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CARDIO KIT

FDA Adverse Event
Malfunction ·MEDTRONIC, INC.·Product code OEU·September 8, 2011

Medtronic One Source Pack Magellan, Catalog Number: COS310. Kits are packaging convenience kits containing previously released sterile-pack products and accessories. Medtronic Ideal MAXPAC Total System

FDA Recall
Terminated ·Medtronic Cardiovascular Revascularization & Surgical Therap·Product code OEU·March 23, 2009

Medtronic Ideal MAXPAC Total System, Catalog Numbers: TS1262R6, TS1262R7, TS1420R, TS1420R1, TS1442R, TS1446R, TS1464T, TS1470R, TS1470T1, TS1480R3, TS1480R5, TS1480R6, TS1487R, TS1487R2, TS8040R28, TS8108R6, TS8163R10, TS8387R5, TS9412R3, TS9453R28, TS9764R9, TS9800R28, TS9800R29, TS9800R31, TS9987R33 and TS9987R34. Sterile and nonpyrogenic, EtO or Gamma Sterilized. Medtronic Purfusion Systems. Kits are packaging convenience kits containing previously released sterile-pack products and accessories.

FDA Recall
Terminated ·Medtronic Cardiovascular Revascularization & Surgical Therap·Product code OEU·March 23, 2009

Medtronic One Source Pack, Catalog Numbers: ATLS21, ATLS24, ATLS2469, EC1S24, EC2S00, EC2S24, EE1S048 and EE2S21. Kits are packaging convenience kits containing previously released sterile-pack products and accessories.

FDA Recall
Terminated ·Medtronic Cardiovascular Revascularization & Surgical Therap·Product code OEU·March 23, 2009

Cardiopulmonary Bypass Catheter Kit

FDA classification
FDA Class 2 ·Cardiopulmonary Bypass Catheter Kit

OEB S.R.L.

FDA registration
OEB S.R.L.·22 products·🇮🇹 Italy

OEM DEVELOPMENT

FDA registration
OEM DEVELOPMENT·1 product·🇫🇷 France

Optim 1 (EU)

FDA UDI
Virox Technologies Inc·07640185070738·

VentStar Resuscitaire CEU

FDA UDI
Drägerwerk AG & Co. KGaA·04048675026600·

BBI SOLUTIONS OEM LIMITED

FDA registration
BBI SOLUTIONS OEM LIMITED·5 products·🇬🇧 United Kingdom

Teleflex Medical OEM LLC

FDA registration
Teleflex Medical OEM LLC·8 products·🇺🇸 United States

Medzah OEM Pvt. Ltd.

FDA registration
Medzah OEM Pvt. Ltd.·4 products·🇵🇰 Pakistan

OEM SYSTEMS CO. LTD.

FDA registration
OEM SYSTEMS CO. LTD.·6 products·🇯🇵 Japan

GE OEC MEDICAL SYSTEMS, INC

FDA registration
GE OEC MEDICAL SYSTEMS, INC·4 products·🇺🇸 United States

Ultra PC % Package D, EU

FDA UDI
ACCUTRON, INC.·00813830025439·

AEU-14CF EXPENDITION

FDA 510(k)
FDA Class 1 ·Dental

WiScope®

FDA UDI
Otu Medical Inc.·00850023925336·Single-Use Digital Flexible Ureteroscope

WiScope®

FDA UDI
Otu Medical Inc.·00850023925428·Single-Use Digital Flexible Cystoscope

WiScope®

FDA UDI
Otu Medical Inc.·00850023925282·Image System, adapting to a monitor of 16:9 asp...

WiScope®

FDA UDI
Otu Medical Inc.·00850023925299·Single-Use Digital Flexible Ureteroscope/Choled...