Transidyne General Corp.
Medical device manufacturer in Spartanburg, SC.
21510(k) clearances
0PMA approvals
0recalls
Device types
- HGW Sampler, Blood, Fetal 3
- JQT Densitometer/Scanner (Integrating… 2
- CHL Electrode Measurement, Blood-Gases (Pco2… 2
- EGS Handpiece, Contra- And Right-Angle… 2
- JJS Controls For Blood-Gases, (Assayed And… 1
- LRO General Surgery Tray 1
- GIM Tubes, Vacuum Sample, With Anticoagulant 1
- CBT Arterial Blood Sampling Kit 1
- FMF Syringe, Piston 1
- MCZ Suture Removal Kit 1
- JOH Tube Tracheostomy And Tube Cuff 1
- LRS I.V. Start Kit 1
- GFA Blade, Saw, General & Plastic Surgery… 1
- GFF Bur, Surgical, General & Plastic Surgery 1
- FRG Wrap, Sterilization 1
- FXX Mask, Surgical 1
510(k) clearances
| 510(k) | Device | Decision |
|---|---|---|
| K961217 | Bodily Fluid Disposal KitFXX · Traditional | 07/25/1996SE |
| K955658 | Laceration TrayFRG · Traditional | 01/25/1996SE |
| K950773 | Prophylaxis PackEGS · Traditional | 03/31/1995SESK |
| K950743 | Oral Procedure PackEGS · Traditional | 03/31/1995SESK |
| K950449 | Surgical BurGFF · Traditional | 03/01/1995SE |
| K950403 | Surgical Saw BladesGFA · Traditional | 02/21/1995SE |
| K924811 | I.V. Start KitLRS · Traditional | 06/17/1993SEKD |
| K924243 | Tracheostomy Care KitJOH · Traditional | 06/16/1993SEKD |
| K922339 | Suture Removal KitMCZ · Traditional | 12/11/1992SESK |
| K922041 | Primary Surgical Dressing TrayFMF · Traditional | 11/06/1992SEKD |
| K897133 | Model 1050 - Umbilical Cord Blood Sampling KitCBT · Traditional | 03/30/1990SE |
| K896373 | 1400 Series Evidence Collection KitGIM · Traditional | 02/26/1990SE |
| K895202 | 1420 Heel-Stick(Tm) Neonatal Blood Sampling KitLRO · Traditional | 09/15/1989SE |
| K891388 | 1570 - Fetal Blood Sampling KitHGW · Traditional | 03/28/1989SE |
| K831459 | Fetal Blood Sampling Kit #1560HGW · Traditional | 06/30/1983SE |
| K812601 | SQC BufferJJS · Traditional | 10/02/1981SE |
| K812552 | Corometrics Medical Syst. 220 PH Analy.CHL · Traditional | 09/23/1981SE |
| K810028 | Fetal Blood Sampling Kit Model 1560HGW · Traditional | 01/16/1981SE |
| K803240 | Corning 760 Fluorometer/DensitometerJQT · Traditional | 01/09/1981SE |
| K800271 | Corometrics Medical Systems 220 PH Sys.CHL · Traditional | 02/26/1980SE |
| K780318 | Modular Scanning Densitometer Sys.JQT · Traditional | 04/12/1978SE |