BEUDAMED
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    Triathlon PS X3 Tibial Insert; No. 3 Triathlon TS Plus Tibial Insert X3 Poly 19 mm Product Usage: The Triathlon PS X3 (posterior stabilized), cat no 5532-G-xxx and X3 TS (total stabilizing) Plus, cat. no. 5537-G-XXX, Tibial Inserts are used in TKA surgeries. During surgery, the tibial insert is locked into the tibial baseplate where it serves as the bearing component for the articulating surface of a corresponding Triathlon femoral component.

    FDA Enforcement
    Class II ·Terminated·Stryker Howmedica Osteonics Corp.·August 19, 2015

    TB-0545PC: THUNDERBEAT 5 mm , 45 em, Pistol Grip TB-0535PC: THUNDERBEAT 5 mm, 35 em, Pi stol Grip TB-0545IC: THUNDERBEAT 5 mm, 45 em, In line Grip TB-0535IC: THUNDERBEAT 5 mm, 35 em, Inline Grip TB-0520IC: THUNDERBEAT 5 mm, 20 em, In line Grip TB-051 OIC: THUNDERBEAT 5 mm, I 0 em, In line Grip TB-545FC: THUNDERBEAT 5 mm, 45 em, Front Actuated Grip TB-0535FC: THUNDERBEAT 5 mm, 35 em, Front Actuated Grip The Olympus Thunderbeat Surgical Tissue Management System ("Thunderbeat") is intended to be used for open, laparoscopic (including single-site surgery), and endoscopic surgery to cut (dissect) or coagulate soft tissue or to ligate (seal and cut) vessels.

    FDA Enforcement
    Class II ·Terminated·Olympus America Inc.·December 11, 2013

    HIP ORTHOPEDIA PACK - (1) BLADE SURGICAL #15 STAINLES /STEEL (1) GOWN XL SMS IMPERVIOUS REINFORCED MMI Ill LIF (1) TABLE COVER REINFORCED 50" X 90" LIF (1) MAYO STAND COVER REINFORCED LIF (4) DRAPE UTILITY WIT APE LIF (4) TOWEL ABSORBENT 15" X 20" LIF (1) YANKAUER SUCTION TUBE WITHOUT VENT LIF (2) DRAPE SHEET 41" X 58" SMS LIF (1) NEEDLE & BLADE COUNTER 20C FOAM/MAG LIF (10) GAUZE 4" X 4" 4PLY (2) UTILITY BOWL 16oz LIF (1) CAUTERY TIP POLISHER LIF (1) SUTURE BAG FLORAL (1) BLADE SURGICAL#10 STAILESS STEEL (1) SURGICAL DURAPREP SOLUTION 26m! LIF (1) SPECIMEN CONTAINER 4oz. WITH LID & LABEL (10)GAUZE SPONGE 4" X 4" 16PLY XRD LIF (5) LAP SPONGE PRE WASH 18" X 18" XRD LIF (1) CAUTERY PENCIL ROCKER SWITCH LIF (1) TUBE SUCTION CONNECT. 3/16" X 12' LIF (1) DRAPE INCISE ANTIMICROBIAL 23" X 33" (2) SHEET DRAPE 70" X 100" LIF (1) DRAPE TOP WITH ADHESIVE 108" X 50" STD SMS LIF (1) SHEET SPLIT WITH ADHESIVE 108" X 77" STD SMS L/F 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

    TOTAL HYCTERECTOMY (I) CANNULA 5MM XCEL SLEEVES LIF ( I ) TROCAR XCEL BLADELESS II MM (I) TROCAR 5MM BLADELESS W/STAB SLEEVE LIF ( I) NEEDLE ULTRA VERES 120MM LIF ( I) TUBING INSUFFLAT SET W/0 R ING ADAPTOR LIF (I) DRAPE VIDEO CAMERA 13cm X 244 em LIF ( I ) DRAPE LAP ABDOM W/POUCH 1 02" X 1 22" X 78" STD SMS (2) LEGGINGS W/7" CUFF 30'' X 42" ( I ) SAFETY SCALP EL # II S/STEEL ( I ) GOWN IMPERV. XTRA REINF. XL T/WRAP LEVEL III ( I ) TABLE COY ER REINFORCED 50" X 90" LIF (4) DRAPE UTILITY WIT APE LIF (2) DRAPE SI-IEET 42" X 57" SMS (I) TUBE SUCTION CONNECT Y." X 1 2' LIF ( I ) MAYO STAND COYER REINFORCED LIF (1 0) GAUZE SPONGE 4" X 4" 16PLY XRD LIF (4) TOWELS ABSORBENT 1 5" X 20" LIF (2) LITE GLOVE ( I ) DRAPE UNDERBUTTOCK W/ PO UCl-144" X 35" (2) SYRINGE I Occ W/0 NEEDLE LILOCK LIF (2) SPEC IMEN CONTA INER 4oz W/LID & LABEL (1 5) LAP SPONGE PREWASH 18'' X 1 8" XRD LIF ( I ) PVP PAINT 8" STICK SPONGE ( I ) UTILITY BOWL QUART 32oz LIF ( I ) ELECTRODE DUAL DEPRES ( I) DRESSING OPSITE POST PO 2!12 X 2" ( I ) MERLINO SK IN PREP APPLIC. 39ML LIF (3) GOWM XL SMS IMPERVIOUS REINFORCED LIF ( I ) CORD LAPAROSCOPY MONOPOLAR FOOD SWICH ING (1) FOLEY CATHETER KIT CONTAINING: (I) CATHETER 1 6FR FOLEY 2WAY, Sec (I) PYP TR IPLE SWABSTICK IODOPHOR (2) SWABSTICK DRY COTTON ( I ) SYR I NGE IOcc WATERFREFIL LIF (2) GLOVE MED FREETOUCH YYN I L P/F (I) TOWEL3PLYPOLY 17" X 18" (I) DRAPE 4" FENESTRATED 18" X 26" (I) LABEL lD PATIENT (I) JELLY LUBRI CATING FIVE GRAM ( I ) URINARY BAG DRAINAGE 2000ML ANTI-REFLUX LIF ( I ) TRAY SBS ( 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

    Ami HTX.

    FDA Enforcement
    Class II ·Ongoing·Spectral Instruments Inc·June 25, 2025

    Am I Pregnant? One Step HCG Pregnancy Test REF 100-17

    FDA Enforcement
    Class II ·Ongoing·Universal Meditech Inc.·November 1, 2023

    Lago X

    FDA Enforcement
    Class II ·Ongoing·Spectral Instruments Inc·June 25, 2025

    Catalog Number: 9003190 SURG GOWN SMS AMMI IV FULL Used by medical staff to perform surgical procedures and patient care procedures such as wound healing, suture removals, irrigate wounds, etc.

    FDA Enforcement
    Class II ·Terminated·Customed, Inc·April 20, 2016

    Turbo Troponin I For in vitro diagnostic use for the quantitative measurement of troponin I in serum, heparinized or EDTA plasma, as an aid in the diagnosis of acute myocardial infarction (AMI).

    FDA Enforcement
    Class II ·Terminated·Siemens Healthcare Diagnostics, Inc.·December 24, 2014

    ABL800 analyzer, model numbers 393-800 and 393-801.

    FDA Enforcement
    Class II ·Terminated·Radiometer America Inc·January 2, 2019

    Stratus CS Acute Care cTNI TestPak, SMN 10445071 Product Usage: In vitro diagnostic test for the measurement of cardiac troponin I in heparinized plasma. Cardiac troponin I measurements can be used as an aid in the diagnosis of acute myocardial infarction (AMI).

    FDA Enforcement
    Class II ·Terminated·Siemens Healthcare Diagnostics Inc·August 7, 2019

    MIM software; System, Image Processing, Radiological

    FDA Enforcement
    Class II ·Ongoing·MIM Software Inc·March 12, 2025

    Dimension Vista Enzyme 1 Calibrator (ENZ 1 CAL) lots 3FD034 and 3HD012. An in vitro diagnostic multi-analyte calibrator for the calibration of Amylase (AMY), Gamma-Glutamyl Transferase (GGT), Lactate Dehydrogenase (LDH), Lipase (LIPL), and Pseudocholinesterase (PCHE) methods on the Dimension Vista System.

    FDA Enforcement
    Class II ·Terminated·Siemens Healthcare Diagnostics, Inc.·March 5, 2014

    VITROS Chemistry Products CRP Slides- In vitro diagnostic quantitatively measures C-reactive protein (CRP) concentration in serum and plasma Model/Catalog Number: 1926740

    FDA Enforcement
    Class II ·Ongoing·Ortho-Clinical Diagnostics, Inc.·December 4, 2024

    BladderScan BVI 9600, Model Numbers: 0270-0451, 0270-0452, 0270-0754, and U270-0451. AortaScan AMI 9700, Model Numbers: 0270-0636, 0270-0639, and U270-0636.

    FDA Enforcement
    Class II ·Terminated·Verathon, Inc.·March 16, 2016

    Synthes CMF Distraction System The product is intended for use as a bone stabilizer and lengthening (and/or transport) device for correction of congenital deficiencies or post-traumatic defects of the mandibular body and ramus, where gradual bone distraction is required. It is intended for single use only.

    FDA Enforcement
    Class II ·Terminated·Synthes USA HQ, Inc.·July 24, 2013

    Lynx TM20 Torquemaster Low Speed Handpiece MTI Dental Products

    FDA Enforcement
    Class II ·Terminated·MTI Precision Products LLC.·July 23, 2014