24 results
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12ms
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Sources: EU EUDAMED, US FDA
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Status: Terminated
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Relief ACP Oral Care Gel intended to relieve discomfort from dentin sensitivity. Sold separately in single, single syringe, 4 packs, 6 packs and in teeth whitening kits
FDA Recall
Terminated
·Discus Dental LLC·Product code LBH·October 24, 2014
Enamelast Cool Mint/OT Varnish 5% NaF Mint Label Enamelast Unit Dose 200pk Cool Mint: Enamelast 5% Sodium Fluoride Unit Dose 200pk Kit - Cool Mint REF/UP 4352 Rx CONTENTS: 200 x 0.4 ml Unit Dose Label Enamelast Unit Dose 50pk Cool Mint: Enamelast 5% Sodium Fluoride Unit Dose 50pk Kit - Cool Mint REF/UP 4353 Rx CONTENTS: 50 x 0.4 ml Unit Dose Manufactured by Ultradent Products Inc. ****Label Enamelast Unit Dose 200pk Variety Pack - The Variety Pack (PN#4368) includes four 50 packs of different Enamelast flavors, including Orange Cream, Bubblegum, Walterberry, and Cool Mint: Enamelast 5% Sodium Fluoride Unit Dose 50pk Kit - Variety Pack REF/UP 4353 Rx CONTENTS: 50 x 0.4 ml Unit Dose Product Usage: Description: Enamelast Fluoride Varnish is a flavored, xylitol-sweetened 5% sodium fluoride in a resin carrier delivered in a 0.4 ml unit dose blister pack. Indications for Use: Enamelast Fluoride Varnish is 5% sodium fluoride in a varnish carrier which produces a mechanical occlusion of the dentinal tubules in the treatment of tooth hypersensitivity.
FDA Recall
Terminated
·Ultradent Products, Inc.·Product code LBH·July 12, 2018
3M Fast Release Varnish, 5% Sodium Fluoride, Mint Flavor, Rx Only, single use. 200 pack, with each package containing 1 0.40 ml varnish and 1 applicator brush. Product is applied to tooth surfaces for sealing dentinal tubules and treatment of hypersensitive teeth.
FDA Recall
Terminated
·3M Company Health Care Business 3m Center·Product code LBH·July 6, 2018
Gluma Desensitizer Power Gel Product Usage: Usage: This is a class 2 medical device. For reduction or elimination of pain in exposed cervical areas that do not require restoration. It is also used for alleviation or reduction of dentinal sensitivity after preparation of teeth to receive fixed prosthesis or restorations.
FDA Recall
Terminated
·Heraeus Kulzer, LLC.·Product code LBH·April 23, 2014
Dharma Cavity Varnish with Fluoride
FDA Recall
Terminated
·Dharma Research, Inc.·Product code LBH·September 29, 2014
Dharma Cavity Varnish 15mL
FDA Recall
Terminated
·Dharma Research, Inc.·Product code LBH·September 29, 2014
AM1054 Randox Ammonia (NH3), Enzymatic UV Method For the quantitative in vitro determination of Ammonia in plasma
FDA Enforcement
Class II
·Terminated·RANDOX LABORATORIES, LTD.·September 23, 2020
AM1015 Randox Ammonia (NH3), Enzymatic UV Method For the quantitative in vitro determination of Ammonia in plasma
FDA Enforcement
Class II
·Terminated·RANDOX LABORATORIES, LTD.·September 23, 2020
smith&nephew EVOS CONDYLAR MEDIAL DISTAL FEMUR PLATE, L, 5H, 115MM, REF 72573102
FDA Enforcement
Class II
·Terminated·Smith & Nephew, Inc.·December 22, 2021
smith&Nephew EVOS MEDIAL DISTAL FEMUR PLATE, L, 5H, 90MM, REF 72573101
FDA Enforcement
Class II
·Terminated·Smith & Nephew, Inc.·December 22, 2021
AR ManoShield, MSS-3599, 10 pack. FGS: MSS-3599, Individual package label: LBL-110275-03, Box label: LBL-110282-03, Package Inserts: DOC-3682, User Manual: DOC-1332-12. Product Usage: The MVS disposable sheath (a.k.a. ManoShield) for the high-resolution MVS catheter is designed to provide a biocompatible barrier between the catheter and patient.
FDA Recall
Terminated
·Sierra Scientific Instruments Inc·Product code FFX·October 12, 2011
-Outer Kit Box (P/N RFIT-LBL-0140) - FilmArray Meningitis/Encephalitis (ME) Panel REF RFIT-ASY-0118 30 For FilmArray systems LOT KIT UDI (01)00815381020123 CE 0086 IVD -Fitment Label (P/N RFIT-LBL-0138) which identifies the pouch label - FilmArray ME Panel v1.4 LOT SN CE 0086 IVD Product Usage: The FilmArray Meningitis/Encephalitis (ME) Panel is a qualitative multiplexed nucleic acid-based in vitro diagnostic test intended for use with FilmArray systems.
FDA Recall
Terminated
·BioFire Diagnostics, LLC·Product code PLO·September 10, 2018
-Outer Kit Box (P/N RFIT-LBL-0140) - FilmArray¿ Meningitis/Encephalitis (ME) Panel REF RFIT-ASY-0118 30 For FilmArray systems LOT KIT UDI (01)00815381020123 CE 0086 IVD -Fitment Label (P/N RFIT-LBL-0138) which identifies the pouch label - FilmArray¿ ME Panel v1.4 LOT SN CE 0086 IVD Product Usage: The FilmArray Meningitis/Encephalitis (ME) Panel is a qualitative multiplexed nucleic acid-based in vitro diagnostic test intended for use with FilmArray systems.
FDA Enforcement
Class II
·Terminated·BioFire Diagnostics, LLC·November 21, 2018
Natus Quantum System with NeuroWorks Software. Catalog /Part Numbers: 013926. The Natus Quantum Amplifier is intended to be used as an electroencephalograph: to acquire, display, store and archive electrophysiological signals. The amplifier should be used in conjunction with Natus NeuroWorks /SleepWorks software to acquire scalp and intracranial electroencephalographic (EEG) signals as well as polysomnographic (PSG) signals.
FDA Recall
Terminated
·Natus Neurology DBA Excel Tech., Ltd. (XLTEK)·Product code GWQ·November 11, 2015
A20975A "Working insert, with ramp, one way" (Lots 13ZW to 172W; A20976A "Bridge, one way" (Lots 146W to 172W) and A20977A "Bridge, two way" (Lots 146W to 174W) Product Usage: A20975A: Working insert for endoscopic diagnosis and treatment in urologic applications. A20976A: Bridge for endoscopic diagnosis and treatment in urologic applications. A20977A: Bridge for endoscopic diagnosis and treatment in urologic applications.
FDA Enforcement
Class II
·Terminated·Olympus Corporation of the Americas·March 7, 2018
ILLICO Straight CP TI Rod, -5.5MM x 110M; REF#73601-110; Qty 1; LBL-005; REV.B; RX ONLY; Alphatec Spine, Inc. The ILLICO¿ MIS Posterior Spinal Fixation System is intended to facilitate the surgical correction of non-cervical spinal deformities by providing temporary internal fixation and stabilization during bone graft healing and/or fusion mass development.
FDA Enforcement
Class II
·Terminated·Alphatec Spine, Inc.·March 27, 2013
ILLICO Straight CP TI Rod, -5.5MM x 110M; REF#73601-110; Qty 1; LBL-005; REV.B; RX ONLY; Alphatec Spine, Inc. The ILLICO MIS Posterior Spinal Fixation System is intended to facilitate the surgical correction of non-cervical spinal deformities by providing temporary internal fixation and stabilization during bone graft healing and/or fusion mass development.
FDA Recall
Terminated
·Alphatec Spine, Inc.·Product code KWP·July 6, 2011
The 1500T9 Cardiac Ablation Generator, RO#lBl-89000 is part of the Therapy Cardiac Ablation System, along with the Cool Point irrigation Pump, the Therapy 1300 Series Steerable Ablation Catheters, the Therapy Cool Path Ablation Catheters and accessories. The generator is a microprocessor-controlled device that produces a continuous unmodulated radiofrequency (RF) output delivered from the generator between its tip electrode and a dispersive pad for the treatment of atrial flutter.
FDA Recall
Terminated
·St Jude Medical Inc·Product code OAD·January 5, 2012
Bacterin International, Inc., Osteoselect Demineralized Bone Matrix DMB Putty; Graft ID# B090056-664 Donor# B090056 2.5cc Expiration Date: 12/25/2011; LBL 210-0010-1 REV: 040109; and Graft ID# B090056-675. Bone void filler for voids or gaps in bone. Indicated for treatment of surgically created osseous defects. On 07/12/2012 an additional expired product was discovered by a Bacterin sales rep. B100078-908 with expiration date 04/27/2012
FDA Enforcement
Class II
·Terminated·Bacterin International, Inc.·February 20, 2013
Bacterin International, Inc., Osteoselect Demineralized Bone Matrix DMB Putty; Graft ID# B090056-664 Donor# B090056 2.5cc Expiration Date: 12/25/2011; LBL 210-0010-1 REV: 040109; and Graft ID# B090056-675. Bone void filler for voids or gaps in bone. Indicated for treatment of surgically created osseous defects. On 07/12/2012 an additional expired product was discovered by a Bacterin sales rep. B100078-908 with expiration date 04/27/2012
FDA Recall
Terminated
·Bacterin International, Inc.·Product code MBP·April 18, 2012