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
| Code | Device | Records |
|---|---|---|
| LRO | General Surgery Tray | 51 |
| LRS | I.V. Start Kit | 4 |
| OWL | Peripheral Catheter Insertion Kit | 3 |
| FMF | Syringe, Piston | 2 |
| FSM | Tray, Surgical, Instrument | 2 |
| KPE | Container, I.V. | 2 |
| OFF | Central Venous Catheter Tray | 2 |
| LCJ | Tissue Expander And Accessories | 1 |
| MCZ | Suture Removal Kit | 1 |
| OXQ | Dressing Change Tray | 1 |
| PKD | Laceration Tray | 1 |
| PPG | Urinary Drainage Collection Kit | 1 |
| PXC | Personal Protection Kit | 1 |
Latest 510(k) clearances
Latest recalls
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Jan 11, 2023 | Stradis Healthcare Vital Care Products NEONATAL PICC TRAY, Sterile, QTY 20. Manufactured for Vital Care Products, Inc. Open, Classified |
OWL | None listed |
| Jan 11, 2023 | Stradis Healthcare Tacy Medical, Inc PORT ACCESS TRAY, Sterile, QTY 20. Manufactured for Tracy Medical, Inc. Open, Classified |
LRS | None listed |
| Jan 11, 2023 | Stradis 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 |
LRS | None listed |
| Jan 11, 2023 | Stradis Healthcare Tacy Medical, Inc Fluid Filter Transfer Kit, Sterile, 60 kits per bag, 5 bags per case. Manufactured for Tracy Medical, Inc. Open, Classified |
LRS | None listed |
| Jan 11, 2023 | Stradis Healthcare Stradis Healthcare TCTR Convenience Kit. Manufactured by Stradis Healthcare. Open, Classified |
FSM | None listed |
| Jan 11, 2023 | Stradis Healthcare McCormick Medical Distribution PORT TRAY, 25 trays per case. Distributed by McCormick Medical Distribution. Open, Classified |
LRS | None listed |
| Jan 11, 2023 | Stradis Healthcare Stradis Healthcare NEONATAL PICC Tray *PGBK* 20 trays per case. Manufactured by Stradis Healthcare, Distributed by Med Alliance Group Open, Classified |
OWL | None listed |
| Jan 11, 2023 | Stradis Healthcare HCT MAX BARRIER PICC INSERTION TRAY 12 per case. Distributed by Health Care Technology Open, Classified |
OFF | None listed |
| Jan 11, 2023 | Stradis Healthcare HCT CENTRAL LINE Insertion Tray, I2 per case. Distributed by Health Care Technology Open, Classified |
OFF | None listed |
| Jan 11, 2023 | Stradis Healthcare HCT 6 CC SYRINGE KIT, 25/TRAY, 4 TRAYS/BAG, 5 BAGS/CASE. Distributed by Health Care Technology. Open, Classified |
FMF | K102969 |
| Jan 11, 2023 | Stradis Healthcare HCT 12 CC SYRINGE KIT, 20/TRAY,5 TRAYS/BAG, 5 BAGS /CASE HCT. Distributed by Health Care Technology. Open, Classified |
FMF | K102969 |
| Jan 11, 2023 | Stradis 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 |
KPE | K190328 |
| Jan 11, 2023 | Stradis Healthcare HCT 500mL BAGS, 2 Port, Sterile, Triple Packaged, 10 EVA BAGS/Pack, 7 Packs PER CASE. Distributed by Health Care Technology. Open, Classified |
KPE | K190328 |
| Jan 11, 2023 | Stradis Healthcare PICC KIT, 10/CS, ACCESS MEDICAL LABEL Open, Classified |
OWL | None listed |
| Jan 11, 2023 | Stradis 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 |
PXC | None listed |
| Jan 11, 2023 | Stradis Healthcare Henry Shein CYSTO SET UP PACK, 20 per case. Distributed by Henry Schein. Open, Classified |
FSM | None listed |
| Jan 11, 2023 | Stradis Healthcare PHS Lacertaion Tray, Sterile, 20 per case, Manufactured for Professional Hosptial Supply, Inc. Open, Classified |
PKD | None listed |
| Jan 11, 2023 | Stradis Healthcare Stradis Healthcare Foley Catheter Insertion Tray with preconnected bag and catheter, Sterile Open, Classified |
PPG | None listed |
| May 10, 2022 | Stradis Healthcare VYGON DRESSING CHANGE W/MAXISWAB kit, REF AMS-8465CS Open, Classified |
OXQ | None listed |
| Apr 22, 2022 | Stradis Healthcare Surgical Suture Kit Terminated |
MCZ | None listed |
| Jul 7, 2015 | Stradis Healthcare, LLC. Upper Extremity Pack - contains Devon Light Glove
Used during surgery Completed |
LRO | None listed |
| Jul 7, 2015 | Stradis Healthcare, LLC. Arthroscopy Pack - contains Devon Light Glove
Used during surgery Completed |
LRO | None listed |
| Jul 7, 2015 | Stradis Healthcare, LLC. Orthopedic Split Drape Pack - contains Devon Light Glove
Used during surgery Completed |
LRO | None listed |
| Jul 7, 2015 | Stradis Healthcare, LLC. DND Pack - contains Devon Light Glove
Used during surgery Completed |
LRO | None listed |
| Jul 7, 2015 | Stradis Healthcare, LLC. Custom Pack - contains Devon Light Glove
Used during surgery Completed |
LRO | None listed |
| Jul 7, 2015 | Stradis Healthcare, LLC. Blepharoplasty Pack - contains Devon Light Glove
Used during surgery Completed |
LRO | None listed |
| Jul 7, 2015 | Stradis Healthcare, LLC. Set Up Pack - contains Devon Light Glove
Used during surgery Completed |
LRO | None listed |
| Jul 7, 2015 | Stradis Healthcare, LLC. Face Lift Pack - contains Devon Light Glove
Used during surgery Completed |
LRO | None listed |
| Jul 7, 2015 | Stradis Healthcare, LLC. Pediatric Pack - contains Devon Light Glove
Used during surgery Completed |
LRO | None listed |
| Jul 7, 2015 | Stradis Healthcare, LLC. Open Pack - contains Devon Light Glove
Used during surgery Completed |
LRO | None listed |
| Jul 7, 2015 | Stradis Healthcare, LLC. Cysto Pack - contains Devon Light Glove
Used during surgery Completed |
LRO | None listed |
| Jul 7, 2015 | Stradis Healthcare, LLC. Neurosurgery Pack - contains Devon Light Glove
Used during surgery Completed |
LRO | None listed |
| Jul 7, 2015 | Stradis Healthcare, LLC. Minor Pack and Minor Pack II Pack - contains Devon Light Glove
Used during surgery Completed |
LRO | None listed |
| Jul 7, 2015 | Stradis Healthcare, LLC. Podiatry Pack - contains Devon Light Glove
Used during surgery Completed |
LRO | None listed |
| Jul 7, 2015 | Stradis Healthcare, LLC. Hand Pack - contains Devon Light Glove
Used during surgery Completed |
LRO | None listed |
| Jul 7, 2015 | Stradis Healthcare, LLC. ENT Pack - contains Devon Light Glove
Used during surgery Completed |
LRO | None listed |
| Jul 7, 2015 | Stradis Healthcare, LLC. Knee Arthro Pack and Knee Arthro Pack II - contains Devon Light Glove
Used during surgery Completed |
LRO | None listed |
| Jul 7, 2015 | Stradis Healthcare, LLC. Shoulder Pack - contains Devon Light Glove
Used during surgery Completed |
LRO | None listed |
| Jul 7, 2015 | Stradis Healthcare, LLC. Glaucoma Pack - contains Devon Light Glove
Used during surgery Completed |
LRO | None listed |
| Jul 7, 2015 | Stradis Healthcare, LLC. Eye Pack - contains Devon Light Glove
Used during surgery Completed |
LRO | None listed |
| Jul 7, 2015 | Stradis Healthcare, LLC. Head & Neck Pack - contains Devon Light Glove
Used during surgery Completed |
LRO | None listed |
| Jul 7, 2015 | Stradis Healthcare, LLC. Gyn Pack - contains Devon Light Glove
Used during surgery Completed |
LRO | None listed |
| Jul 7, 2015 | Stradis Healthcare, LLC. Stradi 4500 - contains Devon Light Glove
Used during surgery Completed |
LRO | None listed |
| Jul 7, 2015 | Stradis Healthcare, LLC. Abdominal Pack and Abdom Pack - contains Devon Light Glove
Used during surgery Completed |
LRO | None listed |
| Jul 7, 2015 | Stradis Healthcare, LLC. Face Neck Pack - contains Devon Light Glove
Used during surgery Completed |
LRO | None listed |
| Jul 7, 2015 | Stradis Healthcare, LLC. Bariatric Pack - contains Devon Light Glove
Used during surgery Completed |
LRO | None listed |
| Jul 7, 2015 | Stradis Healthcare, LLC. Vasc Custom Kit - contains Devon Light Glove
Used during surgery Completed |
LRO | None listed |
| Jul 7, 2015 | Stradis Healthcare, LLC. Skin and Vein Pack - contains Devon Light Glove
Used during surgery Completed |
LRO | None listed |
| Jul 7, 2015 | Stradis Healthcare, LLC. Lima Pack - contains Devon Light Glove
Used during surgery Completed |
LRO | None listed |
| Jul 7, 2015 | Stradis Healthcare, LLC. Hand Pack - contains Devon Light Glove
Used during surgery Completed |
LRO | None listed |
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