| BreathID Hp System (K221896) | Meridian Bioscience Israel , Ltd. | 2022-12-19 |
| BreathID® Smart System (K223185) | Meridian Bioscience Israel , Ltd. | 2022-11-10 |
| BreathID Hp Lab System, BreathID Smart System (K220494) | Meridian Bioscience Israel , Ltd. | 2022-06-23 |
| BreathID Smart System (K193610) | Exalenz Bioscience , Ltd. | 2020-02-06 |
| BreathID Hp System (K173772) | Exalenz Bioscience , Ltd. | 2018-03-08 |
| BreathID Hp Lab System (K173777) | Exalenz Bioscience , Ltd. | 2018-03-08 |
| BreathID Hp Lab System (K162150) | Exalenz Bioscience , Ltd. | 2016-10-31 |
| BREATHID HP SYSTEM (K130524) | Exalenz Bioscience , Ltd. | 2013-05-22 |
| CRIT-LINE ANEMIA MANAGEMENT SOFTWARE (K093834) | Hema Metrics, LLC | 2010-09-29 |
| POC-AS10 AUTO SAMPLER (K092817) | Otsuka Pharmaceutical Co., Ltd. | 2010-03-09 |
| POCONE INFRARED SPECTROPHOTOMETER (K041148) | Otsuka Pharmaceutical Co., Ltd. | 2004-07-15 |
| BREATHTEK - UBIT UBT FOR H. PYLORI (K014225) | Meretek Diagnostics, Inc. | 2002-01-17 |
| VALIDATION OF THE BREATHID SYSTEM, FOR THE DETECTION OF HELICBACTOR PYLORI (K011668) | Oridion Medical 1987 , Ltd. | 2001-07-09 |
| MERETEK UBT_LITE BREATH TEST FOR H. PYLORI (K000316) | Meretek | 2000-02-24 |
| EZ-HBT HELICOBACTER BLOOD TEST (K990931) | Metabolic Solutions, Inc. | 1999-09-24 |
| ALIMENTERICS LARA (TM) BREATH TEST SYSTEM (K973000) | Alimenterics, Inc. | 1998-02-26 |
| THE MERETEK UBT BREATH TEST FOR H.PYLORI (K972352) | Meretek Diagnostics, Inc. | 1997-10-29 |