BEUDAMED
    278 results · 13ms · Sources: EU EUDAMED, US FDA

    Get notified when this changes

    We'll email you when new records match this search — new devices, new clearances, certificate changes, or withdrawals.
    Filters Status: Terminated ×

    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 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

    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 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

    Coulter PrepPlus 2 (part # 378600) is a microprocessor-controlled pipetting and diluting system. PrepPlus 2 is a microprocessor-controlled pipetting and diluting system, designed for automating sample preparation or assay methods. It is capable of aspirating and dispensing liquid samples. The PrepPlus 2 is a compact, fully automated sample work station which can be programmed to perform a wide variety of liquid handling operations where volumes required range from 5 uL to 1000 uL.

    FDA Recall
    Terminated ·Beckman Coulter Inc.·Product code JQW·January 18, 2011

    Arjo Citadel beds originally assembled with the IndiGo modules during manufcturing, model number CX812A3J3AMAD0; and IndiGo modules (retrofit kits) that can be installed on Citadel (model no. INDIDAA) or Enterprise (model no. INDIJAA) beds manufactured without IndiGo modules assembled at the time of manufacturing and subsequently retrofitted on the beds.

    FDA Recall
    Terminated ·ARJOHUNTLEIGH POLSKA Sp. z.o.o. Ul. Ks. Piotra Wawrzyniaka 2 Komorniki Poland·Product code FNL·June 10, 2021

    Sara Plus Active Floor Lift

    FDA Recall
    Terminated ·ARJOHUNTLEIGH POLSKA Sp. z.o.o. Ul. Ks. Piotra Wawrzyniaka 2 Komorniki Poland·Product code FSA·April 5, 2022

    Depuy Preservation Uni Knee All Poly Tibial, LM/RL, Sz 4, 7.0 mm, sterile; Product code/REF 1498-12-406.

    FDA Recall
    Terminated ·Depuy Orthopaedics, Inc.·Product code NJL·September 27, 2007

    Depuy P.F.C. E Knee System Stabilized Tibial Insert (STAB), 71 mm M/L, 47 mm A/P, 8.0 mm, 3, UHMWPE, sterile; Product Code/REF 96-0440.

    FDA Recall
    Terminated ·Depuy Orthopaedics, Inc.·Product code NJL·September 27, 2007

    Depuy P.F.C. E Knee System Stabilized Tibial Insert (STAB), 67 mm M/L, 45 mm A/P, 10.0 mm, 2.5, UHMWPE, sterile; Product Code/REF 96-0431.

    FDA Recall
    Terminated ·Depuy Orthopaedics, Inc.·Product code NJL·September 27, 2007

    Depuy P.F.C. E Knee System, stabilized all-polyethylene tibia, Sz 2, 10.0 mm; Ref 96-2621.

    FDA Recall
    Terminated ·Depuy Orthopaedics, Inc.·Product code NJL·May 26, 2005

    Depuy P.F.C. E Knee System, stabilized plus tibial insert; polyethylene tibial insert, Sz 2, 15 mm; Ref 96-2712.

    FDA Recall
    Terminated ·Depuy Orthopaedics, Inc.·Product code NJL·May 26, 2005

    Depuy P.F.C. E Knee System, all polyethylene posterior-lipped tibial component, Sz 3, 8 mm; Ref 96-2540.

    FDA Recall
    Terminated ·Depuy Orthopaedics, Inc.·Product code NJL·May 26, 2005

    Depuy P.F.C. E knee system, TC3 tibial insert; polyethylene tibial insert, Sz 4, 15.0 mm; Ref 96-0542.

    FDA Recall
    Terminated ·Depuy Orthopaedics, Inc.·Product code NJL·May 26, 2005

    Depuy P.F.C. E Knee System, all polyethylene curved tibial component, Sz 5, 12.5 mm; Ref 96-0662.

    FDA Recall
    Terminated ·Depuy Orthopaedics, Inc.·Product code NJL·May 26, 2005

    Depuy P.F.C. E knee system, TC3 tibial insert; polyethylene tibial insert, Sz 2.5, 15.0 mm; Ref 96-0522.

    FDA Recall
    Terminated ·Depuy Orthopaedics, Inc.·Product code NJL·May 26, 2005

    Depuy LCS Complete RP insert; polyethylene tibial insert STD, 17.5 mm; Ref 1294-05-417.

    FDA Recall
    Terminated ·Depuy Orthopaedics, Inc.·Product code NJL·May 26, 2005

    Depuy P.F.C. E knee system, TC3 tibial insert; polyethylene tibial insert, Sz 5, 25.0 mm; Ref 96-0556.

    FDA Recall
    Terminated ·Depuy Orthopaedics, Inc.·Product code NJL·May 26, 2005

    Depuy P.F.C. E knee system, TC3 tibial insert; polyethylene tibial insert, Sz 2, 12.5 mm; Ref 96-0511.

    FDA Recall
    Terminated ·Depuy Orthopaedics, Inc.·Product code NJL·May 26, 2005

    Depuy P.F.C. E knee system, TC3 tibial insert; polyethylene tibial insert, Sz 5, 22.5 mm; Ref 96-0555.

    FDA Recall
    Terminated ·Depuy Orthopaedics, Inc.·Product code NJL·May 26, 2005