521 results
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Sources: EU EUDAMED, US FDA
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Stryker Vision Mounting Arm, for use with other Stryker Endoscopy medical device products for human patients. Model number 0240-095-200, manufactured by Stryker Endoscopy San Jose The intended use of the Stryker Vision Mount is to hold and position an LCD monitor. The Stryker Vision Mounting Arm can be used with any Stryker flat panel display and is It is compatible with Stryker Carts (0240099001, 0240099011 or 0240099020). It is indicated for use in a surgical operating room environment and is exposed to environmental conditions associated with the storage and shipping of the product. It is not intended to enter the sterile field. The Stryker Vision Mount does not deliver to and/or extract from the patient any energy or material. It does not process any biological materials, as it is not intended to be sterilized by the user. The Stryker Vision Mount is only used to display surgical images and video and does not sustain or support life.
FDA Enforcement
Class II
·Terminated·Stryker Endoscopy·October 2, 2013
Stryker Endoscopy PrepStrap Shoulder Sleeve, Model Number 3910900200, Manufactured by Stryker Endoscopy, San Jose, CA
FDA Recall
Terminated
·Stryker Endoscopy·Product code HST·July 27, 2009
Formula Shaver Handpiece (with buttons); Formula 180 Shaver Handpiece (with button) Rx only, Made USA.: Stryker Endoscopy 5900 Optical Court San Jose, CA 95138 Components within the Crossfire System that provided abrasion, resection, debridement and removal of bone and soft tissue through the Formula Shaver and blade, and the ablation and coagulation of soft tissue, as well as hemostasis of blood vessels through its SERFAS Energy electrosurgical probe.
FDA Enforcement
Class II
·Terminated·Stryker Endoscopy·July 4, 2012
Stryker Endoscopy brand 3.5mm Super 90-S SERFAS Energy Suction Probe; Model Number: 279-351-300; Manufactured By: Stryker Endoscopy, Puerto Rico
FDA Recall
Terminated
·Stryker Endoscopy·Product code GEI·June 20, 2008
Stryker Infravision Esophageal Kit, Model Numbers 220180548, 220180540, 220180560, manufactured by Stryker Endoscopy San Jose.
FDA Recall
Terminated
·Stryker Endoscopy·Product code FAT·August 20, 2009
Shaver Handpiece Sterilization Tray. Model number 272-700-000. For sterilization of Stryker Endoscopy arthroscopic shaver.
FDA Enforcement
Class II
·Terminated·Stryker Endoscopy·July 2, 2014
Stryker brand Arthroscope and Hardware Set Tray (sterilization tray); Model/Part Number: 233-032-116; Product is manufactured and distributed by Stryker Endoscopy, San Jose, CA The Arthroscope and Hardware Set Tray is used to hold and protect surgical devices during the sterilization process. Specifically this tray is used for arthroscopes and arthroscopic hardware devices. The tray consists of an interlocking tray and lid which are perforated to allow for the passage of sterilizing agent from outside the tray to the inside of the tray where the devices are held.
FDA Enforcement
Class II
·Terminated·Stryker Endoscopy·July 18, 2012
Stryker Peek Intraline Anchor, 5.5 mm with Needles, Model number 3910-400-015 Used for tissue fixation to bone in certain areas.
FDA Recall
Terminated
·Stryker Endoscopy·Product code HWC·February 7, 2008
Stryker Peek Intraline Anchor, 6.5 mm, Model number 3910-400-020 Used for tissue fixation to bone in certain areas.
FDA Recall
Terminated
·Stryker Endoscopy·Product code HWC·February 7, 2008
Stryker Peek Intraline Anchor, 6.5 mm with Needles, Model number 3910-400-025 Used for tissue fixation to bone in certain areas.
FDA Recall
Terminated
·Stryker Endoscopy·Product code HWC·February 7, 2008
Stryker Peek Intraline Anchor, 5.5 mm, Model number 3910-400-010 Used for tissue fixation to bone in certain areas.
FDA Recall
Terminated
·Stryker Endoscopy·Product code HWC·February 7, 2008
Stryker Titanium Intraline Anchor, Model Numbers 3910400050, 3910400055, 3910400060, 3910400065, Soft Eyelet Anchor, manufactured by Stryker Endoscopy, Puerto Rico
FDA Recall
Terminated
·Stryker Endoscopy·Product code HWC·August 20, 2009
Stryker Disposable StrykeProbe 32cm L- Tip, Ref: 250-070-550, Electrosurgical Suction Tip, Stryker Endoscopy, San Jose, CA 95138.
FDA Recall
Terminated
·Stryker Endoscopy·Product code GEI·November 16, 2007
Stryker Digital Capture System Ultra (SDC Ultra), Model Number 240-050-988, Stryker Endoscopy, image and video archiving system.
FDA Recall
Terminated
·Stryker Endoscopy·Product code LMB·February 15, 2008
Stryker Disposable StrykeProbe 32cm Spatula Tip, Ref: 250-070-551, Electrosurgical Suction Tip, Stryker Endoscopy, San Jose, CA 95138.
FDA Recall
Terminated
·Stryker Endoscopy·Product code GEI·November 16, 2007
Formula Shaver Handpiece (with buttons); Formula 180 Shaver Handpiece (with button) Rx only, Made USA.: Stryker Endoscopy 5900 Optical Court San Jose, CA 95138 Components within the Crossfire System that provided abrasion, resection, debridement and removal of bone and soft tissue through the Formula Shaver and blade, and the ablation and coagulation of soft tissue, as well as hemostasis of blood vessels through its SERFAS Energy electrosurgical probe.
FDA Recall
Terminated
·Stryker Endoscopy·Product code GFA·May 21, 2012
Stryker Endoscopy 3.55 MM Super 90 S-SERFAS Energy Probe; electrosurgical device. Model number: 279-351-300;
FDA Recall
Terminated
·Stryker Endoscopy·Product code GEI·October 24, 2011
Stryker Wedge HS Suture Anchor II with Needles, 5.0 mm, Model number 3910-100-135. Intended for use in securing soft tissue to bone in certain procedures in specific areas.
FDA Recall
Terminated
·Stryker Endoscopy·Product code MBI·February 7, 2008
Stryker Wedge HS Suture Anchor II with Needles, 6.5 mm, Model number 3910-100-145 Intended for use in securing soft tissue to bone in certain procedures in specific areas.
FDA Recall
Terminated
·Stryker Endoscopy·Product code MBI·February 7, 2008
Stryker Endoscopy, Infravision Esophageal Kit, Model Numbers: 220180548, 220180540, 220180560
FDA Recall
Terminated
·Stryker Endoscopy·Product code FAT·May 11, 2010