30 results · 12ms · Sources: EU EUDAMED, US FDA

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Silatrix Oral Gel Polymerized Sucralfate Gel 10% (1 gm/10 gm

FDA Recall
Terminated ·SA3, LLC·Product code OLR·February 21, 2022

TS Crown Component 4UR (5/pk), TS Crown Component 5UR (5/pk), TS Crown Component 6UR (5/pk), TS Crown Component 4LR (5/pk), TS Crown Component 5LR (5/pk), TS Crown Component 6LR (5/pk), TS Crown Component 4UL (5/pk), TS Crown Component 5UL (5/pk), TS Crown Component 4LL (5/pk), TS Crown Component 5LL (5/pk), and TS Crown Component 6LL (5/pk) A Herbst Appliance is used to affect changes in the skeletal relationship and/or occlusion of a patient. the Universal Nut is a component of a Herbst Appliance

FDA Enforcement
Class II ·Terminated·Specialty Appliance Works, Inc.·April 29, 2015

TS ROC Crown Component 4UR (5/pk), TS ROC Crown Component 5UR (5/pk), TS ROC Crown Component 6UR (5/pk), TS ROC Crown Component 7UR (5/pk), TS ROC Crown Component 8UR (5/pk), TS ROC Crown Component 4LR (5/pk), TS ROC Crown Component 5LR (5/pk), TS ROC Crown Component 6LR (5/pk), TS ROC Crown Component 7LR (5/pk), TS ROC Crown Component 8LR (5/pk), TS ROC Crown Component 4UL (5/pk), TS ROC Crown Component 5UL (5/pk), TS ROC Crown Component 6UL (5/pk), TS ROC Crown Component 7UL (5/pk), TS ROC Crown Component 8UL (5/pk), TS ROC Crown Component 4LL (5/pk), TS ROC Crown Component 5LL (5/pk), TS ROC Crown Component 6LL (5/pk), TS ROC Crown Component 7LL (5/pk), TS ROC Crown Component 8LL (5/pk) A Herbst Appliance is used to affect changes in the skeletal relationship and/or occlusion of a patient. the Universal Nut is a component of a Herbst Appliance.

FDA Enforcement
Class II ·Terminated·Specialty Appliance Works, Inc.·April 29, 2015

TS Crown Component 4UR (5/pk), TS Crown Component 5UR (5/pk), TS Crown Component 6UR (5/pk), TS Crown Component 4LR (5/pk), TS Crown Component 5LR (5/pk), TS Crown Component 6LR (5/pk), TS Crown Component 4UL (5/pk), TS Crown Component 5UL (5/pk), TS Crown Component 4LL (5/pk), TS Crown Component 5LL (5/pk), and TS Crown Component 6LL (5/pk) A Herbst Appliance is used to affect changes in the skeletal relationship and/or occlusion of a patient. the Universal Nut is a component of a Herbst Appliance

FDA Recall
Terminated ·Specialty Appliance Works, Inc.·Product code ECN·March 9, 2015

TS ROC Crown Component 4UR (5/pk), TS ROC Crown Component 5UR (5/pk), TS ROC Crown Component 6UR (5/pk), TS ROC Crown Component 7UR (5/pk), TS ROC Crown Component 8UR (5/pk), TS ROC Crown Component 4LR (5/pk), TS ROC Crown Component 5LR (5/pk), TS ROC Crown Component 6LR (5/pk), TS ROC Crown Component 7LR (5/pk), TS ROC Crown Component 8LR (5/pk), TS ROC Crown Component 4UL (5/pk), TS ROC Crown Component 5UL (5/pk), TS ROC Crown Component 6UL (5/pk), TS ROC Crown Component 7UL (5/pk), TS ROC Crown Component 8UL (5/pk), TS ROC Crown Component 4LL (5/pk), TS ROC Crown Component 5LL (5/pk), TS ROC Crown Component 6LL (5/pk), TS ROC Crown Component 7LL (5/pk), TS ROC Crown Component 8LL (5/pk) A Herbst Appliance is used to affect changes in the skeletal relationship and/or occlusion of a patient. the Universal Nut is a component of a Herbst Appliance.

FDA Recall
Terminated ·Specialty Appliance Works, Inc.·Product code ECN·March 9, 2015

Biopsy Trays (CT, Puncture & Prep), Packaged individually in header bags, 10 per case. Sterile, Disposable Convenience Kits used for diagnostic radiology procedures. A diagnostic radiology kit used in CT and general biopsies

FDA Recall
Terminated ·North Coast Medi-Tek Inc·Product code LOR·May 13, 2011

Dentsply, MAILLEFER, CYTCO-K TITANIUM POST SYSTEM, dental implant components, Model numbers (SKU): C106KL0050A20 (12 posts) and C117K00000020 (4 posts), Swiss Made, Manufactured for DENTSPLY Maillefer, Johnson City, TN 37604

FDA Recall
Terminated ·Dentsply Worldwide Headqrt·Product code ELR·March 20, 2009

ParaPost Plus 25 Titanium Alloy Spiral Vented and Serrated Posts Catalog Number: P2845B Dental Posts are implanted into teeth for dental restoration purposes. The normal procedure requires a hole to be drilled into the tissue of a tooth with an intraoral drill prior to installation.

FDA Recall
Terminated ·Coltene Whaledent Inc·Product code ELR·August 21, 2018

Trumpf Universal Imaging Extension (OEM) Catalog NUmber: F-PMT-A2

FDA Recall
Terminated ·The OR Group·Product code FPS·November 6, 2003

Ronci Surgical Universal Imaging Extension used with the Ronci Pain Management Table System Catalog Number: R-934-25A

FDA Recall
Terminated ·The OR Group·Product code FPS·November 6, 2003

Stryker Universal Imaging Extension (OEM) Catalog Number: R--934-TRIO-A1

FDA Recall
Terminated ·The OR Group·Product code FPS·November 6, 2003

SSCOR Suction Device Model 2310V

FDA Recall
Terminated ·S S C O R Inc·Product code BTA·January 6, 2005

SSCOR Suction Device Model 2310BV

FDA Recall
Terminated ·S S C O R Inc·Product code BTA·January 6, 2005

SSCOR Suction Device Model 2310BV-230

FDA Recall
Terminated ·S S C O R Inc·Product code BTA·January 6, 2005

SSCOR Suction Device Model 2315

FDA Recall
Terminated ·S S C O R Inc·Product code BTA·January 6, 2005

SSCOR Suction Device Model 2314

FDA Recall
Terminated ·S S C O R Inc·Product code BTA·January 6, 2005

SSCOR Suction Device Model 2314B

FDA Recall
Terminated ·S S C O R Inc·Product code BTA·January 6, 2005

TheraSphere(R) YTTRIUM-90 CLASS MICROSPHERE INJECTION TheraSphere is indicated for radiation treatment or as a neoadjuvant to surgery or transplantation in patients with unresectable HCC who can have placement of appropriately positioned hepatic arterial catheters.

FDA Recall
Terminated ·Biocompatibles U.K., Ltd. Bortoli House Weydon Lane; Old Farnham Lane Farnham United Kingdom·Product code NAW·September 21, 2015

ActiveCare DVT Medical Compression Systems OR Aqiva, IL Intended for use in: Preventing deep Vein Thrombosis; Enhancing blood circulation; Diminishing post-operative pain and swelling; Reducing wound healing time; treatment and assistance in healing of stasis dermatitis, venous stasis ulcers and diabetic leg ulcers; Treatment of chronic venous insufficiency and; Reducing edema

FDA Recall
Terminated ·Medical Compression Systems 2 Hallan St OR Aqiva Israel·Product code JOW·August 28, 2011

ActiveCare +SFT Medical Compression Systems OR Aqiva, IL Intended for use in: Preventing deep Vein Thrombosis; Enhancing blood circulation; Diminishing post-operative pain and swelling; Reducing wound healing time; treatment and assistance in healing of stasis dermatitis, venous stasis ulcers and diabetic leg ulcers; Treatment of chronic venous insufficiency and; Reducing edema

FDA Recall
Terminated ·Medical Compression Systems 2 Hallan St OR Aqiva Israel·Product code JOW·August 28, 2011