Medical Device Manufacturer · US , Mchenry , IL

Transidyne General Corp.

21 submissions · 15 cleared · Since 1978
21
Total
15
Cleared
0
Denied

Transidyne General Corp. — FDA 510(k) Submissions

Transidyne General Corp. has submitted 21 FDA 510(k) premarket notifications since 1978, of which 15 received clearance as substantially equivalent to a predicate device.

The company's most frequent device categories include Sampler, Blood, Fetal, Handpiece, Contra- And Right-angle Attachment, Dental, Densitometer/scanner (integrating, Reflectance, Tlc, Radiochromat.) Clinica, Electrode Measurement, Blood-gases (pco2, Po2) And Blood Ph, Controls For Blood-gases, (assayed And Unassayed) . Use the specialty filter in the sidebar to narrow results.

21 devices
1–21 of 21
BODILY FLUID DISPOSAL KIT
K961217 · FXX Mask, Surgical · General Hospital
Jul 1996 119d
LACERATION TRAY
K955658 · FRG Wrap, Sterilization · General Hospital
Jan 1996 44d
ORAL PROCEDURE PACK
K950743 · EGS Handpiece, Contra- And... · Dental
Mar 1995 42d
PROPHYLAXIS PACK
K950773 · EGS Handpiece, Contra- And... · Dental
Mar 1995 38d
SURGICAL BUR
K950449 · GFF Bur, Surgical, General &... · General & Plastic Surgery
Mar 1995 26d
SURGICAL SAW BLADES
K950403 · GFA Blade, Saw, General &... · General & Plastic Surgery
Feb 1995 21d
I.V. START KIT
K924811 · LRS I.v. Start Kit · General & Plastic Surgery
Jun 1993 265d
TRACHEOSTOMY CARE KIT
K924243 · JOH Tube Tracheostomy And... · Anesthesiology
Jun 1993 296d
SUTURE REMOVAL KIT
K922339 · MCZ Suture Removal Kit · General & Plastic Surgery
Dec 1992 206d
PRIMARY SURGICAL DRESSING TRAY
K922041 · FMF Syringe, Piston · General Hospital
Nov 1992 189d
MODEL 1050 - UMBILICAL CORD BLOOD SAMPLING KIT
K897133 · CBT Arterial Blood Sampling Kit · Anesthesiology
Mar 1990 93d
1400 SERIES EVIDENCE COLLECTION KIT
K896373 · GIM Tubes, Vacuum Sample,... · Pathology
Feb 1990 112d
1420 HEEL-STICK(TM) NEONATAL BLOOD SAMPLING KIT
K895202 · LRO General Surgery Tray · General & Plastic Surgery
Sep 1989 28d
1570 - FETAL BLOOD SAMPLING KIT
K891388 · HGW Sampler, Blood, Fetal · Obstetrics & Gynecology
Mar 1989 14d
FETAL BLOOD SAMPLING KIT #1560
K831459 · HGW Sampler, Blood, Fetal · Obstetrics & Gynecology
Jun 1983 55d
SQC BUFFER
K812601 · JJS Controls For Blood-gases,... · Chemistry
Oct 1981 18d
COROMETRICS MEDICAL SYST. 220 PH ANALY.
K812552 · CHL Electrode Measurement,... · Chemistry
Sep 1981 19d
FETAL BLOOD SAMPLING KIT MODEL 1560
K810028 · HGW Sampler, Blood, Fetal · Obstetrics & Gynecology
Jan 1981 10d
CORNING 760 FLUOROMETER/DENSITOMETER
K803240 · JQT Densitometer/scanner... · Chemistry
Jan 1981 17d
COROMETRICS MEDICAL SYSTEMS 220 PH SYS.
K800271 · CHL Electrode Measurement,... · Chemistry
Feb 1980 20d
MODULAR SCANNING DENSITOMETER SYS.
K780318 · JQT Densitometer/scanner... · Chemistry
Apr 1978 47d
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