BEUDAMED
    10 results · 14ms · Sources: EU EUDAMED, US FDA

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    Filters Classification: Class Ii × Regulation: Us FDA × Clear all

    The OEC 9900 C-Arm is designed to provide fluoroscopic and spot-film images of the patient during diagnostic, surgical and interventional procedures. Examples of clinical application may include cholangiography, endoscopy, urologic, orthopedic, neurologic, vascular, cardiac, critical-care and emergency room procedures. The GE OEC 9800 is designed to provide fluoroscopic and spot-film imaging of the patient during diagnostic, surgical and interventional procedures. The system includes features specifically designed for use in diagnostic and interventional cardiac imaging procedures, and is also intended for cholangiography, endoscopic, urologic, orthopedic, neurologic, vascular, critical care and emergency room procedures.

    FDA Enforcement
    Class II ·Ongoing·Ge Healthcare·September 9, 2020

    Brand name: AGFA Digital Radiography X- Ray system DR 800 with MUSICA Dynamic Common Name: DR 800

    FDA Enforcement
    Class II ·Ongoing·AGFA Healthcare Corp.·December 31, 2025

    HydraVision Digital Imaging System Product ID/Reorder Number: 705559 (65KW)

    FDA Enforcement
    Class II ·Terminated·LIEBEL-FLARSHEIM COMPANY LLC·July 14, 2021

    Cobas b 221 (versions 5 and 6) Blood Gas and Electrolytes Analyzer

    FDA Enforcement
    Class II ·Terminated·Roche Diagnostics Operations, Inc.·February 11, 2015

    Stryker Orthopaedics Modular Handle Triathlon Instruments, Non-Sterile, REF 6541-4-808, Lot 123, NDC M546654148080S Product Usage: Is a reusable instrument that is part of the Triathlon Primary total knee arthroplasty (TKA) system as well as the Triathlon Partial Knee Replacement (PKR) system. The use of the handles in Primary TKA is optional and may be used to: (1) Assist in stabilizing the Triathlon Femoral Sizer, (2) Aid in stabilization during use and removal of the Triathlon 4:1 Cutting Block and (3) Aid in assembly of the Anterior MIS Distal Resection Guide to the Anterior Skim Cut Guide. Per the Triathlon PKR surgical protocol, the handle is required for a PKR surgery and is used to: (1) Assemble and disassemble the Femoral Trial Drill Guide into the Femoral Trial and (2) Remove the Peg Trial from the Femoral Trial.

    FDA Enforcement
    Class II ·Terminated·Stryker Howmedica Osteonics Corp.·August 17, 2016

    Medline Probe Cover Kits containing sterile Ultrasound Gel, Labeled as the following: a) CATH PACK, Model Number DYNJ83105; b) TESIO, Model Number DYNJ83251; c) ANGIOGRAPHY PACK-LF, Model Number DYNJ83508; d) OR ANGIOGRAM PACK-LF, Model Number DYNJ83656; e) FERRELL-DUCAN ANGIO, Model Number DYNJ83696; f) ANGIO KIT PACK, Model Number DYNJ83746; g) M&E ARTERIOGRAM PK, Model Number DYNJ83815; h) ANGIOGRAPHY CV RAD PACK, Model Number DYNJ83918; i) ANGIO PACK, Model Number DYNJ83936; j) ARTERIOGRAM - SUMMIT PACK, Model Number DYNJ84040; k) ANGIO PACK, Model Number DYNJ84190; l) ANGIO, Model Number DYNJ902507C; m) ANGIO, Model Number DYNJ902507D; n) ANGIO, Model Number DYNJ905151B; o) PACK ANGIOPLASTY CV,8405, Model Number DYNJ906766B; p) (13) STC IVC FILTER/ANGIOGRAM, Model Number DYNJ908249A; q) OR ANGIOGRAM, Model Number DYNJ909267; r) RADIOLOGY PACK #108402-LF, Model Number DYNJVB1000; s) HYBRID OR PACK, Model Number SYNJ10303C

    FDA Enforcement
    Class II ·Ongoing·MEDLINE INDUSTRIES, LP - Northfield·July 26, 2023

    Trial Cutting Guide for Triathlon Total Knee System, Triathlon PKR System, Restoris MCK Knee System, prosthesis, knee, patellofemorotibial, semi-constrained, cemented, polymer/metal/polymer. Catalog Number: I-K3834CG00 Specialty Triathlon TS Trial Cutting Guide Set I-K3834CG1L Specialty Triathlon TS Trial Cutting Guide Size 1 Left I-K3834CG1R Specialty Triathlon TS Trial Cutting Guide Size 1 Right I-K3834CG2L Specialty Triathlon TS Trial Cutting Guide Size 2 Left I-K3834CG2R Specialty Triathlon TS Trial Cutting Guide Size 2 Right I-K3834CG3L Specialty Triathlon TS Trial Cutting Guide Size 3 Left I-K3834CG3R Specialty Triathlon TS Trial Cutting Guide Size 3 Right I-K3834CG4L Specialty Triathlon TS Trial Cutting Guide Size 4 Left I-K3834CG4R Specialty Triathlon TS Trial Cutting Guide Size 4 Right I-K3834CG5L Specialty Triathlon TS Trial Cutting Guide Size 5 Left I-K3834CG5R Specialty Triathlon TS Trial Cutting Guide Size 5 Right I-K3834CG6L Specialty Triathlon TS Trial Cutting Guide Size 6 Left I-K3834CG6R Specialty Triathlon TS Trial Cutting Guide Size 6 Right I-K3834CG7L Specialty Triathlon TS Trial Cutting Guide Size 7 Left I-K3834CG7R Specialty Triathlon TS Trial Cutting Guide Size 7 Right I-K3834CG8L Specialty Triathlon TS Trial Cutting Guide Size 8 Left I-K3834CG8R Specialty Triathlon TS Trial Cutting Guide Size 8 Right

    FDA Enforcement
    Class II ·Terminated·Howmedica Osteonics Corp.·April 14, 2021

    Medline Probe Cover Kits containing sterile Ultrasound Gel, Labeled as the following: a) BLOCK PACK, Model Number DYNJ81722; b) PAIN BLOCK TRAY, Model Number DYNJRA0827A; c) PAIN PREP TRAY W/PROBE COVER, Model Number DYNJRA0881; d) PAIN PREP TRAY W/PROBE COVER, Model Number DYNJRA0881A; e) PAIN TRAY, Model Number DYNJRA1603; f) FEMORAL BLOCK TRAY, Model Number DYNJRA1739A; g) TAP BLOCK, Model Number DYNJRA1823; h) NERVE BLOCK PREP TRAY, Model Number DYNJRA1837; i) PAIN PREP TRAY W/PROBE COVER, Model Number DYNJRA1847; j) ANESTHESIA BLOCK PACK - TBR, Model Number DYNJRA1864; k) 18G CPNB 20G STYLETED CATHETER, Model Number DYNJRA1869; l) NERVE BLOCK TRAY, Model Number DYNJRA1878; m) BLOCK KIT, Model Number DYNJRA1893; n) NERVE BLOCK TRAY, Model Number DYNJRA1900; o) US TPI KIT, Model Number DYNJRA1945; p) PAIN PREP TRAY W/PROBE COVER, Model Number DYNJRA1975; q) DR LEWIS US TRAY, Model Number DYNJRA1998; r) ULTRASOUND GUIDED NERVE BLOCK, Model Number DYNJRA2013; s) ULTRASOUND TRAY, Model Number DYNJRA2022; t) NERVE BLOCK INSERTION, Model Number DYNJRA2027; u) PAIN PREP W/ PROBE COVER TRAY, Model Number DYNJRA2028; v) PAIN PREP W/ PROBE COVER TRAY, Model Number DYNJRA2028A; w) PAIN TRAY, Model Number DYNJRA2041; x) SUPPORT TRAY, Model Number DYNJRA2044; y) SUPERFICIAL NERVE BLOCK, Model Number DYNJRA2086; z) NERVE BLOCK TRAY, Model Number DYNJRA2148; aa) TRAY 18G CPNB 20G STYLETED, Model Number DYNJRA9040; bb) ULTRASOUND BLOCK TRAY, Model Number DYNJRA9044; cc) PERIPHERAL NERVE CATHETER KT, Model Number PAIN1560; dd) PAIN PREP W/PROBE COVER TRAY, Model Number PAIN1762

    FDA Enforcement
    Class II ·Ongoing·MEDLINE INDUSTRIES, LP - Northfield·July 26, 2023

    Medline Probe Cover Kits containing sterile Ultrasound Gel, Labeled as the following: a) ANGIOGRAPHY PACK, Model Number DYNJ55252C; b) CATH LAB PACK, Model Number DYNJ55455A; c) CATH LAB 2, Model Number DYNJ55680A; d) IR ANGIO TRAY, Model Number DYNJ56038A; e) CATH PACK, Model Number DYNJ56547C; f) HYBRID, Model Number DYNJ57049G; g) HYBRID, Model Number DYNJ57049I; h) HYBRID, Model Number DYNJ57049J; i) PERCUTANEOUS ANGIO PACK-LF, Model Number DYNJ57645C; j) GENERAL ANGIO PACK, Model Number DYNJ57760C; k) ENSEMBLE ANGIOGRAPHIE-LF, Model Number DYNJ57792C; l) ANGIO PACK, Model Number DYNJ58111D; m) ANGIO PACK, Model Number DYNJ58111F; n) PORT PACK, Model Number DYNJ58162; o) ENSEMBLE ANGIO CEREBRALE-LF, Model Number DYNJ58178B; p) PERIPHERAL CATHETER #668236-V, Model Number DYNJ58510A; q) OR ANGIO PACK, Model Number DYNJ59184B; r) PORT A CATH PACK, Model Number DYNJ59307F; s) CATH PACK, Model Number DYNJ59632D; t) PACK PERCUTANEOUS ANGIO CHRG, Model Number DYNJ60112B; u) I.R. PACK, Model Number DYNJ60343B; v) I.R. PACK, Model Number DYNJ60343C; w) CATH LAB PACK, Model Number DYNJ60763; x) CRMC ANGIOGRAM-LF, Model Number DYNJ61082C; y) CRMC ANGIOGRAM-LF, Model Number DYNJ61082D; z) CRMC MINOR IR PROCEDURE PK-LF, Model Number DYNJ61099B; aa) CRMC MINOR IR PROCEDURE PK-LF, Model Number DYNJ61099C; bb) CRMC TUNNEL CATH TRAY-LF, Model Number DYNJ61118C; cc) CRMC TUNNEL CATH TRAY-LF, Model Number DYNJ61118D; dd) CRMC TUNNEL CATH TRAY-LF, Model Number DYNJ61118F; ee) MAIN OR CATH LAB, Model Number DYNJ61373A; ff) CARDIAC CATH PACK-LF, Model Number DYNJ61527A; gg) IR PACK, Model Number DYNJ61646A; hh) PERMA CATH PACK, Model Number DYNJ62007A; ii) IR PACK, Model Number DYNJ62037D; jj) AV FISTULA PACK, Model Number DYNJ62733A; kk) ANGIOGRAPHY DRAPE PACK, Model Number DYNJ63060B; ll) CATH PACK, Model Number DYNJ63181A; mm) CATH PACK, Model Number DYNJ63181B; nn) CATH PACK, Model Number DYNJ63181C; oo) CATH ANGIO PACK, Model Number DYNJ64050A; pp) ANGIOPLASTY PACK-LF, Model Number DYNJ64655C; qq) IR GENERAL PACK, Model Number DYNJ64976; rr) HEART TAVR PACK, Model Number DYNJ65174D; ss) ANGIOGRAPHY PACK, Model Number DYNJ65190D; tt) ANGIOGRAPHY PACK, Model Number DYNJ65190F; uu) PACK,CARDIAC CATH, Model Number DYNJ65481; vv) RADIOFREQUENCY ABLATION PACK, Model Number DYNJ65913; ww) CATH LAB PACK, Model Number DYNJ66166A; xx) CATH I W SPLIT DRAPE PACK, Model Number DYNJ66182; yy) PORT A CATH INSERT PK, Model Number DYNJ66257; zz) PORT A CATH INSERT PK, Model Number DYNJ66257A; aaa) PORT A CATH INSERT PK, Model Number DYNJ66257B; bbb) FISTULAGRAM PACK, Model Number DYNJ66259A; ccc) ANGIOGRAM SET UP PACK, Model Number DYNJ66260A; ddd) CATH PACK, Model Number DYNJ66473A; eee) ANGIOGRAPHY PACK, Model Number DYNJ66476A; fff) FEMORAL PACK, Model Number DYNJ66515A; ggg) IR PACK UNION, Model Number DYNJ66926A; hhh) STANDARD ANGIO TRAY MV, Model Number DYNJ67136A; iii) ANGIOGRAPHY PACK, Model Number DYNJ67144A; jjj) DRAINAGE PROCEDURE PACK, Model Number DYNJ67149A; kkk) CARDIAC CATH PACK, Model Number DYNJ67174A; lll) CARDIAC CATH PACK, Model Number DYNJ67174B; mmm) OR ANGIOGRAPHY PACK, Model Number DYNJ67245A; nnn) OR ANGIOGRAPHY PACK, Model Number DYNJ67245B; ooo) ANGIOGRAPHIC TRAY, Model Number DYNJ67320A; ppp) IR PACK, Model Number DYNJ67737; qqq) TUNNEL LINE PACK, Model Number DYNJ67990A; rrr) ANGIOGRAPHY DRAPE PACK, Model Number DYNJ68065B; sss) NEURO RADIOLOGY RICHMOND, Model Number DYNJ68365B; ttt) IR PACK, Model Number DYNJ68538; uuu) SPECIAL PROCEDURE CATH LAB PK, Model Number DYNJ68729; vvv) IR PACK, Model Number DYNJ68729B; www) CATH LAB ANGIO TRAY, Model Number DYNJ68763; xxx) CATH LAB ANGIO TRAY, Model Number DYNJ68763A; yyy) IR RADIOLOGY PACK, Model Number DYNJ69056; zzz) IR RADIOLOGY PACK, Model Number DYNJ69056A; aaaa) ANGIO PACK, Model Number DYNJ69200; bbbb) HGH TAVI PACK, Model Number DYNJ69298; cccc) ANGIO TRAY, Model Number DYNJ69421; dddd) ENDOV

    FDA Enforcement
    Class II ·Ongoing·MEDLINE INDUSTRIES, LP - Northfield·July 26, 2023

    Brand Name: Alcon Laboratories, Inc. Product Name: Custom Pak Model/Catalog Number: Many - See 'Attachment 1 - Affected Product List' Software Version: N/A Product Description: Alcon Custom Paks are customer-designed sterile surgical procedure packs / convenience kits intended for use by trained ophthalmic surgeons in a variety of ophthalmic surgeries. Custom Pak is a collection of various ophthalmic surgical instruments and the necessary materials necessary to perform an ophthalmic surgical procedure. Component: N/A

    FDA Enforcement
    Class II ·Ongoing·Alcon Research LLC·July 16, 2025