Company · US
Halyard Health, Inc
FDA 510(k) clearances and medical device recalls filed under this name, 2014 to 2019. Name variants (Inc, Corp, punctuation) are merged.
14510(k) clearances (0 in 12 months)
57recalls (0 in 12 months)
9recalls that name a 510(k)
Product codes
| Code | Device | Records |
|---|---|---|
| BSY | Catheters, Suction, Tracheobronchial | 48 |
| BTR | Tube, Tracheal (W/Wo Connector) | 5 |
| GXI | Probe, Radiofrequency Lesion | 3 |
| LZA | Polymer Patient Examination Glove | 3 |
| FYA | Gown, Surgical | 2 |
| LZC | Medical Glove, Specialty | 2 |
| BSO | Catheter, Conduction, Anesthetic | 1 |
| BXN | Stimulator, Nerve, Battery-Powered | 1 |
| FPB | Filter, Infusion Line | 1 |
| FRG | Wrap, Sterilization | 1 |
| FXX | Mask, Surgical | 1 |
| KKX | Drape, Surgical, Antimicrobial | 1 |
| KNT | Tubes, Gastrointestinal (And Accessories) | 1 |
| MEB | Pump, Infusion, Elastomeric | 1 |
Latest 510(k) clearances
| Decided | 510(k) | Device and applicant | Code |
|---|---|---|---|
| Mar 22, 2019 | K181360 | ON-Q* Pump with Bolus Halyard Health | MEB |
| Jun 27, 2018 | K180646 | Halyard Lavender Nitrile Powder-Free Exam Glove Tested for Use with Chemotherapy Drugs Halyard Health | LZC |
| Jan 26, 2018 | K173955 | Mic-Key* SF Over-the-Wire Stoma Measuring Device Halyard Health, Inc. | KNT |
| Apr 21, 2017 | K162930 | Aero Chrome* Select Breathable Performance Surgical Gowns Halyard Health, Inc. | FYA |
| Apr 13, 2017 | K163461 | Coolief* Cooled RF Probe Halyard Health, Inc. | GXI |
| Dec 16, 2016 | K163236 | COOLIEF Cooled Radiofrequency Kit Halyard Health, Inc. | GXI |
| Sep 30, 2016 | K161232 | ON-Q* EchoSpark Echogenic Catheter; ON-Q* T-bloc* Echogenic Continuous Nerve Block Kit Halyard Health | BSO |
| Sep 6, 2016 | K160709 | HALYARD* PURPLE NITRILE XTRA* Powder-Free Exam Gloves Halyard Health | LZC |
| Apr 13, 2016 | K153255 | Aero Chrome* Breathable Performance Surgical Gown Halyard Health, Inc. | FYA |
| Mar 31, 2016 | K153708 | Halyard Black-Orange Powder-Free Nitrile Exam Glove Halyard Health | LZA |
| Jun 18, 2015 | K150113 | Fusion Black Powder-Free Nitrile Exam Glove Halyard Health | LZA |
| Mar 24, 2015 | K143287 | Fluidshield* Surgical Mask with Expanded Chamber Halyard Health, Inc. | FXX |
| Mar 24, 2015 | K143095 | MiniStim MS-IVB Peripheral Nerve Stimulator Halyard Health, Inc. | BXN |
| Dec 18, 2014 | K141712 | KIMGUARD ONE STEP STERILIZATION WRAP Halyard Health | FRG |
Latest recalls
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Feb 7, 2018 | Halyard Health, Inc Halyard Closed Suction System for Adults, Multi-AccessPortClosedSuctionSystemforAdults. Used to aspirate liquids or semisolids from a patient's upper airway.
a. HALYARD* MULTI-PORT, DSY, ENDO 10FR Terminated |
BSY | None listed |
| Feb 7, 2018 | Halyard Health, Inc Halyard Closed Suction System for Adults, Turbo- cleaningClosedSuctionSystemforAdults,DoubleSwivelElbow (DSE). Used to aspirate liquids or semisolids from a patient's upper airway.
a. HALYARD* TUR Terminated |
BSY | None listed |
| Feb 7, 2018 | Halyard Health, Inc Halyard Closed Suction System for Adults, Double Swivel Elbow (DSE). Used to aspirate liquids or semisolids from a patient's upper airway. Labeled as the following:
a. HALYARD* 12FR DSE 21.3IN/54CM Terminated |
BSY | None listed |
| Dec 13, 2017 | Halyard Health, Inc CORTRAK* 2 Nasogastric/Nasointestinal (NG/NI) Feeding Tubes with Electromagnetic Transmitting Stylet and CORFLO* Enteral Feeding tube, ANTI-IV* Connector, 10 Fr, 140 cm
The device is used in patients Terminated |
FPB | K083210 |
| Nov 18, 2017 | Halyard Health, Inc NOVAPLUS* Endotracheal WET PAK* Closed Suction System for Adults with BALLARD* Technology, Double Swivel Elbow, 14 F. 6 vials per kit, 20 kits per case. Terminated |
BSY | None listed |
| Nov 18, 2017 | Halyard Health, Inc Halyard Closed Suction System for Adults, 14 F, T-Piece, MDI, Wet Pak. 12 vials per kit, 20 kits per case. Terminated |
BSY | None listed |
| Nov 18, 2017 | Halyard Health, Inc Halyard Turbo-Cleaning Closed Suction System for Adults, 14 F, DSE, MDI, Wet Pak. 12 vials per kit, 20 kits per case. Terminated |
BSY | None listed |
| Nov 18, 2017 | Halyard Health, Inc Halyard Closed Suction System for Adults, 14 F, T-Piece, Wet Pak. 12 or 6 vials per kit, 20 kits per case. Terminated |
BSY | None listed |
| Nov 18, 2017 | Halyard Health, Inc Halyard Turbo-Cleaning Closed Suction System for Adults, 14 F, T-Piece, Wet Pak. 12 vials per kit, 20 kits per case. Terminated |
BSY | None listed |
| Nov 18, 2017 | Halyard Health, Inc Halyard Closed Suction System for Adults, 14 F, Elbow, Directional Tip, Wet Pak. 12 vials per kit, 20 kits per case. Terminated |
BSY | None listed |
| Nov 18, 2017 | Halyard Health, Inc Halyard Closed Suction System for Adults, 14 F, DSE, Wet Pak. 12 or 6 vials per kit, 20 kits per case. Terminated |
BSY | None listed |
| Nov 18, 2017 | Halyard Health, Inc Halyard Turbo-Cleaning Closed Suction System for Adults, 14 F, DSE, Wet Pak. 12 saline vials per kit, 20 kits per case. Terminated |
BSY | None listed |
| Nov 18, 2017 | Halyard Health, Inc Halyard Closed Suction System for Adults with BALLARD Technology WET PAK. 12 saline vials per kit, 20 kits per case. Terminated |
BSY | None listed |
| Dec 14, 2016 | Halyard Health Sterling Nitrile Sterile Powder Free Exam Gloves, S, Sterile. Terminated |
LZA | K081027 |
| Dec 8, 2016 | Halyard Health, Inc Halyard C-Section Drape with Clear Screen and Full Incise (Non-Sterile), Product Code 44965 NS; C-Section Drape with Clear Screen and Full Incise (Sterile), Product Code 44966 00; C-Section Drape with Terminated |
KKX | K862801 |
| Jun 16, 2016 | Halyard Health, Inc Coolife Sinergy Radiofrequency Kit, SIK-17-75-4 (109971504); Kit used in conjunction with a Radiofrequency Generator to create radiofrequency lesions in nervous tissue. Terminated |
GXI | K053082 |
| Aug 31, 2015 | Halyard Health, Inc KimVent* Wet Pak* Closed Suction System for Pediatrics, 10 F, Y Adapter (Product Code 8281)
A tracheobronchial suction catheter is a device that is attached to a port of the airway circuit for use as Terminated |
BSY | None listed |
| Aug 31, 2015 | Halyard Health, Inc KimVent* Closed Suction System for Neonates/Pediatrics, 6 F, Elbow (Product Code 206); KimVent* Closed Suction System for Neonates/Pediatrics, 8 F, Elbow (Product Code 208); KimVent* Closed Suction Sy Terminated |
BSY | None listed |
| Aug 31, 2015 | Halyard Health, Inc KimVent* Closed Suction System for Neonates/Pediatrics, 5 F, Manifold (Product Code 201)
A tracheobronchial suction catheter is a device that is attached to a port of the airway circuit for use as nee Terminated |
BSY | None listed |
| Aug 31, 2015 | Halyard Health, Inc KimVent* Closed Suction System for Neonates/Pediatrics, 5 F, Y-Adapter (Product Code 195); KimVent* Closed Suction System for Neonates/Pediatrics, 6 F, Y-Adapter (Product Code 196); KimVent* Closed Su Terminated |
BSY | None listed |
| Aug 31, 2015 | Halyard Health, Inc KimVent* Multi-Access Port Replacement Catheter for Adults, Endotracheal,16 F (Product Code 240165-5)
A tracheobronchial suction catheter is a device that is attached to a port of the airway circuit Terminated |
BSY | None listed |
| Aug 31, 2015 | Halyard Health, Inc KimVent* Multi-Access Port Closed Suction System for Adults,Tracheostomy, DSY, MDI, 14 F (Product Code 240438-5)
A tracheobronchial suction catheter is a device that is attached to a port of the airwa Terminated |
BSY | None listed |
| Aug 31, 2015 | Halyard Health, Inc KimVent* Multi-Access Port Replacement Catheter for Adults,Tracheostomy, 14 F (Product Code 2401453-5)
A tracheobronchial suction catheter is a device that is attached to a port of the airway circuit Terminated |
BSY | None listed |
| Aug 31, 2015 | Halyard Health, Inc KimVent* Multi-Access Port Closed Suction System for Adults, Endotracheal, DSY, 14 F (Product Code 24014-5)
A tracheobronchial suction catheter is a device that is attached to a port of the airway cir Terminated |
BSY | None listed |
| Aug 31, 2015 | Halyard Health, Inc KimVent* Turbo-Cleaning Closed Suction System for Adults, 14 F, DSE, MDI (Product Code 2271418)
A tracheobronchial suction catheter is a device that is attached to a port of the airway circuit for use Terminated |
BSY | None listed |
| Aug 31, 2015 | Halyard Health, Inc KimVent* Turbo-Cleaning Closed Suction System for Adults, 14 F, T-Piece (Product Code 22705); KimVent* Turbo-Cleaning Closed Suction System for Adults, 14 F, T-Piece (Product Code 2270135)
A tracheob Terminated |
BSY | None listed |
| Aug 31, 2015 | Halyard Health, Inc KimVent* Closed Suction Systems for Adults, 14 F, Qwik Clip (Product Code 2273)
A tracheobronchial suction catheter is a device that is attached to a port of the airway circuit for use as needed to as Terminated |
BSY | None listed |
| Aug 31, 2015 | Halyard Health, Inc KimVent* Turbo-Cleaning Closed Suction System for Adults, 14 F, DSE (Product Code 227); KimVent* Turbo-Cleaning Closed Suction System for Adults, 14 F, DSE (Product Code 22703); KimVent* Turbo-Cleanin Terminated |
BSY | None listed |
| Aug 31, 2015 | Halyard Health, Inc NovaPlus Trach Care* Closed Suction System for Adults, Double Swivel Elbow, 14F (Product Code 2V2210)
A tracheobronchial suction catheter is a device that is attached to a port of the airway circuit f Terminated |
BSY | None listed |
| Aug 31, 2015 | Halyard Health, Inc NovaPlus Trach Care* Closed Suction System for Adults, Double Swivel Elbow, Directional Tip, 14F (Product Code 2V22109)
A tracheobronchial suction catheter is a device that is attached to a port of th Terminated |
BSY | None listed |
| Aug 31, 2015 | Halyard Health, Inc KimVent* Closed Suction System for Adults, 14 F, DSE, DT (Product Code 22109)
A tracheobronchial suction catheter is a device that is attached to a port of the airway circuit for use as needed to aspi Terminated |
BSY | None listed |
| Aug 31, 2015 | Halyard Health, Inc KimVent* Closed Suction System for Adults, 14 F, DSE, MDI (Product Code 22108); KimVent* Closed Suction System for Adults, 14 F, DSE, MDI (Product Code 221038)
A tracheobronchial suction catheter is a Terminated |
BSY | None listed |
| Aug 31, 2015 | Halyard Health, Inc KimVent* Wet Pak* Closed Suction System for Adults, 14 F, DSE, MDI (Product 8224); KimVent* Wet Pak* Closed Suction System for Adults, 14 F, DSE (Product Code 22106); KimVent* Closed Suction System fo Terminated |
BSY | None listed |
| Aug 31, 2015 | Halyard Health, Inc KimVent* Closed Suction System for Adults, 14 F, DSE (Product Code 2210); KimVent* Closed Suction System for Adults, 12 F, DSE (Product 21603); KimVent* Closed Suction System for Adults, 14 F, DSE (Pr Terminated |
BSY | None listed |
| Aug 31, 2015 | Halyard Health, Inc KimVent* Wet Pak* Closed Suction System for Adults, 14 F, Elbow (Product Code 2276); KimVent* Wet Pak* Closed Suction System for Adults, 14 F, Elbow (Product Code 22169)
A tracheobronchial suction cat Terminated |
BSY | None listed |
| Aug 31, 2015 | Halyard Health, Inc KimVent* Closed Suction System for Adults, 14 F, Elbow, D-Tip (Product Code 2219)
A tracheobronchial suction catheter is a device that is attached to a port of the airway circuit for use as needed to Terminated |
BSY | None listed |
| Aug 31, 2015 | Halyard Health, Inc KimVent* Closed Suction System for Adults, 12 F, Elbow (Product Code 216); KimVent* Closed Suction KimVent* Closed Suction System for Adults, 14 F, Elbow (Product Code 221); KimVent* Closed Suction S Terminated |
BSY | None listed |
| Aug 31, 2015 | Halyard Health, Inc NovaPlus Trach Care* Closed Suction System for Adults, T-Piece, Directional Tip, 14F (Product Code 2V22059)
A tracheobronchial suction catheter is a device that is attached to a port of the airway cir Terminated |
BSY | None listed |
| Aug 31, 2015 | Halyard Health, Inc NovaPlus Trach Care* Closed Suction System for Adults, Clear T-Piece MDI Adapter, 14F (Product Code 2V220158)
A tracheobronchial suction catheter is a device that is attached to a port of the airway Terminated |
BSY | None listed |
| Aug 31, 2015 | Halyard Health, Inc NovaPlus Trach Care* Closed Suction System for Adults, T-Piece, 14F (Product Code 2V220135); NovaPlus Trach Care* Closed Suction System for Adults, Clear T-Piece, 14F (Product Code 2V2205)
A tracheobr Terminated |
BSY | None listed |
| Aug 31, 2015 | Halyard Health, Inc KimVent* Closed Suction System for Adults, 14 F, MDI, T-Piece, 12 in Tracheostomy (Product Code 2201358); KimVent* Closed Suction System for Adults, 14 F, MDI, T-Piece (Produce Code 2201258)
A tracheo Terminated |
BSY | None listed |
| Aug 31, 2015 | Halyard Health, Inc KimVent* Turbo-Cleaning Closed Suction System for Adults, 10 F, T-Piece (Product Code 227105)
A tracheobronchial suction catheter is a device that is attached to a port of the airway circuit for use a Terminated |
BSY | None listed |
| Aug 31, 2015 | Halyard Health, Inc KimVent* Closed Suction System for Adults, 12 F, T-Piece,12 in Tracheostomy (Product Code 215135); KimVent* Closed Suction System for Adults, 12 F, T-Piece, 12 in Trach (Product Code 21513511)
A trac Terminated |
BSY | None listed |
| Aug 31, 2015 | Halyard Health, Inc KimVent* Closed Suction System for Adults, 14 F, D-Tip, T-Piece (Product Code 22059); KimVent* Closed Suction System for Adults, 14 F, T-Piece, Directional Tip (Product Code 8155)
A tracheobronchial s Terminated |
BSY | None listed |
| Aug 31, 2015 | Halyard Health, Inc KimVent* Wet Pak* Closed Suction System for Adults, 14 F, T-Piece (Product Code 22056); KimVent* Wet Pak* Closed Suction System for Adults, 16 F, T-Piece (Product Code 22556); KimVent* Wet Pak* Closed Terminated |
BSY | None listed |
| Aug 31, 2015 | Halyard Health, Inc KimVent* Wet Pak* Closed Suction System for Adults, 14 F, DT, T-Piece (Product Code 220569)
A tracheobronchial suction catheter is a device that is attached to a port of the airway circuit for use as Terminated |
BSY | None listed |
| Aug 31, 2015 | Halyard Health, Inc KimVent* Closed Suction System for Adults, 14 F, T-Piece, MDI (Product Code 8308)
A tracheobronchial suction catheter is a device that is attached to a port of the airway circuit for use as needed to Terminated |
BSY | None listed |
| Aug 31, 2015 | Halyard Health, Inc KimVent* Closed Suction System for Adults, 12 F, T-Piece (Product Code 2155); KimVent* Closed Suction System for Adults, 14 F, T-Piece (Product Code 2205, 8169, 8248, 22015, 22025, 220125, 220135)
Terminated |
BSY | None listed |
| May 26, 2015 | Halyard Health, Inc KimVent Turbo-Cleaning Closed Suction System for Adults, 10 F T-Piece (Product Code 227105); KimVent Turbo-Cleaning Closed Suction System for Adults, 12 F, DSE (Product Code 2271603); KimVent Turbo-Cl Terminated |
BSY | None listed |
| Feb 27, 2015 | Halyard Health KimVent Wet Pak, Closed Suction System for Adults, Double Swivel Elbow, 14 Fr. Sterile, Distributed by Kimberly Clark Global Systems, LLC. Terminated |
BSY | None listed |
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