8888145065P
FDA Enforcement
Class II
·Terminated·Covidien LLC·July 8, 2015
Palindrome Precision HSI Chronic Catheter Kit w/VenaTrac Stylet 14.5 Fr x 19cm Item Code: 8888145057CP
FDA Enforcement
Class II
·Terminated·Covidien LLC·July 8, 2015
Palindrome SI Chronic Catheter Kit w/VenaTrac Stylet 14.5 Fr x 28cm Item Code:8888145064
FDA Enforcement
Class II
·Terminated·Covidien LLC·July 8, 2015
Palindrome HSI Chronic Catheter Kit w/VenaTrac Stylet 14.5 Fr x 23cm Item Code: 8888145048C
FDA Enforcement
Class II
·Terminated·Covidien LLC·July 8, 2015