170 results
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24ms
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Sources: EU EUDAMED, US FDA
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FDA Recall
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Dimension Creatine Kinase MB (MBI) assay (Product Number: DF32/10464510) (Mfr: Siemens Healthcare Diagnostics, Newark, DE)
FDA Recall
Terminated
·Siemens Healthcare Diagnostics, Inc.·Product code CGS·June 29, 2017
Dimension Vista Creatine Kinase MB (MBI) assay; (Product Number: K3032/10464339) (Mfr: Siemens Healthcare Diagnostics, Newark, DE)
FDA Recall
Terminated
·Siemens Healthcare Diagnostics, Inc.·Product code CGS·June 29, 2017
Revogene SARS-CoV-2 Catalog Number: 410700 IVD for real-time Reverse Transcription Polymerase Chain Reaction (rRT-PCR) qualitative test run on the Revogene instrument for the detection of SARS-CoV-2 nucleic acid from nasopharyngeal swab (NPS) specimens from individuals suspected of COVID-19
FDA Recall
Terminated
·Meridian Bioscience Inc·Product code QJR·April 8, 2021
Brand Name: Transcend Product Name: Transcend Econo Kit (UB) - Singles Model/Catalog Number: 4817- Software Version: N/A Product Description: Transcend universal composite is a light-cured, tooth shade resin composite material (Bis-GMA-based) to be used for direct and indirect posterior and anterior tooth restorations. Transcend universal composite is radiopaque and available in a range of dentin, enamel, and body shades. It is 79% filled by weight and 60-61% filled by volume and has an average particle size of 0.9 m (by weight) with narrow upper limit particle distribution. Component: N/A
FDA Recall
Open, Classified
·Ultradent Products, Inc.·Product code EBF·August 2, 2024
Revogene RNA Software Upgrade Kit Revogene RNA Software Upgrade USBs Catalog Number: 610240 IVD used to install the Revogene System Software version 4.2.0, import the Revogene Instrument Control Protocol file for RNA-based assay, and install the Assay Definition File (ADF) file
FDA Recall
Terminated
·Meridian Bioscience Inc·Product code QJR·April 8, 2021
Brand Name: Transcend Product Name: Transcend Singles Universal Body (UB) Refill 10pk Model/Catalog Number: 4757- Software Version: N/A Product Description: Transcend universal composite is a light-cured, tooth shade resin composite material (Bis-GMA-based) to be used for direct and indirect posterior and anterior tooth restorations. Transcend universal composite is radiopaque and available in a range of dentin, enamel, and body shades. It is 79% filled by weight and 60-61% filled by volume and has an average particle size of 0.9 m (by weight) with narrow upper limit particle distribution. Component: N/A
FDA Recall
Open, Classified
·Ultradent Products, Inc.·Product code EBF·August 2, 2024
"***PressFT***2.6 w/ One #2 (5 metric) Hi-Fi***Suture***NP261***2009-02***CONMED LINVATEC 11311 CONCEPT BLVD LARGO, FL 33773-4908 USA*** To reattach soft tissue to bone in orthopedic surgical procedures
FDA Recall
Terminated
·Linvatec Corp. dba ConMed Linvatec·Product code MBI·June 26, 2012
ANSPACH***Arthroscopic Knotless Suture Anchor***Rx Only*** This device is intended to be used with Anspach Systems
FDA Recall
Terminated
·The Anspach Effort, Inc.·Product code MBI·November 28, 2012
SUTUREFIX Ultra S with 1 #2 Ultrabraid (blue) Product Code: 72203852 Fastener, fixation, nondegradable, soft tissue
FDA Recall
Terminated
·Smith & Nephew, Inc. Endoscopy Division·Product code MBI·June 2, 2014
Axya Bone Anchor 6.5 mm Bioabsorbable with Nylon Suture Catalog Number: CAT1265, Axya Medical, Inc., Beverly, MA 01915
FDA Recall
Terminated
·Axya Medical·Product code MBI·September 27, 2007
Axya Bone Anchor 5.0 mm Bioabsorbable with Nylon Suture Catalog Number: CAT1234, Axya Medical, Inc., Beverly, MA 01915
FDA Recall
Terminated
·Axya Medical·Product code MBI·September 27, 2007
Arthrocare 3.0mm ParaSorb, Preloaded with 2 MagnumWire sutures (1 white/1 co-braid), Part Number: 22-5030, Axya Medical, Inc., Beverly, MA 01915
FDA Recall
Terminated
·Axya Medical·Product code MBI·September 27, 2007
AMS In-Fast Ultra Kit with Polypropylene Suture, REF 72403885. Sterile Transvaginal Bladder Neck Support System.
FDA Recall
Terminated
·American Medical Systems·Product code MBI·January 28, 2008
Smith & Nephew 5.5 mm TWINFIX Ultra Ti Anchor with two #2 sutures (COBRAID-blue, COBRAIDblack), sterile Part Number: 72202896 Product Usage: intended for use for the reattachment of soft tissue to bone
FDA Recall
Terminated
·Smith & Nephew, Inc. Endoscopy Division·Product code MBI·July 3, 2012
CinchLock SS Knotless Anchor with Inserter; Model number CAT02462; Orthopedic: The Pivot CinchLock SS Knotless Anchor (CAT02462) and Pivot CinchLock Flex Knotless Anchor (CAT02463) are non-degradable implant devices intended for the fixation of soft tissue to bone. Used for repair of hip, shoulder, foot and ankle, elbow, wrist and hand and knee.
FDA Recall
Terminated
·Stryker Corporation·Product code MBI·April 12, 2016
Iconix Knotless 1.4mm Anchor with XBraid S (Blue/Black) REF 3911-714-520 Iconix Knotless 1.4mm Anchor with XBraid S (Black/White) REF 3911-714-521 The Iconix Knotless anchors are intended to be used for soft-tissue to bone fixation in the foot, ankle, knee, hip, hand, wrist, elbow and shoulder.
FDA Recall
Open, Classified
·Riverpoint Medical, LLC·Product code MBI·October 25, 2023
Arthrex Suture Anchor, Nano Corkscrew FT (consists of an anchor pre-loaded on a handled inserter including suture, with needles.) Part Number AR-1317FT Product Usage: Soft tissue fixation to bone in the hand and wrist
FDA Recall
Open, Classified
·Arthrex, Inc.·Product code MBI·November 19, 2018
SUTUREFIX ULTRA Suture, Product number 72203855
FDA Recall
Open, Classified
·Smith & Nephew, Inc.·Product code MBI·June 24, 2020
Smith & Nephew FOOTPRINT ULTRA PK SUTURE ANCHOR 4.5 Part Number: 72202901
FDA Recall
Open, Classified
·Smith & Nephew, Inc.·Product code MBI·March 17, 2020
Juggerknot Mini Soft Anchors, Model/Catalog Number: 912080
FDA Recall
Open, Classified
·Biomet, Inc.·Product code MBI·September 9, 2025