ECB
12 FDA 510(k) clearances · Product code
89 daysmedian time to decision
269 days90th percentile
12clearances measured
FDA profile
- Official device name
- Unit, Syringe, Air And/Or Water
- Device class
- Class I (low risk)
- Regulation
- 21 CFR 872.4565
- Medical specialty
- Dental
- Adverse events (MAUDE)
- 1995: 1 · 1997: 1 · 2000: 1
Reports received by FDA, not confirmed device causation - volume tracks device popularity as much as risk.
Export predicate table (CSV) Shareable report ◉ Watch exports: 3 free/month · reports & watching: free
| Record | Firm | Date |
|---|---|---|
| UNI-SYRINGE, UNI-TIP AND ACCESS SYRINGE TIPS (K942519) | Bull Frog Mfg. Co. | 1994-08-23 |
| SURETIP SYRINGE TIP COVER (K931772) | Western M/D, Inc. | 1994-03-07 |
| DENTAL SYRINGE TIP (K931137) | A-Dec, Inc. | 1993-11-29 |
| RISKONTROL SINGLE USE (K923876) | Riskontrol | 1993-04-05 |
| PRO-TIP DISPOSABLE 3/1 SYRINGE NOZZLE (K923285) | Smith & Nephew, Inc. | 1992-09-15 |
| SANI-TIP (K920499) | Dw Industries, Inc. | 1992-05-03 |
| POSTERIOR NASAL EPISTAXIS INSTRUMENTS (K911756) | Richard Wolf Medical Instruments Corp. | 1991-10-24 |
| BRACE (ORAFIX SPECIAL) (K890290) | Norcliff Thayer, Inc. | 1989-03-29 |
| SERINGA TRIPLICE S.L. (K863024) | Sds Dental, Inc. | 1986-09-25 |
| TUBING SYRING (K854699) | Almore Intl., Inc. | 1986-01-06 |
| SPACELINE THREE WAY SYRINGE (K801686) | Pacific Dental Corp. | 1980-08-04 |
| DENTAL WARM WATER IRRIGATING SYSTEM (K781594) | Rama Corp. | 1978-12-04 |
Track ECB automatically
Every clearance here is in the API, with alerts when new ones post.