Regard™ - REGARD TELEMETRY POUCH, CLEAR, CLIP, DISPOSABLE
2026-03-11
| Registration | FEI | Name | Status | Initial importer | Expiration year | Address |
|---|---|---|---|---|---|---|
| 3004513970 | 3004513970 | Resource Optimization & Innovation, LLC | 1 | Y | 2026-01-01 | 1100 Dr Martin L King Jr Blvd Ste 1100 Nashville TN US 37203 |
| Registration key | Listing key | Premarket submission | Device | Product code | Decision date |
|---|---|---|---|---|---|
| 90620 | 2023598163 | K982188 | STERI-PAK BOWIE DICK TEST PACK | JOJ | 1998-11-20 |
| 90620 | 1277702277 | K921997 | CUFF-M | DXQ | 1992-07-23 |
| 90620 | 1916325549 | K903590 | KEJUMP DIGITAL CLINICAL THERMOMETER | FLL | 1990-10-22 |
| 90620 | 1331523091 | K222128 | Protective Gown AAMI Level 4 | QPC | 2023-08-08 |
| 90620 | 1514058427 | K213001 | Procedure Mask, Surgical Mask | FXX | 2022-05-11 |
| 90620 | 1094911507 | K212504 | Isolation Gown AAMI Level 3 | FYC | 2021-11-07 |
| 90620 | 1987073863 | K192290 | 50g SMS Standard Surgical Gown, 45g SMS Surgical Gown with Reinforcement, 68g BVB Surgical Gown, 68g BVB Splicing Surgical Gown | FYA | 2020-04-30 |
| 90620 | 1850319527 | K181857 | Powder Free Nitrile Patient Examination Glove, Blue Colored, Non-Sterile, Low Dermatitis Potential. Tested for Use with Chemotherapy Drugs and Fentanyl Citrate | LZA | 2018-11-20 |
| 90620 | 1622566360 | K160271 | N95 Particulate Respirator and Surgical Mask, Models TN01-11 and TN01-12 | MSH | 2016-07-15 |
| 90620 | 1129014784 | K160269 | Surgical Face Masks (Ear loops and Tie-on) | FXX | 2016-09-06 |
| 90620 | 1075201750 | K141303 | ZHIDA NITRILE POWDER FREE PATIENT EXAMINATION GLOVES, BLUE COLOR | LZA | 2014-12-12 |
| 90620 | 1233556345 | K093169 | SURGIPLUS STANDARD SURGICAL GOWN (STERILE) ( NON STERILE), REINFORCED SURGICAL GOWN (STERILE) (NON STERILE) | FYA | 2009-11-12 |
| 90620 | 1630720440 | K080366 | DURACHECK BLOOD PRESSURE CUFF, MODEL ZDC4000 SERIES | DXQ | 2008-06-09 |
| 90620 | 1655257012 | K080189 | TEMPA-KUFF SOFT BLOOD PRESSURE CUFF, MODEL 39XXX ; VINYL,MODEL 99XXX | DXQ | 2008-08-15 |
| 90620 | 1194912572 | K063587 | XODUS MEDICAL ANTI-FOG SOLUTION | OCT | 2007-01-09 |
| 90620 | 1630254545 | K031353 | SOLUTION FACE MASKS | FXX | 2003-06-19 |
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