BEUDAMED
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    Metasul Head 40, 12/14, SZ M/0 total hip prosthesis - metal femoral heads Noninflammatory degenerative joint disease (NIDJD) including avascular necrosis, osteoarthritis, post-traumatic arthritis and congenital hip dysplasia and inflammatory joint disease (IJD) e.g. rheumatoid arthritis if bone quality is adequate. Failed previous surgery where pain, deformity, or dysfunction persists. Revision of previously failed hip arthroplasty. Total hip replacements may be considered for younger patients if any unequivocal indication outweighs the risks associated with the age of the patient and modified demands regarding activity and hip joint loading are assured. This includes severely handicapped patients with multiple joint involvement, for whom an immediate need of hip mobility leads to an expectation of significant improvement in the quality of their lives. The system is intended for use either with or without bone cement in total hip arthroplasty."

    FDA Enforcement
    Class II ·Terminated·Zimmer Biomet, Inc.·March 2, 2016

    Duo-Flow IJ Full Tray; MCDLT114IJ MCDLT116IJ MCDLT118IJ

    FDA Enforcement
    Class II ·Terminated·Medical Components, Inc dba MedComp·September 5, 2018

    DUO FLOW DOUBLE LUMEN CATHETER, XTP114CT, XTP114MT, ; RAULERSON DUO FLOW IJ DOUBLE LUMEN CATHETER/CATHETER SET, XTP114IJC, XTP114IJS, XTP114IJSE, XTP114MT-C, XTP116IJC, XTP116IJS, XTP116IJSE RAULERSON PRE-CURVED DUO-FLOW IJ DOUBLE LUMEN CATHETER W/SOFT TIP SET, W/MINI SCALPEL, SYRINGE, AND NEEDLE, XTP118IJS-ID; DOUBLE LUMEN CATHETER WITH CURVED EXTENSIONS (CATHETER ONLY), XTP114IJC=, XTP116IJC=, DOUBLE LUMEN IJ CATHETER SET, XTP114IJS=, XTP115IJS=, XTP116IJS=, XTP116IJS=JO, DOUBLE LUMEN CATHETER SET, XTP114MT= DUO-FLOW DOUBLE LUMEN CATHETER, XTP116CT, INTERNAL JUGULAR CATHETER SET, XTP96IJS= (additional product codes/catalog numbers in attached spreadsheet)

    FDA Enforcement
    Class II ·Terminated·Medical Components, Inc dba MedComp·September 5, 2018

    The 2.7mm Drilling Guide is a reusable instrument used in conjunction with a drill to prepare oriented holes in bone for insertion of a Standard Surfix¿ Locking Screw with plates for the Tiblaxis, Uni-CP, Advansys MLP and Advansys DLP compression plate systems. The Drilling Guides are initially supplied to users in kits containing the devices that comprise the Tibiaxis, Uni-CP, Advansys MLP and Advansys DLP systems. Should the Drilling Guides need to be replaced, they can be replenished by the customer placing an order. The replacement is shipped to the customer in sealed plastic bags. Uni-CP" Compression Plate The Uni-CP" Compression Plate is indicated for fixation of bone fractures or for bone reconstruction: - Arthrodesis in foot and ankle surgery - Fracture management in the foot and ankle - Mono or bi-cortical osteotomies in the foot and ankle TIBIAXYS" Plates The Newdeal¿ TIBIAXYS" Plates are indicated For fixation of bone fractures or for bone reconstruction. Examples include Osteotomies and fractures of ankle joint, distal tibia and fibula. The Newdeal¿ TIBIAXYS" Plates must be fixed with the Newdeal Surfix¿ 3.5mm diameter fixation screws and lock-screws. ADVANSYS¿ Mid-Foot Plating System: Dorsal Lisfranc Plate (DLP) and Medical Lisfranc Plate (MLP) The Dorsal Lisfranc Plates are intended for fractures, fusions, osteotomies and replantations of small bones at the tarsometatarsal joints The Medial Lisfranc Plates are intended for bone fixation such as: arthrodesis of the 1st metatarsocuneiform joint to reposition and stabilize a metatarsus primus varus: - Lisfranc arthrodesis - Mono or bi-cortical osteotomies or fractures near the 1st metatarsocuneiform joint

    FDA Enforcement
    Class II ·Terminated·Integra Life Sci.·September 26, 2012

    NKII CSTI Porous Femoral NKII NP Femoral prosthesis, knee, patellofemorotibial, semi-constrained, cemented, polymer/metal/polymer variou sizes Product Usage "" The Natural-Knee II System with Cancellous-Structured Titanium (CSTi) Porous Coating is indicated for uncemented or cemented use in skeletally mature individuals with intact medial and lateral collateral ligaments undergoing primary surgery for rehabilitating knees damaged as a result of Noninflammatory Degenerative Joint Disease (NIDJD) or Inflammatory Joint Disease (IJD). " The Natural-Knee II primary components without CSTi Porous Coating, all posterior stabilized and revision components, the N-K II Constrained Knee System, the modular cemented tibial baseplate, and the revision stem and revision fluted stem are indicated for cemented use only in skeletally mature individuals with conditions of Noninflammatory Degenerative Joint Disease (NIDJD) or Inflammatory Joint Disease (IJD), correctable valgus-varus deformity and moderate flexion contracture, or failed previous surgery where pain, deformity or dysfunction persists. When the primary or N-K II Constrained Knee System components are used, the medial and collateral ligaments must be intact. " The Natural-Knee II Durasul polyethylene components are indicated for patient conditions of noninflammatory degenerative joint disease (NIDJD), e.g., avascular necrosis, osteoarthritis, and inflammatory degenerative joint disease (IJD), e.g., rheumatoid arthritis; correctable valgus-varus deformity and moderate flexion contracture; those patients with failed previous surgery where pain, deformity, or dysfunction persists; and revision of previously failed knee arthroplasty. These devices are intended for cemented use only in the United States."

    FDA Enforcement
    Class II ·Terminated·Zimmer Biomet, Inc.·March 2, 2016

    EZ Derm Porcine Xenograft, labeled as the following: a. EZ Derm 3x4 (8x10 cm) Non-Perforated, Part Number: 131703-03; b. EZ Derm 7 x 18 (17 x 46 cm) Non-Perforated, Part Number: 131704-03; c. EZ Derm 2 x 2 (5 x 5 cm) Non-Perforated, Part Number: 131705-03; d. EZ Derm 3 x 48 (8 x 122 cm) Perforated, Part Number: 131710-03; e. EZ Derm 3 x 24 (8 x 61 cm) Perforated, Part Number: 131711-03; f. EZ Derm 3 x 12 (8 x 30 cm) Perforated, Part Number: 131712-03; g. EZ Derm 3 x 4 (8 x 10 cm) Perforated, Part Number: 131713-03; h. EZ Derm 7 x 18 (17 x 46 cm) Perforated, Part Number: 131714-03; i. EZ Derm 2 x 2 (5 x 5 cm) Perforated. Part Number: 131715-03 Product Usage: EZ Derm is a porcine derived xenograft in which the collagen has been cross linked with an aldehyde. EZ Derm (porcine xenograft) can be used for partial thickness skin loss injuries. Use of EZ Derm for burns, donor sites and chronic vascular ulcers reduces pain and fluid loss. EZ Derm can also be used as a temporary cover, or test graft, prior to auto grafting and as a protective covering over perforated auto grafts.

    FDA Enforcement
    Class II ·Terminated·Molnlycke Health Care, Inc·May 8, 2019

    GENDER SOLUTIONS NATURAL-KNEE FLEX SYSTEM GENDER SOLUTIONS FEMALE (GSF) FEMORAL COMPONENT NONPOROUS¿ N-K FLX GSF NP FEM SZ 0 RT N-K FLX GSF NP FEM SZ 4 LT N-K FLX GSF NP FEM SZ 4 RT Components with CSTi porous coating are indicated for uncemented or cemented use in skeletally mature individuals with intact medial and lateral collateral ligaments undergoing primary surgery for rehabilitating knees damaged as a result of Noninflammatory Degenerative Joint Disease (NIDJD) or Inflammatory Joint Disease (IJD).

    FDA Enforcement
    Class II ·Terminated·Zimmer Biomet, Inc.·March 21, 2018

    CR Flex GSF Precoat Fem Natural Knee GSF NP Flex Natural Knee GSF POR Flex Natural Knee GSM NP Flex Natural Knee GSM POR Flex prosthesis, knee, patellofemorotibial, semi-constrained, cemented, polymer/metal/polymer various sizes Components with CSTi porous coating are indicated for uncemented or cemented use in skeletally mature individuals with intact medial and lateral collateral ligaments undergoing primary surgery for rehabilitating knees damaged as a result of Noninflammatory Degenerative Joint Disease (NIDJD) or Inflammatory Joint Disease (IJD). " Components without CSTi porous coating are indicated for cemented use in skeletally mature individuals with intact medial and lateral collateral ligaments with conditions of Noninflammatory Degenerative Joint Disease (NIDJD) or Inflammatory Joint Disease (IJD), correctable varus-valgus deformity and moderate flexion contracture, or failed previous surgery where pain, deformity or dysfunction persists. " The N-K Flex femoral provides increased flexion capability for patients who have both the flexibility and desire to increase their flexion range. When used with N-K Flex, NexGen CR-Flex Mobile*, NexGen UC-Flex Mobile*, NexGen Trabecular Metal" CR Monoblock, 90-prefix NexGen CR, 00-prefix 10, 12 or 14mm or 90-prefix 17 or 20mm Prolong¿ Highly Crosslinked Polyethylene CR articular surfaces, it is designed for use when load bearing ROM is expected to be less than or equal to 155 degrees."

    FDA Enforcement
    Class II ·Terminated·Zimmer Biomet, Inc.·March 2, 2016

    GENDER SOLUTIONS NATURAL-KNEE FLEX SYSTEM FEMORAL COMPONENT¿ N-K FLX GSM POR FEM SZ 2 RT N-K FLX GSM POR FEM SZ 3 LT N-K FLX GSM POR FEM SZ 4 LT N-K FLX GSM POR FEM SZ 4 RT N-K FLX GSM POR FEM SZ 5 LT N-K FLX GSM POR FEM SZ 5 RT Components with CSTi porous coating are indicated for uncemented or cemented use in skeletally mature individuals with intact medial and lateral collateral ligaments undergoing primary surgery for rehabilitating knees damaged as a result of Noninflammatory Degenerative Joint Disease (NIDJD) or Inflammatory Joint Disease (IJD).

    FDA Enforcement
    Class II ·Terminated·Zimmer Biomet, Inc.·March 21, 2018

    Human lgG Subclass Liquid Reagent Kits for use on the Siemens BN"IJ Analyser Product Code: NK001.T This kit is intended for qualifying human IgG subclasses 1,2,3 and 4 immunoglobulins in serum on the Beckman Coulter AU series. Meaurement of these immunoglobulins ais in the diagnosis of abnormal protein metabolism and the body's lack of ability to resist infectious agents

    FDA Enforcement
    Class II ·Terminated·The Binding Site Group, Ltd.·February 1, 2017

    Centurion- Dressing Change Tray DT10290S CENTRAL LINE PREPARATION PACK DT10290S CENTRAL LINE PREPARATION PACK DT10415 PICC INSERTION TRAY DT10495 PICC INSERTION TRAY DT10525 CENTRAL LINE INSERTION DRAPE KIT DT10675 CENTRAL LINE INSERTION PROCEDURE KIT DT10755 DRESS UP KIT DT10850 PORT DRESSING CHANGE TRAY DT10850 PORT DRESSING CHANGE TRAY DT11300 DIALYSIS ON/OFF KIT DT11610 DRESSING CHANGE TRAY DT11955 UNIVERSAL LINE FULL BODY DRAPE KIT - REG DT12220 CVC DRESSING CHANGE TRAY DT12270 DRESSING CHANGE TRAY DT12270 DRESSING CHANGE TRAY DT12415 NEONATAL PICC INSERTION TRAY DT12415 NEONATAL PICC INSERTION TRAY DT12485 PEDI CENT LINE TRAY W/SORB SHIELD DT12540 CENTRAL LINE PACK DT12555 UNIVERSAL CVC INS SUPP TRAY DT12725 CENTRAL LINE DRESSING TRAY DT12900 CL / PICC DRESSING CHANGE TRAY DT13005A CVC DRESSING CHANGE TRAY DT13055 PICC/CENTRAL LINE DRESSING CHANGE DT13055 PICC/CENTRAL LINE DRESSING CHANGE DT13055 PICC/CENTRAL LINE DRESSING CHANGE DT13125 CENTRAL LINE TRAY DT13525 DRESSING CHANGE TRAY DT13560 PORT ACCESS TRAY DT13560 PORT ACCESS TRAY DT13560 PORT ACCESS TRAY DT13635 DRESSING CHANGE TRAY DT13725 ON/OFF KITS DT13835 DRESSING CHANGE TRAY W/BIOPATCH DT13885 DRESSING CHANGE TRAY DT14065 CVC KIT DT14100 CENTRAL LINE DSG CHG TRAY W/BIOPATCH DT14135 PICC/CVC DRSG CHNG TRAY W/SORB SHIELD DT14180 UNIVERSAL CATHETER INSERTION SET DT14215 CVC LINE DRESSING CHANGE DT14215 CVC LINE DRESSING CHANGE DT14380 PICC MAINTENANCE PACK DT14470 CVC DRSG CH W/BIOPATCH & SORB SHLD DT14500 CENTRAL LINE DRESSING CHANGE TRAY DT14500 CENTRAL LINE DRESSING CHANGE TRAY DT14500 CENTRAL LINE DRESSING CHANGE TRAY DT14650 MAXIMUM PROTECTION KIT DT14865 PORT CATH FLUSH KIT DT14965 PROCEDURE KIT DT15160 ADULT PORT FLUSH KIT DT15370 IN-PATIENT VAD KIT DT15370 IN-PATIENT VAD KIT DT15600 DRESSING CHANGE TRAY DT15605A CVC DRESSING CHANGE TRAY DT15655 CVC INSERTION TRAY DT15775 NICU PICC LINE DRESSING CHANGE KIT DT15780A PORT AND IO ACCESS DRESSING KIT DT15970 MAXIMUM PROTECTION KIT DT15970 MAXIMUM PROTECTION KIT DT15975 CENTRAL LINE INSERTION KIT DT15995 BOND CLINIC PORT DRESSING TRAY DT16435 CENTRAL LINE DRESSING KIT DT16480 PICC CENTRAL CVC CHANGE TRAY DT16550 ICU ARTERIAL LINE TRAY DT16550 ICU ARTERIAL LINE TRAY DT17055 CENTRAL LINE ACCESSORY PACK DT17120 VAD ACCESS KIT DT17135 NEONATAL DRESSING CHANGE TRAY DT17265 SUBC/PICC DRESS TRAY W/4MM BIOPATCH DT17365 SINGLE PORT ACCESS TRAY DT17380 IJ VAS-CATH DRESSING CHANGE TRAY DT17410 ON/OFF KIT & DRESSING CHANGE TRAY DT17420 ACCESS PORT KIT DT17500 PICC DRESSING KIT DT17675 DRIVELINE MANAGEMENT SYSTEM W/O BIOPATCH DT17745 DRESSING CHANGE TRAY DT17850 PORT DRESSING TRAY WITH BIOPATCH DT17870 WEEKLY DRIVELINE MANAGEMENT SYSTEM DT17965 PORT ACCESS TRAY DT18030 PORT ACCESS TRAY DT18375 DRIVELINE MANAGEMENT SYSTEM (W) DT18395 PORT ACCESS TRAY DT18415 PORT DRESSING CHANGE TRAY DT18450 PORT ACCESS DRESSING CHANGE TRAY DT18545 PORT DRESSING CHANGE TRAY DT18600 DRIVELINE MANAGEMENT SYSTEM w/CHG DT18600 DRIVELINE MANAGEMENT SYSTEM w/CHG DT18655 DAILY LVAD DRESSING KIT DT18675 LVAD MANAGEMENT SYSTEM-WEEKLY DT18690 DRIVELINE MANAGEMENT SYSTEM DT18690 DRIVELINE MANAGEMENT SYSTEM DT18695A DRIVELINE MGMT. KIT WITH SILVER ALGINATE DT18775 PORT ACCESS TRAY DT19625 PORT ACCESS TRAY DT19665 CENTRAL LINE DRESSING CHANGE KIT DT19665 CENTRAL LINE DRESSING CHANGE KIT DT19820 PEDIATRIC DRESSING CHANGE TRAY DT19835A PEDIATRIC PORT ACCESS BUNDLE DT19840 PORT ACCESS TRAY DT19900 CENTRAL LINE DRESSING CHANGE OVAL SHIELD DT20060 PORT ACCESS KIT DT20100 PORT ACCESS TRAY W/SECUREVIEW DT20160 PORT ACCESS KIT DT20335 KAISER CENTRAL LINE MANAGEMENT SYSTEM DT20335 KAISER CENTRAL LINE MANAGEMENT SYSTEM DT20350A DIALYSIS OFF KIT DT20370A CVC/PORT ACCESS TRAY DT20385 CENTRAL LINE DRESSING KIT DT20405 PICU MAX BARRIER KIT DT20480 PICC AND PORT DRESSING KIT DT20570 CENTRAL LINE CARE & MAINTENANCE BUNDLE DT20640 PORT DRESSING CHANGE TRAY DT20

    FDA Enforcement
    Class II ·Terminated·Centurion Medical Products Corporation·February 12, 2020