Product code LHD ยท Class U
Device, Fertility Diagnostic, Proceptive
0510(k)s in 12 months (24 all time)
0recalls in 12 months (0 all time)
0recalls that name a 510(k)
Top companies in LHD
| Company | 510(k)s | Recalls |
|---|---|---|
| Bioself, Inc. | 3 | 0 |
| Nishitomo Co., Inc. | 2 | 0 |
| Ava AG | 1 | 0 |
| Bd Becton Dickinson Vacutainer Systems Preanalytic | 1 | 0 |
| Cambridge Temperature Concepts , Ltd. | 1 | 0 |
| Fertil-A-Chron, Inc. | 1 | 0 |
| Fertile Time, Ltd. | 1 | 0 |
| Fertility Focus, Ltd. | 1 | 0 |
| Forecaster Co. | 1 | 0 |
| Joel R.L. Ehren Kranz | 1 | 0 |
| Decided | 510(k) | Device and applicant | Code |
|---|---|---|---|
| Jan 19, 2021 | K200163 | Ava Fertility Tracker Ava AG, CH | LHD |
| Aug 6, 2013 | K122337 | OVUSENSE Fertility Focus, Ltd. | LHD |
| Dec 20, 2011 | K102499 | DUOFERTILITY Cambridge Temperature Concepts , Ltd. | LHD |
| Apr 20, 2006 | K050094 | LADY COMP USA Lady Comp USA | LHD |
| Sep 12, 2003 | K030961 | MICROLIFE DIGITAL BASAL THERMOMETER, MODEL MT 1921 Microlife Corp. | LHD |
| Apr 8, 2003 | K021978 | PETIT SOPHIA Nishitomo Co., Inc. | LHD |
| Apr 6, 2001 | K002726 | TCOYF FERTILITY SOFTWARE VERSION 1.0 Ovusoft, LLC | LHD |
| Sep 25, 1995 | K952756 | MEDI-AID BASAL THERMOMETER Polymedica Industries, Inc. | LHD |
| Jun 15, 1995 | K945427 | B-D DIGITAL THERMOMETER Bd Becton Dickinson Vacutainer Systems Preanalytic | LHD |
| Oct 14, 1992 | K904211 | BIOSELF 2000 FERTILITY INDICATOR Bioself, Inc., CH | LHD |
| Jul 20, 1990 | K901512 | L SOPHIA Nishitomo Co., Inc., JP | LHD |
| Jun 24, 1988 | K880618 | FERTILITY FORECASTER COMPUTER PROGRAM Fertile Time, Ltd. | LHD |
| Jul 14, 1987 | K870999 | GENDER CHOICE INFORMATION KIT, FEMALE AND MALE Procare C/O Wiley, Rein & Fielding | LHD |
| May 6, 1987 | K870528 | OVU-TRAC OVULATION TIMING KIT Ob/Gyn Concepts, Ltd. | LHD |
| Sep 27, 1985 | K852194 | MODEL MT-50 DIGITAL MEMORY FEVER & BASAL THERMOMET Sharp Electronics Corp. | LHD |
| Sep 19, 1985 | K852801 | BIOCHRON FERTILITY INDICATOR Fertil-A-Chron, Inc. | LHD |
| Apr 10, 1985 | K845009 | RABBIT-PERSONAL COMPUTER FOR WOMEN Sanimor, Inc. | LHD |
| Feb 15, 1985 | K844043 | OVUDATE Joel R.L. Ehren Kranz | LHD |
| Dec 4, 1984 | K843699 | BIOSELF TM 110 Bioself, Inc. | LHD |
| Mar 17, 1983 | K823463 | RIGHT TIME RHYTHM CLOCK P.K. Morgan Instruments, Inc. | LHD |
| Feb 15, 1983 | K823209 | BIOSELF 101 Bioself, Inc. | LHD |
| Oct 14, 1982 | K821507 | SYMPTOTHERM 8 FERTILITY INDICATOR Ovix Corp., Inc. | LHD |
| May 3, 1982 | K813497 | RHYTHM WHEEL Tropical Enterprises, Inc. | LHD |
| Jun 24, 1981 | K810832 | FORECASTER Forecaster Co. | LHD |
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