Company · US
Amsino International, Inc.
FDA 510(k) clearances and medical device recalls filed under this name, 2002 to 2026. Name variants (Inc, Corp, punctuation) are merged.
28510(k) clearances (1 in 12 months)
0recalls (0 in 12 months)
0recalls that name a 510(k)
Product codes
| Code | Device | Records |
|---|---|---|
| EZL | Catheter, Retention Type, Balloon | 5 |
| FPA | Set, Administration, Intravascular | 5 |
| FCM | Tray, Catheterization, Sterile Urethral, With Or Without Catheter (Kit) | 3 |
| EZD | Catheter, Straight | 2 |
| LZH | Pump, Infusion, Enteral | 2 |
| NGT | Saline, Vascular Access Flush | 2 |
| BTR | Tube, Tracheal (W/Wo Connector) | 1 |
| CAF | Nebulizer (Direct Patient Interface) | 1 |
| EYB | Catheter, Ureteral, Gastro-Urology | 1 |
| FMF | Syringe, Piston | 1 |
| FRO | Dressing, Wound, Drug | 1 |
| LRO | General Surgery Tray | 1 |
| LRS | I.V. Start Kit | 1 |
| MCZ | Suture Removal Kit | 1 |
| PNR | Enteral Syringes With Enteral Specific Connectors | 1 |
Latest 510(k) clearances
| Decided | 510(k) | Device and applicant | Code |
|---|---|---|---|
| May 4, 2026 | K252543 | AMSafe Administration Set (BA-70075, BA-70071-D, BA-70070, BA-70071-P, BA-70072, BA-70072-F, BA-70071-DF, BA-70071-DF-12 Amsino International, Inc. | FPA |
| Nov 10, 2022 | K220230 | AMSure Enteral Feeding Pump Amsino International, Inc. | LZH |
| Oct 7, 2022 | K220267 | AMSafe NeuFlo Needleless Connector Amsino International, Inc. | FPA |
| Mar 22, 2022 | K213522 | AMSafe Pre-Filled Normal Saline Flush Syringe Amsino International, Inc. | NGT |
| Sep 25, 2020 | K200051 | PUGGLE Enteral Feeding Pump and Feeding Set Amsino International, Inc. | LZH |
| Jul 12, 2019 | K183473 | AMSafe(R) Pre-Filled Normal Saline Flush Syringe Amsino International, Inc. | NGT |
| Oct 1, 2018 | K181445 | AMSure Hydrophilic Intermittent Catheter Amsino International, Inc. | EZD |
| Sep 7, 2018 | K181423 | AMSure Sterile Water, and Sterile Normal Saline for Wound Flush Amsino International, Inc. | FRO |
| Sep 5, 2018 | K173665 | AMSafe Sure-Lok Needle-Free Connector Amsino International, Inc. | FPA |
| Sep 4, 2018 | K181814 | AMSure Pre-filled Syringe for Balloon Inflation with Sterile Water Amsino International, Inc. | EZL |
| Mar 30, 2018 | K171857 | AMSure® Enteral Feeding Syringe with ENFit Tip Amsino International, Inc. | PNR |
| Sep 29, 2010 | K101958 | AMSINO I.V. ADMINISTRATION AND EXTENSION SETS Amsino International, Inc. | FPA |
| Sep 13, 2010 | K101824 | AMSURE 3-WAY HYDROPHILIC LATEX FOLEY CATHETER Amsino International, Inc. | EZL |
| Mar 10, 2010 | K093773 | AMSINO I.V. ADMINISTRATION SET, AMSAFE3 I.V ADMINISTRATION SET, EXTENSION SETS Amsino International, Inc. | FPA |
| Aug 21, 2009 | K091306 | AMSURE PVC INTERMITTENT CATHETER Amsino International, Inc. | EZD |
| Aug 10, 2009 | K091699 | AMSURE HYDROPHILIC LATEX FOLEY CATHETER Amsino International, Inc. | EZL |
| Oct 23, 2008 | K082831 | AMSELF CLOSED CATHETERIZATION SYSTEM Amsino International, Inc. | FCM |
| Oct 1, 2007 | K070411 | AMSURE NEBULIZER Amsino International, Inc. | CAF |
| Jun 29, 2006 | K061039 | AMSURE DISPOSABLE SYRINGE WITH/WITHOUT NEEDLE Amsino International, Inc. | FMF |
| Jul 15, 2005 | K050785 | AMSINO ENDOTRACHEAL TUBE Amsino International, Inc. | BTR |
| Jun 28, 2005 | K051059 | AMSURE 100% SILICONE FOLEY CATHETER Amsino International, Inc. | EZL |
| May 2, 2005 | K050656 | AMSINO SUTURE REMOVAL KIT Amsino International, Inc. | MCZ |
| May 2, 2005 | K050654 | AMSINO I.V. START KIT Amsino International, Inc. | LRS |
| Feb 4, 2004 | K030293 | AMSURE RED RUBBER URETHRAL CATHETER Amsino International, Inc. | EYB |
| Oct 29, 2003 | K030120 | AMSURE FOLEY CATHETER Amsino International, Inc. | EZL |
| May 23, 2003 | K030712 | AMSURE URETHRAL CATHETERIZATION TRAY Amsino International, Inc. | FCM |
| May 23, 2003 | K030664 | AMSURE FOLEY INSERTION TRAY Amsino International, Inc. | FCM |
| Dec 9, 2002 | K023276 | AMSINO TRACHEOSTOMY CARE TRAY Amsino International, Inc. | LRO |
Latest recalls
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| No recalls in this window. | |||