BEUDAMED
    21 results · 8ms · Sources: EU EUDAMED, US FDA

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

    Centrella Max - The Centrella Smart+ Bed is intended for use in healthcare environments as a patient support system to prevent and/or treat pressure injuries.Multiple model numbers of Centrella Max mattresses and pro+ mattresses. (1) Centrella Max Surface, REF P7922A01; (2) Centrella Max Surface, REF P7922A02; (3) Centrella Max Surface with X-Ray, REF P7922A03; (4) Centrella Max,Narrow, Rental, REF P7922ARENT01; (5) Centrella Pro+ 36" Surface with X-Ray, REF P7923A01; (6) Centrella Pro+ 40" Surface with X-Ray, REF P7923A02; (7) Centrella Pro+36" Surface, REF P7923A03; (8) Centrella Pro+ 40" Surface, REF P7923A04; (9) Pro+ MRS Surface for Hillrom 900 with X-Ray, REF P006800A01; (10) 80" MRS with X-Ray AU/NZ REF P006800A03; (11) Pro+ MRS Surface for Versacare with X-Ray, REF P3255A01; (12) Pro+ MRS Surface for Versacare, REF P3255A02; (13) Pro + MRS Surface for Versacare with X-Ray, REF P3255ARENT01; (14) Pro+ 36"MRS Surface with X-Ray, REF P7924A01; (15) Pro+ 40" MRS Surface with X-Ray, REF P7924A02; (16) Pro+ 36" MRS Surface, REF P7924A03; (17) Pro+ 40" MRS Surface, REF P7924A04; (18) Pro+ 36" MRS Rental Surface with X-Ray, REF P7924ARENT01.

    FDA Enforcement
    Class II ·Ongoing·Baxter Healthcare Corporation·June 26, 2024

    Hill-Rom PRO+ 36" MRS Surface With X-Ray mattress, REF P7924A01; and REF P7924ARENT01, PRO+ MRS Rental Surface with X-Ray mattress.

    FDA Enforcement
    Class II ·Ongoing·Baxter Healthcare Corporation·July 27, 2022

    Hill-Rom PRO+ 36" MRS Surface mattress, REF P7924A03.

    FDA Enforcement
    Class II ·Ongoing·Baxter Healthcare Corporation·July 27, 2022

    Hill-Rom PRO+ MRS Surface For Versacare mattress, REF P3255A02.

    FDA Enforcement
    Class II ·Ongoing·Baxter Healthcare Corporation·July 27, 2022

    Hill-Rom PRO+ MRS Surface For Versacare With X-Ray mattress, REF P3255A01.

    FDA Enforcement
    Class II ·Ongoing·Baxter Healthcare Corporation·July 27, 2022

    Hill-Rom PRO+ 36" MRS Surface, REF P7924A03, The pro+ mattress is intended for patient support and for the prevention and/or treatment of pressure injuries.

    FDA Enforcement
    Class II ·Ongoing·Baxter Healthcare Corporation·April 10, 2024

    ATTUNE Revision CRS Femoral RT SZ 5 Cemented, Catalog No. 150440205, Femoral Revision Implant, Knee

    FDA Enforcement
    Class II ·Terminated·DePuy Orthopaedics, Inc.·May 16, 2018

    ATTUNE Revision CRS Femoral LT SZ 5 Cemented, Catalog No. 150440105, Femoral Revision Implant, Knee

    FDA Enforcement
    Class II ·Terminated·DePuy Orthopaedics, Inc.·May 16, 2018

    G1 Dissection Tool - 6MM CRS DBALL, 2mm Shaft EXP, M; For cutting and shaping bone including spine and cranium.

    FDA Enforcement
    Class II ·Terminated·The Anspach Effort, Inc.·September 28, 2016

    G1 Dissection Tool - 3mm CRS DBALL, 2mm SHAFT EXP, M; For cutting and shaping bone including spine and cranium.

    FDA Enforcement
    Class II ·Terminated·The Anspach Effort, Inc.·September 28, 2016

    Ultraslim. These include all products labeled as UltraSlim, Luxurian, BioSlim Lipo, Cellulize, Slim 'n Trim, UltraRed, UltraBlue, Slim-PRO, Dazzle Light, UltraSlim Cold Light, SlenderRay, and U-Slim It, as well as those products with private labelling branding. Company claims that the program combines detoxification, red light exposure, hydration, full body vibration, massage, Niacin, Milk Thistle, and the use of compression garments. Sensible diet and exercise are recommended, but not required.

    FDA Enforcement
    Class II ·Terminated·Advanced Photonic Systems, LLC·September 24, 2014

    OPHTHALMIC DRS TRAY The Covidien Curity Oval Eye Pads are individually packaged and sterilized by the manufacturer; they are then placed into non-sterile Centurion Convenience Kits along with other components.

    FDA Enforcement
    Class II ·Terminated·Centurion Medical Products Corporation·April 12, 2017

    Brand Name: Q-Stop Product Name: Suture Retention Device Model/Catalog Number: QS Software Version: N/A Product Description: The DRS Vascular Q-Stop Suture Retention Appliance is a sterile, single-use, lightweight device made of biocompatible materials that can be easily installed within minutes to assist with venous access hemostasis. Component: No

    FDA Enforcement
    Class II ·Ongoing·Drs Vascular, Inc·August 27, 2025

    NxStage Cartridge Express with Speedswap, Catalog No. CAR-535. An accessory device for facilitating the removal and replacement of a flow-compromised filter during treatment of acute and chronic renal failure or fluid overload.

    FDA Enforcement
    Class II ·Ongoing·NxStage MDS Corporation·March 6, 2024

    T/S2 0.9% Sodium Chloride Injection, USP, AMUSA Sterile Field Flush Syringe, 10 mL in 12 mL Single Use Syringe, Rx only, Part no. 2S0706 Usage: Flush syringe.

    FDA Enforcement
    Class II ·Terminated·MRP, LLC dba AMUSA·June 24, 2015

    0.9% Sodium Chloride Injection, USP, Flush Syringe, 10 mL in 12 mL, Sterile, Rx only, Code No. 2T0806 Usage: Flush syringe.

    FDA Enforcement
    Class II ·Terminated·MRP, LLC dba AMUSA·June 10, 2015

    0.9% Sodium Chloride Injection, USP, 10mL in 12mL., Single use, Rx only, Sterile Solution.

    FDA Enforcement
    Class II ·Terminated·MRP, LLC dba AMUSA·September 2, 2015

    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

    Medical convenience kits Item number/ Product description AKGN82E GENERAL AMCB08Y CHEST BREAST PACK ANBP10AC BASIC PACK - 205939 ANIR77AM INTERVENTIONAL RADIOLOGY PACK - 205953 CFLA39G LAPAROTOMY PACK CIBL33I BASIC LAP PACK EVMN24E MINOR ESC EVST48E STARTER FDTA11AA T & A PACK FHHY25P HYSTEROSCOPY PACK HGML99G MAJOR LAP PACK HGXR41H X-RAY PACK HISU54M SET-UP PACK IHAA19AP PK A A A IHMP89K MINOR PROCEDURE PACK IHPD14AM PK PEDIATRIC LKVG10O VAG DELIVERY LMAG20G VASCULAR PACK LMLE46AA EXTREMITY LOWER PK MIEN58A DTC GENERAL ENDOSCOPY PACK(PS 209468) NUMB04H MAJOR BASIN SET 314666 OWBS11U BASIN SET - 206021 RCMS71B MIS SPECIALTY RCH SFMB55X MINOR BASIN - 208293 STBA09F BASIN SET TNBS21O BASIN SET 612833 UDBH37AX BASIC HEART PACK - 206044 UDMA50X MINOR ADULT - 206067 UICR54W ACS CRS PACK (PS055042) UIPC89D PROCUREMENT PACK UIPT13F PITCHER (PS 907953) UISB96AB SMALL BACK TABLE SETUP (PS 907419)

    FDA Enforcement
    Class II ·Ongoing·American Contract Systems Inc.·October 22, 2025

    Medline medical procedure convenience kits labeled as: 1) DRAWER 1 AIRWAY, Kit SKU ACC010270A; 2) DRAWER 2, Kit SKU ACC010690; 3) DRAWER 3 SYR/DRS/MON/NG 1 OF 3, Kit SKU ACC011073; 4) HYPOSPADIUS PACK, Kit SKU DYNJ00282Q; 5) SJ NEURO PACK RFID-LF, Kit SKU DYNJ0101360K; 6) CENTRAL LINE PACK-LF, Kit SKU DYNJ0220136S; 7) SPINE PACK-LF, Kit SKU DYNJ0376635Q; 8) ORTHO SPINAL PACK-LF, Kit SKU DYNJ0460768T; 9) W.C. MINOR LAPAROTOMY PK-LF, Kit SKU DYNJ0509186J; 10) NEURO SHUNT PACK-LF, Kit SKU DYNJ0578815W; 11) ANCILLARY SPINE PACK-LF, Kit SKU DYNJ0610290T; 12) MINOR LAPAROTOMY PACK-LF, Kit SKU DYNJ0753436P; 13) KNEE SCOPE PACK-LF, Kit SKU DYNJ0890502R; 14) PEDIATRIC PACK-LF, Kit SKU DYNJ28212L; 15) ANTERIOR CERVICAL PACK, Kit SKU DYNJ31341P; 16) PEDIATRIC MINOR PROCEDURE PACK, Kit SKU DYNJ37615J; 17) LAPAROSCOPY PACK, Kit SKU DYNJ39215N; 18) MAJOR LAP VCH, Kit SKU DYNJ39217P; 19) NEURO PACK, Kit SKU DYNJ39220N; 20) CAS HAND PK, Kit SKU DYNJ39468G; 21) RFT ISC NOBLES MINOR PACK, Kit SKU DYNJ43954B; 22) PED OPEN HEART PACK, Kit SKU DYNJ45373G; 23) MAJOR GENERAL PACK-LF, Kit SKU DYNJ51436F; 24) MINOR PK-LF, Kit SKU DYNJ51437C; 25) VEIN ABLATION & EXCISION ASC, Kit SKU DYNJ52586C; 26) SHOULDER PACK, Kit SKU DYNJ56889B; 27) LAP CHOLE PACK, Kit SKU DYNJ57206F; 28) TRANSGENDER MASTECTOMY 2, Kit SKU DYNJ58257I; 29) SHOULDER ARTH PACK, Kit SKU DYNJ58410D; 30) MAJOR PACK, Kit SKU DYNJ58528J; 31) PACK BREAST, Kit SKU DYNJ60157F; 32) CH TRANSPHENOIDAL PACK, Kit SKU DYNJ61696I; 33) RR-SPINE PACK, Kit SKU DYNJ62643B; 34) MINOR PACK, Kit SKU DYNJ64238D; 35) PBMS NECK PACK-LF, Kit SKU DYNJ64961C; 36) BREAST PACK, Kit SKU DYNJ64988C; 37) MINOR PACK 180110, Kit SKU DYNJ65447C; 38) PACK,V-P SHUNT, Kit SKU DYNJ65472C; 39) BASIC PACK, Kit SKU DYNJ65996D; 40) MINOR SS, Kit SKU DYNJ66094A; 41) CRMC ROBOTIC GENERAL PACK, Kit SKU DYNJ66613D; 42) PEDIATRIC GENERAL PACK, Kit SKU DYNJ66644F; 43) URO/GYN PACK, Kit SKU DYNJ66675F; 44) SHOULDER SCOPE PACK, Kit SKU DYNJ68707B; 45) SPECIALTY FACIAL PLASTICS PACK, Kit SKU DYNJ68844B; 46) SPECIALTY FACIAL PLASTICS PACK, Kit SKU DYNJ68844C; 47) ACF PACK, Kit SKU DYNJ69112C; 48) SM OR-DR. YEH PACK-LF, Kit SKU DYNJ69705C; 49) SHOULDER ARTHROSCOPY PACK, Kit SKU DYNJ81752C; 50) C BIRTH SET UP PACK, Kit SKU DYNJ81994C; 51) TRIAL PACK, Kit SKU DYNJ82770A; 52) PROSTATE ROBOTIC PACK, Kit SKU DYNJ84120C; 53) HAND PACK, Kit SKU DYNJ85033A; 54) ARTHROSCOPY PACK, Kit SKU DYNJ85197A; 55) GU-GYN-LITHO PACK, Kit SKU DYNJ86013A; 56) DBD-ARTHROSCOPY PACK, Kit SKU DYNJ86963A; 57) BREAST PACK, Kit SKU DYNJ87587A; 58) PACK,PEDIATRIC MINOR, Kit SKU DYNJ88718; 59) UNIVERSAL-ASC, Kit SKU DYNJ900071C; 60) BASIC, Kit SKU DYNJ905869G; 61) PACK,PEDIATRIC MAJOR, Kit SKU DYNJ906888F; 62) HAND/FOOT PACK, Kit SKU DYNJT3131A; 63) SHOULDER PACK, Kit SKU DYNJT3266; 64) LUMBAR PACK, Kit SKU DYNJT4178; 65) CVS ICU PACK, Kit SKU PHS41728D; 66) SINGLE TAP BLOCK TRAY, Kit SKU SPEC0156A.

    FDA Enforcement
    Class II ·Ongoing·Medline Industries, LP·February 4, 2026