ILI
21 FDA 510(k) clearances · Product code
22 daysmedian time to decision
33 days90th percentile
21clearances measured
FDA profile
- Official device name
- Sling, Arm
- Device class
- Class I (low risk)
- Regulation
- 21 CFR 890.3640
- Medical specialty
- Physical Medicine
- Flags
- GMP exempt
- Adverse events (MAUDE)
- 1995: 1 · 1997: 1 · 1999: 3 · 2001: 1 · 2002: 3
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 |
|---|---|---|
| MATRX, PYRAMID TRIANGLE BANDAGE (K912661) | Matrix Medica, Inc. | 1991-08-21 |
| ARM SLINGS (K831549) | Fred Sammons, Inc. | 1983-06-30 |
| SATO FAMILY FIRST AID KIT (K831706) | Food and Drug Service, Inc. | 1983-06-24 |
| VARIOUS ARM SLING (K823808) | Danek Medical, Inc. | 1983-01-14 |
| A.C. SPLINT (K823810) | Danek Medical, Inc. | 1983-01-14 |
| UNIVERSAL SLING, SLING & SWATHE (K823664) | Warm & Form, Orthopedic Materials | 1982-12-30 |
| UNIVERSAL SLING, SLING & SWATHE (K823162) | Warm & Form, Orthopedic Materials | 1982-11-10 |
| ORTHOPEDIC SOFT GOODS (K820590) | Abco Dealers, Inc. | 1982-03-26 |
| ARM SLING, POUCH TYPE (K812477) | Maddak, Inc. | 1981-09-14 |
| MADDACOMFORT SLING (K812478) | Maddak, Inc. | 1981-09-14 |
| LIMB HOLDER ARM SLING (K812480) | Maddak, Inc. | 1981-09-14 |
| ARM SLINGS (K812345) | Fred Sammons, Inc. | 1981-09-11 |
| BAUER & BLACK ARM SLING W/DETACH. POUCH (K803212) | Bd Becton Dickinson Vacutainer Systems Preanalytic | 1981-01-08 |
| CONPHAR ARM SLINGS (K803139) | Conphar, Inc. | 1981-01-08 |
| TRIANGULAR BANDAGE CAT.#191 (K802006) | Pollak (Intl.), Ltd. | 1980-09-16 |
| BK-6157-02 C.V.A SLING, MEDIUM&LARGE (K801713) | Fred Sammons, Inc. | 1980-08-07 |
| ARM SLING (K801626) | The Owenby Co. | 1980-07-28 |
| ARM SLING (K801531) | The Owenby Co. | 1980-07-21 |
| STROKE SLING (K771031) | Stat Medical Corp. | 1977-06-27 |
| ECONOMY IMMOBILIZATION AND VELPEAN SLING (K760574) | Richard'S Medical Equip., Inc. | 1976-10-06 |
| BANDAGE, TRIANGULAR NO. 8068 (K760250) | Johnson & Johnson Professionals, Inc. | 1976-07-26 |
Track ILI automatically
Every clearance here is in the API, with alerts when new ones post.