Company ยท US
Kells Medical, Inc.
FDA 510(k) clearances and medical device recalls filed under this name, 1982 to 1993. Name variants (Inc, Corp, punctuation) are merged.
12510(k) clearances (0 in 12 months)
0recalls (0 in 12 months)
0recalls that name a 510(k)
Product codes
| Code | Device | Records |
|---|---|---|
| KPE | Container, I.V. | 2 |
| BXP | Transducer, Gas Flow | 1 |
| ESE | Larynx, Artificial (Battery-Powered) | 1 |
| ETF | Unit, Examining/Treatment, Ent | 1 |
| ETY | Tester, Auditory Impedance | 1 |
| KCJ | Applicator, Ent | 1 |
| KGX | Tape And Bandage, Adhesive | 1 |
| KNT | Tubes, Gastrointestinal (And Accessories) | 1 |
| LIX | Aid, Cardiopulmonary Resuscitation | 1 |
| NAD | Dressing, Wound, Occlusive | 1 |
Latest 510(k) clearances
| Decided | 510(k) | Device and applicant | Code |
|---|---|---|---|
| Nov 8, 1993 | K926333 | CPR PLUS Kells Medical, Inc. | LIX |
| Jul 24, 1989 | K890093 | PVC EMPTY SOLUTION CONTAINER ENTERAL PUMP SET Kells Medical, Inc. | KNT |
| May 24, 1989 | K890095 | PVC EMPTY SOLUTION CONTAINER W/3 LEAD TRANSFER SET Kells Medical, Inc. | KPE |
| May 24, 1989 | K890094 | EVA EMPTY SOLUTION CONTAINER W/3 LEAD TRANSFER SET Kells Medical, Inc. | KPE |
| Jun 27, 1986 | K861972 | DERMISTRIP Kells Medical, Inc. | NAD |
| Jan 8, 1985 | K844463 | DERMIDRESS Kells Medical, Inc. | KGX |
| Nov 5, 1984 | K844072 | DERMIZIP SKIN CLOSURE DEVICE Kells Medical, Inc. | |
| Mar 7, 1984 | K832678 | PHONATORY FUNCTION ANALYZER PS-77 Kells Medical, Inc. | BXP |
| Sep 29, 1983 | K832667 | LUCAE'S EAR & NASAL APPLICATORS Kells Medical, Inc. | KCJ |
| Jan 7, 1983 | K823118 | SAY Kells Medical, Inc. | ESE |
| Nov 22, 1982 | K823227 | IMPEDANCE METER ON-1 Kells Medical, Inc. | ETY |
| Nov 22, 1982 | K823226 | SN-100 DOCTOR'S ROUND Kells Medical, Inc. | ETF |
Latest recalls
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| No recalls in this window. | |||