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Sources: EU EUDAMED, US FDA
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Abbott Healon EndoCoat Ophthalmic Viscosurgical Device 3% sodium hyaluronate 0.85 mL 30 mg/mL Sterile A Solution Sterile EO Packaging and Cannula Product of USA Abbott Healon Duet Dual Pack 0.55 ml OVD 0.85 ml Healon EndoCoat OVD Contents: -one sterile syringe of Healon Ophthalmic Viscosurgical Device (OVD) 0.55 ml (10 mg/ml Sodium Hyaluronate) -one sterile syringe of Healon EndoCoat Ophthalmic Viscosurgical Device (OVD) 0.85 ml (30 mg/ml Sodium Hyaluronate) Part Number: US: VT585U and 57502000 (packaged in Healon Duet 10290080) OUS: VT585 and 57550500 (packaged in Healon duet 10220010, 10220011 and 10220012)
FDA Recall
Terminated
·Abbott Medical Optics Inc (AMO)·Product code LZP·November 6, 2014
AMO Healon D Ophthalmic Viscosurgical Device, Product Code: 10204011, Lot Number: UD30654, 30 mg/mL fill size
FDA Recall
Terminated
·Advanced Medical Optics, Inc.·Product code LZP·October 29, 2008
Healon 5 Pro, Part No. 10270015
FDA Recall
Terminated
·Abbott Medical Optics Inc. (AMO)·Product code LZP·April 1, 2017
Healon Pro, Part No. 10270012
FDA Recall
Terminated
·Abbott Medical Optics Inc. (AMO)·Product code LZP·April 1, 2017
Healon V, Part No. 10290045
FDA Recall
Terminated
·Abbott Medical Optics Inc. (AMO)·Product code LZP·April 1, 2017
Healon, Part No. 10290953, 10295210, 10200011, 10200012, 10201012, 10203012, 10213012, 10223012, 10290701, 10294751, 10295701
FDA Recall
Terminated
·Abbott Medical Optics Inc. (AMO)·Product code LZP·April 1, 2017
Healon GV, Part No. 10294701, 10294801, 10200014, 10201014, 10202014, 10203014
FDA Recall
Terminated
·Abbott Medical Optics Inc. (AMO)·Product code LZP·April 1, 2017
Healon Duet, Part No. 10290080, 10220010, 10220011 and 10220012
FDA Recall
Terminated
·Abbott Medical Optics Inc. (AMO)·Product code LZP·April 1, 2017
Beaver-Visitec International (Beaver-Visitec) BD 1% OVD Sodium Hyaluronate, 10 mg/ml 1.0 mL. Sterile. Rx For Intraocular Use REF 585304 Use as a surgical aid to protect corneal endothelium during cataract extraction procedures, intraocular lens implantation and anterior segment surgery.
FDA Recall
Terminated
·Becton Dickinson and Company·Product code LZP·October 4, 2010
Healon GV PRO 0.85 mL, Model (U.S.): 10-2400-14, Model (O.U.S.): 10-2705-14, 10-2715-14, 10-2725-14, and 10-2755-14
FDA Recall
Terminated
·Johnson & Johnson Surgical Vision Inc·Product code LZP·December 3, 2019
Bausch and Lomb 27G sterile cannula packed in the Bausch and Lomb Amvisc 1.2% Sodium Hyaluronate ( Model 59051, 59081, 59051L, 59081L) and Amvisc Plus 1.6% Sodium Hyaluronate (Model 60081, 60051, 60051L, 60081L) ophthalmic viscosurgical device. The 27G disposable cannula is attached to the syringe standard luer fitting to deliver the Amvis or Amvis Plus during use as a surgical aid in opthalmic anterior or posterior segment procedures.
FDA Recall
Terminated
·Bausch and Lomb, Incorporated·Product code HMX·November 15, 2012
Monterey AL Implant Inserter; 22mm; Catalog 48019140.
FDA Recall
Open, Classified
·Stryker Spine·Product code OVD·February 28, 2025
Monterey AL Implant Inserter; 10/12mm; Catalog 48019100.
FDA Recall
Open, Classified
·Stryker Spine·Product code OVD·February 28, 2025
TiBrid Stand Alone Intervertebral Body Fusion Device, SA Angled Punch Awl, Sizes: 30 degree, 45 degree and 60 degree.
FDA Recall
Open, Classified
·Product code OVD·July 15, 2024
MectaLIF ANTERIOR - Lag Plate Flush H14, REF 03.30.302, interbody fusion device
FDA Recall
Completed
·Medacta Usa Inc·Product code OVD·March 8, 2023
Irix-A Integrated Lumbar Fusion System, Model Number X080-423011-08PC (Spacer Assy, 42 X 30 X 8, 11mm, PC (STERILE)) and Model Number X080-382819-08PC (Spacer ASSY, 38 X 28 X 8, 19mm, PC, (STERILE))
FDA Recall
Open, Classified
·XTANT Medical Holdings, Inc·Product code OVD·January 3, 2025
Monterey AL Implant Inserter; 14/16mm; Catalog 48019120.
FDA Recall
Open, Classified
·Stryker Spine·Product code OVD·February 28, 2025
Endoskeleton" TAS Interbody System with Titan nanoLOCK" Surface Technology, Nanolock 12 Dg Interbody, Large, 12mm
FDA Recall
Terminated
·Medtronic Sofamor Danek USA Inc·Product code OVD·September 2, 2021
MectaLIF ANTERIOR - Lag Plate Flush H18, REF 03.30.304, interbody fusion device
FDA Recall
Completed
·Medacta Usa Inc·Product code OVD·March 8, 2023
JULIET Ti LL, LATERAL LUMBAR TI-LIFE PLATE SMALL, REF: JLT-PL 02 08-S, JLT-PL 02 10-S, JLT-PL 02 12-S, JLT-PL 02 14-S, JLT-PL 02 16-S; JULIET Ti LL, LATERAL LUMBAR TI-LIFE PLATE LARGE, REF: JLT-PL 04 08-S, JLT-PL 04 10-S, JLT-PL 04 12-S, JLT-PL 04 14-S, JLT-PL 04 16-S, JLT-PL 04 18-S
FDA Recall
Open, Classified
·SPINEART SA Chemin Du Pre-Fleuri 3 Plan-Les-Ouates Switzerland·Product code OVD·March 16, 2023