8 results
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20ms
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Sources: EU EUDAMED, US FDA
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FDA Enforcement
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VariSoft infusion set, Model Number 1002830
FDA Enforcement
Class I
·Ongoing·Unomedical A/S·November 29, 2023
Smith&Nephew SmartStitch PerfectPasser Connector, REF # OM-8010, Rx Only, CE 0123, UDI: 00817470006971
FDA Enforcement
Class II
·Terminated·ArthroCare Corporation·September 30, 2020
Orthopedic Pack, catalog #900-2830 Used by medical staff to perform patient care procedures such as wound healing, suture removals, irrigate wounds, etc.
FDA Enforcement
Class I
·Terminated·Customed, Inc·December 10, 2014
Catalog Number: 9002830 ORTHOPEDIC SURGICAL PACK Used by medical staff to perform surgical procedures and patient care procedures such as wound healing, suture removals, irrigate wounds, etc.
FDA Enforcement
Class II
·Terminated·Customed, Inc·April 20, 2016
ORTHOPEDIC PACK BASIC CODE 900-2830. CONTENTS: (3) TOWELS ABSORBENT 15" X 20" (1) COVER MAYO STAND REINFORCED (1) U-DRAPE 60" X 70" WITH TAPE SPLIT 6 X 21 SPLIT (1) DRAPE% ECONOMY 53" X 77" (4) DRAPE UTILITY WITH TAPE (1) BAG SUTURE FLORAL (1) SHEET SPLITW/ADHES 108" X 77" STD SMS (1) COVER TABLE REINFORCED 50" X 90" (1) STOCKINETTE IMPERVIOUS 14" X 48" (1) TIME OUT BEACON NON WOVEN (1) GOWN XL SMS IMPERVIOUS REINFORCED AAMI LEVEL Ill (1) POLISHER CAUTERY TIP (1) SKIN MARKER INK W/8 LABEL/TIME OUT/RULER (1) COUNTER NDLIBLADE 20C FOAM/MAG (1) PENCIL CAUTERY ROCKER SWITCH WITH HOLSTER (1) GOWN IMPERVIOUS EXTRA REINFORCED LGE T/WRAP AAMI LEVEL Il (1) BAG GLASSINE PLAIN (1) ELECTRODE DUAL DEPRES Product Usage: 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
CADD-Solis Ambulatory Infusion Pumps, Model 2100. Intended for the following uses: Indicated for the following uses: Intra-arterial, subcutaneous, intraperitoneal, in close proximity to nerves, into an intraoperative site, epidural space or subarachnoid space. Therapies that require a continuous rate of infusion, intermittent bolus, and/or with patient-controlled demand doses.
FDA Enforcement
Class I
·Ongoing·Smiths Medical ASD Inc.·August 14, 2024
Alaris System PC Unit Model 8000, a modular infusion pump and monitoring system
FDA Enforcement
Class I
·Terminated·CareFusion 303, Inc.·August 12, 2020
Unify, Sterile EO, Model #/ Part #: CD3231-40/100029240, 100030104, 100041904; CD3231-40Q/100029281, 100030124, 100041905; CD3235-40/100029256, 100029293, 100029307, 100031111, 100037047, 100048897, 100070009; CD3235-40Q/100029257, 100029294, 100029308, 100031059, 100037048, 100070010; CD3281-40Q/100056770; CD3297-40/100056933
FDA Enforcement
Class II
·Terminated·St Jude Medical Inc.·July 4, 2018