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    Proteus 235 The Proton Therapy System - Proteus 235 (brand names: Proteus Plus and Proteus ONE) is a medical device designed to produce and deliver a proton beam for the treatment of patients with localized tumors and other conditions susceptible to treatment by radiation.

    FDA Enforcement
    Class II ·Terminated·Ion Beam Applications S.A.·August 19, 2020

    GAP Nail 4.8mm (diameter size) of the GAP ENDO-EXO MEDULLARY SYSTEM. Catalog number GAP-N48-16; GAP-N48-18; GAP-N48-26; GAP-N48-28. Product Usage: The GAP Endo-Exo Medullary System is used for the treatment of fractures or correction of deformities in the femur, tibia and humerus of pediatric patients, who have reached skeletal maturity. The GAP Nail is an intramedullary nail. It is the main component of the GAP Endo-Exo Medullary System. The rest of the components of the system are screws, plates and caps that are assembled to the nail during the surgical procedure. The GAP Endo-Exo Medullary System is indicated as a temporary implant to assure alignment, stabilization and fixation of: long bones that have been surgically prepared (osteotomy) for correction of deformities or fractures caused by trauma or disease. The GAP System is used for pediatric patients (child and adolescent) ages 2 to 21. It can be used to correct the following conditions: -Diaphyseal fracture of the femur, tibia and humerus -Fractures of the femoral neck -Subtrochanteric, intertrochanteric and combination fractures -Correction of deformities (OI, Coxa vara, Coxa valga) -Nonunions and malunions

    FDA Enforcement
    Class II ·Terminated·Pega Medical Inc.·April 8, 2015

    Merge Eye Station f/k/a: DFC-1024 & DFC-512 Digital Imaging System, WinStation, and WinStation Retinal Imager distributed by Ophthalmic Imaging Systems (OIS). Versions: 11.6.0 and prior

    FDA Enforcement
    Class II ·Terminated·Merge Healthcare, Inc.·January 18, 2017

    Merge Eye Station. f/k/a: DFC-1024 & DFC-512 Digital Imaging System, WinStation, and WinStation Retinal Imager distributed by Ophthalmic Imaging Systems (OIS). Model number 136 T1700 Capture Stations & 46 T5810 Capture Stations.

    FDA Enforcement
    Class II ·Terminated·Merge Healthcare, Inc.·February 15, 2017

    SIEMENS brand ARTISTE syngo RT Therapist (RTT) version 4.3, ARTISTE Model, Part No. 08162815, Digital linear accelerators, MOSAIQ OIS system, Distributed by SIEMENS Healthcare IM CR RO, CR Radiation Oncology, Manufactured by SIEMENS AG, MEDICAL SOLUTIONS, GERMANY.

    FDA Enforcement
    Class II ·Terminated·Siemens Medical Solutions USA, Inc·March 13, 2013

    ARTISTE or ONCOR Digital Linear Accelerators with syngo RT Therapist version 4.2/MOSAIQ OIS Systems and Multiple-X, Manufactured by SIEMENS AG. The ARTISTE and ONCOR family of Linear Accelerators are used to deliver X-ray photon and electron radiation for the therapeutic treatment of cancer.

    FDA Enforcement
    Class II ·Terminated·Siemens Medical Solutions USA, Inc·August 1, 2012

    IntellaTip MiFi Open-Irrigated radiofrequency Ablation Catheters: Material number: M004EPM96200, Catalog Number: EPM9620: Material number: M004EPM9620K20, Catalog Number: EPM9620K2; Material number : M004EPM9620N40; Catalog number: EPM9620N4. The IntellaTip MiFi Open-Irrigated Ablation Catheter is a 7.5F (2.5 mm) quadrapolar open-irrigated (OI) ablation catheter designed to deliver radiofrequency (RF) energy to the 4.5 mm catheter tip electrode for cardiac ablation The product is not approved for use/sale in the US.

    FDA Enforcement
    Class I ·Terminated·Boston Scientific Corp·March 11, 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

    Siemens LANTIS System ; LANTIS Commander, 10 Users ; LANTIS 6.1 Commander ; LANTIS 8.3 Commander The intended use of the linear accelerator is to deliver x-ray radiation for therapeutic treatment of cancer.

    FDA Enforcement
    Class II ·Terminated·Siemens Medical Solutions USA, Inc·July 2, 2014

    FEMORAL ANGIOGRAPHY PACK - (1) TABLE COVER REINFORCED 50" X 90" UF (1) GOWN LARGE SMS IMPERVIOUS REINFORCED LIF (1) TOWEL ABSORBENT 15" X 20" UF (1) DRAPE ANGlO 75" X 145" (4) TOWELS CLOTH HUCK (BLUE) UF (3) SYRINGE 1 Occ WITHOUT NEEDLE LUER LOCK UF (1) IV ADM SET 15ML 1 06" LONG LIF (20) GAUZE SPONGE 4" X 4" 12PL Y LIF (1) NEEDLE HYPODERMIC 18G X 1Y:. ST. UF (1) NEEDLE HYPODERMIC 21G X 1Y:. ST. LIF (2) MEDICINE CUP 2oz. CLEAR LIF (1) SCALPEL WEIGHTED SAFETY #11 (2) CHLORASCRUB SWABSTICK 5.1 ML LIF (1) GOWN SURG REINFORCED LARGE TOWEL/WRAP LIF (1) SPECIMEN CONTAINER 4oz. W/LID & LABEL LIF (1) NEEDLE HYPODERMIC 25G X 5/8 ST. LIF (1) SYRINGE 3cc WITHOUT NEEDLE LUER LOCK LIF (1) FORCEP ADS ON TISS. WITH TIP LIF (1) UTILITY BOWL 32oz LIF (1) UTILITY BOWL 16oz L/F (1) FORCEP KELLY STRAIGHT 5.5" LIF (1) MOSQUITO HALSTED CVD 5" LIF (1) TRAY ORGANIZER FULL DEEP LIF (1) SCISSOR MAYO 6.75 STRAIGHT LIF (1) HOLDER NEEDLE WEBSTER 4.75 LIF (1) GUIDEWIRE .035" X 150cm UF (1) TIME OUT BEACON NON WOVEN ST. UF (1) MAYO TRAY SMALL LIF (2) TOWEL CLAMP UF (2) BAG BAND RUBBAND & TAPE LIF (1) Pr. GLOVE SURG. #7Y:. DERMA PRENE P/F LIF (2) SYRINGE 20cc WITHOUT NEEDLE LUER LOCK LIF LABEL SAMPLE (1) NEEDLE & BLADE COUNTER 60C FOAM STRIP/MAG STRIP LIF (1) NEEDLE 18G X 2 o/.i AMC/4 (1) SKIN MARKER INK WITH/8 LABEL EO sterilized surgical convenient packs packaged into polyester/polyethylene breather bag with Tyvek double vents.

    FDA Enforcement
    Class I ·Terminated·Customed, Inc·September 10, 2014

    NICO Myriad Handpiece Product Number/Product Name: NN-8000 15x10 MHP; NN-8001 15x 13 MHP; NN-8002 15x 25 MHP - MINOP; NN-8003 13x10 MHP; NN-8004 13x13 MHP; NN-8005 15x25 MHP GAAB; NN-8006 11X10 MHP; NN-8007 11x13 MHP; NN-8008 19x28 MHP OI; NN-8010 17x31.5 MHP DECQ; NN-8015 NICO Fluid System (NFS); NN-8017 11x13 MHP/PB; NN-8018 13X13 MHP/PB; NN-8019 19x28 MHP Little LOTTA; NN-8020 19x21.5 MHP PaediScope; NN-8021 15x26.5 MHP LOTTA; NN-8500 15x10 MHP; NN-8501 15x13 MHP; NN-8502 15x25 MINOP MHP; NN-8503 13x10 MHP; NN-8504 13x13 MHP; NN-8505 15x25 GAAB MHP; NN-8506 11X10 MHP; NN-8507 11x13 MHP; NN-8508 19x28 OI MHP; NN-8510 17x31.5 DECQ MHP; NN-8517 13X13 MHP/PB; NN-8518 11x13 MHP/PB; NN-8519 19x28 Little LOTTA MHP; NN-8520 19x21.5 PaediScope MHP; NN-8521 15X26.5 LOTTA MHP;

    FDA Enforcement
    Class II ·Ongoing·Stryker Corporation·December 3, 2025

    Volcano s5i/s5ix/s5iz/CORE Intravascular Ultrasound Imaging and Pressure System; Product/Part numbers: s5i -806300-020 ; s5ix/s5iz - 807400-001; CORE - 400-0 I 00.02. Intravascular Imaging and Pressure System for evaluation of blood flow, perfusion and vascular structures.

    FDA Enforcement
    Class II ·Terminated·Volcano Corp·July 15, 2015

    GE Inspection Technologies, LP, Cabinet X-ray system used for industrial quality control.

    FDA Enforcement
    Class II ·Terminated·GE Inspection Technologies, LP·April 13, 2016

    Terumo Cardioplegia Delivery Set- Item Number: 16130 Product Usage: The Cardioplegia Delivery Sets are indicated for delivery of cardioplegic solutions to the heart during cardiopulmonary bypass surgery.

    FDA Enforcement
    Class II ·Terminated·Terumo Cardiovascular Systems Corp·November 12, 2014

    GE Inspection Technologies Blade|line Industrial Cabinet X-ray system

    FDA Enforcement
    Class II ·Terminated·GE Inspection Technologies, LP·August 9, 2017

    Bandeja para Debridacion, code 900-2702, contains: (1) FORCEP ADSON TISS (20) GAUZE SPONGES 4 X 4 12PL Y (1) SCISSORS IRIS STRAIGHT 4.5 W/PROTECTOR TIP (1) TOWEL 3 PLY POLY 13 X 18 (1) DRAPE 18 X 26 WHITE/WHITE POLYPROPYLENE (1) CHLORASCRUB SWABSTICK 1.6 ML (1) TRAY KUTIER (1) SCALPEL W/HANDLE 20 (1 i WRAPPER 24 X 24 Product Usage: EO sterilized surgical convenient packs packaged into polyester/polyethylene breather bag with Tyvek double vents.

    FDA Enforcement
    Class I ·Terminated·Customed, Inc·September 10, 2014

    Penner Pacific Bathing Spa, Model Numbers 361910-1A, 361910-1A, 361910-XA, 361910-2I, 361910-1A, 361910-1, 361910-XI, 361910-1I, 361910-2A, 36191-1A, 361910-X

    FDA Enforcement
    Class III ·Ongoing·Penner Patient Care, Inc.·March 18, 2026

    LAPAROSCOPY PACK CONTENTS: ( I ) BULB SYRINGE 60cc LIF ( I 0) GAUZE SPONGE 4" X 4" 1 6PLY XRD LIF ( I ) MAYO STAND COYER REINFORCED LIF ( I ) TABLE COVER REINFORCED 50" X 90" LIF (3) GOWN SURG. REINFORCED XL EXTRA LONG LEVEL I V (4) TOWEL ABSORBENT I 5" X 20" LIF ( I ) DRAPE VIDEO CAMERA I 3cm X 244cm LIF (3) LITE G LOVE LIF ( I ) DRAPE LAP ABDOM. WI POUCH 102" X 122" X 78" ( I ) BLADE SURG ICA L # II STAIN LESS STEEL ( I) SYRINGE I Occ W ITHOUT NEEDLE LUER LOCK LIF (4) DRAPE UTILITY WITH TAPE LIF ( I ) SUTURE BAG FLORAL (I) NEEDLE & BLADE COUNTER I OC MAG I C LEAR L/1' ( I ) CABLE LAP. IOFR 4MM MALE MONOP. LIF (2) DRESSING NON ADH TELfoA 4 X 3 ( I ) SPECIMEN CONTAINER 4oz WITH LID & LABEL (2) SH EET 'll.o 60" X 77" DRAPE R EI NFORCED LIF ( I ) TUBING INSUFFLAT SET WIO RING ADAPTOR LIF ( I ) CI-I LORAPREP 26ML APPLICATOR TEAL LIF ( I ) WRAPPER 24" X 24" (2) DENTURE CUP 8oz WILID ADHERED OUTSIDE OF THE PACK INTO A POUCH: ( I ) NEEDLE ULTRA VERES 1 20MM LIF ( I ) TROCAR ENDO.XCEL DILATING TIP IIM M (D IILT) ( I ) TROCA R ENDO.XCEL DILATING TIP LIF (K5LT) ( I ) CANNU LA 5MM XCEL SLEEVES LIF Product Usage: EO sterilized surgical convenient packs packaged into polyester/polyethylene breather bag with Tyvek double vents.

    FDA Enforcement
    Class I ·Terminated·Customed, Inc·September 10, 2014

    REEMPLAZO DE RODILLA Y CADERA CONTENTS: (6) TOWELS ABSORBENT 15" X 20" (I) PK. STRIP STERICLOSURE Y," X 4" (I) COVER MAYO STAND RErNFORCED (I) SKIN MARKERINK W/8 LABEIJfiME OUT/RULER (I) BAG SUTURE FLORAL (2) SCALPEL WEIGHTED SAFETY # I0 (I) STOCKrNETTE IMPERV 14" X 48" (I) TIME OUT BEACON NON WOVEN (2) DRAPE U 60" X 70"WI TAPE SPLIT 6" X 21 " (2) TUBE SUCTION CONNECT'/.'' X 12' (2) DRAPE INCISE ANTIMICROBIAL 23" X 17" (2) LIGHT SHIELD (I) NEEDLE SPINAL ANESTH 18G X 3 Y, (4) STR IPS TAPE 24" X 4" (I ) GOWN IMP. XTRA REINF SMS XL T/W LEVEL (20)GAUZE SPONGES 4" X 4" 16PLY (3) DRAPE '!. ECONOMY 53" X 77" (I) DRAPE UNDERBUTTOCK W/POUCI-1 44" X 35" (I) DRAPE TOP WIADHESIVE 108" X 50" STD SMS (I) COUNTER NEEDLE 60C FOAM STRIP/MAG STRIP (I) YANKAUER OPEN TIP CLEAR W/0 CIV (2) DRAPE SIDE 36" X 77" W/ADl-1. (I) SHEET SPLIT W/ADHES 108" X 77" STD SMS (I) SYRINGE 60ML UL W/0 NEEDLE (I) POLISHER CAUTERY TIP (I) NEEDLE BLUNT FILL 1 8G X I Y, (2) COVER TABLE BTC 77" X I I 0"l-ID FULL COVERAGE (2) GLOVE SURG. DERMA PRENE #8 POWDER FREE (10) SPONGE LAP PREWASH 18" X 18" XRD (I) COVER MAYO STAND W/CSR 23" X 54" (I) BOWL UTILITY QUART 32oz. (3) CLAMP TOWEL (I) BOWL UTILITY PINT 16oz. (3) GOWN MICROCOOL IMP. XTRA LONG XL (3) BANDAGE ELASTIC 6" X 5YRD WIVELCRO (I) MERLING SKrN PREP APPLIC.39ML (2) PADDING CAST SOFT ROLL 6 X 4YRD (I) MAYO TRAY LARGE Product Usage: EO sterilized surgical convenient packs packaged into polyester/polyethylene breather bag with Tyvek double vents.

    FDA Enforcement
    Class I ·Terminated·Customed, Inc·September 10, 2014

    LineSider Spinal System 5.5/6.0mm, Non-mod Standard 7.1mm - Dual Lead, Cannulated. Thoracolumbosacral pedicle screw system; Spinal interlaminal fixation orthosis. Product sold as non-sterile and shipped in protective sterilization trays. Screws can also be shipped individually, as tray replenishments. Labeled as the following sizes: a. 5.5mm x 35mm; b. 5.5mm x 40mm; c. 5.5mm x 45mm; d. 5.5mm x 50mm; e. 5.5mm x 55mm; f. 6.5mm x 35mm; g. 6.5mm x 40mm; h. 6.5mm x 45mm; i. 6.5mm x 50mm; j. 6.5mm x 55mm; k. 6.5mm x 60mm; l. 7.5mm x 35mm; m. 7.5mm x 40mm; n. 7.5mm x 45mm; o. 7.5mm x 50mm; p. 7.5mm x 55mm; q. 7.5mm x 60mm; r. 8.5mm x 35mm; s. 8.5mm x 40mm; t. 8.5mm x 45mm; u. 8.5mm x 50mm; v.8.5mm x 55mm; w. 8.5mm x 60mm; Used in spinal fixation surgery.

    FDA Enforcement
    Class II ·Terminated·Integrity Implants Inc.·December 14, 2022