Company ยท US
Mennen Medical, Inc.
FDA 510(k) clearances and medical device recalls filed under this name, 1985 to 2015. Name variants (Inc, Corp, punctuation) are merged.
55510(k) clearances (0 in 12 months)
0recalls (0 in 12 months)
0recalls that name a 510(k)
Product codes
| Code | Device | Records |
|---|---|---|
| DSI | Detector And Alarm, Arrhythmia | 13 |
| DQK | Computer, Diagnostic, Programmable | 5 |
| DRT | Monitor, Cardiac (Incl. Cardiotachometer & Rate Alarm) | 4 |
| DXG | Computer, Diagnostic, Pre-Programmed, Single-Function | 4 |
| DPS | Electrocardiograph | 3 |
| DQA | Oximeter | 3 |
| CCK | Analyzer, Gas, Carbon-Dioxide, Gaseous-Phase | 2 |
| KLK | Monitor, Oxygen, Cutaneous, For Infant Not Under Gas Anesthesia | 2 |
| MHX | Monitor, Physiological, Patient(With Arrhythmia Detection Or Alarms) | 2 |
| OLW | Index-Generating Electroencephalograph Software | 2 |
| CCL | Analyzer, Gas, Oxygen, Gaseous-Phase | 1 |
| DQX | Wire, Guide, Catheter | 1 |
| DRR | Amplifier And Signal Conditioner, Biopotential | 1 |
| DSF | Recorder, Paper Chart | 1 |
| DSH | Recorder, Magnetic Tape, Medical | 1 |
| DSK | Computer, Blood-Pressure | 1 |
| DXJ | Display, Cathode-Ray Tube, Medical | 1 |
| DXN | System, Measurement, Blood-Pressure, Non-Invasive | 1 |
| GWQ | Full-Montage Standard Electroencephalograph | 1 |
| GYE | Encephalogram Telemetry System | 1 |
Latest 510(k) clearances
| Decided | 510(k) | Device and applicant | Code |
|---|---|---|---|
| Jan 9, 2015 | K141441 | MENNTOR X7 Mennen Medical , Ltd., IL | DSI |
| Dec 27, 2013 | K131789 | CEREBRALOGIK- AEEG Mennen Medical , Ltd., IL | OMA |
| Aug 30, 2013 | K123792 | HORIZON XVU (FFR) Mennen Medical , Ltd., IL | DQX |
| May 7, 2010 | K093766 | VITALOGIK 6000/6500 Mennen Medical , Ltd., IL | DSI |
| Aug 7, 2009 | K091165 | HORIZON XVU Mennen Medical , Ltd., IL | DQK |
| Dec 16, 2008 | K083063 | BIS INTERFACE FOR VITALOGIK PATIENT MONITORS Mennen Medical , Ltd., IL | OLW |
| Jun 20, 2008 | K081484 | HORIZON XVU Mennen Medical , Ltd., IL | DQK |
| Nov 21, 2007 | K073140 | VITALOGIK MODEL 4000/4500 Mennen Medical , Ltd., IL | DSI |
| Oct 22, 2007 | K071899 | BIS MODULE FOR ENVOY PATIENT MONITOR Mennen Medical , Ltd., IL | OLW |
| Sep 7, 2007 | K071348 | EMS-XL CARDIAC ELECTROPHYSIOLOGY SYSTEM Mennen Medical , Ltd., IL | DQK |
| Apr 19, 2007 | K070254 | HORIZON SE Mennen Medical , Ltd., IL | DQK |
| Dec 20, 2005 | K052288 | VITALOGIK Mennen Medical , Ltd., IL | DSI |
| Jan 27, 2005 | K043564 | HORIZON ANGIO CATHLAB Mennen Medical , Ltd., IL | DQK |
| May 10, 2004 | K024245 | ENVOY PATIENT MONITOR Mennen Medical , Ltd., IL | OMC |
| Feb 26, 2004 | K030722 | ENVOY PATIENT MONITOR Mennen Medical, Inc., IL | MHX |
| Oct 15, 2003 | K032997 | MODIFICATION TO: HORIZON 9000WS Mennen Medical , Ltd., IL | DXG |
| Dec 3, 2002 | K023798 | MODIFICATION TO ENVOY PATIENT MONITOR Mennen Medical , Ltd., IL | DSI |
| Aug 1, 2002 | K022168 | ENVOY Mennen Medical , Ltd. | DQA |
| Mar 15, 2002 | K020632 | ENGUARD REMOTE PATIENT MONITOR Mennen Medical , Ltd., IL | QYX |
| Aug 16, 2001 | K011784 | MODIFICATION TO ENVOY PATIENT MONITOR Mennen Medical , Ltd., IL | DSI |
| May 8, 2001 | K001120 | ENVOY PATIENT MONITOR Mennen Medical , Ltd., IL | DSI |
| May 17, 2000 | K000563 | MODIFICATION TO ENVOY PATIENT MONITOR Mennen Medical , Ltd., IL | MHX |
| Oct 8, 1999 | K983864 | ETCO2 VITAL SIGNS MODULE Mennen Medical, Inc., IL | CCK |
| Jun 24, 1999 | K991775 | MODIFICATION TO COMPUTERIZED CATHETERIZATION LABORATORY - HORIZON 9000 WS Mennen Medical, Inc., IL | DXG |
| Aug 12, 1998 | K982697 | MODIFICATION TO ENSEMBLE CENTRAL STATION MONITOR Mennen Medical, Inc., IL | DSI |
| Apr 14, 1998 | K974510 | ENVOY PATIENT MONITOR Mennen Medical, Inc., IL | DSI |
| Feb 11, 1998 | K970358 | ENSEMBLE CENTRAL STATION MONITOR Mennen Medical, Inc., IL | DSI |
| Apr 12, 1995 | K940081 | MERCURY Mennen Medical, Inc. | DRT |
| Jan 6, 1995 | K940415 | HORIZON 9000 WS Mennen Medical, Inc. | DXG |
| Mar 23, 1993 | K920915 | CAPNOMED 100 STAND-ALONE ETCO2 MODULE Mennen Medical, Inc. | CCK |
| Jan 28, 1992 | K914381 | HORIZON 9000/HIS OPTION AMPLIFIER Mennen Medical, Inc. | DRR |
| Jan 8, 1992 | K913339 | HORIZON PACEMAKER DETECTION SOFTWARE Mennen Medical, Inc. | DSI |
| Aug 19, 1991 | K911257 | MR-5200 FULL DISCLOSURE SYSTEM Mennen Medical, Inc. | DSH |
| Aug 15, 1991 | K910945 | HORIZON 2000 EEG MONITORING OPTION Mennen Medical, Inc. | GWQ |
| Jul 10, 1991 | K911616 | HORIZON XL Mennen Medical, Inc. | DRT |
| Mar 1, 1991 | K903524 | HORIZON 2000 ST ANALYSIS OPTION Mennen Medical, Inc. | DPS |
| May 22, 1990 | K901774 | HORIZON 2000 PULSE OXIMETRY (SAO2) MONITOR CAPABIL Mennen Medical, Inc. | DQA |
| Feb 22, 1990 | K895895 | MODEL 219 TELEMETRY SYSTEM Mennen Medical, Inc. | GYE |
| Oct 31, 1989 | K894918 | HORIZON 2000 FRACTION OF INSPIRED OXYGEN MON. CAP. Mennen Medical, Inc. | CCL |
| Jul 20, 1989 | K893585 | 14 COLOR VIDEO DISPLAY 211-260-010 Mennen Medical, Inc. | LLZ |
| Jul 14, 1989 | K893133 | HORIZON 2110/HORIZON 2210 264-XXX-XXX/261-XXX-XXX Mennen Medical, Inc. | KLK |
| Jun 22, 1989 | K892066 | HORIZON CENTRAL STATION Mennen Medical, Inc. | DRT |
| May 31, 1989 | K884423 | HORIZON DISPLAY CONTROLLER PART # 266-200-010 Mennen Medical, Inc. | DXJ |
| Apr 19, 1989 | K885204 | HORIZON 2000 ARRHYTHMIA MONITOR OPTION - (ALARMS) Mennen Medical, Inc. | DSI |
| Mar 9, 1989 | K884897 | FOUR-CHANNEL/EIGHT-CHANNEL THERMAL ARRAY RECORDER Mennen Medical, Inc. | DSF |
| Feb 17, 1989 | K885079 | HORIZON 2000 TRANSCUTANEOUS GAS #26X-OPT-275 Mennen Medical, Inc. | LPP |
| Aug 25, 1988 | K882273 | HORIZON 2000 PULSE OXIMETRY AND MODULE Mennen Medical, Inc. | DQA |
| Jul 12, 1988 | K881273 | HORIZON 2000 ARRHYTHMIA MONITORING OPTION Mennen Medical, Inc. | DSI |
| May 31, 1988 | K875167 | HORIZON 9000 Mennen Medical, Inc. | DXG |
| May 6, 1988 | K880595 | HORIZON 2000/S 266-XXX-XXX Mennen Medical, Inc. | DPS |
Newest 50 of 55.
Latest recalls
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| No recalls in this window. | |||