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    Neuro Kinetics, Inc. (NKI) I-Portal NOTC system with the OVAR research test; a rotary chair system used in vestibular and neuro-otologic diagnostic testing. This device provides no diagnoses nor does it provide diagnostic recommendations.The OVAR test has not yet been cleared by the FDA, and until then can only be used as an investigational device.

    FDA Recall
    Terminated ·Neuro Kinetics, Inc.·Product code GWN·July 21, 2015

    Neuro Kinetics, Inc. (NKI) I-Portal¿ NOTC system with the OVAR research test; a rotary chair system used in vestibular and neuro-otologic diagnostic testing. This device provides no diagnoses nor does it provide diagnostic recommendations.The OVAR test has not yet been cleared by the FDA, and until then can only be used as an investigational device.

    FDA Enforcement
    Class II ·Terminated·Neuro Kinetics, Inc.·September 9, 2015

    BRAINLAB Curve; Model/catalogue (article) numbers for Curve: 19901; 19901B; 19900; 19905 UDI (GTIN) for Curve: 04056481138011

    FDA Enforcement
    Class II ·Terminated·Brainlab AG·August 19, 2020

    BRAINLAB Kick 2; Model/catalogue (article) numbers for Kick: 18170; 18070 UDI (GTIN) for Kick: 04056481006655

    FDA Enforcement
    Class II ·Terminated·Brainlab AG·August 19, 2020

    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 Enforcement
    Class II ·Terminated·Zimmer, Inc.·March 26, 2014

    Cyberkinetics Inserter Wand & V2 Trigger Assembly, Expiration: July 14, 2009; Catalog Number: 4468.

    FDA Recall
    Terminated ·Cyberkinetics Neurotechnology Systems, Inc.·Product code GZL·February 4, 2009

    Natural-Knee¿ II System ULTRA CONG INS LT SZA/9MM ULTRA CONG INS LT SZA/13M ULTRA CONG INS LT SZA/19M ULTRA CONG INS RT SZA/9MM ULTRA CONG INS RT SZA/11M ULTRA CONG INS RT SZA/13M ULTRA CONG INS RT SZA/19M ULTRA CONG INS LT SZB/13M ULTRA CONG INS LT SZB/16M ULTRA CONG INS RT SZB/19M ULTRA CONG INS RT SZB/22M NKII ROT PLTFM U/C INS, 9 NKII ROT PLTFM U/C INS, 1 NKII ROT PLTFM U/C INS, 1 NKII ROT PLTFM U/C INS, 1 NKII ROT PLTFM U/C INS, 1 NKII ROT PLTFM U/C INS, 1 NKII ROT PLTFM U/C INS, 1 NKII ROT PLTFM U/C INS, 1 NKII ROT PLTFM U/C INS, 1 NKII ROT PLTFM U/C INS, 1 NKII ROT PLTFM U/C INS, 1 NKII ROT PLTFM U/C INS, 1 NKII ROT PLTFM U/C INS, 1 NKII ROT PLTFM U/C INS, 1 ALL POLY CONG TIB LT SZ00 ALL POLY CONG TIB LT SZ0/ ALL POLY CONG TIB LT SZ0/ ALL POLY CONG TIB RT SZ0/ ALL POLY CONG TIB RT SZ0/ ALL POLY CONG TIB LT SZ1/ ALL POLY CONG TIB LT SZ1/ ALL POLY CONG TIB RT SZ1/ ALL POLY CONG TIB RT SZ1/ ALL POLY CONG TIB RT SZ1/ ALL POLY CONG TIB LT SZ2/ ALL POLY CONG TIB LT SZ2/ ALL POLY CONG TIB LT SZ2/ ALL POLY CONG TIB LT SZ2/ ALL POLY CONG TIB RT SZ2/ ALL POLY CONG TIB RT SZ2/ ALL POLY CONG TIB RT SZ2/ ALL POLY CONG TIB LT SZ3/ ALL POLY CONG TIB LT SZ3/ ALL POLY CONG TIB LT SZ3/ ALL POLY CONG TIB RT SZ3/ ALL POLY CONG TIB RT SZ3/ ALL POLY CONG TIB RT SZ3/ ALL POLY CONG TIB LT SZ4/ ALL POLY CONG TIB LT SZ4/ ALL POLY CONG TIB RT SZ4/ ALL POLY CONG TIB RT SZ4/ ALL POLY CONG TIB RT SZ5/ PS TIB INS RT SZ1/2 16MM PS TIB INS RT SZ1/2 19MM PS TIB INS LT SZ00/0 19MM PS TIB INS RT SZ00/0 11MM PS TIB INS RT SZ00/0 16MM

    FDA Enforcement
    Class II ·Terminated·Zimmer, Inc.·March 26, 2014

    NDI P7 Position Sensor, Stereotaxic Instrument

    FDA Enforcement
    Class II ·Terminated·Orthosoft, Inc. dba Zimmer CAS·May 17, 2017

    NDI Disposable Reflective Marker Spheres for Brainlab IGS (Image Guided Surgery) system. Product Usage: Disposable reflective marker spheres are attached to reference arrays and instruments, thus enabling the infrared tracking systems to detect the position of the patient and instruments in the surgical field.

    FDA Enforcement
    Class II ·Terminated·Northern Digital Inc.·July 22, 2015

    BioCare Medical Vina Green Chromogen Kit; 25 mL, 100ml IVD. Kits include: Vina Green Chromogen 1. 0 mL; Vina Green Buffer, 25 mL and Vina Green Dropper Bottle. BioCare Medical, Concord, CA 94520. Vina Green is intended for both IHC and ISH applications including HPV, CMV, EBV, Kappa, TTF-1, Ki-67 and other targets/antigens such as blood and lymphatic vessels and basal and myoepithelial cells.

    FDA Recall
    Terminated ·Biocare Medical Llc·Product code NJT·March 13, 2012

    Propper short gas-chex EO sterilization indicators, 250 strips per box, Reorder No. 269001, Propper Manufacturing Co., Inc., Long Island City, N.Y. 11101

    FDA Recall
    Terminated ·Propper Mfg Co Inc·Product code JOJ·February 7, 2008

    NDI Disposable Reflective Marker Spheres for Brainlab IGS (Image Guided Surgical) system. Product Usage: Disposable reflective marker spheres are attached to reference arrays and instruments, thus enabling the infrared tracking systems to detect the position of the patient and instruments in the surgical field.

    FDA Enforcement
    Class II ·Terminated·Northern Digital Inc.·July 22, 2015

    VITROS VALP Reagent , REF 680 1710. Each box contains 6 packs. Each pack contains liquid reagent for 50 tests. Responsible firm on the label: Ortho-Clinical Diagnostics, Inc., Rochester, N.Y. 14626.

    FDA Recall
    Terminated ·Ortho-Clinical Diagnostics·Product code LEG·April 18, 2005

    TRIATHLON FEMORAL DISTAL AUGMENT 10MM - SIZE 2 LEFT Catalog # 5541-A-201 - Product Usage: Triathlon Femoral Distal Augments are used with Triathlon TS Femoral Components during revision Total Knee Arthroplasty (TKA) and with Triathlon Primary PS Femoral Components during TKA to address distal femoral defects. (See attached IFU (IFU_Triathlon Total Knee_QIN 4376 Rev AB).

    FDA Enforcement
    Class II ·Terminated·Howmedica Osteonics Corp.·October 9, 2019

    Ki Mobility, Little Wave Tyke (Weight Limit: 95 lbs), Specifically the IFU The Little Wave Tyke is a manually operated device that can be used for medical purposes and is used to assist a disabled person to move from one place to another while sitting. Intended to be used by persons up to 95 pounds for transport.

    FDA Recall
    Terminated ·Ki Mobility Llc·Product code INM·November 19, 2021

    KODAK GP FLEXIBLE PHOSPHOR SCREENS, for use with Kodak DirectView CR 500 systems. Responsible firm on label: Made in U.S.A. by Eastman Kodak Company, Rochester, N.Y. 14650. Screens are sold in the following sizes and Cat. Nos: (1) Cat. #812-7334 - 15 x 30 cm; (2) Cat #825-9269 - 18 x 24 cm; (3) Cat #167-8663 - 24 x 30 cm; (4) Cat #810-7823 - 35 x 35 cm; (5) Cat #160-5906 - 35 x 43 cm

    FDA Recall
    Terminated ·Eastman Kodak Co·Product code IXJ·April 8, 2005

    Ki Mobility, Little Wave Tyke (Weight Limit: 95 lbs), Specifically the IFU The Little Wave Tyke is a manually operated device that can be used for medical purposes and is used to assist a disabled person to move from one place to another while sitting. Intended to be used by persons up to 95 pounds for transport.

    FDA Enforcement
    Class III ·Terminated·Ki Mobility Llc·January 19, 2022

    propper brand cal-mark(R), Micro-Hematocrit Calibrated Capillary Tubes, CALIBRATED-HEPARINIZED, reorder no. 043021, 6 Vials, 100 Tubes per Vial, Length 75 mm., 0.55 mm. I.D., 1.40-1.75mm. O.D. Calibrated 60mm from end for use in direct reading centrifuges. Fill to the 60mm mark with blood and seal opposite end by flame or with sealing compound. If centrifuged on a direct reading centrifuge, read percent hematocrit directly from scale on the centrifuge. Otherwise, read in normal manner as a percent ratio of packed cells with 60mm of sample as 100%. Firm on label: propper manufacturing co., inc., long island city, n.y. 11101.

    FDA Recall
    Terminated ·Propper Mfg Co Inc·Product code G-IO·August 9, 2002

    Revanesse Versa, PN40081

    FDA Recall
    Terminated ·Prollenium Medical Technologies Inc. 138 Industrial Pky N Aurora Canada·Product code LMH·November 15, 2018

    Schoitz weights are manual devices used with Schoitz tonometers and are intended to measure intraocular pressure by applying a known force on the globe of the eye and measuring the amount of indentation produced (Schiotz type) or to measure intraocular tension by applanation (applying a small flat disk to the cornea) and are sold under the Ambler Surgical brand name.

    FDA Recall
    Terminated ·Instrumed International, Inc.·Product code HKY·September 8, 2014