36 results
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8ms
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Sources: EU EUDAMED, US FDA
Filters
Classification: Class Ii
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Knee Scope Pack, part number AMS2498(A Knee Scope Pack, part number AMS2498(B Knee Scope Pack, part number AMS2498(C
FDA Enforcement
Class II
·Terminated·Windstone Medical Packaging, Inc.·March 8, 2017
OSCOR ADELANTE BREEZWAY 8F STRAIGHT S79CM D84CM Catalog # AB081211 Is designed to facilitate the introduction of catheters to any of the heart chambers, including the left atrium via a transseptal puncture.
FDA Enforcement
Class II
·Terminated·Oscor, Inc.·December 28, 2016
OSCOR ADELANTE BREEZEWAY 8F C55¿ S61CM D66CM Catalog # AB081040 Is designed to facilitate the introduction of catheters to any of the heart chambers, including the left atrium via a transseptal puncture.
FDA Enforcement
Class II
·Terminated·Oscor, Inc.·December 28, 2016
Knee Arthroscopy Pack , part number AMS2610(A Knee Arthroscopy Pack, part number AMS3236(A Knee Arthroscopy Pack, part numbre AMS3860
FDA Enforcement
Class II
·Terminated·Windstone Medical Packaging, Inc.·March 8, 2017
Arthroscopy Pack, part number AMS2938 Arthroscopy Pack, part number AMS3639 Arthroscopy Pack, part number AMS4765 Arthroscopy Pack, part number PSS1799 Arthroscopy Pack, part number PSS1845(A
FDA Enforcement
Class II
·Terminated·Windstone Medical Packaging, Inc.·March 8, 2017
Bayview Abdominoplasty Pack, part number 009079-1
FDA Enforcement
Class II
·Terminated·Windstone Medical Packaging, Inc.·March 8, 2017
General Surgery Pack, part number PSS1380(A
FDA Enforcement
Class II
·Terminated·Windstone Medical Packaging, Inc.·March 8, 2017
Peri GYN, part number PSS2193(A
FDA Enforcement
Class II
·Terminated·Windstone Medical Packaging, Inc.·March 8, 2017
HSG Pack, part number PSS3287
FDA Enforcement
Class II
·Terminated·Windstone Medical Packaging, Inc.·March 8, 2017
21Y14 PushValve Product Usage: The PushValves/ MagValves is intended exclusively for the prosthetic fitting of lower limb amputees. The valve is a threadless one-way valve. It is used to evacuate air from the prosthetic socket.
FDA Enforcement
Class II
·Terminated·Ottobock Orthopedic Industrie·February 20, 2019
21Y15 MagValve Product Usage: The PushValves/ MagValves is intended exclusively for the prosthetic fitting of lower limb amputees. The valve is a threadless one-way valve. It is used to evacuate air from the prosthetic socket.
FDA Enforcement
Class II
·Terminated·Ottobock Orthopedic Industrie·February 20, 2019
21Y14=S PushValve upper part Product Usage: The PushValves/ MagValves is intended exclusively for the prosthetic fitting of lower limb amputees. The valve is a threadless one-way valve. It is used to evacuate air from the prosthetic socket.
FDA Enforcement
Class II
·Terminated·Ottobock Orthopedic Industrie·February 20, 2019
Vado Steerable Sheath 8.8F, REF SS8FMU67, packaged in a lidded tray that is within a pouch which is inserted into a shelf carton, Sterile, Rx. The firm name on the label is Kalila Medical, Campbell, CA.
FDA Enforcement
Class II
·Terminated·Kalila Medical·February 21, 2018
Vado Bi-Directional Steerable Sheath 8.8F, REF SS8FMB74, packaged in a lidded tray that is within a pouch which is inserted into a shelf carton, Sterile, Rx. The firm name on the label is Kalila Medical, Campbell, CA.
FDA Enforcement
Class II
·Terminated·Kalila Medical·February 21, 2018
Lumbar Laminectomy Pack, part number AMS2501 Lumbar Laminectomy Pack, part number AMS2501(A Lumbar Laminectomy Pack, part number AMS2501(B
FDA Enforcement
Class II
·Terminated·Windstone Medical Packaging, Inc.·March 8, 2017
D & C Kit, Kit number CMP1466 and CMP1466(A convenience custom kits used for general surgery in hospital operating room
FDA Enforcement
Class II
·Terminated·Windstone Medical Packaging, Inc.·October 26, 2016
Brow Pack, Kit part number PSS1785(A, PSS1785(B, and PSS1785(C. convenience custom kits used for general surgery in hospital operating room
FDA Enforcement
Class II
·Terminated·Windstone Medical Packaging, Inc.·October 26, 2016
Custom Pack - with Introducer Kit, part number TVS4011NI(L
FDA Enforcement
Class II
·Terminated·Windstone Medical Packaging, Inc.·March 8, 2017
Basic Face Kit, part number PS517A(D
FDA Enforcement
Class II
·Terminated·Windstone Medical Packaging, Inc.·March 8, 2017
ENT Pack, part number AMS3237(A ENT Pack, part number AMS4214
FDA Enforcement
Class II
·Terminated·Windstone Medical Packaging, Inc.·March 8, 2017