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

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    Filters FDA Recall × Status: Terminated × Clear all

    Passport 2/Passport 2 LT Vital Signs Monitor. Multi-parameter patient monitoring system.

    FDA Recall
    Terminated ·Datascope Corp·Product code MSX·April 5, 2004

    GYRUS ACMI, dissector PlasmaKnife" , REF 7035-3005, Rx only, STERILE R, CE 0344, 161416-CA, MANUFACTURED FOR; GYRUS ACMI, INC., 136 TURNPIKE ROAD, SOUTHBOROUGH, MA 01722-2104, USA, EC REP, GYRUS MEDICAL LIMITED, FORTRAN ROAD, ST. MELLONS, CARDIFF, CF3 0LT, UK

    FDA Recall
    Terminated ·Gyrus Acmi, Incorporated·Product code GEI·August 6, 2010

    LAPAROSCOPY CHOLE PACK - (6) TOWELS ABSORBENT 15" X 20" LIF (1) MAYO STAND COVER REINFORCED L/F (1) SYRINGE 3cc WITHOUT NEEDLE LUER LOCK LIF (1) SURGICAL BLADE #11 CARBON STEEL (1) TUR Y SET, 2LEAD L/F (4) DRAPE UTILITY WITH TAPE LIF (1) TROCAR ENDO. XCEL DILATING TIP 5mm (K5LT) (1) ULTRA VERES NEEDLE 120mm (1) NEEDLE & BLADE COUNTER 20C FOAM/MAG LIF (1) DRAPE LAP. ABDOM. WITH POUCH 102" X 122" X 78" (2) DRAPE SHEET 41" X 58" SMS (2) GOWN IMPERVIOUS REINFORCED X-LARGE SMS LIF (10) GAUZE SPONGE 4" X 4" 16PLY XRD L/F (5) LAP SPONGE PREWASH XRD LIF (1 ) DRAPE LASER CAMERA W/EL. 6" X 96" LIF (1) TUBE SUCTION CONNECT. 3/16" X 12' LIF (1) TROCAR ENDOPATH XCEL DILATING TIP 11mm (K1 1LT) (1) TUBING INSUFLATION SET W/0 RING ADAPTOR LIF (1) SURGICAL DURAPREP SOLUTION 26ML LIF (1) TABLE COVER REINFORCED 50" X 90" LIF Product Usage: EO sterilized surgical convenient packs packaged into polyester/polyethylene breather bag with Tyvek double vents

    FDA Recall
    Terminated ·Customed, Inc Calle Igualdad Final # 7·Product code FDE·May 20, 2014

    Synchron Systems Drug Calibrator 1 (Carbamaxepine, Phenobarbitol, Phentoin, Theophylline, and Valproic Acid).

    FDA Recall
    Terminated ·Beckman Coulter Inc·Product code KLT·June 11, 2003

    VITROS Chemistry Products CRBM Slides, REF 889 2382, IVD -- Ortho-Clinical Diagnostics, Inc. For in vitro diagnostic use only. VITROS Chemistry Products CRBM Slides quantitatively measure carbamazepine (CRBM) concentration in serum and plasma using VITROS 250/350/950/5,1 FS and 4600 Chemistry Systems and the VITROS 5600 Integrated System.

    FDA Recall
    Terminated ·Ortho-Clinical Diagnostics·Product code KLT·March 5, 2014

    Vitros Chemistry CRBM Slides, REF 889 2382. There are 90 slides per box. For in vitro diagnostic use. Firm on label: Ortho-Clinical Diagnostics, Inc., Rochester, NY 14626.

    FDA Recall
    Terminated ·Ortho-Clinical Diagnostics·Product code KLT·May 26, 2005

    VITROS Chemistry Products CRBM Slides packaged as 90 slides/pack catalog number 8892382

    FDA Recall
    Terminated ·Ortho-Clinical Diagnostics·Product code KLT·June 12, 2013

    Centurion-Pelvic PE120 LARGE/MEDIUM PELVIC TRAY PE2200 PELVIC EXAM TRAY PE2200 PELVIC EXAM TRAY PE2400 PELVIC EXAM TRAY PE2515 SMALL GYN EXAM TRAY PE2515 SMALL GYN EXAM TRAY PE2610 PELVIC EXAM TRAY PE2700 ULTRASOUND TRAY PE2700 ULTRASOUND TRAY PE2820 VAG/VIRGIN VAG EXAM TRAY PE2835 PELVIC EXAM TRAY PE2835 PELVIC EXAM TRAY PE2905 HSG TRAY PE2955 7PELVIC EXAM TRAY PE2965 DISPOSABLE PELVIC EXAM TRAY PE2965 DISPOSABLE PELVIC EXAM TRAY PE3125 PELVIC EXAM TRAY PE3195 PELVIC EXAM TRAY PE3285 PELVIC EXAM TRAY PE3360 PELVIC EXAM TRAY W/LIGHT PE3375 PELVIC EXAM TRAY PE3400 MEDIUM GYN EXAM TRAY PE3475 IUD TRAY PE3585 MEDIUM/LARGE PELVIC EXAM TRAY PE860 VAGINAL BLEEDER KIT

    FDA Recall
    Terminated ·Centurion Medical Products Corporation·Product code MLT·December 11, 2019

    Bravo pH Monitoring capsule, UPC 7290101361695 (FGS# 0312) and UPC 7290101361688 (FGS# 0313). Product Usage: The Bravo pH Monitoring System is intended to be used for gastroesophageal pH measurement and monitoring of gastric reflux in adults and children form 4 years of age. The Bravo pH Capsule can be attached following either endoscopy or manometry.

    FDA Recall
    Terminated ·Given Imaging Ltd.·Product code LLT·January 11, 2012

    Centurion-Vaginal Speculum VS2000LST STERILE ER VAGINAL SPECULUM W/LIGHT

    FDA Recall
    Terminated ·Centurion Medical Products Corporation·Product code MLT·December 11, 2019

    Package Insert for TDx/TDxFLx and TDxFLx Carbamazepine Reagents, REF 9515, item number 69-5121/R4; Abbott Laboratories, Diagnostics Division, Abbott Park, IL 60064

    FDA Recall
    Terminated ·Abbott Laboratories HPD/ADD/GPRD·Product code KLT·November 17, 2003

    Centurion- Pelvic Exam Kits DYNDE1037 PELVIC EXAM TRAY,UNIVERSITY H 2019032090 DYNDE1037 PELVIC EXAM TRAY,UNIVERSITY H 2018091790

    FDA Recall
    Terminated ·Centurion Medical Products Corporation·Product code MLT·December 11, 2019

    OsteoBridge Intramedullary Diaphysis Segment Fixation (IDSF) nails (tibia)

    FDA Recall
    Terminated ·Merete Medical GmbH Alt-Lankwitz 102 Berlin Germany·Product code HSB·September 18, 2020

    OsteoBridge Intramedullary Diaphysis Segment Fixation (IDSF) nails (femur)

    FDA Recall
    Terminated ·Merete Medical GmbH Alt-Lankwitz 102 Berlin Germany·Product code HSB·September 18, 2020

    Merete PediatrOS RigidTack, REF CP20120, Size 20 mm, Sterile, Rx Only

    FDA Recall
    Terminated ·Merete Medical GmbH Alt-Lankwitz 102 Berlin Germany·Product code JDR·January 18, 2022

    OsteoBridge Intramedullary Diaphysis Segment Fixation (IDSF) nails (humerus)

    FDA Recall
    Terminated ·Merete Medical GmbH Alt-Lankwitz 102 Berlin Germany·Product code HSB·September 18, 2020

    OsteoBridge Intremedullary Knee Arthrodesis (IKA) nails

    FDA Recall
    Terminated ·Merete Medical GmbH Alt-Lankwitz 102 Berlin Germany·Product code HSB·September 18, 2020

    AmerisourceBergen PF Latex SG (Surgical Glove), Sterile, Powder Free, Size 6.5, Item No. 10112

    FDA Recall
    Terminated ·WRP Asia Pacific Sdn Bhd Lot 1, Perusahaan Bandar Baru Jalan·Product code KGO·May 7, 2018

    Allez Spine Del Mar Pedicle Screw System; Catalog Number: IT-FN1001 Laguna Pedicle Screw System Tray #1; IT-FN 1002 Laguna Pedicle Screw System Tray #2; lT-CT1001Counter Torque (w/Large Rubber Handle); IT-HP1001 Head Positioner (w/Rubber Handle); IT-RP1001Rod Pusher; lT-RK1001 Rocker (Goal Post Style Tip); lT-BA1002 Vampire Awl; IT-RG1001 Rod Gripper, Ratcheting (Long Nose); IT-TP1001Tap, 4mm (Thin Style, Gold Tip); IT-TP1002 Tap, 5mm (Thin Style, Gold Tip) IT-TP1003 Tap, 6mm (Thin Style, Gold Tip); IT-TP1004 Tap, 7mm (Thin Style, Gold Tip); IT-SD 1002 Multiaxial Screwdriver (No Windows); IT-SD1005 Screwdriver Shaft 75 (w/BaIl Bearing); IT-CT1002 Counter Torque (Short No Windows); IT-SD1006 Multiaxial Screwdriver (w/Windows); IT-TP1005 Tap, 4mm (Silver Tn-Fluted); IT-TP1006 Tap, 5mm (Silver Tn-Fluted); IT-TP1007 Tap, 6mm (Silver Tn-Fluted); IT-TP1008 Tap, 7mm (Silver Tn-Fluted); lT-HP1002 Head Positioner (All Metal Handle); IT-RK1002 Rocker (Horse Shoe Style Tip); IT-SD1007 Screwdriver Shaft 8.5 (w/Ball Bearing); IT-CT1003 Counter Torque (Short w/Windows); IT-TP1014 Tap, 4mm (Silver Circumferential); IT-TP1015 Tap, 5mm (Silver Circumferential); IT-TP1016 Tap, 6mm (Silver Circumferential); IT-TP1017 Tap, 7mm (Silver Circumferential); IT-SD1007 Screwdriver Shaft 8.5 (No Ball Bearing); IT-XR1001 Extension Remover; IT-S01006 Screwdriver_Shaft 10 (No Ball Bearing); IT-FB1001 French Rod Bender; IT-SP1001 Ball Tip Probe; IT-TR1001 Trial Rod; IT-RG 1002 Rod Gripper, Ratcheting (Short Nose); IT-BP1003 Lumbar Probe, Straight (Long); IT-BP1004 Lumbar Probe, Curved (Long); IT-SP1002 Sounder (Ball Tip) Probe, Heavy Duty; RD-ST5540 Rod 5,5 x 400mm, Straight; IT-BA1001 Newport Awl; IT-PU 1001 Persuader; IT-RR1001 Retaining Ring; lT-NS1001 In-Situ Left; IT-N51002 In-Situ Right; IT-BP100S Lumbar Probe, Straight (Short); IT-BP1006 Lumbar Probe, Curved (Short); IT-CP1001 Compressor; IT-DT1001 Distractor; IT-BP1001 Thoracic Ball Handle Probe, Curved; IT-BP1002 Thoracic Ball Handle Probe, Straight; IT-RH1002 Ratcheting T-Handle; IT-NC1001 Locking Nut Caddy; IT-SG1001 Screw Gauge Block; IT-RH1002 Ratcheting Handle, Straight; IT-T01002 Preset Torque Wrench (With Connector); LG-LN1002 Locking Nut, Single Piece; LG-PR0530C Polyaxial Screw, Non-Winged, 5 X 30; LG-PR0535C Polyaxial Screw, Non-Winged, 5 X 35; LG-PR0540C Polyaxial Screw, Non-Winged, 5 X 40; LG-PR0545C Polyaxial Screw, Non-Winged, 5 X 45; LG-PR0550C Polyaxial Screw, Non-Winged, 5 X 50; LG-PR0630C Polyaxial Screw, Non-Winged, 6 X 30; LG-PR0635C Polyaxial Screw, Non-Winged, 6 X 35; LG-PR0640C Polyaxial Screw, Non-Winged, 6 X 40; LG-PR0645C Polyaxial Screw, Non-Winged, 6 X 45; LG-PR0650C Polyaxial Screw, Non-Winged, 6 X 50; LG-PR0730C Polyaxial Screw, Non-Winged, 7 X 30; LG-PR0735C Polyaxial Screw, Non-Winged, 7 X 35; LG-PR0740C Polyaxial Screw, Non-Winged, 7 X 40; LG-PR074SC Polyaxial Screw, Non-Winged, 7 X 45; LG-PR0750C Polyaxial Screw, Non-Winged, 7 X 50; LG-PR0755C Polyaxial Screw, Non-Winged, 7 X 55; LG-PR083SC Polyaxial Screw, Non-Winged, 8 X 35; LG-PR0840C Polyaxial Screw, Non-Winged, 8 X 40; LG-PR0845C Polyaxial Screw, Non-Winged, 8 X 45; LG-PR0850C Polyaxial Screw, Non-Winged, 8 X 50; LG-PR0855C Polyaxial Screw, Non-Winged, 8)( 55; LG-PW0535C Polyaxial Screw, Winged, S X 35; LG-PW0540C Polyaxial Screw, Winged, 5 X 40; LG-PW0545C Polyaxial Screw, Winged, 5 X 45; LG-PW0635C Polyaxial Screw, Winged, 6 X 35; LG-PW0640C Polyaxial Screw, Winged, 6 X 40; LG-PW0645C Polyaxial Screw, Winged, 6 X 45; LG-PW0735C Polyaxial Screw, Winged, 7 X 35; LG-PW0740C Polyaxial Screw, Winged, 7 X 40; LG-PW0745C Polyaxial Screw, Winged, 7 X 45; RD-PB5504 ROD 5.5 X 40, PRE-BENT; RD-PB5505 ROD 5.5 X 50, PRE-BENT; RD-PB5506 ROD 5.5 X 60, PRE-BENT; RD-PB5507 ROD 5.5 X 70, PRE-BENT; RD-PB5508 ROD 5.5 X 80, PRE-BENT; RD-PB5509 ROD 5.5 X 90, PRE-BENT; RD-PB5510 ROD 5.5 X 100, PRE-BENT; RD-PB5511 ROD 5.5 X 110, PRE-BENT; RD-PB5

    FDA Recall
    Terminated ·Allez Spine, LLC·Product code NKB·August 21, 2008

    TheraSphere(R) YTTRIUM-90 CLASS MICROSPHERE INJECTION TheraSphere is indicated for radiation treatment or as a neoadjuvant to surgery or transplantation in patients with unresectable HCC who can have placement of appropriately positioned hepatic arterial catheters.

    FDA Recall
    Terminated ·Biocompatibles U.K., Ltd. Bortoli House Weydon Lane; Old Farnham Lane Farnham United Kingdom·Product code NAW·September 21, 2015