7 results
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19ms
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Sources: EU EUDAMED, US FDA
RUSCH Foley Urinary Catheter Insertion Tray with 10cc syringe, BZK Swabs, Sterile, Rx only, Teleflex Medical Product Code: 76730.
FDA Enforcement
Class III
·Terminated·Teleflex Medical·August 13, 2014
Olympus DISPOSABLE GRASPING FORCEPS, FG-51D
FDA Enforcement
Class II
·Terminated·Olympus Corporation of the Americas·June 1, 2022
Terumo Advanced Perfusion System 1 Ultrasonic Air Sensor 1/4x1/16 UAS BLK, Catalog Number 5785 - Product Usage: intended for use with Terumo and Sarns brand air detection and heart-lung systems to detect gross air bubbles in the line during extracorporeal procedures.
FDA Enforcement
Class II
·Terminated·Terumo Cardiovascular Systems Corporation·September 23, 2020
Benchmark XT/LT and Discovery XT Model Numbers: N750-BMK-FS, N750-BMKXT-FS, N750-BMKLT-FS, N750-DIS-FS, N750-DISXT-FS. Product Usage: Usage: The Benchmark product lines are intended to automatically stain histological or cytological specimens on microscope slides with specific immunohistochemistry or in situ hybridization reagents for in vitro diagnostic use. The Discovery Systems are research use only instruments with similar functionality.
FDA Enforcement
Class II
·Terminated·Ventana Medical Systems Inc·September 4, 2013
Replacement leadwires with grabber ends: REF/Catalog Number Description 2106388-005 Replacement ECG Leadwire, grabber, BRN V, AHA, 74 cm/ 29 in 2106388-101 Replacement ECG Leadwire, grabber, LL , AHA, 130 cm/ 51 in 2106388-103 Replacement ECG Leadwire, grabber, GRN RL, AHA, 130 cm/ 2106388-107 Replacement ECG Leadwire, grabber, BLK N, IEC, 130 cm/ 51 in 2106392-004 Replacement ECG Leadwire, grabber, ORG V, AHA, 74 cm/ 29 in The reusable ECG leadwire sets enable ECG monitoring with GE equipment requiring rectangular 11-pin ECG trunk cable. Use leadwire sets with ECG trunk cable or telemetry transmitter.
FDA Enforcement
Class III
·Terminated·GE Healthcare, LLC·July 3, 2019
BK Medical ApS Ultrasound System Scanner bk2300 - Model #: bk3500 with software releases 1.2.0, 1.2.1 and 1.2.2. The system is intended for diagnostic ultrasound imaging or fluid flow analysis of the human body, data processing and guidance of puncture and biopsy. The system performs simple geometric measurements and calculations in the following areas: Emergency Medicine, Anesthesia, MSK, Vascular, Cardiology, OB/GYN
FDA Enforcement
Class II
·Terminated·B-K Medical A/S·August 10, 2016
UMBILICAL VESSEL CATHETER KIT - CUSTOMED- (1) PAPER TAPE MEASURE DISP. 24" (1) FENESTRATED DRAPE 18" x 26" LIF (1) NEEDLE HOLDER BAUMGARTNER 5" (2) HALSTED MOSQUITO CVD 5" SERRAT (1) ADSON FORCEP TISS. Wff (1) SYRINGE 3cc WITHOUT NEEDLE LUER LOCK LIF (6) GAUZE SPONGE 2" X 2" 8PL Y (6) GAUZE 4" X 4" 16PL Y (1) SYRINGE 1 cc TB SffiP (1) IRIS FORCEP SERR Y. CVD 4" WITH PROTECTOR TIP (1) NEEDLE WITH FILTER 18 X 1 Y. BLUNTffiP (1) SUTURE 3-0 BLK MONOFIL (1) TRAY ORGANIZER FULL DEEP (1) WRAPPER 30" X 30" L/F (1) PVP TRIPLE IODOPHOR SWABSTICK (1) TONGUE DEPRESSOR 6" WOOD (1) IRIS SCISSOR STRAIGHT 4 Y. W/PROTECTOR TIP (1) SCALPEL WITH HANDLE #11 (1) MOSQUITO FORCEP STRAIGHT 5" (2) SYRINGE 5cc WITHOUT NEEDLE LUER LOCK LIF (2) 3 PLY POLY TOWEL (1) UMBILICAL TAPE (1 ) PROBE GRONED & DISNEETNS 6" 2ML (1) EYE DRESSING EXT FINE POINT FULL (2) NEEDLE WITH FILTER 18 X 1 Y. NOKOR PO (1) PLASTIC TRAY 2/COMPARTMENT (1) HALF TRAY (1) STOPCOCK 3 WAY LUER SLIP EO sterilized surgical convenient packs packaged into polyester/polyethylene breather bag with Tyvek double vents.
FDA Enforcement
Class I
·Terminated·Customed, Inc·September 10, 2014