38 results
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14ms
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Sources: EU EUDAMED, US FDA
Filters
Status: Terminated
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Smith & Nephew Dyonics Saw Blade, Long, Special, Product Number 3706
FDA Recall
Terminated
·Smith & Nephew, Inc.·Product code HAB·February 2, 2017
DYONICS POWER Shaver Blades, 4.5mm Long Curved Full Radius Convex, package of 3. Catalog Number: 7205336 Product Usage: Smith & Nephew DYONICS Disposable Endoscopic Blades are indicated for resection of soft and osseous tissues in both large and small articular cavities.
FDA Recall
Terminated
·Smith & Nephew, Inc. Endoscopy Division·Product code HAB·May 6, 2011
Smith & Nephew Dyonics Saw Blade, Short, Product Number 3703
FDA Recall
Terminated
·Smith & Nephew, Inc.·Product code HAB·February 2, 2017
Smith & Nephew Dyonics Saw Blade, Narrow, Product Number 3705
FDA Recall
Terminated
·Smith & Nephew, Inc.·Product code HAB·February 2, 2017
Biomet Stablecut Saw Blade - Reprocessed Sterile device -- Powered Saw and Accessories.
FDA Recall
Terminated
·Ascent Healthcare Solutions, Inc.·Product code HAB·March 11, 2008
Smith & Nephew Dyonics Saw Blade, Standard, Product Number 3701
FDA Recall
Terminated
·Smith & Nephew, Inc.·Product code HAB·February 2, 2017
DYONICS POWER Shaver Blades, 4.5mm Long Full Radius, package of 3 Catalog Number: 7205341 Product Usage: Smith & Nephew DYONICS Disposable Endoscopic Blades are indicated for resection of soft and osseous tissues in both large and small articular cavities.
FDA Recall
Terminated
·Smith & Nephew, Inc. Endoscopy Division·Product code HAB·May 6, 2011
Smith & Nephew Dyonics Saw Blade, Short, Narrow, Product Number 3704
FDA Recall
Terminated
·Smith & Nephew, Inc.·Product code HAB·February 2, 2017
Stryker Oscillating & Sagittal Blade - Reprocessed Sterile device -- Powered Saw and Accessories.
FDA Recall
Terminated
·Ascent Healthcare Solutions, Inc.·Product code HAB·March 11, 2008
Smith & Nephew Dyonics Saw Blade, Standard, Thick, Product Number 3702
FDA Recall
Terminated
·Smith & Nephew, Inc.·Product code HAB·February 2, 2017
UNIVERSAL Modular Electric/Battery Handpiece for surgery The electric handpiece is packaged within a foam bag 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. Product Usage: Surgical instrument motors and accessories are AC-powered, battery-powered, or air-powered devices intended for use during surgical procedures to provide power to operate various accessories or attachments to cut hard tissue or bone and soft tissue. Accessories or attachments may include a bur, chisel (osteotome), dermabrasion brush, dermatome, drill bit, hammerhead, pin driver, and saw blade.
FDA Recall
Terminated
·Zimmer Surgical Inc·Product code HAB·October 6, 2014
Zimmer UNIVERSAL Power System Loaner and Modular Electric/Battery Single Trigger Handpiece. Rx only Made in Switzerland
FDA Recall
Terminated
·Zimmer, Inc.·Product code HAB·November 10, 2015
Stryker Oscillating & Sagittal Blade - Reprocessed Sterile device -- Powered Saw and Accessories.
FDA Recall
Terminated
·Ascent Healthcare Solutions, Inc.·Product code HAB·March 11, 2008
Zimmer UNIVERSAL Power System Loaner and Modular Electric/Battery Double Trigger Handpiece. Rx only Made in Switzerland
FDA Recall
Terminated
·Zimmer, Inc.·Product code HAB·November 10, 2015
Zimmer Gender Solutions" Patellofemoral Joint Prosthesis Milling Handpiece
FDA Recall
Terminated
·Zimmer Biomet, Inc.·Product code HAB·September 28, 2016
(1) Arrow¿ STIM CPNB TUOHY NDL: 18G x 14CM (5-1/2") AB-18140-N (2) Arrow¿ STIM CPNB TUOHY NDL: 18G x 11CM (4-3/8") AB-18110-N (3) Arrow¿ STIM CPNB TUOHY NDL: 18G x 8CM (3-1/8") AB-18080-N (4) Arrow¿ STIM CPNB TUOHY NDL: 17G x 8CM (3-1/8") AB-17080-N (5) Arrow¿ STIM CPNB TUOHY NDL: 17G x 14CM (5-1/2") AB-17140-N (6) Arrow¿ INSL CPNB TUOHY NDL: 17G x 15CM (6") AB-00150 (7) Arrow¿ STIM CPNB TUOHY NDL: 17G x 11CM (4-3/8") AB-17110-N
FDA Enforcement
Class II
·Terminated·Arrow International Inc·February 26, 2020
(1) Arrow STIM CPNB TUOHY NDL: 18G x 14CM (5-1/2") AB-18140-N (2) Arrow STIM CPNB TUOHY NDL: 18G x 11CM (4-3/8") AB-18110-N (3) Arrow STIM CPNB TUOHY NDL: 18G x 8CM (3-1/8") AB-18080-N (4) Arrow STIM CPNB TUOHY NDL: 17G x 8CM (3-1/8") AB-17080-N (5) Arrow STIM CPNB TUOHY NDL: 17G x 14CM (5-1/2") AB-17140-N (6) Arrow INSL CPNB TUOHY NDL: 17G x 15CM (6") AB-00150 (7) Arrow STIM CPNB TUOHY NDL: 17G x 11CM (4-3/8") AB-17110-N
FDA Recall
Terminated
·Arrow International Inc·Product code CAZ·December 20, 2019
Open Heart Tray, Pack A, code 900-1196C, contains: (1) TABLE COVER REINFORCED L/Free (1) CARDIOVASCU.LAR INCISE DRAPE L/Free (2) 3/4 ABS. REINFORCED SHEET (1) PLASTIC SHEET (5) DRAPE SHEET SMS (18) CLOTH HUCK TOWELS Blue (4) CLOTH HUCK TOWELS White (1 0) ABSORBENT TOWELS L/Free (4) GOWN IMP. BREATHABLE LGE. (3) MAYO STAND COVER L/Free (2) IMPERV. STOCKINETTE (1) WRAPPER 54" X 54" (1) TRAY PLATFORM LGE (1) TABLE COVER HD L/Free (1) WRAPPER 24" X 24" Product Usage: EO sterilized surgical convenient packs packaged into polyester/polyethylene breather bag with Tyvek double vents.
FDA Recall
Terminated
·Customed, Inc Calle Igualdad Final # 7·Product code OFA·May 20, 2014
Pausch Uroview FD fluoroscopic X-ray system UDI number (01)04260491620040 Primarily for urological applications (functional X-ray diagnostics, endourology and minimal invasive urology / surgery). The system, which includes a radiologic / urologic treatment table, maybe used for urological treatment, planning and diagnostic procedures, including but not limited to.
FDA Enforcement
Class II
·Terminated·Hans Pausch Rontgengeratebau Gmbh·June 7, 2017
Alaris Pump Module, Model 8100, serviced/repaired by Step-Har Medical with an impacted bezel repair part
FDA Enforcement
Class I
·Terminated·STEP-HAR MEDICAL LLC·May 19, 2021