BEUDAMED
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    HOURGLASS VERTEBRAL BODY SPACER

    FDA 510(k)
    FDA Class 2 ·Orthopedic

    R90 SPACERS

    FDA Adverse Event
    Malfunction ·WARSAW ORTHOPEDIC INC.·Product code MQP·October 9, 2009

    R90 SPACERS

    FDA Adverse Event
    Other ·WARSAW ORTHOPEDIC INC·Product code MAX·November 6, 2009

    R90 SPACERS

    FDA Adverse Event
    Injury ·SOFAMOR DANEK DEGGENDORF GMBH·Product code MAX·December 21, 2009

    R90 SPACER

    FDA Adverse Event
    Malfunction ·MSD DEGGENDORF MFG·Product code NKB·August 5, 2011

    Baltic Denture System BDLoad

    FDA UDI
    Merz Dental GmbH·D7091033926·Baltic Denture System BDLoad BDLoad Mw6 PLSEbi...

    SHARPS COLL 9GAL GASKET RED

    FDA Adverse Event
    Malfunction ·BECTON DICKINSON·Product code FMI·June 17, 2019

    QIZHOU ACUPUNCTURE NEEDLE

    FDA 510(k)
    FDA Class 2 ·General Hospital

    FAST THROW STAINLESS STEEL SURGICAL SUTURE

    FDA 510(k)
    FDA Class 2 ·General, Plastic Surgery

    COAPTITE INJECTABLE IMPLANT

    FDA Adverse Event
    Other ·MERZ NORTH AMERICA, INC.·Product code LNM·October 17, 2013

    INTERMATE

    FDA Adverse Event
    Malfunction ·BAXTER HEALTHCARE - IRVINE·Product code FRN·April 3, 2013

    TRANSTAR STRETCHER

    FDA Adverse Event
    Malfunction ·HILL-ROM, INC.·Product code FPO·March 23, 2011

    PFC SIGMA C/S NPOR FEM RT SZ 3

    FDA Adverse Event
    Injury ·DEPUY ORTHOPAEDICS, INC.·Product code JWH·April 24, 2008

    BARD EP XT Steerable, Product Number 200794; REPROCESSED ELECTROPHYSIOLOGY CATHETER

    FDA Enforcement
    Class II ·Ongoing·Stryker Sustainability Solutions·May 20, 2026

    SHARPS COLL 9GAL GASKET RED

    FDA Adverse Event
    Malfunction ·BECTON DICKINSON·Product code FMI·August 19, 2019

    Brilliance 64 Computed Tomography X-Ray System, 510(k) #K033326, Model Number: 728231, Serial Numbers: 9745, 90169, and 95414. The recalled device systems are equipped with Version 3.5 Beta 1 software.

    FDA Recall
    Terminated ·Philips Medical Systems (Cleveland) Inc·Product code JAK·September 22, 2011

    Ingenuity CT (Computed Tomography) System, 510 (k) #K033326, Model #728326, Serial Numbers: 300003, 300004, and 300005. The recalled CT systems are equipped with Software Version 3.5 Beta 2. Product Usage: The Brilliance Big Bore is a Computed Tomography X-Ray System intended to produce cross-sectional images of the body by computer reconstruction of x-ray transmission data taken at difference angles and planes. This device may include signal analysis and display equipment, patient, and equipment supports, components and accessories.

    FDA Recall
    Terminated ·Philips Medical Systems (Cleveland) Inc·Product code JAK·August 29, 2011

    Brilliance 64 CT (Computed Tomography) System, 510 (k) #K033326, Model #728231, Serial Numbers: 4003, 9875, and 90135. The recalled CT systems are equipped with Software Version 3.5 Beta 2. Product Usage: The Brilliance Big Bore is a Computed Tomography X-Ray System intended to produce cross-sectional images of the body by computer reconstruction of x-ray transmission data taken at difference angles and planes. This device may include signal analysis and display equipment, patient, and equipment supports, components and accessories.

    FDA Recall
    Terminated ·Philips Medical Systems (Cleveland) Inc·Product code JAK·August 29, 2011

    Ingenuity CT (Computed Tomography) System, 510 (k) #K033326, Model #728326, Serial Numbers: 300005, 300010, 300011, 300012, 300013, 300014, 300015, 300016, 300017, 300018, 300019, 300020 and 300021. Product Usage: The Ingenuity CT is a Computed Tomography X-Ray System intended to produce cross-sectional images of the body by computer reconstruction of X-Ray transmission data taken at different angles and planes. This device may include signal analysis and display equipment, patient, and equipment supports, components and accessories.

    FDA Recall
    Terminated ·Philips Medical Systems (Cleveland) Inc·Product code JAK·November 11, 2011

    Brilliance 64 Computed Tomography System, Model #728231, 510(k) #K 033326, Serial Numbers: 95504, 91003, 300030, 95130, and 95157. The Brilliance 64 is a Computed Tomography X-Ray System intended to produce cross-sectional images of the body by computer reconstruction of x-ray transmission data taken at difference angles and planes. This device may include signal analysis and display equipment, patient, and equipment supports, components and accessories.

    FDA Recall
    Terminated ·Philips Medical Systems (Cleveland) Inc·Product code JAK·September 6, 2011