ClearanceBrief
Company ยท US

Stradis Healthcare, LLC.

FDA 510(k) clearances and medical device recalls filed under this name, 2016 to 2016. Name variants (Inc, Corp, punctuation) are merged.

1510(k) clearances (0 in 12 months)
71recalls (0 in 12 months)
4recalls that name a 510(k)

Product codes

CodeDeviceRecords
LROGeneral Surgery Tray51
LRSI.V. Start Kit4
OWLPeripheral Catheter Insertion Kit3
FMFSyringe, Piston2
FSMTray, Surgical, Instrument2
KPEContainer, I.V.2
OFFCentral Venous Catheter Tray2
LCJTissue Expander And Accessories1
MCZSuture Removal Kit1
OXQDressing Change Tray1
PKDLaceration Tray1
PPGUrinary Drainage Collection Kit1
PXCPersonal Protection Kit1

Latest 510(k) clearances

Decided510(k)Device and applicantCode
Oct 31, 2016K161483Unger Quad Injector
Stradis Healthcare
LCJ

Latest recalls

DateFirm and productCodeLinked 510(k)
Jan 11, 2023Stradis Healthcare
Vital Care Products NEONATAL PICC TRAY, Sterile, QTY 20. Manufactured for Vital Care Products, Inc.
Open, Classified
OWLNone listed
Jan 11, 2023Stradis Healthcare
Tacy Medical, Inc PORT ACCESS TRAY, Sterile, QTY 20. Manufactured for Tracy Medical, Inc.
Open, Classified
LRSNone listed
Jan 11, 2023Stradis Healthcare
Tacy Medical, Inc Syringe Convenience Pack, IML L/L, Sterile, 60 packs per bag, 5 bags per case. Manufactured for Tracy Medical, Inc.
Open, Classified
LRSNone listed
Jan 11, 2023Stradis Healthcare
Tacy Medical, Inc Fluid Filter Transfer Kit, Sterile, 60 kits per bag, 5 bags per case. Manufactured for Tracy Medical, Inc.
Open, Classified
LRSNone listed
Jan 11, 2023Stradis Healthcare
Stradis Healthcare TCTR Convenience Kit. Manufactured by Stradis Healthcare.
Open, Classified
FSMNone listed
Jan 11, 2023Stradis Healthcare
McCormick Medical Distribution PORT TRAY, 25 trays per case. Distributed by McCormick Medical Distribution.
Open, Classified
LRSNone listed
Jan 11, 2023Stradis Healthcare
Stradis Healthcare NEONATAL PICC Tray *PGBK* 20 trays per case. Manufactured by Stradis Healthcare, Distributed by Med Alliance Group
Open, Classified
OWLNone listed
Jan 11, 2023Stradis Healthcare
HCT MAX BARRIER PICC INSERTION TRAY 12 per case. Distributed by Health Care Technology
Open, Classified
OFFNone listed
Jan 11, 2023Stradis Healthcare
HCT CENTRAL LINE Insertion Tray, I2 per case. Distributed by Health Care Technology
Open, Classified
OFFNone listed
Jan 11, 2023Stradis Healthcare
HCT 6 CC SYRINGE KIT, 25/TRAY, 4 TRAYS/BAG, 5 BAGS/CASE. Distributed by Health Care Technology.
Open, Classified
FMFK102969
Jan 11, 2023Stradis Healthcare
HCT 12 CC SYRINGE KIT, 20/TRAY,5 TRAYS/BAG, 5 BAGS /CASE HCT. Distributed by Health Care Technology.
Open, Classified
FMFK102969
Jan 11, 2023Stradis Healthcare
HCT 50mL EVA BAGS, 2 Port, Sterile, Tripple Packaged, 20 EVA BAGS/Pack, 7 Packs PER CASE. Distributed by Health Care Technology.
Open, Classified
KPEK190328
Jan 11, 2023Stradis Healthcare
HCT 500mL BAGS, 2 Port, Sterile, Triple Packaged, 10 EVA BAGS/Pack, 7 Packs PER CASE. Distributed by Health Care Technology.
Open, Classified
KPEK190328
Jan 11, 2023Stradis Healthcare
PICC KIT, 10/CS, ACCESS MEDICAL LABEL
Open, Classified
OWLNone listed
Jan 11, 2023Stradis Healthcare
Henry Shein GLOVES, packaged in the following sizes and descriptions: a. Glove 6.5 Pack, 25 Pairs, 10 packs per case; b. Glove 7.0 Pack, 25 Pairs, 10 packs per case; c. Glove 7.5 Pack, 25 Pairs,
Open, Classified
PXCNone listed
Jan 11, 2023Stradis Healthcare
Henry Shein CYSTO SET UP PACK, 20 per case. Distributed by Henry Schein.
Open, Classified
FSMNone listed
Jan 11, 2023Stradis Healthcare
PHS Lacertaion Tray, Sterile, 20 per case, Manufactured for Professional Hosptial Supply, Inc.
Open, Classified
PKDNone listed
Jan 11, 2023Stradis Healthcare
Stradis Healthcare Foley Catheter Insertion Tray with preconnected bag and catheter, Sterile
Open, Classified
PPGNone listed
May 10, 2022Stradis Healthcare
VYGON DRESSING CHANGE W/MAXISWAB kit, REF AMS-8465CS
Open, Classified
OXQNone listed
Apr 22, 2022Stradis Healthcare
Surgical Suture Kit
Terminated
MCZNone listed
Jul 7, 2015Stradis Healthcare, LLC.
Upper Extremity Pack - contains Devon Light Glove Used during surgery
Completed
LRONone listed
Jul 7, 2015Stradis Healthcare, LLC.
Arthroscopy Pack - contains Devon Light Glove Used during surgery
Completed
LRONone listed
Jul 7, 2015Stradis Healthcare, LLC.
Orthopedic Split Drape Pack - contains Devon Light Glove Used during surgery
Completed
LRONone listed
Jul 7, 2015Stradis Healthcare, LLC.
DND Pack - contains Devon Light Glove Used during surgery
Completed
LRONone listed
Jul 7, 2015Stradis Healthcare, LLC.
Custom Pack - contains Devon Light Glove Used during surgery
Completed
LRONone listed
Jul 7, 2015Stradis Healthcare, LLC.
Blepharoplasty Pack - contains Devon Light Glove Used during surgery
Completed
LRONone listed
Jul 7, 2015Stradis Healthcare, LLC.
Set Up Pack - contains Devon Light Glove Used during surgery
Completed
LRONone listed
Jul 7, 2015Stradis Healthcare, LLC.
Face Lift Pack - contains Devon Light Glove Used during surgery
Completed
LRONone listed
Jul 7, 2015Stradis Healthcare, LLC.
Pediatric Pack - contains Devon Light Glove Used during surgery
Completed
LRONone listed
Jul 7, 2015Stradis Healthcare, LLC.
Open Pack - contains Devon Light Glove Used during surgery
Completed
LRONone listed
Jul 7, 2015Stradis Healthcare, LLC.
Cysto Pack - contains Devon Light Glove Used during surgery
Completed
LRONone listed
Jul 7, 2015Stradis Healthcare, LLC.
Neurosurgery Pack - contains Devon Light Glove Used during surgery
Completed
LRONone listed
Jul 7, 2015Stradis Healthcare, LLC.
Minor Pack and Minor Pack II Pack - contains Devon Light Glove Used during surgery
Completed
LRONone listed
Jul 7, 2015Stradis Healthcare, LLC.
Podiatry Pack - contains Devon Light Glove Used during surgery
Completed
LRONone listed
Jul 7, 2015Stradis Healthcare, LLC.
Hand Pack - contains Devon Light Glove Used during surgery
Completed
LRONone listed
Jul 7, 2015Stradis Healthcare, LLC.
ENT Pack - contains Devon Light Glove Used during surgery
Completed
LRONone listed
Jul 7, 2015Stradis Healthcare, LLC.
Knee Arthro Pack and Knee Arthro Pack II - contains Devon Light Glove Used during surgery
Completed
LRONone listed
Jul 7, 2015Stradis Healthcare, LLC.
Shoulder Pack - contains Devon Light Glove Used during surgery
Completed
LRONone listed
Jul 7, 2015Stradis Healthcare, LLC.
Glaucoma Pack - contains Devon Light Glove Used during surgery
Completed
LRONone listed
Jul 7, 2015Stradis Healthcare, LLC.
Eye Pack - contains Devon Light Glove Used during surgery
Completed
LRONone listed
Jul 7, 2015Stradis Healthcare, LLC.
Head & Neck Pack - contains Devon Light Glove Used during surgery
Completed
LRONone listed
Jul 7, 2015Stradis Healthcare, LLC.
Gyn Pack - contains Devon Light Glove Used during surgery
Completed
LRONone listed
Jul 7, 2015Stradis Healthcare, LLC.
Stradi 4500 - contains Devon Light Glove Used during surgery
Completed
LRONone listed
Jul 7, 2015Stradis Healthcare, LLC.
Abdominal Pack and Abdom Pack - contains Devon Light Glove Used during surgery
Completed
LRONone listed
Jul 7, 2015Stradis Healthcare, LLC.
Face Neck Pack - contains Devon Light Glove Used during surgery
Completed
LRONone listed
Jul 7, 2015Stradis Healthcare, LLC.
Bariatric Pack - contains Devon Light Glove Used during surgery
Completed
LRONone listed
Jul 7, 2015Stradis Healthcare, LLC.
Vasc Custom Kit - contains Devon Light Glove Used during surgery
Completed
LRONone listed
Jul 7, 2015Stradis Healthcare, LLC.
Skin and Vein Pack - contains Devon Light Glove Used during surgery
Completed
LRONone listed
Jul 7, 2015Stradis Healthcare, LLC.
Lima Pack - contains Devon Light Glove Used during surgery
Completed
LRONone listed
Jul 7, 2015Stradis Healthcare, LLC.
Hand Pack - contains Devon Light Glove Used during surgery
Completed
LRONone listed

Newest 50 of 71.

Get alerts for these product codes