14 results
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12ms
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Sources: EU EUDAMED, US FDA
Animas Vibe Insulin Infusion Pump. This product is indicated for continuous subcutaneous infusion of insulin for the treatment of diabetes and has a continuous glucose monitoring feature.
FDA Enforcement
Class II
·Terminated·Animas Corporation·November 5, 2014
JUDKINS PACK
FDA Enforcement
Class II
·Terminated·Cardinal Health 200, LLC·March 24, 2021
Percutaneous Insertion Tray; Product Code: IAK-S7IT The Arrow¿ IAB is utilized for intra aortic balloon counterpulsation therapy in the aorta, whereby balloon inflation, during diastole and deflation, during systole increases blood supply to the heart muscle and decreases work of the left ventricle.
FDA Enforcement
Class I
·Terminated·Arrow International, Inc., Division of Teleflex Medical Inc.·March 16, 2016
Percutaneous Insertion Tray; Product Code: IAK-06845 The Arrow¿ IAB is utilized for intra aortic balloon counterpulsation therapy in the aorta, whereby balloon inflation, during diastole and deflation, during systole increases blood supply to the heart muscle and decreases work of the left ventricle.
FDA Enforcement
Class I
·Terminated·Arrow International, Inc., Division of Teleflex Medical Inc.·March 16, 2016
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
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
BRASSELER KM166-310-35 Twist Drill Quick Connect Diameter 3.5 mm, Total Length 112mm, Effective Length, 86mm - Product Usage: Twist drill intended use: to drill into bone in hip or knee surgeries.
FDA Enforcement
Class II
·Terminated·Brasseler USA I Lp·December 11, 2019
Brasseler USA KM169-39-76 Steinmann Pin Single Diamond Smooth, Diameter 2.8 mm, Length 228 mm Product Usage: A Steinmann Pin is used for internal fixation of large bone fractures.
FDA Enforcement
Class II
·Terminated·Brasseler USA I Lp·February 5, 2020
ENROUTE Transcarotid Stent System REF SR-XXYY-CS
FDA Enforcement
Class II
·Terminated·Silk Road Medical Inc·March 3, 2021
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
Dexcom Receiver, REF: MT22719, (Black, Pin, Blue), Rx Only, containing software version SW10617 and revision 4.0.1.048 - Product Usage: A non-adjunctive invasive glucose sensor is intended to determine glucose levels, and the direction and rate of change of glucose levels in people with diabetes. The device is indicated to replace information obtained from standard blood glucose monitoring devices to make diabetes-related treatment decisions. The device also provides historical glucose information, facilitating long-term therapy adjustments.
FDA Enforcement
Class II
·Terminated·Dexcom Inc·February 12, 2020
Vial2BAG DC 20mm: 1) REF 6070112 & 2) REF 6070112C, Single use only, Rx Only
FDA Enforcement
Class I
·Terminated·WEST PHARMA. SERVICES IL, LTD·February 6, 2019
Vial2BAG Transfer Device, REF 6070104, Single use only, Rx Only
FDA Enforcement
Class I
·Terminated·WEST PHARMA. SERVICES IL, LTD·February 6, 2019
Vial2BAG DC 13mm, REF 6070111, Single use only, Rx Only
FDA Enforcement
Class I
·Terminated·WEST PHARMA. SERVICES IL, LTD·February 6, 2019