Company
Stradis Medical, LLC dba Stradis Healthcare
FDA 510(k) clearances and medical device recalls filed under this name. Name variants (Inc, Corp, punctuation) are merged.
0510(k) clearances (0 in 12 months)
93recalls (0 in 12 months)
7recalls that name a 510(k)
Product codes
| Code | Device | Records |
|---|---|---|
| OEZ | Cardiovascular Procedure Kit | 18 |
| LRO | General Surgery Tray | 16 |
| PWL | Oral Surgery Tray | 15 |
| FTN | Plastic Surgery And Accessories Kit | 6 |
| HDC | Tenaculum, Uterine | 6 |
| OJH | Orthopedic Tray | 6 |
| OEQ | Angiography/Angioplasty Kit | 4 |
| HTD | Forceps | 2 |
| OFX | General Purpose Dental Tray | 2 |
| PXO | Bone Marrow Biopsy Tray | 2 |
| EHZ | Evacuator, Oral Cavity | 1 |
| EIC | Syringe, Periodontic, Endodontic, Irrigating | 1 |
| FPA | Set, Administration, Intravascular | 1 |
| HIO | Sampler, Amniotic Fluid (Amniocentesis Tray) | 1 |
| HOZ | Sponge, Ophthalmic | 1 |
| KXG | Applicator, Absorbent Tipped, Sterile | 1 |
| LRW | Scissors, General, Surgical | 1 |
| NYD | Endodontic Kit | 1 |
| OFL | Percutaneous Sheath Introducer Kit | 1 |
| OFQ | Anesthesia Kit | 1 |
Latest 510(k) clearances
| Decided | 510(k) | Device and applicant | Code |
|---|---|---|---|
| No clearances in this window. | |||
Latest recalls
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Dec 14, 2022 | Stradis Medical, LLC dba Stradis Healthcare STRADIS HEALTHCARE, TIP, SURGE-O-VAC .125" GREEN, Item No.SS077225, Open, Classified |
EHZ | None listed |
| Dec 14, 2022 | Stradis Medical, LLC dba Stradis Healthcare HENRY SCHEIN, Vas Reversal Pack, Item No.888-2549, Open, Classified |
PVY | None listed |
| Dec 14, 2022 | Stradis Medical, LLC dba Stradis Healthcare HENRY SCHEIN, Vas Pack, Item No.888-2520, Open, Classified |
LRO | None listed |
| Dec 14, 2022 | Stradis Medical, LLC dba Stradis Healthcare STRADIS HEALTHCARE, Breast, Item No.693-276, Open, Classified |
FTN | None listed |
| Dec 14, 2022 | Stradis Medical, LLC dba Stradis Healthcare STRADIS HEALTHCARE, Angio Pack, Item No.686-199, Open, Classified |
OEQ | None listed |
| Dec 14, 2022 | Stradis Medical, LLC dba Stradis Healthcare STRADIS HEALTHCARE, Femoral, Vasc, Item No.686-142, Open, Classified |
OEQ | None listed |
| Dec 14, 2022 | Stradis Medical, LLC dba Stradis Healthcare STRADIS HEALTHCARE, Varicosity Basic Pack, Item No.682-947, Open, Classified |
OEZ | None listed |
| Dec 14, 2022 | Stradis Medical, LLC dba Stradis Healthcare STRADIS HEALTHCARE, Vein, Item No.682-577, Open, Classified |
OEZ | None listed |
| Dec 14, 2022 | Stradis Medical, LLC dba Stradis Healthcare STRADIS HEALTHCARE, Endo Pack, Item No.682-509, Open, Classified |
OEZ | None listed |
| Dec 14, 2022 | Stradis Medical, LLC dba Stradis Healthcare www.StradisHealthcare.com, Endovenous Pack, Item No.682-494, Open, Classified |
OEZ | None listed |
| Dec 14, 2022 | Stradis Medical, LLC dba Stradis Healthcare STRADIS HEALTHCARE, Vein & Laser, Item No.682-334R1, Open, Classified |
OEZ | None listed |
| Dec 14, 2022 | Stradis Medical, LLC dba Stradis Healthcare STRADIS HEALTHCARE, Medical Vein, Item No.682-330, Open, Classified |
OEZ | None listed |
| Dec 14, 2022 | Stradis Medical, LLC dba Stradis Healthcare STRADIS HEALTHCARE, VENOUS ACCESS PACK, Item No.682-1993R1, Open, Classified |
LRO | None listed |
| Dec 14, 2022 | Stradis Medical, LLC dba Stradis Healthcare STRADIS HEALTHCARE, Vein RF Pack, Item No.682-1942NL1, Open, Classified |
OEZ | None listed |
| Dec 14, 2022 | Stradis Medical, LLC dba Stradis Healthcare STRADIS HEALTHCARE, Angioplasty, Item No.682-1937, Open, Classified |
OEQ | None listed |
| Dec 14, 2022 | Stradis Medical, LLC dba Stradis Healthcare STRADIS HEALTHCARE, Vein, Item No.682-1732, Open, Classified |
OEZ | None listed |
| Dec 14, 2022 | Stradis Medical, LLC dba Stradis Healthcare STRADIS HEALTHCARE, Surgery PK, Item No.682-1728, Open, Classified |
OEZ | None listed |
| Dec 14, 2022 | Stradis Medical, LLC dba Stradis Healthcare STRADIS HEALTHCARE, Vasc Vein, Item No.682-1583, Open, Classified |
OEZ | None listed |
| Dec 14, 2022 | Stradis Medical, LLC dba Stradis Healthcare STRADIS HEALTHCARE, Phleb, Item No.682-1425, Open, Classified |
OEZ | None listed |
| Dec 14, 2022 | Stradis Medical, LLC dba Stradis Healthcare STRADIS HEALTHCARE, Ablation Pack, Item No.682-130, Open, Classified |
OEZ | None listed |
| Dec 14, 2022 | Stradis Medical, LLC dba Stradis Healthcare STRADIS HEALTHCARE, Thoracic Phleb, Item No.682-1228, Open, Classified |
FTN | None listed |
| Dec 14, 2022 | Stradis Medical, LLC dba Stradis Healthcare STRADIS HEALTHCARE, Phlebectomy Pack, Item No.682-001, Open, Classified |
OEZ | None listed |
| Dec 14, 2022 | Stradis Medical, LLC dba Stradis Healthcare STRADIS HEALTHCARE, Lipo, Item No.681-254, Open, Classified |
FTN | None listed |
| Dec 14, 2022 | Stradis Medical, LLC dba Stradis Healthcare STRADIS HEALTHCARE, CURVED TIP SYRINGE, Item No.60060GCTS, Open, Classified |
EIC | None listed |
| Dec 14, 2022 | Stradis Medical, LLC dba Stradis Healthcare HENRY SCHEIN, ILR Insertion Tray, Item No.570-3131 Open, Classified |
OEZ | None listed |
| Dec 14, 2022 | Stradis Medical, LLC dba Stradis Healthcare HENRY SCHEIN, Labiaplasty PackItem No.570-3118, Open, Classified |
LRO | None listed |
| Dec 14, 2022 | Stradis Medical, LLC dba Stradis Healthcare HENRY SCHEIN, BONE MARROW KIT, Item No.570-3092 Open, Classified |
PXO | None listed |
| Dec 14, 2022 | Stradis Medical, LLC dba Stradis Healthcare HENRY SCHEIN, Blue Tail Custom Pack, Item No.570-3091, Open, Classified |
PXO | None listed |
| Dec 14, 2022 | Stradis Medical, LLC dba Stradis Healthcare HENRY SCHEIN, SINGLE SHOT EPIDURAL, Item No.570-3089 Open, Classified |
OGE | None listed |
| Dec 14, 2022 | Stradis Medical, LLC dba Stradis Healthcare HENRY SCHEIN, CUSTOM PK 2, Item No.570-3072 Open, Classified |
LRO | None listed |
| Dec 14, 2022 | Stradis Medical, LLC dba Stradis Healthcare HENRY SCHEIN, RHINO PACK, Item No.570-3070 Open, Classified |
FTN | None listed |
| Dec 14, 2022 | Stradis Medical, LLC dba Stradis Healthcare HENRY SCHEIN, Amnio Tray, Item No.570-3059, Open, Classified |
HIO | None listed |
| Dec 14, 2022 | Stradis Medical, LLC dba Stradis Healthcare HENRY SCHEIN, EXTREMITY PACK, Item No.570-2946 Open, Classified |
OJH | None listed |
| Dec 14, 2022 | Stradis Medical, LLC dba Stradis Healthcare HENRY SCHEIN, CATH ANGIO PACK, Item No.570-2930 Open, Classified |
OEQ | None listed |
| Dec 14, 2022 | Stradis Medical, LLC dba Stradis Healthcare HENRY SCHEIN, Knee Pack, Item No.570-2908, Open, Classified |
OJH | None listed |
| Dec 14, 2022 | Stradis Medical, LLC dba Stradis Healthcare HENRY SCHEIN, PROCEDURE TRAY, Item No.570-2900, Open, Classified |
LRO | None listed |
| Dec 14, 2022 | Stradis Medical, LLC dba Stradis Healthcare HENRY SCHEIN, LOOP RECORDER PACK, Item No.570-2891 Open, Classified |
OEZ | None listed |
| Dec 14, 2022 | Stradis Medical, LLC dba Stradis Healthcare HENRY SCHEIN, BASIC EXTENDED PACK, Item No.570-2890 Open, Classified |
LRO | None listed |
| Dec 14, 2022 | Stradis Medical, LLC dba Stradis Healthcare HENRY SCHEIN, TEMP STIMULATOR SUPPLIES, Item No.570-2883 Open, Classified |
LRO | None listed |
| Dec 14, 2022 | Stradis Medical, LLC dba Stradis Healthcare HENRY SCHEIN, PACEMAKER PACK IItem No.570-2793 Open, Classified |
LRO | None listed |
| Dec 14, 2022 | Stradis Medical, LLC dba Stradis Healthcare HENRY SCHEIN, CATH PACK Item No.570-2789 Open, Classified |
OEZ | None listed |
| Dec 14, 2022 | Stradis Medical, LLC dba Stradis Healthcare HENRY SCHEIN, UNIVERSAL TRAY, Item No.570-2787 Open, Classified |
LRO | None listed |
| Dec 14, 2022 | Stradis Medical, LLC dba Stradis Healthcare HENRY SCHEIN, MAJOR EXTREMITY PACK, Item No.570-2783, Open, Classified |
OJH | None listed |
| Dec 14, 2022 | Stradis Medical, LLC dba Stradis Healthcare HENRY SCHEIN, OMFS, Item No.570-2779, Open, Classified |
OFX | None listed |
| Dec 14, 2022 | Stradis Medical, LLC dba Stradis Healthcare HENRY SCHEIN, ENT SET UP PACK, Item No.570-2742 Open, Classified |
OGR | None listed |
| Dec 14, 2022 | Stradis Medical, LLC dba Stradis Healthcare HENRY SCHEIN, VEIN TRAY, Item No.570-2738, Open, Classified |
OEZ | None listed |
| Dec 14, 2022 | Stradis Medical, LLC dba Stradis Healthcare HENRY SCHEIN, BASIC PACK, Item No.570-2719, UDI/DI (case) H65857027191, UDI/DI (kit)M75257027190, Serial/Lot Numbers: 22242489505 Open, Classified |
LRO | None listed |
| Dec 14, 2022 | Stradis Medical, LLC dba Stradis Healthcare HENRY SCHEIN, ENT PACK, Item No.570-2718 Open, Classified |
PWL | None listed |
| Dec 14, 2022 | Stradis Medical, LLC dba Stradis Healthcare HENRY SCHEIN, GYN PACK, Item No.570-2625 Open, Classified |
PVX | None listed |
| Dec 14, 2022 | Stradis Medical, LLC dba Stradis Healthcare HENRY SCHEIN, BREAST PACK, Item No.570-2397 Open, Classified |
FTN | None listed |
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