| BIOMONITOR IV (471155) (K261074) | Biotronik, Inc. | 2026-05-01 |
| Passeo-35 Xeo Peripheral Dilatation Catheter; Passeo-18 Peripheral Dilatation Catheters; Passeo-14 Peripheral Dilatation Catheter; Oscar Peripheral Multifunctional Catheter System; Pantera Pro Percutaneous Transluminal Coronary Angioplasty Catheter; Pantera LEO Percutaneous Transluminal Coronary Angioplasty (PTCA) Catheter (K250706) | Biotronik, Inc. | 2025-04-04 |
| Pantera Pro; Pantera LEO (K242969) | Biotronik, Inc. | 2024-10-25 |
| Selectra 3D Lead Delivery System (443624-443629, 451789-451791); Selectra Slitter Tool (383119); Selectra Accessory Kit (375518) (K240787) | Biotronik, Inc. | 2024-09-12 |
| Oscar Peripheral Multifunctional Catheter system (K241711) | Biotronik, Inc. | 2024-07-11 |
| BIOMONITOR IV (K230375) | Biotronik, Inc. | 2023-05-19 |
| Passeo-35 Xeo Peripheral Dilatation Catheter (K222065) | Biotronik, Inc. | 2023-02-16 |
| BIOMONITOR IIIm, BIOMONITOR III (K221856) | Biotronik, Inc. | 2022-07-27 |
| Selectra Lead Implantation System (K222037) | Biotronik, Inc. | 2022-07-19 |
| Oscar Peripheral Multifunctional Catheter system (K214038) | Biotronik, Inc. | 2022-07-06 |
| MultiCath, AcQRate Dx Fixed Curve Catheter (K201445) | Biotronik, Inc. | 2021-09-02 |
| Biomonitor III, Biomonitor IIIm (K201865) | Biotronik, Inc. | 2020-12-08 |
| Selectra 3D Outer Guiding Catheters (K193474) | Biotronik, Inc. | 2020-10-16 |
| Biomonitor III, Biomonitor IIIm (K200444) | Biotronik, Inc. | 2020-04-23 |
| Selectra Catheters, Selectra Accessory Kit, Selectra Slitter Tool (K192996) | Biotronik, Inc. | 2019-11-21 |
| Biotronik Stylets (K191469) | Biotronik, Inc. | 2019-08-01 |
| BIOMONITOR III, Remote Assistant III (K190548) | Biotronik, Inc. | 2019-07-05 |
| Selectra Catheters, Selectra Accessory Kit (K183265) | Biotronik, Inc. | 2018-12-13 |
| BioMonitor 2-AF, BioMonitor 2-S, FIT - Fast Insert Tool 1 + 2, Set (K171514) | Biotronik, Inc. | 2017-06-29 |
| BioMonitor 2-AF, BioMonitor 2-S (K170628) | Biotronik, Inc. | 2017-03-31 |
| Pantera LEO (K163660) | Biotronik, Inc. | 2017-01-26 |
| Pantera Pro (K160985) | Biotronik, Inc. | 2016-10-07 |
| BioMonitor 2-AF, BioMonitor 2-S (K152995) | Biotronik, Inc. | 2016-04-11 |
| Passeo-18 Peripheral Dilation Catheter (K151744) | Biotronik, Inc. | 2015-10-08 |
| Passeo-14 Peripheral Dilatation Catheter (K152240) | Biotronik, Inc. | 2015-10-08 |
| Selectra Catheters and Selectra Accessory Kit (K151409) | Biotronik, Inc. | 2015-08-07 |
| BioMonitor (K143503) | Biotronik, Inc. | 2015-03-19 |
| Passeo-35 PTA Catheter (K142379) | Biotronik, Inc. | 2014-12-05 |
| BIOMONITOR (K132960) | Biotronik, Inc. | 2014-06-06 |
| SELECTRA ACCESSORY KIT, SELECTRA SLITTER TOOL (K131978) | Biotronik, Inc. | 2013-08-23 |
| PASSEO-35 (K130161) | Biotronik, Inc. | 2013-04-23 |
| SELECTRA 7F CATHETERS (K123324) | Biotronik, Inc. | 2013-01-11 |
| SELECTRA ACCESSORY KIT (K111839) | Biotronik, Inc. | 2011-09-26 |
| SELECTRA SLITTER TOOL (K112482) | Biotronik, Inc. | 2011-09-26 |
| SELECTRA IC-50-60, SELECTRA IC-50-75, SELECTRA IC-90-65, SELECTRA IC-90-75 (K111154) | Biotronik, Inc. | 2011-05-23 |
| SELECTRA CS LEAD INTRODUCER SYSTEM (K110461) | Biotronik, Inc. | 2011-04-20 |
| SCOUTPRO ACS (K101776) | Biotronik, Inc. | 2010-07-23 |
| SCOUTPRO HEMOSTATIC VALVE (K101282) | Biotronik, Inc. | 2010-07-21 |
| SCOUTPRO 7F LONG CATHETERS (K093303) | Biotronik, Inc. | 2009-11-20 |
| PK-141 PATIENT CABLE (K083674) | Biotronik, Inc. | 2009-04-01 |
| VISION WIRE CORONARY GUIDEWIRE (K082935) | Biotronik, Inc. | 2008-12-04 |
| PASSEO-35 PTA CATHETER (K082933) | Biotronik, Inc. | 2008-11-03 |
| SCOUTPRO CS LEAD INTRODUCER SYSTEM (K080988) | Biotronik, Inc. | 2008-05-07 |
| SCOUTPRO 8F, 7F AND SLITTER TOOL ADVANCED (K072329) | Biotronik, Inc. | 2008-03-25 |
| MODELS ERA 300 AND 3105 PACING SYSTEM ANALYZERS (K073230) | Biotronik, Inc. | 2007-12-20 |
| PASSEO 18 (K072765) | Biotronik, Inc. | 2007-12-12 |
| SCOUTPRO SLITTER TOOL ADVANCED, MODEL 356 552 (K071665) | Biotronik, Inc. | 2007-07-18 |
| BIOTRONIK ENDOCARDIAL PACING LEADS (K061212) | Biotronik, Inc. | 2006-07-10 |
| SCOUTPRO 7F CORONARY SINUS LEAD DELIVERY SYSTEM (K060807) | Biotronik, Inc. | 2006-04-24 |
| SCOUTPRO 8F, MODELS 342 262; HEMOSTATIC VALVE, MODELS 345 968; HOOK GUIDING CATHETER, MODELS 342 263; MULTI-PURPOSE H (K060655) | Biotronik, Inc. | 2006-04-04 |
| GALEO FOCUS GUIDE WIRE (K042373) | Biotronik, Inc. | 2005-03-02 |
| ERA 3000 PACING SYSTEM ANALYZER (K042708) | Biotronik, Inc. | 2004-10-20 |
| MODIFICATION TO ERA 300 DUAL CHAMBER PACING SYSTEM ANALYZER (K033613) | Biotronik, Inc. | 2003-12-08 |
| SCOUT PRO (K033320) | Biotronik, Inc. | 2003-11-19 |
| PHERON PTA CATHETER (K033217) | Biotronik, Inc. | 2003-10-31 |
| ELOX P 45-BP; ELOX P 53-BP; ELOX P 60-BP (K023205) | Biotronik, Inc. | 2003-04-24 |
| ERA 3000; PA-2 IS-1 ADAPTER; EK-4-N PACEMAKER TEST CABLE; ERA 3000 CHARGER; ERA 3000 BATTERY (TYPE 2); NK-11 POWER SUPP. (K022360) | Biotronik, Inc. | 2003-01-27 |
| MODIFICATION TO BIOTRONIK'S STERILIZATION PROCESS (K023803) | Biotronik, Inc. | 2002-12-11 |
| AROX 45-JBP; AROX 53-JBP; MEROX 45-JBP; MEROX 53-JBP (K023099) | Biotronik, Inc. | 2002-10-18 |
| SCOUT (SINUS CORNARIUS UTILITY TOOL), MODEL 335 117 (K020821) | Biotronik, Inc. | 2002-06-03 |
| AROX 53-BP; AROX 60-BP; AROX 45-JBP; AROX 53-JBP (K021217) | Biotronik, Inc. | 2002-05-01 |
| MEROX BIPOLAR HIGH IMPEDANCE LEAD MODELS: MEX 53/13-BP; 60/15-BP; 45-JBP; 53-JBP (K010281) | Biotronik, Inc. | 2002-04-09 |
| A1-CS-SB Y-ADAPTER, MODEL 124 871 (K003454) | Biotronik, Inc. | 2001-01-18 |
| PACING LEADS, GUIDE WIRES, AND VARIOUS ACCESSORIES (K003072) | Biotronik, Inc. | 2001-01-09 |
| GALEO HYDRO AND GALEO HYDRO J-TIP (K001736) | Biotronik, Inc. | 2000-08-02 |
| ELOX 45-BP, MODEL 330 132, EFH-27, MODEL 331 549, EXTENSION TOOL, MODEL 331 668 (K001413) | Biotronik, Inc. | 2000-06-02 |
| EX 45-BP, MODEL 330 132; EX 53-BP, MODEL 130 018; EX 60-BP, MODEL 330 133 (K994240) | Biotronik, Inc. | 2000-04-13 |
| YP 45/15-BP; YP 53/15-BP; YP 60/15-BP (K993139) | Biotronik, Inc. | 1999-12-17 |
| PIKOS 01, PIKOS E01, PIKOS 01-B, PIKOS E01-B, PIKOS 01-A, PIKOS E01-A (K993434) | Biotronik, Inc. | 1999-11-10 |
| SX 53/15-BP, MODEL 124 853, SX 60/15-BP, MODEL 124 854 (K991169) | Biotronik, Inc. | 1999-07-01 |
| RETROX RX 45-JBP 124774, 53-JBP 124775, 53-BP 124776, 60-124777 (K990483) | Biotronik, Inc. | 1999-06-03 |
| GALEO HS 014 MODEL 117 130, GALEO S 014 MODEL 115 488, GALEAO M 014 MODEL 114156, GALEO F 014 MODEL 115 487 GALEO HF 018 (K982272) | Biotronik, Inc. | 1999-01-08 |
| SYNOX SX 53-BP, SX 60-BP, SX 45-JBP, SX 53-JBP , MODELS 120 444, 119 684, 120 438 AND 120 143 (K980869) | Biotronik, Inc. | 1998-09-10 |
| RETROX RX 53-BP, RETROX RX 60-BP, RETROX RX 45-JBP, RETROX RX 53-JBP MODEL NUMBERS 124 396, 124 397, 124 395, 124 000 (K981083) | Biotronik, Inc. | 1998-07-22 |
| TIR/TIJ AND POLYROX (K972500) | Biotronik, Inc. | 1998-03-04 |
| ELC 35-UP MODEL NUMBER 116015 AND ELC 54-UP MODEL NUMBER 115606 (K965106) | Biotronik, Inc. | 1998-01-27 |
| BK-N SEALING CAP (K971930) | Biotronik, Inc. | 1997-08-14 |
| A1-A,ABP,B,MBP, LEAD CONNECTORS; PEH ADAPTER SLEEVE (K970388) | Biotronik, Inc. | 1997-08-14 |
| ERA 300 DUAL CHAMBER PACING SYSTEM ANALYZER (K964190) | Biotronik, Inc. | 1997-07-10 |
| BK-A; BK-B; BK-IS SEALING CAP (K970204) | Biotronik, Inc. | 1997-04-29 |
| BIPOLAR IMPLANTABLE ENDOCARDIAL PACING LEADS, WITH SILICONE RUBBER INSULATION AND PASSIVE FIXATION (K964604) | Biotronik, Inc. | 1997-03-10 |
| UNIPOLAR & BIOPLAR IMPLANTABLE ENDOCARDIAL PACING LEADS, WITH SILICONE RUBBER INSULATION & PASSIVE FIXATION (K953044) | Biotronik, Inc. | 1996-09-27 |
| PIKOS LP 01, PIKOS LP E01 (K945627) | Biotronik, Inc. | 1996-03-04 |
| NANOS, PIKOS 01/E01, 01-A, E01-B, LP 01/LP E01 (K952328) | Biotronik, Inc. | 1995-09-29 |
| PIKOS E 01-B (K941937) | Biotronik, Inc. | 1994-08-30 |