BEUDAMED
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    MODEL 7600 REGIONAL OXIMETER SYSTEM WITH EQUANOX TECHNOLOGY

    FDA 510(k)
    FDA Class 2 ·Cardiovascular

    CAPSURE

    FDA UDI
    Davol Inc.·00801741094989·Capsure Permanent Fixation System, 37 cm length...

    DD tempMED

    FDA UDI
    Dental Direkt GmbH·EDDIK112151·DD tempMED are pre-colored dental milling blank...

    Zavation

    FDA UDI
    Zavation LLC·00842166146563·eZspand PLIF/T-PLIF 11x32x15°, 10.5-15mm

    Navagio

    FDA UDI
    Kalitec Direct LLC·B07330K0132150·Trial, TLIF, 27L OB CRV 7Deg, 15mm

    CAPSURE PERMANENT FIXATION SYSTEM

    FDA Adverse Event
    Malfunction ·DAVOL INC.·Product code GDW·February 6, 2024

    CIANNA S1, SINGLE LUMEN BALLOON APPLICATOR KIT

    FDA 510(k)
    FDA Class 2 ·Radiology

    MODIFIED INS-1 INTRAOPERATIVE NERVE SURVEILLANCE SYSTEM

    FDA 510(k)
    FDA Class 2 ·Anesthesiology

    ENDOTAK RELIANCE G

    FDA Adverse Event
    Injury ·CARDIAC PACEMAKERS, INC·Product code LWS·February 8, 2007

    PEG SMOOTH 2.0X22MM (3 EACH)

    FDA Adverse Event
    Injury ·DEPUY ORTHOPAEDICS, INC.·Product code LXT·May 20, 2011

    EPIX UNIVERSAL CLIP APPLIER

    FDA Adverse Event
    Malfunction ·APPLIED MEDICAL·Product code FZP·May 8, 2013

    FRESENIUS 2008K

    FDA Adverse Event
    Death ·FRESENIUS MEDICAL CARE NORTH AMERICA·Product code KDI·September 2, 2014

    Philips Ingenia 3.0T CX with MR Elastography (MRE). 1. Model Number (REF): 781271. 2. Model Number (REF): 782105. 510(k) Numbers: K173079, K183063, K193215, K213583, K223458, K251397, K251808.

    FDA Recall
    Open, Classified ·Philips North America·Product code LNH·April 14, 2026

    Philips Ingenia 3.0T with MR Elastography (MRE). 1. Model Number (REF): 781342. 2. Model Number (REF): 781377. 3. Model Number (REF): 782103. 510(k) Numbers: K163116, K173079, K183063, K193215, K213516, K213583, K223458, K251397, K251808

    FDA Recall
    Open, Classified ·Philips North America·Product code LNH·April 14, 2026

    Philips Ingenia 3.0T CX with MR Elastography (MRE). 1. Model Number (REF): 781271. 2. Model Number (REF): 782105. 510(k) Numbers: K173079, K183063, K193215, K213583, K223458, K251397, K251808.

    FDA Enforcement
    Class II ·Ongoing·Philips North America·May 6, 2026

    Philips Ingenia 1.5T with MR Elastography (MRE). 1. Model Number (REF): 781315. 2. Model Number (REF): 781341. 3. Model Number (REF): 781396. 4. Model Number (REF): 782115. 510(k) Numbers: K163116, K173079, K183063, K193215, K213583, K223458, K251397, K251808

    FDA Recall
    Open, Classified ·Philips North America·Product code LNH·April 14, 2026

    Philips Ingenia 3.0T with MR Elastography (MRE). 1. Model Number (REF): 781342. 2. Model Number (REF): 781377. 3. Model Number (REF): 782103. 510(k) Numbers: K163116, K173079, K183063, K193215, K213516, K213583, K223458, K251397, K251808

    FDA Enforcement
    Class II ·Ongoing·Philips North America·May 6, 2026

    Philips Ingenia 1.5T with MR Elastography (MRE). 1. Model Number (REF): 781315. 2. Model Number (REF): 781341. 3. Model Number (REF): 781396. 4. Model Number (REF): 782115. 510(k) Numbers: K163116, K173079, K183063, K193215, K213583, K223458, K251397, K251808

    FDA Enforcement
    Class II ·Ongoing·Philips North America·May 6, 2026

    EMBLEM S-ICD Model A209

    FDA Enforcement
    Class I ·Terminated·Boston Scientific Corporation·February 17, 2021

    OPTETRAK Comprehensive Knee System including OPTETRAK Logic RBK PS Tibial Components (Product Line: 02-012-38-XXXX). NOTE: Information reflects Exactech recall expansion initiated on 02/07/2022.

    FDA Enforcement
    Class II ·Ongoing·Exactech, Inc.·October 13, 2021