Company · US
Midmark Corp.
FDA 510(k) clearances and medical device recalls filed under this name, 1981 to 2026. Name variants (Inc, Corp, punctuation) are merged.
39510(k) clearances (2 in 12 months)
7recalls (6 in 12 months)
6recalls that name a 510(k)
Product codes
| Code | Device | Records |
|---|---|---|
| FLE | Sterilizer, Steam | 10 |
| MWI | Monitor, Physiological, Patient (Without Arrhythmia Detection Or Alarms) | 6 |
| LGX | Table, Examination, Medical, Powered | 4 |
| EIA | Unit, Operative Dental | 3 |
| ETF | Unit, Examining/Treatment, Ent | 3 |
| MUH | System, X-Ray, Extraoral Source, Digital | 3 |
| FPO | Stretcher, Wheeled | 2 |
| FQO | Table, Operating-Room, Ac-Powered | 2 |
| DPS | Electrocardiograph | 1 |
| DRG | Transmitters And Receivers, Physiological Signal, Radiofrequency | 1 |
| FMF | Syringe, Piston | 1 |
| FMS | Bed, Pediatric Open Hospital | 1 |
| FSQ | Light, Surgical, Instrument | 1 |
| GBB | Chair, Surgical, Ac-Powered | 1 |
| GDC | Table, Operating-Room, Electrical | 1 |
| INQ | Table, Powered | 1 |
| INW | Table, Mechanical | 1 |
| IZW | Collimator, Automatic, Radiographic | 1 |
| KZF | Device, Medical Examination, Ac Powered | 1 |
| OAS | X-Ray, Tomography, Computed, Dental | 1 |
Latest 510(k) clearances
| Decided | 510(k) | Device and applicant | Code |
|---|---|---|---|
| Jun 12, 2026 | K253196 | Midmark 800 Digital Vital Signs Device (1-300-0100, 1-300-0200, 1-300-0300, 1-300-0400) Midmark Corporation | MWI |
| Nov 3, 2025 | K251626 | Midmark Dental Delivery System Midmark Corporation | EIA |
| Apr 4, 2024 | K233026 | Midmark Smart M9® Sterilizer, Midmark Smart M11® Sterilizer Midmark Corporation | FLE |
| Aug 6, 2020 | K201667 | Midmark Extraoral Imaging System (EOIS) Midmark Corporation | OAS |
| Aug 31, 2017 | K163337 | Midmark and Ritter M9 and M11 UltraClave® Automatic Sterilizers and Ritter M9D AutoClave® Automatic Sterilizer Midmark Corporation | FLE |
| Nov 17, 2016 | K161909 | IQvitals Zone Midmark Corporation | MWI |
| Jan 7, 2013 | K122643 | VANTAGE MODEL V5000, V5100, V5000C, V5100C Midmark Corp. | MUH |
| Aug 24, 2012 | K120239 | ELEVANCE Midmark | EIA |
| Nov 22, 2011 | K112380 | CLEARVISION Midmark Corp. | MUH |
| Jul 20, 2009 | K091866 | PROGENY VANTAGE PANORAMIC X-RAY SYSTEM Midmark | MUH |
| Jul 7, 2009 | K090670 | MIDMARK M3 ULTRAFAST AUTOMATIC STERILIZER Midmark Corp. | FLE |
| Mar 3, 2003 | K023348 | MIDMARK M9 ULTRACLAVE STEAM STERILIZER Midmark Corp. | FLE |
| Oct 18, 2000 | K003090 | MIDMARK PROCENTER INSTRUMENT DELIVERY SYSTEM Midmark Corp. | EIA |
| Jan 10, 2000 | K992744 | MIDMARK M4*9 EASYCLAVE STEAM STERILIZER Midmark Corp. | FLE |
| Apr 19, 1999 | K990189 | MODIFICATION OF: MIDMARK M-11 ULTRACLAVE STEAM STERILIZER Midmark Corp. | FLE |
| Nov 30, 1994 | K936181 | MIDMARK M-11 ULTRACLAVE STEAM STERILIZER Midmark Corp. | FLE |
| Oct 21, 1994 | K926463 | RITTERMODEL 75 EVOLUTION UNIV POW EXAM TABLE/ACCES Midmark Corp. | FQO |
| Mar 28, 1994 | K934744 | MIDMARK MAGNUM GENERAL SURGICAL TABLE Midmark Corp. | GDC |
| Feb 9, 1994 | K923730 | MODEL 561 C-ARM PROCEDURES STRETCHER Midmark Corp. | FPO |
| Dec 2, 1993 | K932719 | RITTER MODEL 158 AND 159 EXAM LIGHTS Midmark Corp. | KZF |
| Jul 30, 1993 | K930686 | MIDMARK SURGICAL LIGHTING SYSTEMS Midmark Corp. | FSQ |
| Jan 9, 1992 | K915141 | 712 PLASTIC SURGERY TABLE & ACCESORIES Midmark Corp. | FQO |
| Aug 26, 1991 | K911322 | MODEL #M9 ULTRACLAVE STEAM STERILIZER Midmark Corp. | FLE |
| May 15, 1991 | K910781 | #491 POWER OTOLARYNGOLY CH/#498 PROCED CTR & ACCES Midmark Corp. | ETF |
| Oct 3, 1990 | K904011 | MODEL #527 OPHTHALMIC STRETCHER Midmark Corp. | FPO |
| Jul 27, 1990 | K900432 | MODEL #M8 ELECTRONIC STERILIZER Midmark Corp. | FLE |
| Sep 12, 1989 | K894335 | MODEL #535 PACU STRETCHER/BED & #530 ED/TRAUMA STR Midmark Corp. | FMF |
| Sep 11, 1989 | K895016 | MODEL #510/515 GENERAL TRANSPORT STRETCHER Midmark Corp. | INW |
| Aug 28, 1989 | K894144 | POWER EXAMINATION TABLE MODEL # 405 Midmark Corp. | LGX |
| Aug 28, 1989 | K894134 | POWER EXAMINATION TABLE MODEL # 411 Midmark Corp. | LGX |
| Jul 14, 1989 | K894017 | POWER PODIATRY CHAIR/TABLE #414, #416 & #417 Midmark Corp. | INQ |
| Jul 5, 1985 | K852422 | MODEL 500 PEDIATRIC STRETCHER/CRIB Midmark Corp. | FMS |
| Apr 25, 1984 | K841505 | SURGI-MED TABLE MODEL 485-LT Midmark Corp. | |
| Jun 2, 1983 | K831385 | LITHOTOMY CHAIR #415 Midmark Corp. | GBB |
| Sep 28, 1982 | K822531 | MULTIPLE, ENT CABINET #448 Midmark Corp. | ETF |
| Sep 14, 1982 | K822530 | MULTIPLE, ENT CHAIR #418 Midmark Corp. | ETF |
| Apr 21, 1982 | K820823 | MULTIPLE, MODEL #17 Midmark Corp. | LGX |
| May 8, 1981 | K811190 | THREE MODELS OF TABLES, STOOLS, & LIGHTS Midmark Corp. | LGX |
| Apr 10, 1981 | K810598 | X-RAY COLLIMATING DEVICES Midmark Corp. | IZW |
Latest recalls
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Sep 18, 2026 | Midmark Corporation Midmark IQvitals Zone, automatically and noninvasively measures systolic and diastolic blood pressure, pulse rate, temperature (temporal), and oxygen saturation (SpO2) for adult and pediatric patients Open, Classified |
MWI | K161909 |
| Sep 18, 2026 | Midmark Corporation Midmark IQvitals Zone, automatically and noninvasively measures systolic and diastolic blood pressure, pulse rate, temperature (temporal), and oxygen saturation (SpO2) for adult and pediatric patients Open, Classified |
MWI | K161909 |
| Sep 18, 2026 | Midmark Corporation Midmark IQvitals Zone, automatically and noninvasively measures systolic and diastolic blood pressure, pulse rate, temperature (temporal), and oxygen saturation (SpO2) for adult and pediatric patients Open, Classified |
MWI | K161909 |
| Sep 18, 2026 | Midmark Corporation Midmark IQvitals Zone, automatically and noninvasively measures systolic and diastolic blood pressure, pulse rate, temperature (temporal), and oxygen saturation (SpO2) for adult and pediatric patients Open, Classified |
MWI | K161909 |
| Aug 25, 2026 | Midmark Corporation Midmark Digital ECG HD+12, HD+15, Model/Catalog Number: 4-000-0080
Software Version: Midmark IQecg Plugin versions starting with v10 and prior to v10.1.0.18. Open, Classified |
DRG | K220526 |
| Aug 25, 2026 | Midmark Corporation Midmark IQecg Digital ECG, Model/Catalog Number: 4-000-0061, 4-000-0062
Software Version: Midmark IQecg Plugin versions starting with v10 and prior to v10.1.0.18. Open, Classified |
DPS | K103640 |
| Apr 1, 2003 | Midmark Corp Midmark M7 UltraClave and Ritter M7 SpeedClave, Tabletop Steam Sterilizers. Terminated |
FLE | None listed |