124 results
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11ms
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Sources: EU EUDAMED, US FDA
@ Home Strep Test Rapid Strep Test Product Usage: For in-vitro diagnostic use - detection of Strep.
FDA Recall
Terminated
·Jay Bird Investments Inc·Product code GTY·July 6, 2011
Santajoy Ornament & Giftware Co., Ltd E-Z Illuminations Northern Lights E-Z Illuminations Galaxy Laser projectors that emit various colors and light patterns for entertainment and decorative purposes.
FDA Recall
Terminated
·SANTA JOY ORNAMENT & GIFTWARE CO 3rd Block Changtian Ind Hengli Town Dongguan City China·Product code RDZ·November 21, 2017
Patient-Fitted Temporomandibular (TMJ) Right Mandibular Component part of TMJ Reconstruction Prosthesis System. Model /catalog # TYY-NNNNRM The TMJ Concepts Patient-Fitted TMJ Reconstruction Prosthesis System is intended to be used for the reconstruction of the temporomandibular joint. It is indicated for patients with one or more of the following conditions: Inflammatory arthritis involving the temporomandibular joint not responsive to other modalities of treatment; Recurrent fibrous and/or bony ankylosis not responsive to other modalities of treatment; Failed tissue graft; Failed alloplastic joint reconstruction; Loss of vertical mandibular height and/or occlusal relationship due to bone resorption, trauma, developmental abnormality, or pathologic lesion
FDA Recall
Terminated
·TMJ Solutions Inc·Product code LZD·March 12, 2018
Histoplasma Immunodiffusion (ID) Antigen; The IFU labeling is for multiple products which included Fungal Antigens, Positive Controls and ID Plates,and Immunodiffusion (ID) Plates for use in the ID Test, Histoplasma ID Antigen
FDA Recall
Terminated
·Immuno-Mycologics, Inc·Product code GMJ·November 4, 2019
S.M.A.R.T. CONTROL Transhepatic Biliary Stent. The Self-Expanding Nitinol Biliary Stent is delivered by catheter for the palliation of malignant neoplasms in the biliary tree. Model numbers are CxxyyyMB, CxxyyySB, CxxyyyML, and CxxyyySL, where xx is the stent diameter in mm and yyy is the stent length in mm; but not including catalogs where yyy is 120 or 150. The Removal only includes Catalog Numbers in the above sequence with S.M.A.R.T CONTROL in the logo/description. All unexpired lot numbers 15112447 through 15525516.
FDA Recall
Terminated
·Cordis Corporation·Product code FGE·January 31, 2012
S.M.A.R.T. CONTROL NITINOL STENT SYSTEM ILIAC: Self-Expanding Vascular Stents delivered by catheter for the indication of improving luminal diameter in patients with symptomatic atherosclerotic disease of the iliac arteries. catalog numbers are CxxyyyMB, CxxyyySB, CxxyyyML, and CxxyyySL, where xx is the stent diameter in mm and yyy is the stent length in mm; but not including catalogs where yyy is 120 or 150. The Removal only includes Catalog Numbers in the above sequence with S.M.A.R.T. CONTROL in the logo/description. All unexpired lots from 15112447 through 15525516.
FDA Recall
Terminated
·Cordis Corporation·Product code NIO·January 31, 2012
PREVI Isola Insrument and PREVI Isola Printer spares PSUs (power supply units), P1028888-001 PSU (used in Zebra LP2824 Plus printers) PSUs with the following date code; 0639XX through 1253XX (YYWWXX, where YY=Year, and WW=week).
FDA Recall
Terminated
·bioMerieux, Inc.·January 24, 2020
1.5 mm Inion CPS Baby, 4 hole plate, REF PLT-1000, sterile, Manufacturer, INION Oy, Finland.
FDA Recall
Terminated
·Stryker Craniomaxillofacial Division·Product code JEY·April 14, 2010
1.5 mm Inion CPS Baby , X- plate 7 holes, REF PLT-1003, sterile, Manufacturer, INION Oy, Finland.
FDA Recall
Terminated
·Stryker Craniomaxillofacial Division·Product code JEY·April 14, 2010
2.0 mm Inion CPS, 2.0 x 5 mm screw, REF SCR-1224, sterile, Manufacturer, INION Oy, Finland.
FDA Recall
Terminated
·Stryker Craniomaxillofacial Division·Product code JEY·April 14, 2010
2.0 mm Inion CPS, 2.0 x 20 mm screw, REF SCR-1289, sterile, Manufacturer, INION Oy, Finland.
FDA Recall
Terminated
·Stryker Craniomaxillofacial Division·Product code JEY·April 14, 2010
3.1 mm Inion CPS, 3.1 x 16 mm screw, REF SCR-1229, sterile, Manufacturer, INION Oy, Finland.
FDA Recall
Terminated
·Stryker Craniomaxillofacial Division·Product code JEY·April 14, 2010
1.5 mm Inion CPS Baby , 2 hole plate, REF PLT-1004, sterile, Manufacturer, INION Oy, Finland.
FDA Recall
Terminated
·Stryker Craniomaxillofacial Division·Product code JEY·April 14, 2010
1.5 mm Inion CPS Baby, 1.5 x 6 mm screw, REF SCR-1221, sterile, Manufacturer, INION Oy, Finland.
FDA Recall
Terminated
·Stryker Craniomaxillofacial Division·Product code JEY·April 14, 2010
1.5 mm Inion CPS Baby, 1.5 x 4 mm screw, REF SCR-1220, sterile, Manufacturer, INION Oy, Finland.
FDA Recall
Terminated
·Stryker Craniomaxillofacial Division·Product code JEY·April 14, 2010
2.0 mm Inion CPS, L-plate left, 7 holes, REF PLT-1040, sterile, Manufacturer, INION Oy, Finland.
FDA Recall
Terminated
·Stryker Craniomaxillofacial Division·Product code JEY·April 14, 2010
2.0 mm Inion CPS, 4 hole plate, REF PLT-1013, sterile, Manufacturer, INION Oy, Finland.
FDA Recall
Terminated
·Stryker Craniomaxillofacial Division·Product code JEY·April 14, 2010
SYNTHES TI MATRIXMANDIBLE SAGITTAL SPLIT PL 1.5MM THK/4H/42MM, Catalog # SD448.004. Synthes Titanium Matrix Mandible Sagittal Plates and Instruments are intended for general use in orthognathic surgery.
FDA Recall
Terminated
·Synthes USA (HQ), Inc.·Product code JEY·September 3, 2009
Lactosorb Trauma Plating System, part numbers: 915-2100, 915-2423, 915-2113, 915-2810, 915-2418, 915-2105, 915-2832 and CP-1323. The system is used in trauma and reconstructive surgical procedures in the mid face and craniofacial skeleton. Used to support non-load bearing tissues of cranial maxillofacial anatomy, including but not limited to brow fixation.
FDA Recall
Terminated
·Biomet Microfixation, Inc.·Product code JEY·March 19, 2008
***BIOMET MICROFIXATION BIOMET MICROFIXATION 1520 TRADEPORT DRIVE JACKSONVILLE, FL 32218 USA www.biometmicrofixation.com***6 HOLE REGULAR DOUBLE Y PLATE***"1.5MM SYSTEM PLATE DOUBLE Y-SHAPE, REGULAR 0.6 MM TITANIUM***NON-STERILE PRODUCT*** This titanium plate is used in the 1.5mm Lorenz Midface System which is indicated for use in trauma, neurosurgery, craniomaxillary reconstruction and orthognathic procedures in the midface.
FDA Recall
Terminated
·Biomet Microfixation, Inc.·Product code JEY·July 28, 2010