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    129 results · 26ms · Sources: EU EUDAMED, US FDA

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    GEO-MED OPTHALMOLOGY CSTM PCK, REF 89-6387.09

    FDA Recall
    Open, Classified ·DeRoyal Industries Inc·Product code LRO·November 3, 2022

    GEO-MED OPTHALMOLOGY CSTM PCK, REF 89-6387.08

    FDA Recall
    Open, Classified ·DeRoyal Industries Inc·Product code LRO·November 3, 2022

    DeRoyal Sterile Custom Kits containing Cardinal Health Gowns. Sold as the following: Ophthalmology CSTM PCK 89-6387.08

    FDA Recall
    Terminated ·Deroyal Industries, Inc. Lafollette·Product code LRO·February 4, 2020

    Medline Convenience kits labeled as: 1) GROTH PELVISCOPY CDS, Pack Number CDS984187T ; 2) GROTH PELVISCOPY, Pack Number CDS984187U ; 3) DERMATOLOGY KIT, Pack Number DYNDA1567D; 4) ER MINOR SUTURE SET, Pack Number DYNDA1977A; 5) HSG TRAY, Pack Number DYNDH1453; 6) TRAY, ER LACERATION, Pack Number DYNDL1569A; 7) LAP/PELVISCOPY CSTM PK-LF , Pack Number DYNJ0157511K ; 8) SMSC-PELVISCOPY PACK-LF , Pack Number DYNJ0161619I ; 9) LAPAROSCOPY/PELVISCOPY PACK-LF, Pack Number DYNJ0477038K ; 10) LITHOTOMY/PELVISCOPY PACK , Pack Number DYNJ0531985R ; 11) GYN PELVISCOPY PACK-LF, Pack Number DYNJ0537705L ; 12) SM-PELVISCOPY PACK-LF , Pack Number DYNJ0780009W ; 13) SM-PELVISCOPY PACK-LF , Pack Number DYNJ0780009Y ; 14) PELVISCOPY PACK-LF, Pack Number DYNJ0843760I ; 15) PELVISCOPY PACK-LF, Pack Number DYNJ0843760J ; 16) PELVISCOPY LAP-LF , Pack Number DYNJ40099B ; 17) PELVISCOPY LAP-LF , Pack Number DYNJ40099C ; 18) PELVISCOPY GYN LAP PACK , Pack Number DYNJ40608D ; 19) PELVISCOPY PACK (PVGSG)227, Pack Number DYNJ47595N ; 20) PELVISCOPY PACK (PVGSG)227, Pack Number DYNJ47595O ; 21) PELVISCOPY PACK (PVGSG)227, Pack Number DYNJ47595P ; 22) RFLAP PELVISCOPY PCK(LPLUH)-LF, Pack Number DYNJ47703G ; 23) PELVISCOPY PACK , Pack Number DYNJ50688D ; 24) PELVISCOPY PACK , Pack Number DYNJ50688F ; 25) HHI LITHOTOMY PELVISCOPY PACK , Pack Number DYNJ51918D ; 26) PELVIC LAP, Pack Number DYNJ53601G ; 27) VAGINAL PACK, Pack Number DYNJ59786B ; 28) PELVIC PACK , Pack Number DYNJ63057D ; 29) PELVIC PACK , Pack Number DYNJ63057F ; 30) PERI GYN, Pack Number DYNJ64239B ; 31) OB GYN PACK , Pack Number DYNJ80831; 32) MON OB GYN PACK , Pack Number DYNJ80831A ; 33) MON OB GYN PACK , Pack Number DYNJ80831B ; 34) LAP PELVISCOPY PACK , Pack Number DYNJ82449; 35) PELVISCOPY PACK , Pack Number DYNJ82555; 36) PELVISCOPY PACK , Pack Number DYNJ82555A ; 37) PELVISCOPY, Pack Number DYNJ82676; 38) PERIPELVIC PACK , Pack Number DYNJ83912; 39) PELVISCOPY PACK , Pack Number DYNJ84379; 40) PELVISCOPY PACK , Pack Number DYNJ85311; 41) D-PELVISCOPY, Pack Number DYNJ900628I; 42) PELVISCOPY, Pack Number DYNJ901655F; 43) PELVISCOPY, Pack Number DYNJ901655G; 44) PELVISCOPY, Pack Number DYNJ908446B; 45) NILES LAP PELVIC-LF , Pack Number DYNJ908459A; 46) NILES LAP PELVIC RFID-LF, Pack Number DYNJ908459B

    FDA Recall
    Open, Classified ·MEDLINE INDUSTRIES, LP Northfield·Product code MLT·April 8, 2024

    Apollo" Revision/Constrained Knee System: SZ0-16MM AK CCK TIB INSER SZ1-11MM AK CCK TIB INSER SZ1-16MM AK CCK TIB INSER SZ1-22MM AK CCK TIB INSER SZ1-30MM AK CCK TIB INSER SZ2-11MM AK CCK TIB INSER SZ2-13MM AK CCK TIB INSER SZ2-16MM AK CCK TIB INSER SZ2-22MM AK CCK TIB INSER SZ2-30MM AK CCK TIB INSER SZ3-16MM AK CCK TIB INSER SZ3-22MM AK CCK TIB INSER SZ3-25MM AK CCK TIB INSER SZ4-13MM AK CCK TIB INSER SZ4-16MM AK CCK TIB INSER SZ5-11MM AK CCK TIB INSER

    FDA Recall
    Terminated ·Zimmer, Inc.·Product code JWH·February 25, 2014

    Natural-Knee II Constrained Knee System NKII CCK TIB INS SZ00/0-L NKII CCK TIB INS SZ1/2-LF NKII CCK TIB INS SZ3-5 -L NKII CCK TIB INS SZ00/0-R NKII CCK TIB INS SZ3-5 -R NKII CCK TIB INS SZ1/2-LF NKII CCK TIB INS SZ3-5 -L NKII CCK TIB INS SZ00/0-R NKII CCK TIB INS SZ1/2-RT NKII CCK TIB INS SZ3-5 -R NKII CCK TIB INS SZ00/0-L NKII CCK TIB INS SZ1/2-LF NKII CCK TIB INS SZ3-5 -L NKII CCK TIB INS SZ00/0-R NKII CCK TIB INS SZ3-5 -R NKII CCK TIB INS SZ1/2-LF NKII CCK TIB INS SZ3-5 -L NKII CCK TIB INS SZ00/0-R NKII CCK TIB INS SZ3-5 -R NKII CCK TIB INS SZ00/0-L NKII CCK TIB INS SZ1/2-LF NKII CCK TIB INS SZ00/0-R NKII CCK TIB INS SZ1/2-RT NKII CCK TIB INS SZ1/2-LF NKII CCK TIB INS SZ3-5 -L NKII CCK TIB INS SZ00/0-R NKII CCK TIB INS SZ1/2-RT NKII CCK TIB INS SZ00/0-L NKII CCK TIB INS SZ00/0-R

    FDA Recall
    Terminated ·Zimmer, Inc.·Product code JWH·February 25, 2014

    Waterpik Sonic-Fusion Professional, Model: SF-02 Product Usage: The device is composed of a unit base and an oral irrigator/ battery operated brush power handle. The device provides a pulsating stream of potable water and/or powered toothbrush action to remove plaque and food particles from between the teeth and below the gum line. The power handle can also function as a rechargeable battery powered mechanical toothbrush.

    FDA Recall
    Terminated ·Water Pik, Inc.·Product code JET·July 2, 2018

    Water Pik Sinusense battery operated device including a blue semi-transparent water reservoir, a white hand held button initiated injector device, and a soft seal nozzle affixed to the white injector. The product is sold individually in white, blue red and orange cartons with a photo of the device as well as a stream of water flowing through it. The contents of the container include the device as well as a package insert with utilization instructions. Product Usage: Sinus washing device to keep sinus passages clear of congestion.

    FDA Recall
    Terminated ·Water Pik, Inc.·Product code KMA·April 3, 2012

    MultiLab Series II ROODRA non-invasive vascular diagnostic device, Model Number 11986-0000-01

    FDA Recall
    Open, Classified ·Unetixs Vascular, Inc.·Product code JAF·February 10, 2023

    MultiLab Series II LHS TI & ERGO non-invasive vascular diagnostic device, Model Number 11949-0000-01

    FDA Recall
    Open, Classified ·Unetixs Vascular, Inc.·Product code JAF·February 10, 2023

    MultiLab Series II REVO non-invasive vascular diagnostic device, Model Number 12950-0000-01

    FDA Recall
    Open, Classified ·Unetixs Vascular, Inc.·Product code JAF·February 10, 2023

    MultiLab Series II 2CP & 2CP Express non-invasive vascular diagnostic device, Model Number 11996-0000-01

    FDA Recall
    Open, Classified ·Unetixs Vascular, Inc.·Product code JAF·February 10, 2023

    Microstream SMART CAPNOLINE PLUS O2 ADU/INT 25UN Part Number: 009822 Oridion 3012176-012 Physio Control

    FDA Recall
    Terminated ·Oridion Medical·Product code cck·May 26, 2010

    9200 Advisor Vital Signs Monitor uses power cord WW3005 (Electri-Cord Manufacturing Co., 312 Main St., Westfield, PA 16950).

    FDA Recall
    Terminated ·Smiths Medical PM, Inc. N7·Product code CCK·January 15, 2010

    Adult Divided Cannula end tidal C)2 sampling w/male luer-lock connector. 7 ft, oxygen tube, 7 ft. CO2 tube RX only.For Single Patient Use only. Distributed by Tri-Anium Assembled in Mexico. Usage: Delivery of Anesthesia.

    FDA Recall
    Terminated ·SALTER LABS·Product code CCK·May 30, 2012

    Microstream O2/CO2 NASAL FILTERLINE ADULT 25UN Part Number: 006912

    FDA Recall
    Terminated ·Oridion Medical·Product code CCK·May 26, 2010

    Tidal Wave 610, Refurbished, Respironics/Philips product. Intended use of the monitors is to provide short term monitoring of carbon dioxide and oxygen saturation during anesthesia/recovery, in the intensive care unit (ICU), and in Emergency Medicine/transport of Respiratory Care.

    FDA Recall
    Terminated ·Philips Healthcare Inc.·Product code CCK·November 19, 2009

    Evaluation Kit, Capnostat 5, Respironics/Philips Product. Intended use of the Capnostat 5 CO2 sensor is to provide carbon dioxide monitoring to a host monitoring system.

    FDA Recall
    Terminated ·Philips Healthcare Inc.·Product code CCK·November 19, 2009

    Cholestech LDX High Sensitivity C-Reactive Protein (hs-CRP) Test Cassette. The Cholestech LDX high sensitivity C-Reactive Protein (hs-CRP) is an in vitro diagnostic test for the quantitative determination of C-reactive protein in whole blood or serum. Measurement of CRP is useful as an aid in the detection and evaluation of infection, tissue injury, inflammatory disorders and associated diseases. The test cassettes are for use with the LDX analyzer.

    FDA Recall
    Terminated ·Cholestech Corp·Product code DCK·August 9, 2006

    Philips Microstream Model 989803159581 VITALINE H SET INFANT/NEONATAL 25 UN PHILIPS These products are used with Philips Monitors for the measurement of endtidal CO2 in infants and neonates. They provide a means to transport samples of patient respiratory gases from the patient's airway to the Microstream capnograph. This by performed by placing the airway adapter portion of the FilterLine H Set Infant/Neonate an VitaLine H Set Infant/Neonatal in the patient airway system of a respirator or an anesthesia machine.

    FDA Recall
    Terminated ·Philips Healthcare Inc.·Product code CCK·April 7, 2011