203 results
·
41ms
·
Sources: EU EUDAMED, US FDA
Filters
Status: Terminated
×
18inch Dual Port/Single Bladder Disposable Tourniquet Cuff, Zimmer Surgical, Inc. Tourniquets are intended to be used by qualified medical professionals to exert enough pressure on the arterial blood flow in a limb to produce a bloodless operating field. Single bladder tourniquet cuffs are generally used for operations lasting less than 90 minutes.
FDA Enforcement
Class II
·Terminated·Zimmer Surgical Inc·August 12, 2015
Zimmer 100 mL Hemovac Device Hemovac Mini Evacuator. 00-2568-000-10. Zimmer Surgical, Inc. Intended for post-operative collection of wound drainage.
FDA Enforcement
Class III
·Terminated·Zimmer Surgical Inc·May 20, 2015
30inch Dual Port/Single Bladder Disposable Tourniquet Cuff with PLC, Zimmer Surgical, Inc. Tourniquets are intended to be used by qualified medical professionals to exert enough pressure on the arterial blood flow in a limb to produce a bloodless operating field. Single bladder tourniquet cuffs are generally used for operations lasting less than 90 minutes.
FDA Enforcement
Class II
·Terminated·Zimmer Surgical Inc·August 12, 2015
Zimmer 100 mL Hemovac Device Hemovac Mini Evacuator. 00-2568-000-10. Zimmer Surgical, Inc. Intended for post-operative collection of wound drainage.
FDA Recall
Terminated
·Zimmer Surgical Inc·Product code GCY·April 21, 2015
A.T.S. 2200TS Tourniquet Systems, Personalized Pressure. Zimmer Surgical, Inc. Dover, OH 44622 Intended to be used by qualified professionals to temporarily occlude blood flow in a patient's extremities during surgical procedures on those extremities.
FDA Enforcement
Class II
·Terminated·Zimmer Surgical Inc·February 21, 2018
A.T.S. 2200TS Tourniquet Systems, Personalized Pressure. Zimmer Surgical, Inc. Dover, OH 44622 Intended to be used by qualified professionals to temporarily occlude blood flow in a patient's extremities during surgical procedures on those extremities.
FDA Recall
Terminated
·Zimmer Surgical Inc·Product code KCY·July 27, 2017
18inch Dual Port/Single Bladder Disposable Tourniquet Cuff, Zimmer Surgical, Inc. Tourniquets are intended to be used by qualified medical professionals to exert enough pressure on the arterial blood flow in a limb to produce a bloodless operating field. Single bladder tourniquet cuffs are generally used for operations lasting less than 90 minutes.
FDA Recall
Terminated
·Zimmer Surgical Inc·Product code KCY·June 24, 2015
30inch Dual Port/Single Bladder Disposable Tourniquet Cuff with PLC, Zimmer Surgical, Inc. Tourniquets are intended to be used by qualified medical professionals to exert enough pressure on the arterial blood flow in a limb to produce a bloodless operating field. Single bladder tourniquet cuffs are generally used for operations lasting less than 90 minutes.
FDA Recall
Terminated
·Zimmer Surgical Inc·Product code KCY·June 24, 2015
Product is distributed by Zimmer (Warsaw, Indiana)/Synvasive Technology, Inc. (El Dorado Hills, CA) & manufactured under Synvasive Technology, Inc. El Dorado Hills, CA Reciprocating saw blade: A sterile surgical saw blade used to resect damaged cartilage and/or bond in an orthopaedic reconstructive procedure such as a total knee replacement.
FDA Enforcement
Class II
·Terminated·Synvasive Technology Inc·April 24, 2013
The Zimmer Air Dermatome, REF 00- 8801- 001- 00 , Rx, non-sterile grafting instruments intended to provide variable graft thickness and width capabilities
FDA Recall
Terminated
·Zimmer Surgical Inc·Product code GFD·May 7, 2013
Zimmer Air Dermatome II Width Plate, 1 in., item number 00-8851-201-00 . Width plates is packaged inside of a padded-foam corrugate box. A product label is applied to the lid of the box. The width plates, when sold individually, are placed in a labeled poly zipper bag, which is then placed into a corrugated shipper carton or padded envelope. The Zimmer Air Dermatome II is a skin grafting instrument that is intended to provide variable graft thickness and width capabilities.
FDA Recall
Terminated
·Zimmer Surgical Inc·Product code GFD·July 4, 2016
Zimmer Air Dermatome II Handpiece, item number 00-8851-001-00. The Zimmer Air Dermatome II handpiece and width plates are packaged inside of a padded-foam corrugate box. An operating manual is packed with the handpiece between the top foam pad and box lid. A product label is applied to the lid of the box. The width plates, when sold individually, are placed in a labeled poly zipper bag, which is then placed into a corrugated shipper carton or padded envelope. The Zimmer Air Dermatome II is a skin grafting instrument that is intended to provide variable graft thickness and width capabilities.
FDA Recall
Terminated
·Zimmer Surgical Inc·Product code GFD·July 4, 2016
Zimmer Air Dermatome II Width Plate, 3 inch. Part #00-8851-203-00. Width plate is packaged inside of a padded-foam corrugate box. A product label is applied to the lid of the box. The width plates, when sold individually, are placed in a labeled poly zipper bag, which is then placed into a corrugated shipper carton or padded envelope. The Zimmer Air Dermatome II is a skin grafting instrument that is intended to provide variable graft thickness and width capabilities.
FDA Recall
Terminated
·Zimmer Surgical Inc·Product code GFD·July 4, 2016
Zimmer Air Dermatome II, REF 00-8851-001-00 handpiece Rx, non-sterile grafting instruments intended to provide variable graft thickness and width capabilities
FDA Recall
Terminated
·Zimmer Surgical Inc·Product code GFD·May 7, 2013
Zimmer Air Dermatome II, REF 00-8851-001-01 handpiece, w/o hose, Rx, non-sterile grafting instruments intended to provide variable graft thickness and width capabilities.
FDA Recall
Terminated
·Zimmer Surgical Inc·Product code GFD·May 7, 2013
Zimmer Air Dermatome II Handpiece Loaner, item number 01-8851-001-00. Device is packaged inside of a padded-foam corrugate box. A product label is applied to the lid of the box. The width plates, when sold individually, are placed in a labeled poly zipper bag, which is then placed into a corrugated shipper carton or padded envelope.
FDA Recall
Terminated
·Zimmer Surgical Inc·Product code GFD·July 4, 2016
Zimmer Sterile Disposable Tourniquet Cuff with Protective Sleeve and PLC, Dual Port, Dual Bladder, Item No. 60708015200, UDI (01)00889024377547 (17)230812(10)27968701 The product is a tourniquet - Product Usage: Tourniquets are intended to be used by qualified medical professionals to exert enough pressure on the arterial blood flow in a limb to produce a bloodless operating field.
FDA Recall
Terminated
·Zimmer Surgical Inc·Product code KCY·January 3, 2020
Zimmer Air Dermatome II Width Plate, 4 inch. Part #00-8851-204-00. Width plate is packaged inside of a padded-foam corrugate box. A product label is applied to the lid of the box. The width plates, when sold individually, are placed in a labeled poly zipper bag, which is then placed into a corrugated shipper carton or padded envelope. The Zimmer Air Dermatome II is a skin grafting instrument that is intended to provide variable graft thickness and width capabilities.
FDA Recall
Terminated
·Zimmer Surgical Inc·Product code GFD·July 4, 2016
Zimmer Dermatone AN, Model No. 88710100
FDA Recall
Terminated
·Zimmer Surgical Inc·Product code GFD·June 8, 2018
A.T.S. 4000TS Tourniquet Systems, Personalized Pressure. Intended to be used by qualified professionals to temporarily occlude blood flow in a patient's extremities during surgical procedures on those extremities. .
FDA Recall
Terminated
·Zimmer Surgical Inc·Product code KCY·July 27, 2017