Company ยท US
Life-Tech Intl., Inc.
FDA 510(k) clearances and medical device recalls filed under this name, 1982 to 2000. Name variants (Inc, Corp, punctuation) are merged.
68510(k) clearances (0 in 12 months)
0recalls (0 in 12 months)
0recalls that name a 510(k)
Product codes
| Code | Device | Records |
|---|---|---|
| FAP | Cystometric Gas (Carbon-Dioxide) On Hydraulic Device | 14 |
| FEN | Device, Cystometric, Hydraulic | 5 |
| EGJ | Device, Iontophoresis, Other Uses | 4 |
| HLX | Photostimulator, Ac-Powered | 4 |
| MFD | Cannula, Intrauterine Insemination | 4 |
| BXN | Stimulator, Nerve, Battery-Powered | 3 |
| DXT | Injector And Syringe, Angiographic | 3 |
| EXY | Uroflowmeter | 3 |
| EAT | Tester, Pulp | 2 |
| ETY | Tester, Auditory Impedance | 2 |
| KOI | Stimulator, Nerve, Peripheral, Electric | 2 |
| LIL | Monitor, Penile Tumescence | 2 |
| BXM | Stimulator, Nerve, Ac-Powered | 1 |
| BXQ | Rhinoanemometer (Measurement Of Nasal Decongestion) | 1 |
| CAZ | Anesthesia Conduction Kit | 1 |
| ESD | Hearing Aid, Air-Conduction, Prescription | 1 |
| ETN | Stimulator, Nerve | 1 |
| ETP | Stimulator, Caloric-Water | 1 |
| EWO | Audiometer | 1 |
| EXQ | Cystometer, Electrical Recording | 1 |
Latest 510(k) clearances
| Decided | 510(k) | Device and applicant | Code |
|---|---|---|---|
| Jul 6, 2000 | K001129 | PROLONG, MODELS PL50, PL100, PL150 Life-Tech Intl., Inc. | CAZ |
| Dec 10, 1996 | K955031 | MAXISTIM Life-Tech Intl., Inc. | KOI |
| Dec 10, 1996 | K954505 | EZ STIM Life-Tech Intl., Inc. | KOI |
| Nov 30, 1995 | K954315 | PVC ABDOMINAL/RECTAL PRESSURE CATHETER Life-Tech Intl., Inc. | FEN |
| Oct 17, 1995 | K954341 | URODYNAMICS TUBING AND INFUSION SETS Life-Tech Intl., Inc. | FEN |
| Oct 5, 1995 | K953451 | UROPUMP TUBE & DAMPING CHAMGER Life-Tech Intl., Inc. | FEN |
| Sep 8, 1995 | K953353 | UROVISION JANUS Life-Tech Intl., Inc. | FEN |
| Jun 13, 1995 | K946108 | EAR-A-GATOR Life-Tech Intl., Inc. | KHH |
| Jul 15, 1994 | K913601 | MICROPHOR Life-Tech Intl., Inc. | EGJ |
| Mar 30, 1994 | K940203 | TRIPLE LUMEN URODYNAMIC CATHETER WITH RADIOPAQUE MARKERS Life-Tech Intl., Inc. | FEN |
| Nov 18, 1993 | K931179 | UROLAB SPECTRUM Life-Tech Intl., Inc. | FAP |
| Sep 17, 1993 | K931282 | VOLUME TRANSDUCER Life-Tech Intl., Inc. | EXQ |
| Sep 7, 1993 | K923652 | DULBECCO'S PHOSPHATE BUFFERED SALINE Life-Tech Intl., Inc. | MFD |
| Sep 7, 1993 | K923651 | DISTILLED WATER Life-Tech Intl., Inc. | MFD |
| Sep 7, 1993 | K923634 | MODIFIED F-10 CULTURE MEDIUM Life-Tech Intl., Inc. | MFD |
| Sep 7, 1993 | K923612 | MODIFIED F-10 CULTURE MEDIUM W/O HYPOXANTHINE Life-Tech Intl., Inc. | MFD |
| Jul 29, 1993 | K926349 | PROBLOC INSULATED NEEDLES Life-Tech Intl., Inc. | GXZ |
| Mar 18, 1993 | K923072 | HANDTYMP Life-Tech Intl., Inc. | ETY |
| Feb 19, 1993 | K923073 | AUTOMATIC TYMPANOMETER Life-Tech Intl., Inc. | ETY |
| Sep 28, 1992 | K923071 | DANPLEX DIAGNOSTIC AUDIOMETER, CLIN. DIAG. AUDIOMT Life-Tech Intl., Inc. | ESD |
| Sep 23, 1992 | K923074 | DANPLEX SCREENING AUDIOMETER Life-Tech Intl., Inc. | EWO |
| Jun 10, 1992 | K904385 | JANUS ATAC ENG ANALYSIS SYSTEM Life-Tech Intl., Inc. | GWN |
| Feb 24, 1992 | K915484 | URETHRALPRESSURE PROFILE CATHETER Life-Tech Intl., Inc. | FAP |
| Oct 7, 1991 | K913184 | MS-III MINISTIM Life-Tech Intl., Inc. | BXN |
| Dec 28, 1990 | K904557 | MICROFLO Life-Tech Intl., Inc. | EXY |
| Nov 27, 1990 | K904386 | UROLAB JANUS Life-Tech Intl., Inc. | FAP |
| Oct 17, 1990 | K903494 | MAINTENACE FLOW - ACCESORY DEVICE FOR CAVROPUMP Life-Tech Intl., Inc. | DXT |
| Oct 5, 1990 | K903495 | LIQUID DETECTOR Life-Tech Intl., Inc. | DXT |
| Aug 6, 1990 | K902120 | MERCURY RHINOMANOMETER Life-Tech Intl., Inc. | BXQ |
| Feb 16, 1990 | K896784 | DISPOSABLE URODYNAMIC CATHETER SET Life-Tech Intl., Inc. | KOD |
| Mar 2, 1989 | K882585 | CAVROLAB Life-Tech Intl., Inc. | IYN |
| Dec 23, 1988 | K882554 | MEDITRODE KIT Life-Tech Intl., Inc. | EGJ |
| Aug 31, 1988 | K881842 | TRACER Life-Tech Intl., Inc. | BXN |
| Jan 29, 1988 | K874307 | MODEL DMC-75 MINI-CATHETER SET Life-Tech Intl., Inc. | FPA |
| Jan 27, 1988 | K873695 | MODEL 1859 TUMI/PRESSURE MODULE Life-Tech Intl., Inc. | EXY |
| Nov 13, 1987 | K872039 | MODEL SK-14 STARTER KIT FOR DENTAL IONTOPHORESIS Life-Tech Intl., Inc. | EAT |
| Oct 28, 1987 | K870662 | MODEL SKCK STERILE KNOB COVER KIT Life-Tech Intl., Inc. | BXM |
| Aug 28, 1987 | K873109 | MODEL CC-72 CAVERNOSOMETRY/CAVERNOSOGRAPHY SET Life-Tech Intl., Inc. | OJA |
| Aug 28, 1987 | K871129 | CAVROPUMP Life-Tech Intl., Inc. | DXT |
| Aug 27, 1987 | K872077 | MODEL 1858 CAVRO/PRESSURE MODULE Life-Tech Intl., Inc. | EXY |
| Aug 11, 1987 | K871869 | MODIFIED USE FOR MODEL 6110A IONTOPHORETIC APPLI. Life-Tech Intl., Inc. | EGJ |
| Aug 5, 1987 | K870272 | MODEL 6110C OTOPHOR Life-Tech Intl., Inc. | ETN |
| Apr 10, 1987 | K870118 | MODEL 6110B DENTAPHOR Life-Tech Intl., Inc. | EAT |
| Mar 11, 1987 | K870338 | MODEL MS-II MINISTIM Life-Tech Intl., Inc. | BXN |
| Mar 4, 1987 | K863166 | MODEL 6110 IONTOPHORETIC APPLICATOR Life-Tech Intl., Inc. | EGJ |
| Oct 28, 1986 | K863165 | MODEL 4-SC FOUR WAY STOPCOCK Life-Tech Intl., Inc. | FAP |
| Oct 24, 1986 | K863168 | MODEL 1101M & 1151M UROLAB MICRO URODYNAMIC RECORD Life-Tech Intl., Inc. | FAP |
| Oct 24, 1986 | K863167 | MODEL 1350 URODYNAMIC WAVEFORM PROCESSOR Life-Tech Intl., Inc. | FAP |
| Sep 9, 1986 | K863169 | MODEL AS-72 ADMINISTRATION SET Life-Tech Intl., Inc. | FAP |
| Sep 4, 1986 | K862327 | MODEL RCV REFLUX CHECK VALVE Life-Tech Intl., Inc. | FAP |
Newest 50 of 68.
Latest recalls
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| No recalls in this window. | |||