119 results
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13ms
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Sources: EU EUDAMED, US FDA
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Status: Terminated
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Rusch/MMG Urinary Catheterization System, 14 Fr; the single use sterile kit contains a Rusch/MMG Intermittent Catheter, gauze tissue, povidone iodine swabs, two vinyl gloves and underpad; 100 kits per box; Rusch, 2450 Meadowbrook Pwy, Duluth, GA 30096, Assembled in Mexico from U.S. Components; product number RLA-142-3
FDA Recall
Terminated
·Teleflex Medical·Product code FCM·July 11, 2005
Capio Standard Box 4 (Capio PC); Model #M0068312321. Intended for use in general suturing applications during open or endoscopic surgery to assist in the placement of suture material in tissues at the operative site.
FDA Recall
Terminated
·Boston Scientific Corporation·Product code PWI·February 12, 2018
PFR Kit- Pinnacle, Posterior; Model #M0068317100. Indicated for tissue reinforcement in women with pelvic organ prolapse.
FDA Recall
Terminated
·Boston Scientific Corporation·Product code PWI·February 12, 2018
Safety-Deluxe Lumbar Puncture Tray, Catalog # 974 Product Usage: Surgical procedure
FDA Recall
Terminated
·Robert Busse & Co. Inc. d.b.a. Busse Hospital Disposables·Product code PWY·June 27, 2017
Capio Open Access Box 4 (Capio OPC); Model #M0068311251. Intended for use in general suturing applications during open or endoscopic surgery to assist in the placement of suture material in tissues at the operative site.
FDA Recall
Terminated
·Boston Scientific Corporation·Product code PWI·February 12, 2018
Uphold Vaginal Support System; Model #M0068317080. Indicated for tissue reinforcement in women with pelvic organ prolapse.
FDA Recall
Terminated
·Boston Scientific Corporation·Product code PWI·February 12, 2018
Capio SLIM Box 5, Model #M0068318261; Intended for use in general suturing applications during open surgery to assist in the placement of suture material in tissues at the operative site.
FDA Recall
Terminated
·Boston Scientific Corporation·Product code PWI·February 12, 2018
Safety Deluxe Bone Marrow Biopsy/Aspiration Tray, Catalog # 986 Product Usage: Surgical procedure
FDA Recall
Terminated
·Robert Busse & Co. Inc. d.b.a. Busse Hospital Disposables·Product code PWY·June 27, 2017
Capio RP; Model #M0068321010. Intended for use in general suturing applications during open surgery to assist in the placement of suture material in tissues at the operative site.
FDA Recall
Terminated
·Boston Scientific Corporation·Product code PWI·February 12, 2018
Capio SLIM Suture Capturing Device, Model #M0068318250. Intended for use in general suturing applications during open surgery to assist in the placement of suture material in tissues at the operative site.
FDA Recall
Terminated
·Boston Scientific Corporation·Product code PWI·February 12, 2018
Safety-Deluxe Basic Soft Tissue Biopsy Tray without Biopsy Needle, Catalog # 977 Product Usage: Surgical procedure
FDA Recall
Terminated
·Robert Busse & Co. Inc. d.b.a. Busse Hospital Disposables·Product code PWY·June 27, 2017
Lumbar Puncture Tray, Catalog # 1862 Product Usage: Surgical procedure
FDA Recall
Terminated
·Robert Busse & Co. Inc. d.b.a. Busse Hospital Disposables·Product code PWY·June 27, 2017
Safety Deluxe Bone Marrow Biopsy/ Aspiration Tray with Biopsy Needle and Aspiration Needle Sterile, Catalog # 985 Product Usage: Surgical procedure
FDA Recall
Terminated
·Robert Busse & Co. Inc. d.b.a. Busse Hospital Disposables·Product code PWY·June 27, 2017
Safety-Deluxe Lumbar Puncture Tray, Catalog # 975 Product Usage: Surgical procedure
FDA Recall
Terminated
·Robert Busse & Co. Inc. d.b.a. Busse Hospital Disposables·Product code PWY·June 27, 2017
Uphold LITE w/ Capio SLIM; Model #M0068318170. Indicated for tissue reinforcement in women with pelvic organ prolapse.
FDA Recall
Terminated
·Boston Scientific Corporation·Product code PWI·February 12, 2018
PFR Kit- Pinnacle, Anterior Apical; Model #M0068317100. Indicated for tissue reinforcement in women with pelvic organ prolapse.
FDA Recall
Terminated
·Boston Scientific Corporation·Product code PWI·February 12, 2018
Capio CL; Model #M0068311350. Indicated for the placement of suture in a variety of Transvaginal procedures.
FDA Recall
Terminated
·Boston Scientific Corporation·Product code PWI·February 12, 2018
Posterior LITE w/ Capio SLIM; Model #M0068318150. Indicated for tissue reinforcement in women with pelvic organ prolapse.
FDA Recall
Terminated
·Boston Scientific Corporation·Product code PWI·February 12, 2018
Laceration Tray, Catalog # 1892R1 Product Usage: Surgical procedure
FDA Recall
Terminated
·Robert Busse & Co. Inc. d.b.a. Busse Hospital Disposables·Product code PWY·June 27, 2017
Sekisui Spectrolyse PAI-1, In-Vitro Diagnostic for Quantitative determination of Plasminogen Activator Inhibitor Type- 1 (PAI-1) activity in human plasma. Catalog Number: 101201 For the determination of Plasminogen Activator Inhibitor Type 1 (PAI-1) activity in human plasma. The test is for in Citro diagnostic use.
FDA Enforcement
Class II
·Terminated·Sekisui Diagnostics Llc·September 26, 2012