Safety Syringes, Inc.
United StatesFDA applicant, unverified
- Devices
- 10
- FDA recalls
- 1
At a glance
Market reach
- United States
- FDA recalls
What Safety Syringes, Inc. makes
Safety Syringes, Inc. manufactures passive needle guard syringes and injection systems designed to reduce needle-stick injuries, including dental and medical injectors with built-in safety mechanisms. Products include pre-filled injectors, aspirating syringes, and modifications to existing passive delivery systems. The portfolio also covers tamper-evident models and accessory components like piston guards for X-series syringes.
All devices fall under Class II regulatory classification and are authorised via FDA 510(k) clearance. The company’s products are listed in the FDA’s 510(k) database. The manufacturer operates from the United States.
Catalogue
Ultrasafe Passive Needle Guard Ref K122558
Regimes: 510(k) Registry: 510(k)- Regimes: 510(k) Registry: 510(k)
Ultrasafe Dental Injection System Ref K013801
Regimes: 510(k) Registry: 510(k)- Regimes: 510(k) Registry: 510(k)
Ultrasafe Plus Passive Needle Guard Ref K123743
Regimes: 510(k) Registry: 510(k)Ultrasafe Model T200 Injector Ref K972900
Regimes: 510(k) Registry: 510(k)- Regimes: 510(k) Registry: 510(k)
Tamper Evident Ultrasafe Passive Delivery System Ref K042712
Regimes: 510(k) Registry: 510(k)- Regimes: 510(k) Registry: 510(k)
Ultrasafe Aspirating Syringe Ref K944425
Regimes: 510(k) Registry: 510(k)
FDA recalls
FDA recall records list 1 recall initiated by Safety Syringes, Inc., initiated on 2002-09-05. By recorded status: 1 terminated. The reasons filed fall into these groups: sterility or contamination and packaging. A recall is often a precaution started by the manufacturer, and a count of records is not a verdict on a company.
2002
- 5 Sep 2002 Z-0444-03 Unclassified (pre-2012) Terminated Package integrity not validated. Sterility not assured.
Frequently asked questions
How many devices does Safety Syringes, Inc. have in the registry?
The registry currently lists 10 devices for Safety Syringes, Inc.. Devices recorded under merged duplicate company entries are counted once.
Which registries list Safety Syringes, Inc.'s devices?
Among its 10 most recently registered devices, Safety Syringes, Inc. has devices listed in FDA 510(k) (10 devices).
What risk classes do Safety Syringes, Inc.'s devices fall under?
Among its 10 most recently registered devices, the classes recorded for Safety Syringes, Inc.'s devices are Class II. Each device page shows its own class and authorisation.
Are there FDA recall records for Safety Syringes, Inc.?
FDA recall records list 1 recall initiated by Safety Syringes, Inc., the most recent initiated on 5 Sep 2002. A recall is often a precaution started by the manufacturer; the records say nothing about the company's overall record.
What are the newest devices from Safety Syringes, Inc. in the registry?
The most recently registered devices listed for Safety Syringes, Inc. include ULTRASAFE PASSIVE NEEDLE GUARD, ULTRASAFE INJECTION SYSTEM MODEL C200 INJECTOR WITH NEEDLE GUARD, ULTRASAFE DENTAL INJECTION SYSTEM and ULTRASAFE PASSIVE X-SERIES, NEEDLE GUARD SYRINGE, PISTON (ACCESSORY).