BEUDAMED
    19 results · 26ms · Sources: EU EUDAMED, US FDA

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    Filters Classification: Class Ii ×

    Tornier HRS Max parts: 1. TORNIER HRS Max Tuberosity Body Lat Coat, Small, Cat. No. ARS1041101 2. TORNIER HRS Max Tuberosity Body No Coat, Small, Cat. No. ARS1041102 3. TORNIER HRS Max Trial, Cat. No. ARS10252

    FDA Enforcement
    Class II ·Ongoing·Tornier, Inc·April 15, 2026

    TORNIER PERFORM REVERSED PERIP SCREW 5.0MMX18MM NON STERILE, catalog number DWJ318

    FDA Enforcement
    Class II ·Ongoing·Tornier, Inc·February 11, 2026

    stryker Latitude EV HUMERAL REVISION STEM TRIAL, L: 150mm, Size: LARGE, Side: RIGHT, REF 9030103; Prosthesis, Elbow, Semi-Constrained, Cemented

    FDA Enforcement
    Class II ·Ongoing·Tornier, Inc·April 30, 2025

    Stryker Tornier Perform Humeral System, Reversed Insert, 45%, REF DWP2393, for shoulder arthroplasty

    FDA Enforcement
    Class II ·Ongoing·Tornier, Inc·October 9, 2024

    stryker TORNIER PERFORM HUMERAL SYSTEM - STEMLESS US Anatomic Nucleus, REF DWM003A; anatomic total arthroplasty of the shoulder

    FDA Enforcement
    Class II ·Ongoing·Tornier, Inc·September 25, 2024

    Fornier Phantom Fiber(TM) Sutures: Item Number Description SMB000425 4.5 MM PHANTOM FT BIOCOMPOSITE SUTURE ANCHOR WITH NEEDLES SMB000525 5.5 MM PHANTOM FT BIOCOMPOSITE SUTURE ANCHOR WITH NEEDLES SMP000425 4.5 MM PHANTOM FT PEEK SUTURE ANCHOR WITH NEEDLES SMP000525 5.5 MM PHANTOM FT PEEK SUTURE ANCHOR WITH NEEDLES SMSB0110 1PK PHANTOM FIBER SZ 2 WHITE SMSB0110N lPK BIOFIBER SUTURE SZ 2 WHT NEEDLED SMSB0112 10 PK PHANTOM FIBER SZ 2 WHITE SMSB0112N 10 PK PHANTOM FIBER SUTURE SZ 2WHT NEEDLED SMSB0120 1PK PHANTOM FIBER SZ 2 VIOLET SMSB0120N lPK BIOFIBER SUTURE SZ 2 VLT NEEDLED SMSB0122 10 PK PHANTOM FIBER SZ 2 VIOLET SMSB0122N 10 PK BIOFIBER SUTURE SZ 2 VLT NEEDLED SMSB0130 1PK PHANTOM FIBER SZ 2 WHITE/VIOLET SMSB0132 10 PK PHANTOM FIBER SZ 2 WHITE/VIOLET Indications for use for the Phantom Fiber are: Phantom Fiber suture is indicated for use in general soft tissue approximation and/or ligation, but not for use in cardiovascular or neurological tissues, microsurgery or ophthalmic surgery.

    FDA Enforcement
    Class II ·Terminated·Tornier, Inc·April 25, 2018

    Aequalis Ascend Flex Shoulder System Reversed Platform (Reversed Tray component) Rx Only Sterile Manufacturer Tornier SAS - Saint Martin, France. Shoulder prosthesis component.

    FDA Enforcement
    Class II ·Terminated·Tornier, Inc·July 21, 2021

    AEQUALIS Reversed II or AEQUALIS Reversed Fracture Impactor. These products are contained within the Aequalis reversed II Instrument set tray no.YKAD83 and the Aequalis reversed fracture instrument set tray no.YKAD95. The items affected are MWD21, MWD023, MWD024 and MWD025. The impactor is an instrument used during shoulder arthroplasty; it is not implanted. The impactor is used to set the glenoid sphere, poly insert, spacer, and hemi adapter into place during surgery. The impactor is a two piece instrument which consists of a tip and a handle. The tip is made of plastic and metal that is pressed together for assembly.

    FDA Enforcement
    Class II ·Terminated·Tornier, Inc·September 25, 2013

    Salto Talaris Tibial Guide, Part # MJU333 ,Tray/Kit Code YKAL11, Non sterile. Orthopedic Manual Surgical Instrument

    FDA Enforcement
    Class II ·Terminated·Tornier, Inc·September 2, 2015

    Aequalis Humeral Nail Targeting Jig, Product Code: 9020060. Orthopedic manual surgical instrument.

    FDA Enforcement
    Class II ·Terminated·Tornier, Inc·August 5, 2015

    Aequalis Fx2 implant parts and instrument trays. Insert component : Part Numbers DWK204B-DWK206B, DWK224B-DWK226B, DWK230B-DWK23B, DWK244B-DWK246B, DWK250B-DWK252B, DWK264B-DWK266B, DWK270B-DWK272B. Stem Component: Part Number: DWK111B-DWK115B, DWK121B-DWK126B, DWK131B-DWK135B. Product Usage: Total or partial replacement of the Gleno-humeral articulation.

    FDA Enforcement
    Class II ·Terminated·Tornier, Inc·December 14, 2016

    AEQUALIS HUMERAL NAIL DRILL BIT, REF 7020140 Product Usage: The Aequalis Humeral Nail system is intended to provide temporary stabilization of various types of proximal and/or diaphyseal fractures of the humerus. Types of fractures include, but are not limited to, non-unions, malunions, malalignments, pathological fractures, and impending pathological fractures. Examples of specific indications according to AO classification include Type A-Fractures, dislocated, Type B Fractures, dislocated, Type C-Fractures, with intact humeral head, or Humeral Fractures according to Neer-Classification (2, 3 and 4 part fractures).

    FDA Enforcement
    Class II ·Terminated·Tornier, Inc·May 16, 2018

    Aequalis Ascend Flex Humeral Stem: Part Number UDI DWF601A 3700386944475 DWF601B 3700386944482 DWF601C 3700386944499 DWF602A 3700386944505 DWF602B 3700386944512 DWF602C 3700386944529 DWF603A 3700386944536 DWF603B 3700386944543 DWF603C 3700386944550 DWF604A 3700386944567 DWF604B 3700386944574 DWF605A 3700386944598 DWF605B 3700386944604 DWF605C 3700386944611 DWF606A 3700386944628 DWF606B 3700386944635 DWF606C 3700386944642 DWF607A 3700386944659 DWF607B 3700386944666 DWF607C 3700386944673 DWF608A 3700386944680 DWF608B 3700386944697 DWF608C 3700386944703 DWF609A 3700386944710 DWF609B 3700386944727 DWF609C 3700386944734 DWF611A 3700386944741 DWF611B 3700386944758 DWF611C 3700386944765 DWF612A 3700386944772 DWF612B 3700386944789 DWF612C 3700386944796 DWF613A 3700386944802 DWF613B 3700386944819 DWF613C 3700386944826 DWF614A 3700386944833 DWF614B 3700386944840 DWF614C 3700386944857 DWF615A 3700386944864 DWF615B 3700386944871 DWF615C 3700386944888 DWF616A 3700386944895 DWF616B 3700386944901 DWF616C 3700386944918 DWF617A 3700386944925 DWF617B 3700386944932 DWF617C 3700386944949 DWF618A 3700386944956 DWF618B 3700386944963 DWF618C 3700386944970 DWF619A 3700386944987 DWF619B 3700386944994 DWF619C 3700386945007 DWF702A 3700386945045 DWF702B 3700386945052 DWF702C 3700386945069 DWF703A 3700386945076 DWF703B 3700386945083 DWF703C 3700386945090 DWF704A 3700386945106 DWF704B 3700386945113 DWF704C 3700386945120 DWF705A 3700386945137 DWF705B 3700386945144 DWF705C 3700386945151 DWF706A 3700386945168 DWF706B 3700386945175 DWF706C 3700386945182 DWF707A 3700386945199 DWF707B 3700386945205 DWF707C 3700386945212 DWF708A 3700386945229 DWF708B 3700386945236 DWF708C 3700386945243 DWF709A 3700386945250 DWF709B 3700386945267 DWF709C 3700386945274 DWF712A 3700386945311 DWF712B 3700386945328 DWF712C 3700386945335 DWF713A 3700386945342 DWF713B 3700386945359 DWF713C 3700386945366 DWF714A 3700386945373 DWF714B 3700386945380 DWF714C 3700386945397 DWF715A 3700386945403 DWF715B 3700386945410 DWF715C 3700386945427 DWF716A 3700386945434 DWF716B 3700386945441 DWF716C 3700386945458 DWF717A 3700386945465 DWF717B 3700386945472 DWF717C 3700386945489 DWF718A 3700386945496 DWF718B 3700386945502 DWF718C 3700386945519 DWF719A 3700386945526 DWF719B 3700386945533 DWF719C 3700386945540 Product Usage: The AEQUALIS ASCEND FLEX Convertible Shoulder System is intended for use as: A replacement of shoulder joints in primary anatomic or primary reverse. A replacement of other shoulder joint devices in case of revisions, if sufficient bone stock remains. The AEQUALIS ASCEND FLEX Convertible Shoulder System also allows for conversions from anatomic to reverse shoulder prosthesis in case of revision.

    FDA Enforcement
    Class II ·Terminated·Tornier, Inc·November 20, 2019

    stryker Tornier Perform Reversed Augmented Glenoid Lateralized Baseplate, 25mm, Offset +3mm, REF DWJ502

    FDA Enforcement
    Class II ·Ongoing·Tornier, Inc·October 25, 2023

    AEQUALIS FLEX REVIVE Assembly Screw 0mm, Model Number ARS655101

    FDA Enforcement
    Class II ·Ongoing·Tornier, Inc·July 5, 2023

    Ratcheting Screwdriver Handle, provided in the Aequalis Perform Reversed kit

    FDA Enforcement
    Class II ·Ongoing·Tornier, Inc·June 8, 2022

    AEQUALIS FLEX REVIVE Assembly Screw 0mm Short, Model Number ARS655118

    FDA Enforcement
    Class II ·Ongoing·Tornier, Inc·July 5, 2023

    Stryker Tornier Perform Reversed Glenoid Press-Fit Short Post Ti6AI4V, REF DWJ001, L: 7mm, Cementless Sterile.

    FDA Enforcement
    Class II ·Ongoing·Tornier, Inc·January 31, 2024

    Dornier Diode Laser Fibers:Used with Dornier Medilas D Family Lasers Part Number/Description: K1001291 600 micron single use fiber K2011824 600 micron single use fiber K1001293 600 micron single use fiber K2011826 600 micron 5X reusable fiber K1008084 600 micron single use fiber K2011828 400 micron 5X reusable fiber K1010500 600 micron fibertome fiber K2012021 600 micron single use fiber K1015640 AngioSpot Fiber Kit K2012393 600 micron single use fiber K2010292 400 micron single use fiber K2012439 600 micron 5X reusable fiber K2010667 micron ITT fiber K2012875 600 micron 3X reusable fiber K2010710 400 micron single use fiber K2012879 400 micron 3X reusable fiber K2011822 400 micron single use fiber Product Usage: The Dornier Diode Fibers are accessories to the Dornier Medilas D Family Lasers. The Dornier Medilas D Family Lasers, specifically the Medilas D Litebeam, Medilas D LiteBeam +, Medilas D UroBeam, Medilas D MultiBeam, Medilas D FlexiPulse and Medilas D MagnaPulse, are indicated for use in medicine and surgery, in the following medical specialties: Urology, Plastic Surgery, General Surgery, Dermatology, Gynecology, Pulmonary Surgery, Gastroenterology, ENT, and Radiology. The Dornier Medilas D Family Lasers, specifically the Medilas D Litebeam, Medilas D LiteBeam +, Medilas D UroBeam, Medilas D MultiBeam, Medilas D FlexiPulse. and Medilas D MagnaPulse, are intended for use in cutting, vaporization, ablation and coagulation of soft tissue in conjunction with endoscopic equipment (including laparoscopes, hysteroscopes, bronchoscopes, gastroscopes, cystoscopes, and colonoscopies), in incision/excision, vaporization, ablation and coagulation of soft tissue in contact and non-contact open surgery (with or without a handpiece), in the treatment and/or removal of vascular lesions (tumors) and removal of unwanted hair, for endovascular coagulation of the greater saphenous vein of the thigh in patients with superficial vein reflux and treatment of reticular veins and branch varicosities. The Dornier Medilas D Family Lasers, specifically the Medilas D UroBeam, Medilas D MultiBeam, Medilas D FlexiPulse and Medilas D MagnaPulse, are intended for use in the treatment of symptoms due to urinary outflow obstruction secondary to benign prostatic hyperplasia (BPH) in men over the age of 50 with prostates with median and/or lateral lobes ranging in total volume from 28-85 cc.

    FDA Enforcement
    Class II ·Terminated·Dornier Medtech America, Inc.·May 29, 2019