Company
COVIDIEN MEDTRONIC
FDA 510(k) clearances and medical device recalls filed under this name. Name variants (Inc, Corp, punctuation) are merged.
0510(k) clearances (0 in 12 months)
55recalls (0 in 12 months)
44recalls that name a 510(k)
Product codes
Latest 510(k) clearances
| Decided | 510(k) | Device and applicant | Code |
|---|---|---|---|
| No clearances in this window. | |||
Latest recalls
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Jul 19, 2018 | COVIDIEN MEDTRONIC Tri-Staple 2.0 Curved Tip Intelligent Reload for use with Signia stapling system , Item Code EGIA30CTAV Open, Classified |
GDW | None listed |
| Jul 19, 2018 | COVIDIEN MEDTRONIC Tri-Staple 2.0 Curved Tip Intelligent Reload for use with Signia stapling system 45 mm Vascular/Medium, Item Code SIG45ACTAVM Open, Classified |
GDW | None listed |
| Jul 19, 2018 | COVIDIEN MEDTRONIC Tri-Staple 2.0 Curved Tip Intelligent Reload for use with Signia stapling system 30 mm Vascular/Medium, Item Code SIG30ACTAVM Open, Classified |
GDW | None listed |
| Jul 19, 2018 | COVIDIEN MEDTRONIC Tri-Staple 2.0 Intelligent Reload for use with Signia stapling system 30 mm
Medium/Thick, Item Code SIG30AMT Open, Classified |
GDW | None listed |
| Jul 19, 2018 | COVIDIEN MEDTRONIC Endo GIA 45mm Curved Tip Articulating Vascular/Medium Reload with Tri-Staple Technology, Item Code EGIA45CTAVM Open, Classified |
GDW | None listed |
| Jul 19, 2018 | COVIDIEN MEDTRONIC Endo GIA 45 mm Articulating Vascular/Medium Loading Unit with Tri-Staple Technology, Item Code EGIA454AVM Open, Classified |
GDW | None listed |
| Jul 19, 2018 | COVIDIEN MEDTRONIC Endo GIA 45 mm Extra Thick Black Articulating Reload with Tri-Staple Technology, Item Code EGIA45AXT Open, Classified |
GDW | None listed |
| Jul 19, 2018 | COVIDIEN MEDTRONIC Endo GIA 45mm Gray Articulating Vascular Reload with Tri-Staple Technology, Item Code EGIA45AV Open, Classified |
GDW | None listed |
| Jul 19, 2018 | COVIDIEN MEDTRONIC Tri-Staple 2.0 Intelligent Reload for use with Signia stapling system 30 mm
Vascular/Medium, Item Code SIG30AVM Open, Classified |
GDW | None listed |
| Jul 19, 2018 | COVIDIEN MEDTRONIC Tri-Staple 2.0 Black Intelligent Reload for use with Signia stapling system 60 mm Extra Thick, Item Code SIG60AXT Open, Classified |
GDW | None listed |
| Jul 19, 2018 | COVIDIEN MEDTRONIC Endo GIA 60 mm Articulating Vascular/Medium Loading Unit with Tri-Staple
Technology, Item Code EGIA60AVM Open, Classified |
GDW | None listed |
| Jul 19, 2018 | COVIDIEN MEDTRONIC Endo GIA 60 mm Extra Thick Black Articulating Reload with Tri-Staple Technology, Item Code EGIA60AXT Open, Classified |
GDW | K111825 |
| Jul 19, 2018 | COVIDIEN MEDTRONIC Endo GIA 60 mm Articulating Medium/Thick Reload with Tri-StapleTechnology, Item Code EGIA60AMT Open, Classified |
GDW | K111825 |
| Jul 19, 2018 | COVIDIEN MEDTRONIC Endo GIA 45 mm Articulating Medium/Thick Reload with Tri-Staple Technology, Item Code EGIA45AMT Open, Classified |
GDW | K111825 |
| May 16, 2018 | COVIDIEN MEDTRONIC BOX VWR ZESTAW DO VATS KLIN
Product Usage:
The Endo GIA universal and Endo GIA universal XL staplers place two, triple-staggered rows of titanium staples and simultaneously divides the tissue betwe Terminated |
GDW | K111825 |
| May 16, 2018 | COVIDIEN MEDTRONIC BOX VMIN ZESTAW DO VATS PODSTAWOWY
Product Usage:
The Endo GIA universal and Endo GIA universal XL staplers place two, triple-staggered rows of titanium staples and simultaneously divides the tissu Terminated |
GDW | K111825 |
| May 16, 2018 | COVIDIEN MEDTRONIC BOX VATS1SCDX DO ZABIEGOW VATS
Product Usage:
The Endo GIA universal and Endo GIA universal XL staplers place two, triple-staggered rows of titanium staples and simultaneously divides the tissue be Terminated |
GDW | K111825 |
| May 16, 2018 | COVIDIEN MEDTRONIC BOX TGGLOGOWX1 DO TOTAL GASTRECTOMIII
Product Usage:
The Endo GIA universal and Endo GIA universal XL staplers place two, triple-staggered rows of titanium staples and simultaneously divides the ti Terminated |
GDW | K111825 |
| May 16, 2018 | COVIDIEN MEDTRONIC (1)BOX SLEEVEGK3
(2) BOX SLEEVEGK4 SLEEVE GASTRECTOMY
(3)BOX SLEEVEJAWI SLEEVE GASTRECTOMY BOX
(4) SSLEEVE ZEST DO SLEEVE GASTREKTOMIIX1
Product Usage:
The Endo GIA universal Terminated |
GDW | K111825 |
| May 16, 2018 | COVIDIEN MEDTRONIC SLEEVEGK1 ZESTAW DO ZABIEGOW SLEEVEX1
Product Usage:
The Endo GIA universal and Endo GIA universal XL staplers place two, triple-staggered rows of titanium staples and simultaneously divides the ti Terminated |
GDW | K111825 |
| May 16, 2018 | COVIDIEN MEDTRONIC (1)BOX PST04089 SLEEVE AIWA CLINIC
Item Number:PST04089 SLEEVE AIWA CLINIC
(2)BOX PST04090 BYPASS AIWA CLINIC
Item Number: PST04090 BYPASS AIWA CLINIC
Product Usage: Terminated |
GDW | K111825 |
| May 16, 2018 | COVIDIEN MEDTRONIC BOX PST03699 KIT APP MED ALTERNATIV STAP
Product Usage:
The Endo GIA universal and Endo GIA universal XL staplers place two, triple-staggered rows of titanium staples and simultaneously divides the Terminated |
GDW | K111825 |
| May 16, 2018 | COVIDIEN MEDTRONIC BOX PST03533 KIT APP STAPLER
Product Usage:
The Endo GIA universal and Endo GIA universal XL staplers place two, triple-staggered rows of titanium staples and simultaneously divides the tissue betw Terminated |
GDW | K111825 |
| May 16, 2018 | COVIDIEN MEDTRONIC MGBX ZESTAW GB LS X1
Product Usage:
The Endo GIA universal and Endo GIA universal XL staplers place two, triple-staggered rows of titanium staples and simultaneously divides the tissue between the Terminated |
GDW | K111825 |
| May 16, 2018 | COVIDIEN MEDTRONIC (1)BOX PST01199 BARIATRIC TRISTAPLE (Item Number: PST01199)
(2) BOX PST03403 ALTERNATIVE APPENDIX KIT (Item Number: PST03403)
(3) BOX PST03533 KIT APP STAPLER (Item Number Terminated |
GDW | K111825 |
| May 16, 2018 | COVIDIEN MEDTRONIC BOX MGBGLOGX1 ZESTAW MINI GASTRIC BYPASS
Product Usage:
The Endo GIA universal and Endo GIA universal XL staplers place two, triple-staggered rows of titanium staples and simultaneously divides the Terminated |
GDW | K111825 |
| May 16, 2018 | COVIDIEN MEDTRONIC (1) BOX LAPZD ZESTAW DO SG
(2) BOX LAPISG1 ZESTAW DO SG
(3) BOX LAPISGW ZESTAW DO SG
Product Usage:
The Endo GIA universal and Endo GIA universal XL staplers place two, triple-staggere Terminated |
GDW | K111825 |
| May 16, 2018 | COVIDIEN MEDTRONIC BOX LAPIMBGP1 ZESTAW DO MGBP (LAPIMBGP1)
Product Usage:
The Endo GIA universal and Endo GIA universal XL staplers place two, triple-staggered rows of titanium staples and simultaneously divides th Terminated |
GDW | K111825 |
| May 16, 2018 | COVIDIEN MEDTRONIC (1)LAPBARLECZNA ZESTAW BARIATRYCZNY LECZNA
(2) KITBAR021- BARIATRIC KIT X1
Item Code:KITBAR021- BARIATRIC KIT X0
(3)BOX SGGLOGX1 ZESTAW DO BARIATRII
Item Code: SGGLOGX1 ZESTAW DO BARIATRII
( Terminated |
GDW | K111825 |
| May 16, 2018 | COVIDIEN MEDTRONIC (1)BOX KITDE0183 APPENDIX LIPPE DETMOLD (KITDE0183)
(2) KIT-DE-0083 APPENEKTOMIE KIT NAUENX1
(Item Number: KIT-DE-0083,KIT-DE-0083 APPENEKTOMIE KIT NAUENX1
Product Usage:
The Endo GIA universal an Terminated |
GDW | K111825 |
| May 16, 2018 | COVIDIEN MEDTRONIC (1) BOX KITDE0143 BYPASS BOX (Item Number: KITDE0143,
KITDE0143 BYPASS BOX)
(2) BOX KITDE0154 BYPASS KH NORDWEST
(Item Number: KITDE0154, KITDE0154 BYPASS KH NORDWEST
Product Usage: Terminated |
GDW | K111825 |
| May 16, 2018 | COVIDIEN MEDTRONIC BOX KITDE0108 BYPASS KIT LUEBECK ( KITDE0108)
Product Usage:
The Endo GIA universal and Endo GIA universal XL staplers place two, triple-staggered rows of titanium staples and simultaneously divide Terminated |
GDW | K111825 |
| May 16, 2018 | COVIDIEN MEDTRONIC (1)KIT4184 APEN LOBECTOMY KIT X0
Item Number: KIT4184 APEN LOBECTOMY KIT XO
(2) BOX VATSLOB11 ZESTAW DO VATS LOBECTOMII
(Item Number: VATSLOB11, VATSLOB11 ZESTAW DO VATS LOBECTOMII
P Terminated |
GDW | K111825 |
| May 16, 2018 | COVIDIEN MEDTRONIC KIT-DE-0080 BYPASS KIT LOHNE X1( Item KIT-DE-0080)
Product Usage:
The Endo GIA universal and Endo GIA universal XL staplers place two, triple-staggered rows of titanium staples and simultaneously d Terminated |
GDW | K111825 |
| May 16, 2018 | COVIDIEN MEDTRONIC BOX KIT1171C KIT LAP CYSTECTOMY
Product Usage:
The Endo GIA universal and Endo GIA universal XL staplers place two, triple-staggered rows of titanium staples and simultaneously divides the tissue b Terminated |
GDW | K111825 |
| May 16, 2018 | COVIDIEN MEDTRONIC BOX KIT00714 KIT SLEEVE
Product Usage:
The Endo GIA universal and Endo GIA universal XL staplers place two, triple-staggered rows of titanium staples and simultaneously divides the tissue between t Terminated |
GDW | K111825 |
| May 16, 2018 | COVIDIEN MEDTRONIC BOX KIT00713 KIT BY PASS
Product Usage:
The Endo GIA universal and Endo GIA universal XL staplers place two, triple-staggered rows of titanium staples and simultaneously divides the tissue between Terminated |
GDW | K111825 |
| May 16, 2018 | COVIDIEN MEDTRONIC KIT00486R OBESIDAD D. WORWARLD 2 X1
(Item Number KIT00486R)
Product Usage:
The Endo GIA universal and Endo GIA universal XL staplers place two, triple-staggered rows of titanium staples Terminated |
GDW | K111825 |
| May 16, 2018 | COVIDIEN MEDTRONIC (1)BOX HEMIGX1 ZESTAW DO HEMICOLECTOMII
(Item Number HEMIGX1 ZESTAW DO HEMICOLECTOMII)
(2) BOX LAPPH ZASTAW DO PRAWEJ HEMIKOLEKTOMI
(item number: LAPPH ZASTAW DO PRAWEJ HEMIKOLEKTOMI
Product Terminated |
GDW | K111825 |
| May 16, 2018 | COVIDIEN MEDTRONIC (1) BOX BOX1073180 APPE1 APPENDIX KIT ZAMS
(Item Code BOX1073180)
(2)BOX BOX1073180APPE1 APPENDIX KIT ZAMS
(Item Code BOX1073180APPE1 APPENDIX KIT ZAMS)
Product Usage:
The Endo GIA Terminated |
GDW | K111825 |
| May 16, 2018 | COVIDIEN MEDTRONIC BOX1073076GASB1 BBR GASTRIC BYPASS S(Item Code BOX1073076GASB1 BBR GASTRIC BYPASS S)
Product Usage:
The Endo GIA universal and Endo GIA universal XL staplers place two, triple-staggered rows of tita Terminated |
GDW | K111825 |
| May 16, 2018 | COVIDIEN MEDTRONIC (1) BOX 01KBAR006116V PROC BYPASS 01KBAR0061(Item Code 01KBAR006116V PROC BYPAS)
(2) BOX 1073076GASB0 BBR STVEIT GASTRIC B (Item Code BOX1073076GASB0)
(3) BOX BOX1073076GASB0 BBR STVEIT GASTRIC Terminated |
GDW | K111825 |
| May 16, 2018 | COVIDIEN MEDTRONIC BOX KIT1095V KIT OBESITAS (Item Code KIT1095V)
Product Usage:
The Endo GIA universal and Endo GIA universal XL staplers place two, triple-staggered rows of titanium staples and simultaneously divide Terminated |
GDW | K111825 |
| May 16, 2018 | COVIDIEN MEDTRONIC Covidien" Best Practices" Procedure Kits containing Auto Suture" Endo GIA" Devices
Product Usage:
The Endo GIA universal and Endo GIA universal XL staplers place two, triple-staggered rows of tit Terminated |
GDW | K111825 |
| May 16, 2018 | COVIDIEN MEDTRONIC Endo GIA" 45mm Gray Curved Tip Articulating Vascular Reload with Tri-Staple" Technology( Item Code EGIA45CTAV)
Product Usage:
The Endo GIA universal and Endo GIA universal XL staplers place two, tr Terminated |
GDW | K111825 |
| May 16, 2018 | COVIDIEN MEDTRONIC Endo GIA" 30mm Gray Curved Tip Articulating Vascular Reload with Tri-Staple" Technology( Item Code EGIA30AV)
Product Usage:
The Endo GIA universal and Endo GIA universal XL staplers place two, trip Terminated |
GDW | K111825 |
| May 16, 2018 | COVIDIEN MEDTRONIC Endo GIA" 30mm Gray Curved Tip Articulating Vascular Reload with Tri-Staple" Technology( Item Code EGIA30CTAV)
Product Usage:
The Endo GIA universal and Endo GIA universal XL staplers place two, tr Terminated |
GDW | K111825 |
| May 16, 2018 | COVIDIEN MEDTRONIC Endo GIA" Auto Suture" Universal Articulating Loading Unit 60mm - 3.5mm ( Item Code 030458)
Product Usage:
The Endo GIA universal and Endo GIA universal XL staplers place two, triple-staggered row Terminated |
GDW | K111825 |
| May 16, 2018 | COVIDIEN MEDTRONIC Endo GIA" Auto Suture" Universal Articulating Loading Unit 60mm -2.5mm ( Item Code 030457)
Product Usage:
The Endo GIA universal and Endo GIA universal XL staplers place two, triple-staggered rows Terminated |
GDW | K111825 |
| May 16, 2018 | COVIDIEN MEDTRONIC Endo GIA" Auto Suture" Universal Articulating Loading Unit 45mm- 3.5mm( Item Code 030455)
Product Usage:
The Endo GIA universal and Endo GIA universal XL staplers place two, triple-staggered rows Terminated |
GDW | K111825 |
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