BEUDAMED
    16 results · 12ms · Sources: EU EUDAMED, US FDA

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    GEM Premier 3000 PAK - pH, pCO2, pO2, Hct, Part Numbers 00024307504, 00024330004, 00024345004

    FDA Recall
    Open, Classified ·Instrumentation Laboratory·Product code CHL·September 29, 2023

    GEM Premier 3000 PAK - pH, pCO2, pO2, Hct, Na+, K+, Ca++, Part Numbers 00024307507, 00024315007, 00024330007, 00024345007, 00024360007

    FDA Recall
    Open, Classified ·Instrumentation Laboratory·Product code CHL·September 29, 2023

    GEM Premier 3000 PAK - pH, pCO2, pO2, Hct, Na+, K+, Ca++, Glucose and Lactate, Part Numbers 00024315009, 00024330009, 00024345009, 00024360009

    FDA Recall
    Open, Classified ·Instrumentation Laboratory·Product code CHL·September 29, 2023

    a. DERMA SCIENCES, INC. NG Strip FASTENER, NASAL TUBE IND WRAP(25/BX), Catalog NG25. b. DERMA SCIENCES, INC. Surgitube BANDAGE, GAUZE #2P 7/8"X50YDS DERSCI Catalog GL-242. c. DERMA SCIENCES, INC. Surgilast TUBE NET SZ3 MED 10YDS/EA HAND, ARM, LEG, FOOT SURGILAST Catalog # GL103. d. DERMA SCIENCES, INC. Surgitube & Surgigrip APPLICATOR, SURGITUBE/GRIP METAL SZ3 6" CHLD/ADLT DERSCI Catalog #GL-234.

    FDA Recall
    Open, Classified ·Mckesson Medical-Surgical Inc. Corporate Office 9954 Maryland Drive Deep Run Iii Ste. 4000 Richmond VA 23233·Product code FQM·May 25, 2022

    Convenience kits containing select SKUs of 10mL Polycarbonate Colored Syringes. KIT NEURO CSTM SAMP0551

    FDA Recall
    Open, Classified ·Product code FQM·February 27, 2026

    Medline Convenience kits labeled as: 1) SH STRL UMBILICAL ACC PACK-LF, Pack Number DYNJ0621408V; 2) SH STRL UMBILICAL ACC PACK-LF, Pack Number DYNJ0621408VH; 3) 6" ACE BANDAGE PACK-LF, Pack Number DYNJ0864492A ; 4) 6" ACE BANDAGE PACK-LF, Pack Number DYNJ0864492AH; 5) KIT ANGIO CSTM-PROVIDENCE , Pack Number SAMP0545

    FDA Recall
    Open, Classified ·MEDLINE INDUSTRIES, LP Northfield·Product code FQM·April 8, 2024

    Sterile CoFlex NL: Latex Free Flexible Cohesive Bandage, Tan, 4INx5YD (5400S)

    FDA Recall
    Open, Classified ·Andover Healthcare Inc.·Product code FQM·April 2, 2024

    Medline Convenience kits used for various procedures: 1) CSTM PACEMAKER DRAPE PACK, Model Number: DYNJCD0339

    FDA Recall
    Open, Classified ·MEDLINE INDUSTRIES, LP Northfield·Product code FQM·March 3, 2025

    Lugol s Iodine Solution 500ML, Part Number 624-71

    FDA Recall
    Open, Classified ·EMD Millipore Corporation·Product code IAM·October 17, 2023

    (1) CVS Health Sterile Surgical Pads, Cushion Comfort, packaged 12 pads 5 in. x 9 in. per box, ASO Item No. 781083, SKU 894111 (2) CVS Health 30 Piece Wound Care Kit, For Large Size Wounds, ASO Item No. 781240, SKU 998842; and (3) equate First Aid Kit, 120 Items, containing 1 generic Sterile Trauma Pad 5 in. x 9 in., ASO Item No. 192636, SKU #30174479.

    FDA Recall
    Open, Classified ·ASO LLC·Product code FQM·June 22, 2022

    Software VERIQA (S070031), version 2.0 and 2.1- Software package for display, evaluation and digital processing of medical image data sets and treatment plans in radiation oncology.

    FDA Recall
    Open, Classified ·PTW-FREIBURG Lorracher Str. 7 Freiburg Im Breisgau Germany·Product code IYE·February 8, 2024

    BeamAdjust software Version 2.3.3 Ref: S080032 The following devices are affected when a relative calibration is performed using ArrayCal (module from BeamAdjust S080032, UDI-DI: EPTWS0800320 ): " OCTAVIUS Detector 1600 SRS (T10056) (UDI-DI: EPTWT100560) " OCTAVIUS Detector 1600 MR (T10057) (UDI-DI: EPTWT100570) " OCTAVIUS Detector 1600 XDR (T10058) (UDI-DI: EPTWT100580) " OCTAVIUS Detector 1000 SRS (T10036) (UDI-DI: EPTWT100360)

    FDA Recall
    Open, Classified ·PTW-FREIBURG Lorracher Str. 7 Freiburg Im Breisgau Germany·Product code IYE·June 7, 2023

    DORO Easy-Connect Navigation Adaptor; BRAINLAB (item No. 1204.002)

    FDA Recall
    Open, Classified ·Pro-Med Instruments Gmbh BOETZINGER STRASSE 86 Freiburg Im Breisgau Germany·Product code HBL·March 14, 2025

    Stryker 1,5/1,7MM DYNAMIC MESH- STD-MEDIUM-Intended for the reconstruction, stabilization and rigid fixation of the bony areas of the cranial skeleton. Catalog Number: 56-90614

    FDA Recall
    Open, Classified ·Stryker Leibinger GmbH & Co. KG Botzinger Str. 41 Freiburg Im Breisgau Germany·Product code GWO·March 29, 2024

    Patient-Fitted Temporomandibular (TMJ) Reconstruction Prosthesis

    FDA Recall
    Open, Classified ·Stryker Leibinger GmbH & Co. KG Botzinger Str. 41 Freiburg Im Breisgau Germany·Product code LZD·December 6, 2022

    8000-021-002, Scopis ENT Software with TGS with Sofware Version: NOVA 3.6.0 RC16. Scopis is a next-generation solution for navigating functional endoscopic sinus surgery (FESS) offering surgeons highly advanced image guidance and visualization capabilities in a single system. The Stryker Electromagnetic Navigation Unit (8000-010-003) powered by Scopis ENT Software with TGS (8000-021-002), allows the analysis and identification of sinus cells in the complex patient anatomy and planning of the natural drainage pathways through the sinus cavity. During surgery, the planned pathways are overlaid in real-time onto the endoscopic image, providing a unique Scopis augmented reality technology. Guidance of endoscopic instruments may help perform a minimally invasive, accurate and selective surgery.

    FDA Recall
    Open, Classified ·Stryker Leibinger GmbH & Co. KG Botzinger Str. 41 Freiburg Im Breisgau Germany·Product code PGW·April 4, 2024