Data / Medical devices / United States / Ansell Sandel Medical Solutions LLC
Ansell Sandel Medical Solutions LLC: FDA-registered device maker in Chatsworth, CA, United States, 1 510(k) clearance
Ansell Sandel Medical Solutions LLC is registered with the FDA (registration 3004125670) in Chatsworth, CA, United States. It lists 17 device types. The FDA files 1 510(k) clearance under its listings, the newest dated June 13, 2005. 1 recall event names it as the recalling firm. Registered through 2026. FDA data exported November 3, 2026.
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- FDA registration number
- 3004125670
- Address
- 9301 Oakdale Ave Ste 300, Chatsworth, CA, United States, 91311
- Owner or operator
- ANSELL HEALTHCARE PRODUCTS LLC (8020065)
- Roles
- Complaint file establishment, Manufacturer, Specification developer
- First device listed
- August 25, 2011
- Registered through
- 2026
- Brand names listed
- Gammex Silver Barrier Dressing, KIT TURNOVER STAT-PAC, STAT-STRAP, Sandel Safety Scalpel Non-Sterile
Devices it lists
| Device | Product code | Class | Role | Source |
|---|---|---|---|---|
| Bag, Urine Collection, Leg, For External Use, Non-Sterile | NNW | 1 | Specification developer | accessdata.fda.gov |
| Bedding, Disposable, Medical | KME | 1 | Manufacturer, Specification developer | accessdata.fda.gov |
| Container, Specimen, Sterile | FMH | 1 | Complaint file establishment, Specification developer | accessdata.fda.gov |
| Device, Transfer, Patient, Manual | FMR | 1 | Complaint file establishment, Manufacturer, Specification developer | accessdata.fda.gov |
| Dispenser, Liquid Medication | KYX | 1 | Complaint file establishment, Specification developer | accessdata.fda.gov |
| Dressing, Wound, Drug | FRO | U | Complaint file establishment | accessdata.fda.gov |
| Gauze / Sponge,Nonresorbable For External Use | NAB | 1 | Specification developer | accessdata.fda.gov |
| Handle, Scalpel | GDZ | 1 | Specification developer | accessdata.fda.gov |
| Instrument, Manual, Surgical, General Use | MDM | 1 | Complaint file establishment, Manufacturer, Specification developer | accessdata.fda.gov |
| Instrument, Surgical, Disposable | KDC | 1 | Complaint file establishment, Specification developer | accessdata.fda.gov |
| Kit, Surgical Instrument, Disposable | KDD | 1 | Complaint file establishment | accessdata.fda.gov |
| Label Or Tag, Sterile | LYV | 1 | Complaint file establishment, Specification developer | accessdata.fda.gov |
| Marker, Skin | FZZ | 1 | Complaint file establishment, Manufacturer, Specification developer | accessdata.fda.gov |
| Protector, Skin Pressure | FMP | 1 | Manufacturer, Specification developer | accessdata.fda.gov |
| Restraint, Protective | FMQ | 1 | Specification developer | accessdata.fda.gov |
| Scalpel, One-Piece | GDX | 1 | Complaint file establishment, Manufacturer, Specification developer | accessdata.fda.gov |
| Support, Patient Position | CCX | 1 | Manufacturer, Specification developer | accessdata.fda.gov |
510(k) clearances
The 510(k) numbers this establishment lists, with the FDA decision on each. The applicant is the company that holds the clearance.
| Decided | 510(k) number | Device | Product code | Decision | Applicant | Source |
|---|---|---|---|---|---|---|
| June 13, 2005 | K050649 | SILVERSEAL CONTACTING WOUND DRESSING WITH X-STATIC | FRO | Substantially Equivalent | Noble Fiber Technologies, Inc. | accessdata.fda.gov |
Recalls
Recall events where this establishment is the recalling firm, matched on its FEI.
| Initiated | Event | Class | Status | Product | Reason | Source |
|---|---|---|---|---|---|---|
| November 12, 2013 | 67005 | Class II | Terminated | Sandel Healthcare Safety Devices Weighted Safety Scalpel #3 Disposable Safety Handle with #10 Blade Manufactured for: Ansell Sandel Medical Solutions LLC 19736 Dearborn St. Chatsworth, CA 91311 USA Emergo Europe Molenstr | Select lots of SANDEL Weighted Safety Scalpels are packaged with the scalpel blade exposed beyond the safety shield which could compromise the integrity of the package and the sterility of the scalpel leading to injury. | accessdata.fda.gov |
Compare with other makers
- All makers of Instrument, Manual, Surgical, General Use
- All makers of Protector, Skin Pressure
- All makers of Handle, Scalpel
- All makers of Device, Transfer, Patient, Manual
- All makers of Support, Patient Position
- All makers of Label Or Tag, Sterile
Updated January 8, 2014. Read from openFDA bulk downloads (device registration and listing, 510(k), PMA, recall and enforcement files). CC0 1.0, public domain (openFDA terms of service). The files are joined on FDA identifiers: the 510(k) and PMA numbers a registration lists, and the recalling firm's FEI for recalls. Recall class comes from the FDA enforcement report. The FDA states that openFDA data is unvalidated and is not for decisions about medical care. Free to reuse with credit to SpecStream under CC BY 4.0. Spot a wrong value? Write to [email protected] with the link to this page.