27 results
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38ms
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Sources: EU EUDAMED, US FDA
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Heron toilet and bath chair Model 880505-01 & 880505-11
FDA Enforcement
Class II
·Ongoing·R82 A/S·November 21, 2018
Wombat Living, Size 3, Item Numbers: 953121-00, 953126-00, 953131-00, 953132-00, 935-135-00, 935136-00, 953211-00, 953221-00, 953222-00, 953225-00, 953226-00, 953231-001, 953232-00, 953236-00 Product Usage: Activity chair (wheelchair)
FDA Enforcement
Class II
·Terminated·R82 A/S·May 22, 2019
Chest Support for R82 Mustang, Model Numbers: 861810, 861820, 861830; and Rabbit Up, Model Numbers: 869810, 869820, 869830
FDA Enforcement
Class II
·Terminated·R82 A/S·May 13, 2020
R82 by ETAC Push Brace for High-Low
FDA Enforcement
Class II
·Terminated·R82 A/S·February 16, 2022
Blanketrol III, Model Number 233, Cincinnati Sub-Zero Products, Inc., 12011 Mosteller Road, Cincinnati, OH 45241 Hyper-Hypothermia device used to lower or to raise a patients temperature and/or maintain a desired patient temperature through conductive heat transfer.
FDA Enforcement
Class II
·Terminated·Cincinnati Sub-Zero Products Inc·September 25, 2013
Sofsilk Braided Silk sutures: CS-211 SOFSILK* 4-0 BLK 45CM CVF21 X36 GS-831 SOFSILK* 4-0 BLK 75CM V20 X36 S-176 SOFSILK* 0 BLK 12X45CM PCT X24 S-182 SOFSILK* 5-0 BLK 12X45CM PCT X36 S-184 SOFSILK* 3-0 BLK 12X45CM PCT X36 S-185 SOFSILK* 2-0 BLK 12X45CM PCT X36 S-245 SOFSILK* 2-0 BLK 12X60CM PCT X36 S-246 SOFSILK* 0 BLK 6X60CM PCT X36 S-2782K SOFSILK* 4-0 WHI 45CM SS24 DA S-303 SOFSILK* 4-0 BLK 12X75CM PCT X36 S-304 SOFSILK* 3-0 BLK 12X75CM PCT X36 S-305 SOFSILK* 2-0 BLK 12X75CM PCT X36 S-316 SOFSILK* 0 BLK 12X75CM PCT X24 S-317 SOFSILK* 1 BLK 12X75CM PCT X24 S-605 SOFSILK* 2-0 BLK 2X150CM PCT X36 S-606 SOFSILK* 0 BLK 2X150CM PCT X36 S606-12 SOFSILK* 0 BLK 2X150CM PCT X12 S-610 SOFSILK* 5 BLK 2X150CM PCT X12 SOFSILK 2-0 30 BK CV-24 GS453-2 SOFSLK 4-0 24 BK CV-15 DA VS581-2 ***Added 4/1/24*** CS-792 SOFSILK* 0 BLK 100CM GCC90 X36 S-1172 SOFSILK* 6-0 BLK 45CM C1 X36 S-1735 SOFSILK* 4-0 BLK 30CM C1 DA X12 S-1750K SOFSILK* 6-0 BLK 45CM HE1 DAX12 S-1768K SOFSILK* 7-0 BLK 45CM HE6 DAX12 S-1789K SOFSILK* 4-0 BLK 45CM HE3 X12 S-187 SOFSILK* 1 BLK 6X45CM PCT X36 S-243 SOFSILK* 4-0 BLK 12X60CM PCT X36 S-2780K SOFSILK* 6-0 BLK 45CM SS-24DA S-282 SOFSILK* 5 BLK 3X60CM PCT X36 S-318 SOFSILK* 2 BLK 12X75CM PCT X24 S-608 SOFSILK* 2 BLK 2X150CM PCT X36 VS-872 SOFSILK* 3-0 BLK 75CM CV23 X36 VS872-2 SOFSILK 3-0 30 BK CV-23 VS872-2 SS-1694G SOFSILK 4/0 BLK 45CM P24 X12 SS-5641 SOFSILK* 4-0 BLK 45CM P13 X36 SS-5649G SOFSILK* 6-0 BLK 45CM P13 X12 SS-645 SOFSILK* 4-0 BLK 75CM C12 X36 SS-675 SOFSILK* 3-0 BLK 75CM C16 X36 SS-681 SOFSILK* 6-0 BLK 45CM C12 X36 VS-872 SOFSILK* 3-0 BLK 75CM CV23 X36 XX-5280 SOFSILK* 0 BLK 150CM PCT X36 -- Ti-Cron Coated Braided Polyester Sutures: 3087-31 TICRON* 4-0 BLU 75CM CV-331DA 3226-31 TICRON* 4-0 BLU 60CM CV330 DA 88863026-71 TICRON* 1 BLU 75CM HOS12X36 88863070-51 TICRON* 2-0 BLU 75CM C15X36 88863087-31 TICRON* 4-0 BLU 75CM CV33DA 88863092-71 TICRON* 1 BLU 75CM KV37X36 88863147-83 TICRON 2 BLU 5X75CM KV37X12 88863185-41 TICRON* 3-0 BLU 75CM CV305 88863186-31 TICRON* 4-0 BLU 75CM CV331 88863226-31 TICRON* 4-0 BLU 60CM CV330DA 88863226-41 TICRON* 3-0 BLU 60CM CV330DA 88863229-31 TICRON* 4-0 BLU 75CM CV307DA 88863271-31 TICRON* 4-0 BLU 90CM CV331DA 88863309-71 TICRON* 1 BLU 75CM GS11X36 -- Monosof Monofilament Nylon Sutures: N-63 MONOSOF* 3-0 BLK 12X45CM PCT X36 SN-3695 MONOSOF* 5-0 BLK 45CM P10 X12 -- Steel Monofilament Stainless Steel Sutures 88862224-49 STEEL 7 4X45CM SCC X12
FDA Enforcement
Class II
·Ongoing·Covidien LP·February 7, 2024
Medtronic Grafton Plus Paste a) DBM S45001 GRAFTON 1CC PASTE, REF S45001; b) DBM S45005 GRAFTON 5CC PASTE, REF S45005; c) DBM S45010 GRAFTON 10CC PASTE, REF S45010; d) DBM T45001 1CC PASTE GRAFTON PLUS, REF T45001; e) DBM T45001AUS 1CC PASTE GRAFTON PLUS, REF T45001AUS; f) DBM T45001INT 1CC PASTE GRAFTON PLUS, REF T45001INT; g) DBM T45005 5CC PASTE GRAFTON PLUS, REF T45005; h) DBM T45005INT 5CC PASTE GRAFTON PLUS, REF T45005INT; i) DBM T45010 10CC PASTE GRAFTON PLUS, REF T45010; j) DBM T45010AUS 10CC PASTE GRAFTON PLUS, REF T45010AUS; k) DBM T45010INT 10CC PASTE GRAFTON PLUS, REF T45010INT; Demineralized Bone Matrix (DBM) product
FDA Enforcement
Class II
·Ongoing·Medtronic Sofamor Danek USA Inc·April 12, 2023
Sofsilk Coated Braided Silk Suture Product Description CS-211 SOFSILK* 4-0 BLK 45CM CVF21 X36 CS211 CS-490 SOFSILK* 2-0 BLK 75CM GS11 X36 CS490 CS-562 SOFSILK* 2-0 BLK 75CM GS23 X36 CS562 GS-823 SOFSILK* 2-0 BLK 75CM V30 X36 GS823 GS-835 SOFSILK* 1 BLK 75CM V20 X36 GS835 S-1172 SOFSILK* 6-0 BLK 45CM C1 X36 S1172 S-1173 SOFSILK* 5-0 BLK 45CM C1 X36 S1173 S-1174 SOFSILK* 4-0 BLK 45CM C1 X36 S1174 S-1750K SOFSILK* 6-0 BLK 45CM HE1 DAX12 S1750K S-176 SOFSILK* 0 BLK 12X45CM PCT X24 S176 S-176 SOFSILK* 0 BLK 12X45CM PCT X24 S176 S-1768K SOFSILK* 7-0 BLK 45CM HE6 DAX12 S1768K S-182 SOFSILK* 5-0 BLK 12X45CM PCT X36 S182 S-183 SOFSILK* 4-0 BLK 12X45CM PCT X36 S183 S-184 SOFSILK* 3-0 BLK 12X45CM PCT X36 S184 S-185 SOFSILK* 2-0 BLK 12X45CM PCT X36 S185 S-187 SOFSILK* 1 BLK 6X45CM PCT X36 S187 S-206 SOFSILK* 2 BLK 100CM STDLTH X36 S206 S-243 SOFSILK* 4-0 BLK 12X60CM PCT X36 S243 S-244 SOFSILK* 3-0 BLK 12X60CM PCT X36 S244 S-245 SOFSILK* 2-0 BLK 12X60CM PCT X36 S245 S-246 SOFSILK* 0 BLK 6X60CM PCT X36 S246 S-2782K SOFSILK* 4-0 WHI 45CM SS24 DA S2782K S-303 SOFSILK* 4-0 BLK 12X75CM PCT X36 S303 S-304 SOFSILK* 3-0 BLK 12X75CM PCT X36 S304 S-305 SOFSILK* 2-0 BLK 12X75CM PCT X36 S305 S-316 SOFSILK* 0 BLK 12X75CM PCT X24 S316 S-317 SOFSILK* 1 BLK 12X75CM PCT X24 S317 S-318 SOFSILK* 2 BLK 12X75CM PCT X24 S318 S-346 SOFSILK* 0 BLK 12X60CM PCT X24 S346 S-605 SOFSILK* 2-0 BLK 2X150CM PCT X36 S605 S-607 SOFSILK* 1 BLK 2X150CM PCT X36 S607 S-608 SOFSILK* 2 BLK 2X150CM PCT X36 S608 SS-523 SOFSILK* 2-0 BLK 75CM SC1 X36 SS523 SS-525 SOFSILK* 1 BLK 75CM SC1 X36 SS525 SS-5641 SOFSILK* 4-0 BLK 45CM P13 X36 SS5641 SS-5641G SOFSILK* 4-0 BLK 45CM P13 X12 SS5641G SS-5678 SOFSILK* 5-0 BLK 45CM P11 X36 SS5678 SS-5684 SOFSILK* 3-0 BLK 45CM P14 X36 SS5684 SS-623 SOFSILK* 2-0 BLK 75CM SC2 X36 SS623 SS-645 SOFSILK* 4-0 BLK 75CM C12 X36 SS645 SS-653 SOFSILK* 4-0 BLK 75CM C13 X36 SS653 SS-673 SOFSILK* 5-0 BLK 75CM C12 X36 SS673 SS-683G SOFSILK* 4-0 BLK 45CM C13 X12 SS683G SS-685G SOFSILK* 2-0 BLK 45CM C15 X12 SS685G SS-686 SOFSILK* 4-0 BLK 45CM C12 X12 SS686 SS-689 SOFSILK* 1 BLK 75CM C16 X36 SS689 SS-745 SOFSILK* 3-0 BLK 75CM C12 X36 SS745 SS-786 SOFSILK* 0 BLK 75CM C14 X36 SS786 SS-787 SOFSILK* 1 BLK 75CM C14 X36 SS787 VS-533 SOFSILK* 2-0 BLK 90CM V20 DAX36 VS533 VS-845 SOFSILK* 1 BLK 75CM V26 X36 VS845 VS-870 SOFSILK* 5-0 BLK 75CM CV23 X36 VS870 VS-871 SOFSILK* 4-0 BLK 75CM CV23 X36 VS871 SOFSILK 4-0 30 BK CV-23 VS871-2 VS8712 VS-872 SOFSILK* 3-0 BLK 75CM CV23 X36 VS872 SOFSILK 3-0 30 BK CV-23 VS872-2 VS8722 VS-882 SOFSILK* 3-0 BLK 75CM CV15 X36 VS882 SOFSILK 5-0 30 BK CV-11 VS890-2 VS8902 XX-5278 SOFSILK* 3-0 BLK 150CM PCT X36 XX5278 XX-5280 SOFSILK* 0 BLK 150CM PCT X36 XX5280 XX-5281 SOFSILK* 1 BLK 150CM PCT X36 XX5281 XX-5284 SOFSILK* 4 BLK 150CM PCT X36 XX5284
FDA Enforcement
Class II
·Ongoing·Covidien, LP·March 8, 2023
DynaCad software consist of an MR Analysis Server software and the viewer workstation software. The MR Analysis software consists of DynaCad Breast, DynaCad Prostate, and DynaCad Advanced PK for other MR analyses modules. Product Usage: Intended to be used as a post processing software package designed to provide a reliable means for analyzing MR datasets.
FDA Enforcement
Class II
·Terminated·Invivo Corporation·April 11, 2018
ZOLL Powerheart G5 AED, Semi-Automatic, G5Sxxx Family -Automated external defibrillator (AED) is designed for treating life-threatening heart beat irregularities, such as ventricular fibrillation, that cause Sudden Cardiac Arrest (SCA). Model/Catalog Number: G5S-00A G5S-00A-TSO G5S-00C G5S-01A G5S-02A G5S-02C G5S-02-L G5S-04A G5S-05A G5S-05C G5S-06A G5S-06C G5S-08A G5S-08C G5S-10A G5S-10C G5S-11A G5S-11C G5S-12C G5S-13A G5S-14A G5S-15A G5S-17A G5S-17C G5S-19A G5S-23C G5S-29A G5S-29C G5S-31A G5S-31A-SJA G5S-31C-SJA G5S-36A G5S-37A G5S-41A G5S-41C G5S-80A G5S-80A-TSO G5S-80C G5S-80-L G5S-82A G5S-82C G5S-83C G5S-90C
FDA Enforcement
Class II
·Ongoing·Zoll Medical Corporation·July 17, 2024
Allura Xper FD20 Biplane; Model Numbers: (1) 722008, (2) 722013; Associated 510(k)s: K102005, K130638, K130842, K133292, K141979, K162859, K161563;
FDA Enforcement
Class II
·Ongoing·PHILIPS MEDICAL SYSTEMS NEDERLAND B.V.·October 8, 2025
PRYTIME MEDICAL REBOA Catheter Introducer Kit, REF: KT1835C, Contents: Needle, 18 GA x 7 CM ECHOGENIC, STERILE, 1 EA, SYRINGE, 30CC, STERILE 1 EA, INTRODUCER SHEATH KIT, 7 FR W/.035 SHORT GUIDEWIRE, STERILE 1 EA., PREFILLED, STERILE FIELD SALINE SYRINGE, 10 ML, 4 EA, CLAMP, 5 FR, STERILE, 1 EA, SCALPEL, #11SS, STERILE, 1 EA, SUTURE, NYLON, 18", 2-0, REVERSE CUTTING, STERILE 1 EA, THREE QUARTER DRAPE, STERILE 1 EA, INSERT, SALINE 1 EA, INSERT, CLAMP 1 EA UDI: (01) 0 0863092 00010 1
FDA Enforcement
Class II
·Terminated·Prytime Medical Devices, Inc.·February 17, 2021
Allura Xper FD10/10; Model Numbers: (1) 722005, (2) 722011, (3) 722027; Associated 510(k)s: K102005, K130638, K130842, K133292, K141979, K162859, K161563;
FDA Enforcement
Class II
·Ongoing·PHILIPS MEDICAL SYSTEMS NEDERLAND B.V.·October 8, 2025
MultiDim Eleva 708032 As a multifunctional universal imaging application system, General RJF, Fluoroscopy, Radiography and Angiography can be Performed along with more specialized interventional applications on human patients.
FDA Enforcement
Class II
·Terminated·Philips Medical Systems Nederlands·May 9, 2018
MultiDiagnostic-Eleva with Flat Detector 708038 As a multifunctional universal imaging application system, General RJF, Fluoroscopy, Radiography and Angiography can be Performed along with more specialized interventional applications on human patients.
FDA Enforcement
Class II
·Terminated·Philips Medical Systems Nederlands·May 9, 2018
Mutlidiagnost-Eleva with Flat Detector Eleva with Flat Detector 708037 As a multifunctional universal imaging application system, General RJF, Fluoroscopy, Radiography and Angiography can be Performed along with more specialized interventional applications on human patients.
FDA Enforcement
Class II
·Terminated·Philips Medical Systems Nederlands·May 9, 2018
Esaote PA230E Transducer A portable and cart base ultrasound system for general and cardiovascular imaging
FDA Enforcement
Class II
·Terminated·Biosound Esaote, Inc.·August 20, 2014
FlexLab (FLX) Automation System with the Aliquoter Module (Inpeco P/N FLX-212) The FlexLab (aka Accelerator a3600 and Aptio Automation) is a modular system designed to automate Pre-Analytical and Post-Analytical processing, sample handling in order to automate sample processing in the Laboratory. The systems consolidate multiple Analytical instruments into a unified workstation.
FDA Enforcement
Class II
·Terminated·Inpeco S.A.·November 18, 2020
Inpeco FlexLab Centrifuge Module tube loading algorithm, Inpeco SA P/N: FLX-202, with Firmware Versions: CM_1-7-0.H86 or xCMd_2-5-0.elf and CM_1-7-1.H86 or xCMd_2-5-1-849fad9.elf
FDA Enforcement
Class II
·Ongoing·Inpeco S.A.·May 13, 2020
Accelerator a3600 Automation System with the Aliquoter Module (Inpeco P/N FLX-212) The FlexLab (aka Accelerator a3600 and Aptio Automation) is a modular system designed to automate Pre-Analytical and Post-Analytical processing, sample handling in order to automate sample processing in the Laboratory. The systems consolidate multiple Analytical instruments into a unified workstation.
FDA Enforcement
Class II
·Terminated·Inpeco S.A.·November 18, 2020