Company
Windstone Medical Packaging, Inc.
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)
337recalls (22 in 12 months)
1recalls that name a 510(k)
Product codes
| Code | Device | Records |
|---|---|---|
| FSY | Light, Surgical, Ceiling Mounted | 292 |
| KDD | Kit, Surgical Instrument, Disposable | 17 |
| LRO | General Surgery Tray | 12 |
| LRS | I.V. Start Kit | 3 |
| OGR | Ear, Nose, And Throat Surgical Tray | 3 |
| OJG | Neurological Tray | 2 |
| NGT | Saline, Vascular Access Flush | 1 |
| OEQ | Angiography/Angioplasty Kit | 1 |
| OES | Cardiac Catheterization Kit | 1 |
| OFT | Spinal Epidural Anesthesia Kit | 1 |
| OGE | Epidural Anesthesia Kit | 1 |
| OGJ | Nerve Block Tray | 1 |
| OJH | Orthopedic Tray | 1 |
| OKE | Port Introducer 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) |
|---|---|---|---|
| Sep 10, 2026 | Windstone Medical Packaging, Inc. AMS Convenience Kit:
DSAEK Pack - RX, Part Number AMS12394B Open, Classified |
KDD | None listed |
| Jul 27, 2026 | Windstone Medical Packaging, Inc. AMS ALIGNED MEDICAL SOLUTIONS medical convenience kits labeled as: Port Tray - RX, Part Number 008786-19 Open, Classified |
OKE | None listed |
| Jul 27, 2026 | Windstone Medical Packaging, Inc. AMS ALIGNED MEDICAL SOLUTIONS medical convenience kits labeled as:
1) Loop Recorder Pack 2 -RX, Part Number AMS10164;
2) NY Tray - RX, Part Number AMS10276A;
3) NYC Tray - RX, Part Number AMS10281 Open, Classified |
LRO | None listed |
| Jul 27, 2026 | Windstone Medical Packaging, Inc. AMS ALIGNED MEDICAL SOLUTIONS medical convenience kits labeled as: Block Tray - RX, Part Number AMS12414 Open, Classified |
OJG | None listed |
| Jul 27, 2026 | Windstone Medical Packaging, Inc. AMS ALIGNED MEDICAL SOLUTIONS medical convenience kits labeled as: Heart Cath Tray - RX, Part Number DDS1159B Open, Classified |
OES | None listed |
| Jul 27, 2026 | Windstone Medical Packaging, Inc. AMS ALIGNED MEDICAL SOLUTIONS medical convenience kits labeled as: Angio Pack - RX, Part Number AMS9461 Open, Classified |
OEQ | None listed |
| Jul 27, 2026 | Windstone Medical Packaging, Inc. AMS ALIGNED MEDICAL SOLUTIONS medical convenience kits labeled as:
1) Nerve Block Tray - RX, Part Number AMS13975A;
2) Universal Block Tray- RX, Part Number AMS2009;
3) Nerve Block Tray - RX, Part Open, Classified |
OGJ | None listed |
| Jul 27, 2026 | Windstone Medical Packaging, Inc. AMS ALIGNED MEDICAL SOLUTIONS medical convenience kits labeled as:
1) Dr Fred Chiu Single Shot Epi Tray - Rx, Part Number AMS1095(E ;
2) Single Shot Epidural Tray - RX, Part Number AMS11296A;
3) N Open, Classified |
OGE | None listed |
| Jul 27, 2026 | Windstone Medical Packaging, Inc. AMS ALIGNED MEDICAL SOLUTIONS medical convenience kits labeled as: SPINAL KIT, Part Number AMS13683A Open, Classified |
OFT | None listed |
| Jul 24, 2026 | Windstone Medical Packaging, Inc. AMS ALIGNED MEDICAL SOLUTIONS medical convenience kits labeled as:
1) Laminectomy Pack, Pack Number AMS13574A;
2) ACDF/Fusion Pack, Pack Number AMS14710B;
3) Spine Pack, Pack Number AMS14991A;
4) Open, Classified |
OJH | None listed |
| Jul 24, 2026 | Windstone Medical Packaging, Inc. AMS ALIGNED MEDICAL SOLUTIONS medical convenience kits labeled as:
1) Neuro Pack, Pack Number AMS12195C;
2) Neuro Pack, Pack Number AMS12195D;
3) Neuro Pack, Pack Number AMS12307;
4) Neuro Spine Open, Classified |
OJG | None listed |
| Jul 24, 2026 | Windstone Medical Packaging, Inc. AMS ALIGNED MEDICAL SOLUTIONS medical convenience kits labeled as:
1) ENT Pack, Pack Number AMS12206;
2) ENT Pack, Pack Number AMS15517;
3) ENT Facial Pack, Pack Number AMS15863A. Open, Classified |
OGR | None listed |
| Jul 24, 2026 | Windstone Medical Packaging, Inc. AMS ALIGNED MEDICAL SOLUTIONS medical convenience kits labeled as:
1) ENT Pack, Part Number AMS10411B;
2) ENT Pack, Part Number AMS10411C;
3) Rhinoplasty Pack, Part Number AMS11963A;
4) Spine Pac Open, Classified |
LRO | None listed |
| Jul 1, 2026 | Windstone Medical Packaging, Inc. A M S, ALIGNED MEDICAL SOLUTIONS, Dr. Lewin Pack, Pack Number AMS7200D, surgical convenience kit Open, Classified |
LRO | None listed |
| Jul 1, 2026 | Windstone Medical Packaging, Inc. A M S, ALIGNED MEDICAL SOLUTIONS, Preop Kit-NS, Pack Number AMS18227, surgical convenience kit Open, Classified |
LRO | None listed |
| Jul 1, 2026 | Windstone Medical Packaging, Inc. A M S, ALIGNED MEDICAL SOLUTIONS, Thyroid FNA Pack-RX, Pack Number AMS17729, surgical convenience kit Open, Classified |
OGR | None listed |
| Jul 1, 2026 | Windstone Medical Packaging, Inc. A M S, ALIGNED MEDICAL SOLUTIONS, DSAEK Pack-RX, Pack Number AMS12394B, surgical convenience kit Open, Classified |
LRO | None listed |
| Jun 3, 2026 | Windstone Medical Packaging, Inc. Aligned Medical AMS16835 Fluids Kit RX Open, Classified |
LRO | None listed |
| May 8, 2026 | Windstone Medical Packaging, Inc. Custom Convenience Kit containing recalled Medline Namic Angiographic Control Syringes with Rotating Adapter (Namic RA Syringes)
Angio Pack
Part numbers AMS6908E, AMS6908F Open, Classified |
LRO | None listed |
| Apr 22, 2026 | Windstone Medical Packaging, Inc. Custom Convenience Kits Pre Op Kit - NS, Part Number AMS14994A Open, Classified |
KDD | None listed |
| Apr 22, 2026 | Windstone Medical Packaging, Inc. Custom Convenience Kits Pre Op Kit - NS, Part Number AMS14994 Open, Classified |
KDD | None listed |
| Apr 22, 2026 | Windstone Medical Packaging, Inc. Custom Convenience Kits Pre Op Kit - NS, Part Number AMS14433 Open, Classified |
KDD | None listed |
| Oct 8, 2024 | Windstone Medical Packaging, Inc. Aligned Medical Tonsil Pack REF AMS14809 that contains the Cardinal Health Salem Sump PVC tubes.
Product packaged in a convenient manner for use in a general clinical procedure. Open, Classified |
LRO | None listed |
| Oct 8, 2024 | Windstone Medical Packaging, Inc. Aligned Medical T and A Pack REF AMS11482 that contains the Cardinal Health Salem Sump PVC tubes.
Product packaged in a convenient manner for use in a general clinical procedure. Open, Classified |
LRO | None listed |
| Oct 8, 2024 | Windstone Medical Packaging, Inc. Aligned Medical Septo Pack REF AMS11480 that contains the Cardinal Health Salem Sump PVC tubes.
Product packaged in a convenient manner for use in a general clinical procedure. Open, Classified |
OGR | None listed |
| Oct 8, 2024 | Windstone Medical Packaging, Inc. Aligned Medical Tonsil ENT Pack REF AMS9977 that contains the Cardinal Health Salem Sump PVC tubes.
Product packaged in a convenient manner for use in a general clinical procedure. Open, Classified |
LRO | None listed |
| Oct 8, 2024 | Windstone Medical Packaging, Inc. Aligned Medical Tonsil Tray REF AMS9300A that contains the Cardinal Health Salem Sump PVC tubes.
Product packaged in a convenient manner for use in a general clinical procedure. Open, Classified |
LRO | None listed |
| Feb 16, 2024 | Windstone Medical Packaging, Inc. Aligned Medical Solutions, Closure Kit, AMS13043, STERILEEO Open, Classified |
KDD | None listed |
| Feb 16, 2024 | Windstone Medical Packaging, Inc. Aligned Medical Solutions, In House Ocular Pack, AMS12947, STERILEEO Open, Classified |
KDD | None listed |
| Feb 16, 2024 | Windstone Medical Packaging, Inc. Aligned Medical Solutions, In House Ocular Pack, AMS12947A STERILEEO Open, Classified |
KDD | None listed |
| Feb 16, 2024 | Windstone Medical Packaging, Inc. Aligned Medical Solutions, Local Lower Extremity Pack I, AMS10833, STERILEEO Open, Classified |
KDD | None listed |
| May 23, 2023 | Windstone Medical Packaging, Inc. Aligned Medical Solutions Hand Pack, REF: AmS4601E, containing P 2 Cover Light Handle Blue STE, Sterile EO Open, Classified |
KDD | None listed |
| May 23, 2023 | Windstone Medical Packaging, Inc. Aligned Medical Solutions Minor Hand Pack, REF: AMS6539E, containing P 2 Cover Light Handle Blue STE, Sterile EO Open, Classified |
KDD | None listed |
| May 23, 2023 | Windstone Medical Packaging, Inc. Aligned Medical Solutions Spine Pack, REF: AMS4599(C, containing P 2 Cover Light Handle Blue STE, Sterile EO Open, Classified |
KDD | None listed |
| Jan 4, 2023 | Windstone Medical Packaging, Inc. Various Custom Surgical Instrument Disposable Kits:
Part Numbers / Product Description
26000004M Custom Lasik Kit
AMS10411A Nasal Endoscopy Pack
AMS10710A Ultrasound Tray w/PDI
AMS11941 Total Knee Pac Open, Classified |
KDD | None listed |
| Mar 21, 2022 | Windstone Medical Packaging, Inc. Prevantics swabs and/or swabsticks contained inside the following Aligned Medical Solutions convenience kits with Name/Pack numbers:
Ports Cath Pack (1794)/AMS6569,
Minor Procedure Pack (20527)/AMS65 Open, Classified |
KDD | None listed |
| Aug 19, 2021 | Windstone Medical Packaging, Inc. Monoject 0.9% Sodium Chloride, Flush Prefilled Syringe, 10 mL, REF: 8881570121 inside the following
Aligned Medical Solutions Custom Convenience Kits:
AMS-9041CP Leaderflex Insertion Kit with Ultras Open, Classified |
NGT | K032438 |
| Apr 8, 2021 | Windstone Medical Packaging, Inc. Angio Pack REF: AMS8050A, Sterile EO, Contents:2 Glove Dermassist 7.5 PF PR S
1 Bowl Fluid Containment W/LI
1 Cover Probe 6 X 48 NS
2 Gown surgical STD XLG NR
1 Needle RB 18x1.5
1 Spike Bag Decanter
Terminated |
KDD | None listed |
| Apr 8, 2021 | Windstone Medical Packaging, Inc. Angio Pack REF: AMS6908C, Sterile EO, Contents:1 Blade Scalpel # 11 SS
1 Bowl Guidewire 80 oz
4 Clamp Towel 2.5
1 Cover Probe 6X48 NS
2 Gown Surgical STD XLG NR
16 Label Custom
1 Counter Needle Nest
Terminated |
KDD | None listed |
| Oct 24, 2017 | Windstone Medical Packaging, Inc. AMS, ALIGNED MEDICAL SOLUTIONS, T&A Pack, AMS6357, STERILE EO. Terminated |
LRO | None listed |
| Apr 11, 2017 | Windstone Medical Packaging, Inc. Vitrectomy Pack, part number AMS4952
Product packaged in a convenient manner for use in a general clinical procedure Terminated |
FSY | None listed |
| Apr 11, 2017 | Windstone Medical Packaging, Inc. Vitrectomy Kit, part number CMP1016(A.
Product packaged in a convenient manner for use in a general clinical procedure Terminated |
FSY | None listed |
| Apr 11, 2017 | Windstone Medical Packaging, Inc. Setup Pack, part number AMS3112(A
Product packaged in a convenient manner for use in a general clinical procedure Terminated |
FSY | None listed |
| Apr 11, 2017 | Windstone Medical Packaging, Inc. PRK Tray, part number DDS1044
Product packaged in a convenient manner for use in a general clinical procedure Terminated |
FSY | None listed |
| Apr 11, 2017 | Windstone Medical Packaging, Inc. Plastic Pack, part numbers AMS1028, AMS1028(A, and WAL1189.
Product packaged in a convenient manner for use in a general clinical procedure Terminated |
FSY | None listed |
| Apr 11, 2017 | Windstone Medical Packaging, Inc. Ortho Basic Pack, part number AMS6459
Product packaged in a convenient manner for use in a general clinical procedure Terminated |
FSY | None listed |
| Apr 11, 2017 | Windstone Medical Packaging, Inc. Ophthalmic Pack, Part number WAL1107(A and WAL1190
Product packaged in a convenient manner for use in a general clinical procedure Terminated |
FSY | None listed |
| Apr 11, 2017 | Windstone Medical Packaging, Inc. Minor Operation Kit, part number AMS1530
Product packaged in a convenient manner for use in a general clinical procedure Terminated |
FSY | None listed |
| Apr 11, 2017 | Windstone Medical Packaging, Inc. Lasik Tray, part number DDS1045-2
Product packaged in a convenient manner for use in a general clinical procedure Terminated |
FSY | None listed |
| Apr 11, 2017 | Windstone Medical Packaging, Inc. Eye Pack, part numbers WAL1085(B and WAL1085(C\
Product packaged in a convenient manner for use in a general clinical procedure Terminated |
FSY | None listed |
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