62 results · 15ms · Sources: EU EUDAMED, US FDA

Get notified when this changes

We'll email you when new records match this search — new devices, new clearances, certificate changes, or withdrawals.

iotaSOFT Plus Drive Unit, REF IM-05. The iotaSOFT Insertion System is intended to aid the surgeon in placement of cochlear implant electrode arrays into a radiographically normal cochlea by controlling the speed of implant insertion.

FDA Recall
Completed ·Iotamotion Inc·Product code QQH·September 12, 2024

Liko Universal SlingBars Universal SlingBar" 350, Universal SlingBar" 350 QRH, Universal SlingBar" 350 R2R, Universal SlingBar" 450, Universal SlingBar" 450 QRH, Universal SlingBar" 450 R2R, Universal SlingBar" 600 Universal SlingBar" 600 QRH Component of Liko Lifts Product Usage: Universal SlingBar 350 It is commonly used for lifting children. Universal SlingBar 350 is available with three assembly options - fixed assembly, Quick-release Hook (QRH) or Room 2 Room (R2R). Universal SlingBar 450 Is appropriate in most cases and with most slings. Is installed on most lifts on delivery (does not apply to Viking XL). Universal SlingBar 450 is available with three assembly options - fixed assembly, Quick-release Hook (QRH) or Room 2 Room (R2R). Universal SlingBar 600 It is intended for use with the ComfortSling Plus mod 300/310 and 350/360, or with slings the intention of which is to overlap the leg supports, Universal SlingBar 600 is available with two assembly options - fixed assembly and Quick-release Hook (QRH).

FDA Recall
Terminated ·Hill-Rom, Inc.·Product code FSA·March 8, 2016

Liko Universal Sling Bar 450 Quick Release Hook (QRH) Product Number: 3156085

FDA Recall
Terminated ·Liko, Inc.·Product code FRW·June 13, 2007

Liko Universal Twinbar 670 QRH, an accessory that can be used together with most Liko lifts, model numbers 3156087 and P3156087.

FDA Recall
Open, Classified ·Baxter Healthcare Corporation·Product code FSA·February 21, 2022

Coloplast Elefant Suction/Irrigation Tubing, Part Number: AST 307, Coloplast Corp., Minneapolis, MN 55411

FDA Recall
Terminated ·Coloplast Corp·Product code FQH·November 12, 2007

Pulsavac Plus Wound Debridement System, Hip Kit, Catalog #00-5150-482-00, 10 kits/package, Zimmer Orthopaedic Surgical Products, Dover, Ohio

FDA Recall
Terminated ·Zimmer Orthopaedic Surgical Products·Product code FQH·December 18, 2007

Coloplast Elefant Suction/Irrigation Cannula for Laparoscopy Part Numbers: ASP 105, ASP 150, ASP 145, ASP 180, Coloplast Corp., Minneapolis, MN 55411

FDA Recall
Terminated ·Coloplast Corp·Product code FQH·November 12, 2007

Pulsavac Plus AC Hip Kit, Catalog #00-5150-486-01, 1 kit/package, Zimmer Orthopaedic Surgical Products, Dover, Ohio

FDA Recall
Terminated ·Zimmer Orthopaedic Surgical Products·Product code FQH·December 18, 2007

Coloplast Elefant Suction/Irrigation Cannula for Laparoscopy with Tube, Part Numbers: ASP 165, ASP 170, Coloplast Corp., Minneapolis, MN 55411

FDA Recall
Terminated ·Coloplast Corp·Product code FQH·November 12, 2007

0210-312-000-Woundcare Replacement kit with soft tip; 0210-318-000; Woundcare Replacement with fan tip; 0210-318-100- Woundcare Replacement Kit; 0210-318-200-Woundcare Replacement with retract coax tip. Accessory to Stryker InterPulse Irrigation System, used for wound debridement, soft tissue debridement, and cleansing of medical, clinical, or surgical sites.

FDA Recall
Terminated ·Stryker Instruments Div. of Stryker Corporation·Product code FQH·May 8, 2015

The Stryker InterPulse system is a single patient use, sterile, disposable, pulsed lavage device. The system consists of an irrigation handpiece, irrigation tubing, irrigation tips, suction tips, suction tubing, and splash shields. The components of the InterPulse Irrigation System are used for wound debridement, soft tissue debridement and cleansing of medical, clinical and surgical sites. This includes cleansing of bone in surgical procedures, hydrodebridement of chronic wounds, debridement of loose skin from burns and cleansing of trauma wounds.

FDA Recall
Terminated ·Stryker Instruments Division of Stryker Corporation·Product code FQH·October 4, 2010

Pulsavac Plus AC Fan Spray Kit, Catalog #00-5150-476-01, 1 kit/package, Zimmer Orthopaedic Surgical Products, Dover, Ohio

FDA Recall
Terminated ·Zimmer Orthopaedic Surgical Products·Product code FQH·December 18, 2007

Pulsavac Plus Low Pressure Fan Spray Kit, Catalog #00-5150-975-00, 10 kits/package, Zimmer Orthopaedic Surgical Products, Dover, Ohio

FDA Recall
Terminated ·Zimmer Orthopaedic Surgical Products·Product code FQH·December 18, 2007

Medical Device Exchange FEMORAL CANAL TIP; Pouch, Tyvek/Mylar, Sterile, Single Use Only; OEM Catalog number 210-8-N; EXP (repackager), Stryker (OEM) Lavage, jet

FDA Recall
Terminated ·EXP Pharmaceutical Services Corp·Product code FQH·February 11, 2015

AXIUS Blower Mister Product Code/REF Number: CB-1000 The Axius Blower Mister is intended to clear an anastomotic site for improved visibility

FDA Recall
Terminated ·Maquet Cardiovascular, LLC·Product code FQH·January 24, 2019

DERMARITE INDUSTRIES SafeWash Saline Saline Wound Flush SafeWash 7.1 oz. Can Sterile 0.9% Sodium Chloride Model Number: 00245

FDA Recall
Open, Classified ·Mckesson Medical-Surgical Inc. Corporate Office 9954 Maryland Drive Deep Run Iii Ste. 4000 Richmond VA 23233·Product code FQH·May 25, 2022

Irrisept OR, Finished Bottle Assembly 450 ml STEP 1

FDA Recall
Terminated ·Medex Cardio-Pulmonary Inc., d.b.a. Smiths Medical Company·Product code FQH·September 5, 2017

The Stryker InterPulse system is a single patient use, sterile, disposable, pulsed lavage device. The system consists of an irrigation handpiece, irrigation tubing, irrigation tips, suction tips, suction tubing, and splash shields. The components of the InterPulse Irrigation System are used for wound debridement, soft tissue debridement and cleansing of medical, clinical and surgical sites. This includes cleansing of bone in surgical procedures, hydrodebridement of chronic wounds, debridement of loose skin from burns and cleansing of trauma wounds.

FDA Recall
Terminated ·Stryker Instruments Division of Stryker Corporation·Product code FQH·October 4, 2010

Pulsavac Hip Kit ,Catalog #00-5150-482-01, 1kit/package, Zimmer Orthopaedic Surgical Products, Dover, Ohio

FDA Recall
Terminated ·Zimmer Orthopaedic Surgical Products·Product code FQH·December 18, 2007

Boston Scientific SpyGlass Light Cable Reference Number: 4621 UPN M00546210

FDA Recall
Terminated ·Boston Scientific Corporation·Product code EQH·February 7, 2007