K080706

CONNEXX LOCKING TIBIA NAIL

FDA 510(k)

FDA Class 2 ·Orthopedic

SchureMed

FDA UDI

SCHUERCH CORPORATION·00810014607009·SKYTRON 5001, 6001, 6500, 6600 3.25" DELUXE GEL

LOCATOR R-Tx

FDA UDI

Zest Anchors, LLC·00840481113581·LOCATOR R-Tx Abutment for 4.3mm Conelog Connect...

THINNER RESOLVE FITNESS MONITOR/BODY SCALE, HEALTH-O-METER

FDA 510(k)

FDA Class 2 ·Cardiovascular

DATEX-OHMEDA AESTIVA/5 WITH 7100 VENTILATOR

FDA 510(k)

FDA Class 2 ·Anesthesiology

ADVISOR VITAL SIGNS MONITOR

FDA Adverse Event

Malfunction ·SMITHS MEDICAL PM, INC.·Product code CCK·December 24, 2008

AISYS

FDA Adverse Event

Malfunction ·DATEX-OHMEDA, INC.·Product code BSZ·January 15, 2016

ADVISOR VITAL SIGNS MONITOR

FDA Adverse Event

Malfunction ·SMITHS MEDICAL PM, INC·Product code DQK·April 28, 2010

VISION HOLLOW FIBER OXYGENATOR

FDA Adverse Event

Malfunction ·GISH BIOMEDICAL, INC.·Product code DTZ·February 18, 2011

SPACEMAKER BLUNT TIP TROCAR 10MM

FDA Adverse Event

Malfunction ·COVIDIEN, FORMERLY USSC·Product code GCJ·April 9, 2013

TREK CORONARY DILATATION CATHETER

FDA Adverse Event

Malfunction ·AV-TEMECULA-CT·Product code LOX·May 6, 2011

ACUVUE OASYS BRAND W/HYDRACLEAR PLUS

FDA Adverse Event

Injury ·VISTAKON·Product code LPM·July 14, 2008

Locator-Wand Cover that is sold in a shelf carton (unit packaging) separate to the sterile tray containing and identified as PORT-A-CATH II Dual-lumen Fluoro-Free Venous Access System, Dual Lumen Silicone Catheter, 3.4mm O.D. tray. REF 21-8652-24. Contents: Dual-lumen Portal with WING-LOCK Connector, Radiopaque Dual-lumen PolyFlow Polyurethane Catheter, 10.2 Fr with CATH-FINDER Sensor Wire, Locator-Wand cover, Nonvented Luer Cap, 20G PORT-A-CATH needle, 18G Blunt Needle, Vein Pick, 2 GRIPPER PLUS Non-Coring Safety needles 20G, 20G 90-degree PORT-A-CATH needle, 18G Extra Thin Wall Introducer Needle, 11 Fr Introducer, ''J'' Guidewire, Syringes, Tunneling Tool, 3 Point-Lok Sharps Safety Devices, Product Information. EtO Sterilized. Single Use. Deltec, Inc., St. Paul, MN 55112 U.S.A.

FDA Recall

Terminated ·Smiths Medical MD, Inc.·Product code MMP·March 29, 2006

Locator-Wand Cover that is sold in a shelf carton (unit packaging) separate to the sterile tray containing and identified as PORT-A-CATH P.A.S. PORT T2 Fluoro-Free, Venous Access System, PolyFlow Polyurethane Catheter, 1.9mm O.D. tray. REF 21-4672-24. Contents: Portal with ULTRA-LOCK Connector, Radiopaque PolyFlow polyurethane Catheter 5.8Fr with CATH-FINDER Sensor Wire, Locator-Wand cover, Luer Cap, 20G PORT-A-CATH needle, 18G Blunt needle, Vein Pick, Point-Lok Sharps Safety Device, Product Information. EtO Sterilized. Single Use. Deltec, Inc., St. Paul, MN 55112 U.S.A.

FDA Recall

Terminated ·Smiths Medical MD, Inc.·Product code MMP·September 27, 2006

Locator-Wand Cover that is sold in a shelf carton (unit packaging) separate to the sterile tray containing and identified as PORT-A-CATH P.A.S. PORT Elite Fluoro-Free, Venous Access System, PolyFlow Polyurethane Catheter, 1.9mm O.D. tray. REF 21-4690-24. Contents: Portal with ULTRA-LOCK Connector, Radiopaque PolyFlow polyurethane Catheter 5.8Fr with CATH-FINDER Sensor Wire, Locator-Wand cover, Luer Cap, 20G PORT-A-CATH needle, 18G Blunt needle, Vein Pick, Point-Lok Sharps Safety Device, Product Information. EtO Sterilized. Single Use. Deltec, Inc., St. Paul, MN 55112 U.S.A.

FDA Recall

Terminated ·Smiths Medical MD, Inc.·Product code MMP·September 27, 2006

Locator-Wand Cover that is sold in a shelf carton (unit packaging) separate to the sterile tray containing and identified as PORT-A-CATH P.A.S. PORT T2 Fluoro-Free, Venous Access System, PolyFlow Polyurethane Catheter, 1.9mm O.D. tray. REF 21-4673-24. Contents: Portal with ULTRA-LOCK Connector, Radiopaque PolyFlow polyurethane Catheter with CATH-FINDER Sensor Wire, Locator-Wand cover, Nonvented Luer Cap, 20G PORT-A-CATH needle, 18G Blunt needle, 20G GRIPPER PLUS non-Coring Safety needle, 18G Extra Thin Wall Introducer Needle, 6 Fr introducer, 2 ''J'' Guidewires, 2 Syringes, Vein Pick, Tunneling Tool, 20G 90-degree PORT-A-CATH needle, 3 Point-Lok Sharps Safety Devices, Product Information. EtO Sterilized. Single Use. Deltec, Inc., St. Paul, MN 55112 U.S.A.

FDA Recall

Terminated ·Smiths Medical MD, Inc.·Product code MMP·September 27, 2006

Locator-Wand Cover that is sold in a shelf carton (unit packaging) separate to the sterile tray containing and identified as PORT-A-CATH II Fluoro-Free, Low Profile Venous Access System, PolyFlow Polyurethane Catheter, 1.9mm O.D. tray. REF 21-4683-24. Contents: Portal with ULTRA-LOCK Connector, Radiopaque PolyFlow polyurethane Catheter with CATH-FINDER Sensor Wire, Locator-Wand cover, Nonvented Luer Cap, 20G PORT-A-CATH needle, 18G Blunt needle, 20G GRIPPER PLUS non-Coring Safety needle, 18G Extra Thin Wall Introducer Needle, 6 Fr introducer, 2 ''J'' Guidewires, Syringes, Vein Pick, Tunneling Tool, 20G 90-degree PORT-A-CATH needle, 3 Point-Lok Sharps Safety Devices, Product Information. EtO Sterilized. Single Use. Deltec, Inc., St. Paul, MN 55112 U.S.A.

FDA Recall

Terminated ·Smiths Medical MD, Inc.·Product code MMP·September 27, 2006

On-Board Imager - Exact Arm Elbow Motor Shaft (kVD, kVS, and MV) with ''Type 01" elbow motors. Product Usage: The On-Board Imager device is an x-ray device used for evaluation of correct patient position in relation to isocenter and verification of treatment fields in relation to anatomical and fiducial landmarks.

FDA Enforcement

Class II ·Terminated·Varian Medical Systems, Inc.·April 30, 2014

CADD-Solis VIP ambulatory Infusion Pumps, Model 2110. 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