Company ยท US
Transidyne General Corp.
FDA 510(k) clearances and medical device recalls filed under this name, 1978 to 1996. Name variants (Inc, Corp, punctuation) are merged.
21510(k) clearances (0 in 12 months)
0recalls (0 in 12 months)
0recalls that name a 510(k)
Product codes
| Code | Device | Records |
|---|---|---|
| HGW | Sampler, Blood, Fetal | 3 |
| CHL | Electrode Measurement, Blood-Gases (Pco2, Po2) And Blood Ph | 2 |
| EGS | Handpiece, Contra- And Right-Angle Attachment, Dental | 2 |
| JQT | Densitometer/Scanner (Integrating, Reflectance, Tlc, Radiochromat.) Clinica | 2 |
| CBT | Arterial Blood Sampling Kit | 1 |
| FMF | Syringe, Piston | 1 |
| FRG | Wrap, Sterilization | 1 |
| FXX | Mask, Surgical | 1 |
| GFA | Blade, Saw, General & Plastic Surgery, Surgical | 1 |
| GFF | Bur, Surgical, General & Plastic Surgery | 1 |
| GIM | Tubes, Vacuum Sample, With Anticoagulant | 1 |
| JJS | Controls For Blood-Gases, (Assayed And Unassayed) | 1 |
| JOH | Tube Tracheostomy And Tube Cuff | 1 |
| LRO | General Surgery Tray | 1 |
| LRS | I.V. Start Kit | 1 |
| MCZ | Suture Removal Kit | 1 |
Latest 510(k) clearances
| Decided | 510(k) | Device and applicant | Code |
|---|---|---|---|
| Jul 25, 1996 | K961217 | BODILY FLUID DISPOSAL KIT Transidyne General Corp. | FXX |
| Jan 25, 1996 | K955658 | LACERATION TRAY Transidyne General Corp. | FRG |
| Mar 31, 1995 | K950773 | PROPHYLAXIS PACK Transidyne General Corp. | EGS |
| Mar 31, 1995 | K950743 | ORAL PROCEDURE PACK Transidyne General Corp. | EGS |
| Mar 1, 1995 | K950449 | SURGICAL BUR Transidyne General Corp. | GFF |
| Feb 21, 1995 | K950403 | SURGICAL SAW BLADES Transidyne General Corp. | GFA |
| Jun 17, 1993 | K924811 | I.V. START KIT Transidyne General Corp. | LRS |
| Jun 16, 1993 | K924243 | TRACHEOSTOMY CARE KIT Transidyne General Corp. | JOH |
| Dec 11, 1992 | K922339 | SUTURE REMOVAL KIT Transidyne General Corp. | MCZ |
| Nov 6, 1992 | K922041 | PRIMARY SURGICAL DRESSING TRAY Transidyne General Corp. | FMF |
| Mar 30, 1990 | K897133 | MODEL 1050 - UMBILICAL CORD BLOOD SAMPLING KIT Transidyne General Corp. | CBT |
| Feb 26, 1990 | K896373 | 1400 SERIES EVIDENCE COLLECTION KIT Transidyne General Corp. | GIM |
| Sep 15, 1989 | K895202 | 1420 HEEL-STICK(TM) NEONATAL BLOOD SAMPLING KIT Transidyne General Corp. | LRO |
| Mar 28, 1989 | K891388 | 1570 - FETAL BLOOD SAMPLING KIT Transidyne General Corp. | HGW |
| Jun 30, 1983 | K831459 | FETAL BLOOD SAMPLING KIT #1560 Transidyne General Corp. | HGW |
| Oct 2, 1981 | K812601 | SQC BUFFER Transidyne General Corp. | JJS |
| Sep 23, 1981 | K812552 | COROMETRICS MEDICAL SYST. 220 PH ANALY. Transidyne General Corp. | CHL |
| Jan 16, 1981 | K810028 | FETAL BLOOD SAMPLING KIT MODEL 1560 Transidyne General Corp. | HGW |
| Jan 9, 1981 | K803240 | CORNING 760 FLUOROMETER/DENSITOMETER Transidyne General Corp. | JQT |
| Feb 26, 1980 | K800271 | COROMETRICS MEDICAL SYSTEMS 220 PH SYS. Transidyne General Corp. | CHL |
| Apr 12, 1978 | K780318 | MODULAR SCANNING DENSITOMETER SYS. Transidyne General Corp. | JQT |
Latest recalls
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| No recalls in this window. | |||