BEUDAMED
    558 results · 13ms · Sources: EU EUDAMED, US FDA

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    Acrobat-i Positioner. Model Number C-XP-5000Z

    FDA Enforcement
    Class II ·Ongoing·Maquet Cardiovascular, LLC·November 27, 2024

    Medline Convenience kits labeled as: 1) FILTER-.8 MICRON, Pack Number 2008; 2) ANES CIRCUIT 90IN EXP-LF, Pack Number DYNJAA10295A

    FDA Enforcement
    Class II ·Ongoing·MEDLINE INDUSTRIES, LP - Northfield·September 18, 2024

    IV Administration Set utilized in gravity IV administration sets and pump administration sets utilized with BBMI's Infusomat Space Large Volume Pump, Outlook Pump, and Vista Basic Pump. Labeled as the following with corresponding catalog number: 1. Catalog Number: 490549; Primary UDI-DI: 04046955270323; Unit of Dose UDI-DI: 04046955270316; Expiration Date: Earliest Exp of Comp or 36mths. 2. Catalog Number: 490565; Primary UDI-DI: 04046955275601; Unit of Dose UDI-DI: 04046955275595; Expiration Date: Earliest Exp of Comp or 36mths.

    FDA Enforcement
    Class II ·Ongoing·B Braun Medical Inc·December 3, 2025

    Anesthesia Circuit Kits and other various kits that contain Anesthesia Circuits; Product description/Product numbers: ADULT 120 EXPANDABLE W/MASK DYNJAA10591; ANES CIRC 120IN EXP-LF DYNJAA6555G; ANES CIRCUIT ADULT 120"-LF DYNJAA10817; ANESTHESIA 120" ADLT-LF DYNJAA10775; ANESTHESIA CIRC ADULT 120-LF DYNJAA10601; ANESTHESIA CIRCUIT - LF DYNJAA10261B; ANESTHESIA CIRCUIT 120EXP-LF DYNJAA10741A; ANESTHESIA CIRCUIT ADULT-LF DYNJAA0380A DYNJAA10641 DYNJAA10706B DYNJAA10851 DYNJAA10922B DYNJAA10971A DYNJAA11030A DYNJAA11087 DYNJAA11126; ANESTHESIA CIRCUIT-LF DYNJAA0309A DYNJAA0368A DYNJAA10368A DYNJAA10392 DYNJAA10430A DYNJAA10547A DYNJAA10639A DYNJAA10656A DYNJAA10685A DYNJAA10685B; CIRC 120" EXP 1 BV HMEF 3L GSL DYNJAA10920; EXPANDABLE CIRCUIT-LF DYNJAA11095; NM ANESTHESIA TURNOVER KIT DYNJAA0433; PROV HEALTH HEPA CIRC #2-LF DYNJAA0360; SPTMPX01IA CIRCUIT ADULT-LF DYNJAA10973A;

    FDA Enforcement
    Class I ·Ongoing·Medline Industries, LP·November 19, 2025

    Centered Glenosphere w/Screw, CoCr/TA6V/TiN 10-degrees Tilt 32 mm, REF: 115-3210

    FDA Enforcement
    Class II ·Ongoing·FX SHOULDER·February 7, 2024

    Custom Sterile and Non-Sterile Procedural Kits containing Turkuaz Ultrasound Gel. Labeled as the following: a. CHN OR DAVINCI PROSTATE, Model Number: DYNJ902540N; b. CUSTOM GYN, Model Number: DYNJ63257B; c. DBD-AMNIOCENTESIS PACK-LF, Model Number: DYNJ0771979C; d. DBD-GYN EXP LAPAROTOMY, Model Number: DYNJ906578F; e. DBD-GYN LITHOTOMY, Model Number: DYNJ906579F; f. DBD-GYN LS, Model Number: DYNJ906616G; g. DBD-ROBOTICS GYN, Model Number: DYNJ905824I; h. GYN EXP LAPAROTOMY, Model Number: DYNJ906578D; i. GYN LITHOTOMY, Model Number: DYNJ906579A, DYNJ906579B, DYNJ906579D, DYNJ906579F; j. GYN LS, Model Number: DYNJ906616A, DYNJ906616B, DYNJ906616C, DYNJ906616D, DYNJ906616F; k. GYN ROBOTIC CUSTOM PACK-LF, Model Number: DYNJ0752001K; l. ROBOTIC, Model Number: DYNJ904343D, DYNJ904343F; m. ROBOTIC GYN SSC, Model Number: DYNJ60009B, DYNJ60009C; n. ROBOTIC PACK-LF, Model Number: DYNJ904250G; o. ROBOTIC PROSTATECTOMY, Model Number: DYNJ905826G; p. ROBOTIC-LF, Model Number: DYNJ904254G, DYNJ904254I; q. ROBOTICS GYN, Model Number: DYNJ905824F, DYNJ905824G, DYNJ905824I; r. SSC GU ROBOTIC PACK, Model Number: DYNJ64027A, DYNJ64027B;

    FDA Enforcement
    Class II ·Ongoing·MEDLINE INDUSTRIES, LP - Northfield·August 9, 2023

    Custom Sterile and Non-Sterile Procedural Kits containing Turkuaz Ultrasound Gel. Labeled as the following: a. CUSTOM GYN, Model Number: DYNJ63257C; b. GYN EXP LAPAROTOMY, Model Number: DYNJ906578C; c. INTRAUTERINE TRNSFUSION -LF, Model Number: DYNJ9048708I; d. PERI NEURO BLOCK PACK-LF, Model Number: PHS762887001B; e. PICC TRAY, Model Number: DYNJ32988; f. SLING PACK-LF, Model Number: DYNJ55361, DYNJ55361A; g. TRANS VAGINAL TRAY (KW01JF), Model Number: OBQ056E; h. TVS4700 CUSTOM PACK, Model Number: TVS4700;

    FDA Enforcement
    Class II ·Ongoing·MEDLINE INDUSTRIES, LP - Northfield·August 9, 2023

    Procedural convenience kits and trays, cardiac, labeled as: a) EP LAB BI V IMPLANT PACK, kit number AGBI64J; b) LAB DEVICE IMPLANT, kit number AGDI40J; c) LAB DEVICE IMPLANT, kit number AGDI40K; d) MINOR VASCULAR, kit number AGMV26O; e) OPEN HEART ACCESSORY, kit number AGOH98Q; f) OPEN HEART ACCESSORY, kit number AGOH98R; g) OPEN HEART ACCESSORY, kit number AGOH98S; h) PERIPHERAL VASCULAR, kit number AGPV28O; i) PERIPHERAL VASCULAR, kit number AGPV28P; j) MINOR VASCULAR, kit number AHMV26J; k) MINOR VASCULAR, kit number AHMV26K; l) HEART PACK - 205947, kit number ANCV78AX; m) HEART PACK - 205947 , kit number ANCV78AX1; n) HEART PACK - 205947 Post Open-Heart, kit number ANHK74N; o) OPEN HEART EAST PACK, kit number BHOH43; p) 74OFF PUMP CABG PACK, kit number BHOP48; q) PACEMAKER PACK, kit number BHPM60; r) FORBES EP LAB DEVICE IMPLANT PK, kit number FBDI42K; s) T AND A PACK AGH ASC, kit number FBDI42L; t) T AND A PACK AGH ASC, kit number FBDI42M; u) THORACOSCOPY PACK, kit number FBTO60G; v) OPEN HEART ACCESSORY PACK, kit number JROH00O; w) OPEN HEART ACCESSORY PACK, kit number JROH98O; x) ADULT OPEN HEART PACK, kit number LLOH52; y) ADULT OPEN HEART PACK, kit number LLOP25; z) PACEMAKER PACK, kit number LLPP14; aa) HEART PACK, kit number LMCB06AD; bb) CARDIAC HEART BUNDLE NS, kit number LMCH99O; cc) OPEN HEAART PACK, kit number LMOH50AD; dd) OPEN HEAART PACK, kit number LMOH50AD-01; ee) OPEN HEAART PACK, kit number LMOH50AD-02; ff) OPEN HEAART PACK, kit number LMOH50AE; gg) CV PACK, kit number MMCV98V; hh) CV PACK, kit number MMCV98V-03; ii) CV PACK, kit number MMCV98V-04; jj) KIT OPEN HEART ADULT, kit number MMOH64J; kk) PACEMAKER PACK, kit number MMPM27E; ll) KIT, THORACOTOMY UNIVERSAL, kit number MMTR12F; mm) ANT CERV FUSION PACK, kit number NCAC96; nn) OPEN HEART- ACCESSOR, kit number NCOH11; oo) VASCULAR SAH, kit number SAVA91G; pp) VASCULAR SAH, kit number SAVA91H; qq) VASCULAR SAH, kit number SAVA91I; rr) VASCULAR SAH, kit number SAVA91J; ss) OPEN HEART BRINGBACK SJH, kit number SJOH17I; tt) OPEN HEART CV SJH, kit number SJOH28L; uu) PEDIATRIC HEART SJH, kit number SJPH34K; vv) VASC OPEN CVOR SJH, kit number SJVO56A; ww) VASC OPEN CVOR SJH, kit number SJVO56B; xx) MAJOR CV TRAY, kit number SVMJ20L; yy) MAJOR CV TRAY, kit number SVMJ20M; zz) MINOR CV TRAY¿, kit number SVMN60J; aaa) OPEN HEART COMPONENT PACK, kit number SVOH38Q; bbb) CV B PACK, kit number TNCB10AK; ccc) CARDIOVASCULAR SUPPLY (PS 907285), kit number UICD62AM

    FDA Enforcement
    Class II ·Ongoing·American Contract Systems, Inc.·February 7, 2024

    Custom procedural convenience kits and trays, Othopedic use, labeled as: a) HIP FRACTURE, kit number AHHF15C; b) HIP FRACTURE, kit number AHHF15D; c) Hand Pack, kit number BBHP10E; d) Lower Extremity, kit number BBLE40B; e) Custom Podiatry, kit number BOCP70J; f) ROBOTIC PACK, kit number BPAR65A; g) HIP PINNING PACK, kit number EMHP84; h) HIP PINNING PK, STRL F G, kit number FHHI17V; i) TOTAL HIP PACK, kit number GNTH06L; j) TOTAL KNEE PACK, kit number GNTK07L; k) EXTREMITY PACK, kit number GUEX48I; l) MAJOR ORTHO PACK, kit number GUMO40J; m) TOTAL KNEE ACCESS PACK, kit number HITK58D; n) SHOULDER ARTHROSCOPY, kit number HNSH17H; o) TOTAL HIP PACK, kit number HNTH76M; p) TOTAL KNEE PACK, kit number HNTK81M; q) ORIF HIP PACK, kit number HOHP28; r) DR. GREENWALD TOTAL KNEE, kit number HSGK80S; s) Custom Lower Ext, kit number JSLE08E; t) HAND PACK, kit number LVHD29; u) KIT, LOWER EXTREMITY, kit number MMEX19E; v) KIT, HIP PINNING, kit number MMHP45E; w) KIT, ORTHO SPINE, kit number MMSP21H; x) KIT, TOTAL HIP, kit number MMTH15E; y) KIT, TOTAL KNEE, kit number MMTK66E; z) KIT, UPPER EXTREMITY OPEN SHOULDER, kit number MMUE31E; aa) HIP SCOPE, kit number PTHS10D; bb) HIP SCOPE, kit number PTHS10F; cc) SHOULDER ARTHROSCOPY SAH, kit number SASA18D; dd) SHOULDER ARTHROSCOPY SAH, kit number SASA18F; ee) TOTAL ORTHO SAH, kit number SATO27F; ff) TOTAL ORTHO SAH, kit number SATO27G; gg) PODIATRY PACK, kit number SMPD35; hh) SHOULDER PACK, kit number SMSH12; ii) MAJOR SETUP PACK, kit number SMSU17A; jj) TOTAL HIP, kit number SMTH39; kk) TOTAL KNEE, kit number SMTK21; ll) Knee Arthroscopy, kit number SPKA57Q; mm) SHOULDER ARTHROSCOPY, kit number SPSA58P; nn) Total Hip pack W-O Stryker, kit number SPTH50AF; oo) Total Knee pack W-O Stryker, kit number SPTK51AF; pp) UPPER EXTREMITY, kit number SRUE05M; qq) Arthroscopy Pack, kit number THAR35B; rr) Extremity Pack, kit number THEX27B ss) Shoulder Pack, kit number THSH07F tt) Total Joint, kit number THTJ22G uu) TOTAL HIP PACK, kit number WHTH07D vv) TOTAL HIP PACK, kit number WHTH07E ww) TOTAL KNEE, kit number WHTK06C xx) TOTAL KNEE, kit number WHTK06D yy) CARPAL TUNNEL WEXFORD PACK, kit number WXCT12E

    FDA Enforcement
    Class II ·Ongoing·American Contract Systems, Inc.·February 7, 2024

    Custom procedural convenience kits and trays, general & plastic surgery, labeled as: a) BRACHY THERAPY PROCEDURE PAC, kit number AGBR90E; b) BRACHY THERAPY PROCEDURE PAC, kit number AGBR90E; c) MINI MINOR AGH ASC PACK, kit number AGMM60M; d) OUTPATIENT PORT ACCESS KIT 307907, kit number AHPO55J; e) General Pack, kit number BBGP31C; f) FRACTURE TABLE PACK, kit number FDFT75N; g) Arthroscopy Pack, kit number HCAR04K; h) BARIATRIC PACK, kit number HGBA92F; i) LAPAROTOMY PACK, kit number HNLP12J; j) MIDLINE CHANGE KIT, kit number HSMD20E; k) Minor General, kit number JSMI10I; l) ENDO VASCULAR PACK, kit number LVEV61; m) MAJOR PACK, kit number LVMJ21; n) HEAD AND NECK PACK, kit number MMHN37F; o) KIT, MINOR U BAR, kit number MMNU34E; p) KIT, MAJOR UNIVERSAL, kit number MMUN28E; q) VAG PLASTY PACK, kit number OSVP16; r) DR L MAJOR, kit number SALM40H; s) DR L MAJOR, kit number SALM40I; t) MINOR BASIN SAH, kit number SAMB25E; u) MAJOR SAH, kit number SAMJ36G; v) MINOR PACK, kit number SMMN65; w) General Pack, kit number THGN59D; x) MINOR PACK, kit number TPMN15; y) MAJOR UNIVERSAL PACK, kit number TPUN48

    FDA Enforcement
    Class II ·Ongoing·American Contract Systems, Inc.·February 7, 2024

    DeRoyal TRACECART POSTEROR LUMBAR FUSION TRACECART, REF 53-1961.02

    FDA Enforcement
    Class II ·Ongoing·DeRoyal Industries Inc·December 21, 2022

    Custom procedural convenience kits and trays, gastroenterological & urological, labeled as: a) LAP KIDNEY MODULE, kit number AGKD50L; b) ROBOTIC PROSTATE PACK - 264852, kit number ANPR34S; c) LAP CHOLE - 213388, kit number BFLC02AD; d) GENERAL LAPAROSCOPY PACK, kit number GUGE09I; e) LAP CHOLE PACK, kit number HNLC80I; f) Lap Chole Ovarian Appy, kit number JSLC06I; g) LAP CHOLE, ST LUKES, kit number LMLP08Z; h) ROBOTIC PACK - 242561, kit number MHRB88AJ; i) KIT, GENERAL LAPAROSCOPY, kit number MMLP40F; j) KIT, MAJOR LAPAROTOMY, kit number MMML26F; k) LAP CHOLE - LAP HERNIA PACK - 282807, kit number OWLC07K; l) GENERAL LAPAROSCOPY SAH, kit number SAGL57H; m) ROBOTIC PACK SAH, kit number SARB30K; n) ROBOTIC PACK SAH, kit number SARB30L; o) ROBOTIC PACK SAH, kit number SARB30M; p) LAP CHOLE PACK, kit number SMLC53; q) ROBOTICS PACK, kit number SNRP85D; r) ROBOTIC PACK, kit number SSRO22C; s) ROBOTIC PACK, kit number SSRO22D; t) TPK DAVINCI PROSTATE SYSTEM, kit number TPDV16; u) ASC LAP CHOLE PACK (PS 42279), kit number UICH53Y; v) GENERAL LAPAROSCOPIC PACK, kit number WVGL60E

    FDA Enforcement
    Class II ·Ongoing·American Contract Systems, Inc.·February 7, 2024

    DeRoyal AMG Suction Connector Tubing REF: 71-2083, 71-C506, 71-C510, 71-C512, 71-C520, Tubing is intended for fluid movement

    FDA Enforcement
    Class II ·Ongoing·DeRoyal Industries Inc·February 26, 2025

    Custom procedural convenience kits and trays, cardiac, labeled as: a) HEART CATHETERIZATION TRAY, kit number JRHC45G; b) TAVR PACK, kit number LLTV10; c) CATH PED LF SJH, kit number SJCA21F; d) CATH HEART ADL LF SJH, kit number SJCH22F; e) INT RAD PORTS-LF - 206060, kit number UDIR58AL

    FDA Enforcement
    Class II ·Ongoing·American Contract Systems, Inc.·February 7, 2024

    Custom procedural convenience kits and trays, general hospital use, labeled as: a) IR NEURO PACK, kit number AGNE20J; b) ADULT CRANIOTOMY PACK, kit number LLCR99; c) LAMINECTOMY PACK, kit number LLLC26; d) KIT, CRANIOTOMY, kit number MMCR11J; e) KIT, NEURO SPINE, kit number MMNS20H; f) IR NEURO PACK, kit number OSIN77; g) NEURO SAH, kit number SANE32H; h) NEURO SAH, kit number SANE32I; i) S78FCH CRANI PACK (PS 132432), kit number UICR10U; j) CRANI PACK (PS039498), kit number UICR33AW; k) Laminectomy, kit number UILM77AR; l) DIAGNOSTIC NEURO IR TRAY, kit number WENE21D; m) DIAGNOSTIC NEURO IR TRAY, kit number WENE21F; n) DIAGNOSTIC NEURO IR TRAY, kit number WENE21H; o) DIAGNOSTIC NEURO IR TRAY, kit number WENE21H-01; p) NEURO IR TRAY, kit number WENI56F; q) NEURO IR TRAY, kit number WENI56H; r) NEURO IR TRAY, kit number WENI56H-01

    FDA Enforcement
    Class II ·Ongoing·American Contract Systems, Inc.·February 7, 2024

    AQUABILITI AQUASTAT 0.9% Sodium Chloride Injection syringe, USP, 5mL in 12mL, REF 2T0805; and 3mL in 12mL, REF 2T0807, intermediate cartons containing 100 syringes, shipping cases containing 400 syringes, Rx, Sterile.

    FDA Enforcement
    Class II ·Ongoing·MRP, LLC dba Aquabiliti·February 28, 2024

    BioFire Respiratory Panel 2.1 (RP2.1), REF: 423742, For FILMARRAY systems, IVD, Rx Only

    FDA Enforcement
    Class II ·Ongoing·BioFire Diagnostics, LLC·August 30, 2023

    GeoMed Custom Tracecarts, REF Numbers: a) 53-1831 ORTHO TOTAL JOINT TRACECART, b) 53-1836 GENERAL SURGERY TRACECART

    FDA Enforcement
    Class I ·Ongoing·DeRoyal Industries Inc·April 3, 2024

    Custom procedural convenience kits and trays, Obstetrical & Gynecological use, labeled as: a) LOWER PELVIC PACK, kit number AGLP52L; b) OB/GYN DAVINCI PACK A RG BASIN, kit number HGOB98G; c) DAVINCI GYN PACK, kit number HHDV17; d) KIT, GYNE ROBOTIC, kit number MMGR44D; e) KIT, MAJOR LITHOTOMY, kit number MMJL16E; f) GYN PACK, kit number SMGY46; g) Lithotomy Pack, kit number THLH71C; h) ASC HYSTEROSCOPY PACK (PS 020634), kit number UIHY16AA; i) GYN LAPAROSCOPY HPES, kit number WELP67C; j) GYN LAPAROSCOPY HPES, kit number WELP67C-01; k) GYN LAPAROSCOPY HPES, kit number WELP67C-02

    FDA Enforcement
    Class II ·Ongoing·American Contract Systems, Inc.·February 7, 2024

    DeRoyal CMC POSTERIOR SPINE PACK, REF 89-10570.01

    FDA Enforcement
    Class II ·Ongoing·DeRoyal Industries Inc·December 21, 2022