Company ยท US
Scanlan Intl., Inc.
FDA 510(k) clearances and medical device recalls filed under this name, 1978 to 1996. Name variants (Inc, Corp, punctuation) are merged.
19510(k) clearances (0 in 12 months)
0recalls (0 in 12 months)
0recalls that name a 510(k)
Product codes
| Code | Device | Records |
|---|---|---|
| HRQ | Hemostat | 3 |
| DWS | Instruments, Surgical, Cardiovascular | 2 |
| DWX | Stripper, Artery, Intraluminal | 1 |
| FMP | Protector, Skin Pressure | 1 |
| FSM | Tray, Surgical, Instrument | 1 |
| FZZ | Marker, Skin | 1 |
| GAB | Needle, Suturing, Disposable | 1 |
| GCJ | Laparoscope, General & Plastic Surgery | 1 |
| GFC | Driver, Surgical, Pin | 1 |
| HCH | Clip, Aneurysm | 1 |
| HRG | Engine, Trephine, Accessories, Ac-Powered | 1 |
| KOC | Accessories, Blood Circuit, Hemodialysis | 1 |
| KPK | Marker, Ostia, Aorto-Saphenous Vein | 1 |
| MGZ | Valvulotome | 1 |
Latest 510(k) clearances
| Decided | 510(k) | Device and applicant | Code |
|---|---|---|---|
| Apr 26, 1996 | K960372 | SCANLAN HEIFETZ ANEURYSM ELGILOY CLIP SYSTEM Scanlan Intl., Inc. | HCH |
| Dec 5, 1994 | K945474 | SCANLAN(R) THORACOSCOPIC SCISSORS, CLAMP, FORCEPS, NEEDLE HOLDER Scanlan Intl., Inc. | GCJ |
| Feb 18, 1992 | K911184 | SCANLAN/TAHERI VALVULOTOME Scanlan Intl., Inc. | MGZ |
| Jan 12, 1987 | K864920 | SCANLAN (TM) INSTRUMENT TRAY Scanlan Intl., Inc. | FSM |
| Jan 12, 1987 | K864919 | SCANLAN (TM) VEIN/GRAFT HOLDER Scanlan Intl., Inc. | KPK |
| Jul 12, 1985 | K851825 | SCANLAN TUNNELER, SHEATH & TIP Scanlan Intl., Inc. | DWS |
| Aug 3, 1984 | K841521 | SCANLAN ENDARSECTOR Scanlan Intl., Inc. | DWX |
| Jul 6, 1984 | K841513 | SCANLAN ATRAUM INSTRUMENT JAW COVER Scanlan Intl., Inc. | |
| Jun 11, 1984 | K841085 | SCANLAN COLORMARK SKIN MARKER Scanlan Intl., Inc. | FZZ |
| Jun 5, 1984 | K841515 | SCANLAN VASCU-STATT II Scanlan Intl., Inc. | HRG |
| Jun 5, 1984 | K841514 | SCANLAN VASCU-STATT II APPROXIMATOR Scanlan Intl., Inc. | HRQ |
| Apr 24, 1984 | K841086 | SURGICAL INSTRUMENT DEMAGNETIZER Scanlan Intl., Inc. | |
| Mar 24, 1983 | K823764 | SCANLAN SINGLE-USE AORTA PUNCH Scanlan Intl., Inc. | DWS |
| Jan 7, 1983 | K823694 | VASCU-STATT APPROXIMATOR Scanlan Intl., Inc. | HRQ |
| Jul 28, 1982 | K821887 | SCANLAN SUTURE-STATT Scanlan Intl., Inc. | HRQ |
| Mar 13, 1981 | K810480 | SCANLAN SUTURE BOOTS Scanlan Intl., Inc. | KOC |
| Jan 15, 1981 | K802829 | SCANLAN VASCU-STATT Scanlan Intl., Inc. | FMP |
| Sep 26, 1980 | K801976 | SCANLAN STERNUM NEEDLE-SUTURE Scanlan Intl., Inc. | GAB |
| Apr 18, 1978 | K780255 | NEEDLE DRIVER Scanlan Intl., Inc. | GFC |
Latest recalls
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| No recalls in this window. | |||