Company ยท US
Sil-Med Corp.
FDA 510(k) clearances and medical device recalls filed under this name, 1980 to 1997. Name variants (Inc, Corp, punctuation) are merged.
29510(k) clearances (0 in 12 months)
0recalls (0 in 12 months)
0recalls that name a 510(k)
Product codes
| Code | Device | Records |
|---|---|---|
| GBX | Catheter, Irrigation | 5 |
| GBW | Catheter, Peritoneal | 4 |
| FJS | Catheter, Peritoneal, Long-Term Indwelling | 3 |
| GBS | Catheter, Ventricular, General & Plastic Surgery | 2 |
| GCD | Connector, Catheter | 2 |
| GCY | Apparatus, Suction, Single Patient Use, Portable, Nonpowered | 2 |
| DXC | Clamp, Vascular | 1 |
| FXX | Mask, Surgical | 1 |
| GAH | Stylet, Surgical, General & Plastic Surgery | 1 |
| GBC | Lamp, Surgical, Incandescent | 1 |
| GBI | Material, External Aesthetic Restoration, Used With Adhesive | 1 |
| HFL | Drain, Cervical | 1 |
| KDC | Instrument, Surgical, Disposable | 1 |
| KDG | Chisel (Osteotome) | 1 |
| KYR | Bag, Ice | 1 |
| LJS | Catheter, Intravascular, Therapeutic, Long-Term Greater Than 30 Days | 1 |
| LXZ | Guard, Instrument | 1 |
Latest 510(k) clearances
| Decided | 510(k) | Device and applicant | Code |
|---|---|---|---|
| Oct 1, 1997 | K972521 | NAVIGATOR (STYLET) 2006 Sil-Med Corp. | GAH |
| Jul 18, 1997 | K961392 | ANTIMICROBIAL PERITONEAL DIALYSIS COIL CATHETER WITH SPI-ARGENT II Sil-Med Corp. | FJS |
| Aug 8, 1996 | K961194 | ANTIMICROBIAL MEDIASTINAL SILICONE DRAIN Sil-Med Corp. | GBW |
| Jun 26, 1996 | K961295 | SAPPHIRE LINE FLAT DRAIN/KIT WITH SPI-ARGENT II W/OR W/OUT TROCAR Sil-Med Corp. | GBX |
| Mar 11, 1996 | K960099 | PENROSE DRAIN MODELS 6001 - 6007 Sil-Med Corp. | GCY |
| Jan 23, 1996 | K955463 | GRIP-A-BOOTS Sil-Med Corp. | LXZ |
| Jan 4, 1996 | K942709 | MEDIASTINAL SILICONE DRAINS Sil-Med Corp. | GBW |
| May 24, 1995 | K926496 | SIL-SLIP (COATED/REGULAR(NON-COATED)THORACIC DRAIN Sil-Med Corp. | GBX |
| Feb 2, 1994 | K926495 | SIL-SLIP ROUND WOUND DRAIN (COATED)/BLUE STRIPE Sil-Med Corp. | GBX |
| Feb 2, 1994 | K926408 | SIL-SLIP FLAT SUCTION DRAIN Sil-Med Corp. | GBX |
| Sep 28, 1992 | K921424 | SIL-MED FLAT SUCTION DRAIN Sil-Med Corp. | GBX |
| Jan 31, 1991 | K903989 | SIL-MED T-TUBE DRAIN Sil-Med Corp. | HFL |
| Aug 15, 1989 | K891471 | SIL-MED WASTE FLUID DUMP BAG Sil-Med Corp. | KDG |
| Jan 31, 1989 | K885167 | TRUDELL BENT CATHETER Sil-Med Corp. | FJS |
| Aug 7, 1986 | K862767 | SILICONE SUMP DRAIN Sil-Med Corp. | GBS |
| Nov 19, 1985 | K854418 | ROUND SUCTION DRAIN Sil-Med Corp. | GBS |
| Jun 7, 1985 | K851195 | VASCULAR ACCESS CATHETER Sil-Med Corp. | LJS |
| Jun 4, 1985 | K851196 | INCISION DRAIN Sil-Med Corp. | GCD |
| May 17, 1985 | K851921 | Y CONNECTOR Sil-Med Corp. | GCD |
| Feb 14, 1985 | K850247 | PERITONEAL DIALYSIS COIL CATHETER Sil-Med Corp. | FXX |
| Oct 24, 1984 | K843575 | DERBYSHIRE DRAIN Sil-Med Corp. | GBW |
| Aug 17, 1984 | K842765 | SILIMED BREAST FORM Sil-Med Corp. | GBI |
| Feb 4, 1984 | K833872 | SAV-A-LIMB Sil-Med Corp. | KYR |
| May 2, 1983 | K830607 | SUCTION RESERVOIR Sil-Med Corp. | GCY |
| Mar 29, 1983 | K830610 | FLAT SUCTION DRAIN Sil-Med Corp. | GBC |
| Dec 18, 1981 | K813063 | FLAT DRAIN Sil-Med Corp. | GBW |
| Dec 14, 1981 | K813062 | VASCULAR PAWS Sil-Med Corp. | DXC |
| Apr 2, 1981 | K810080 | VASCULAR TIE (VAS-TIE) Sil-Med Corp. | KDC |
| Oct 23, 1980 | K801818 | TENCKHOFF CATHETER Sil-Med Corp. | FJS |
Latest recalls
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| No recalls in this window. | |||