Safety Syringes, Inc.
Carlsbad, CA, US
Safety Syringes, Inc. appears in FDA device records in Carlsbad, CA. FDA records list 10 510(k) clearances between and , no PMA records and no registered establishments. As of , FDA records show one recall for this company.
FDA records held for this company
510(k) clearance history
FDA records hold 10 510(k) clearances for Safety Syringes, Inc. between 1995 and 2013. The busiest year on record is 1998, with 2. The most recent is 2013, with 1.
Clearances by year, as a table
| Year | Clearances |
|---|---|
| 1995 | 1 |
| 1997 | 1 |
| 1998 | 2 |
| 2001 | 2 |
| 2004 | 1 |
| 2006 | 1 |
| 2012 | 1 |
| 2013 | 1 |
| K number | Device | Product code | Decision | Decision date |
|---|---|---|---|---|
| K123743 | ULTRASAFE PLUS PASSIVE NEEDLE GUARD | MEG | Substantially Equivalent | |
| K122558 | ULTRASAFE PASSIVE NEEDLE GUARD | MEG | Substantially Equivalent | |
| K060743 | MODIFICATION TO: TAMPER EVIDENT ULTRASAFE PASSIVE DELIVERY SYSTEM, ULTRASAFE PASSIVE DELIVERY SYSTEM (X-SERIES) | MEG | Substantially Equivalent | |
| K042712 | TAMPER EVIDENT ULTRASAFE PASSIVE DELIVERY SYSTEM | MEG | Substantially Equivalent | |
| K013801 | ULTRASAFE DENTAL INJECTION SYSTEM | MEG | Substantially Equivalent | |
| K011369 | ULTRASAFE PASSIVE X-SERIES, NEEDLE GUARD SYRINGE, PISTON (ACCESSORY) | MEG | Substantially Equivalent | |
| K972900 | ULTRASAFE MODEL T200 INJECTOR | FMF | Substantially Equivalent | |
| K972877 | ULTRASAFE INJECTION SYSTEM MODEL C200 INJECTOR WITH NEEDLE GUARD | FMF | Substantially Equivalent | |
| K972878 | ULTRASAFE INJECTION SYSTEM NEEDLE GUARD, MODELS B50,B100L,B150,B225, AND B300 | FMF | Substantially Equivalent | |
| K944425 | ULTRASAFE ASPIRATING SYRINGE | MEG | Substantially Equivalent |
Registered establishments
No FDA establishment registrations recorded against this company.
FDA product codes
Recall records
| Recall | Product | Reason | Classification | Initiated | Status |
|---|---|---|---|---|---|
| Z-0444-03 | UltraSafe Dental Needle Guard, P/N: 401801 Lot:T20201501 | Package integrity not validated. Sterility not assured. | Terminated |
Verification record
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Data as of , FDA export datePage updated Source: openFDA, public domain