| Arm Blood Pressure Monitor, Model Name:111, Arm Blood Pressure Monitor, Model Name: B1681, Arm Blood Pressure Monitor, Model Name: B1682, Arm Blood Pressure Monitor, Model Name: B1683 (K222926) | Shenzhen Yuezhongxing Technology Co., Ltd. | 2023-05-05 |
| DLP™ Silicone Coronary Artery Ostial Cannulae (K230960) | Medtronic, Inc. | 2023-05-04 |
| SOZO Pro (K230530) | ImpediMed Limited | 2023-05-04 |
| Finger Pulse Oximeter, Model: X1906P (K221798) | Shenzhen Changkun Technology Co., Ltd. | 2023-05-04 |
| SOZO Pro (K230531) | ImpediMed Limited | 2023-05-04 |
| FloPatch FP120 (K223843) | Flosonics Medical | 2023-05-03 |
| ViewFlex™ Eco Reprocessed ICE Catheter (K230934) | ABBOTT MEDICAL | 2023-05-03 |
| AcQMap® High Resolution Imaging and Mapping System (K230606) | Acutus Medical, Inc. | 2023-05-02 |
| TriSalus TriNav® LV Infusion System (K230957) | Trisalus Life Sciences | 2023-05-02 |
| Samsung ECG Monitor Application with Irregular Heart Rhythm Notification (K230292) | Samsung Electronics Co., Ltd. | 2023-05-02 |
| Artix BG (K230912) | Inari Medical | 2023-05-02 |
| BNLE Access Guidewire (K221390) | Biomerics Nle | 2023-04-28 |
| EmPro EPS (EP4514C-190, EP6514C-190);Nanoparasol EPS (PNP4514C-190,PNP6514C-190) (K222694) | MicroVention, Inc. | 2023-04-27 |
| ClotTriever XL Catheter (K223210) | Inari Medical, Inc. | 2023-04-27 |
| LINQ II Insertable Cardiac Monitor, CareLink SmartSync LINQ II ICM Application (K230553) | Medtronic, Inc. | 2023-04-26 |
| Wallaby 017 Micro Catheter (K223139) | Wallaby Medical | 2023-04-25 |
| Polaris X™ Catheter Cable, Blazer™ Dx-20 Catheter Cable (K230503) | Boston Scientific | 2023-04-25 |
| Tigereye ST CTO-Crossing Catheter (K230594) | Avinger, Inc. | 2023-04-25 |
| The Heart Seat (K222330) | Casana Care, Inc. | 2023-04-24 |
| RAIN Sheath™ Tibial Pedal Introducer (K230704) | Cordis US Corp | 2023-04-24 |
| SmartGUIDE deflectable hydrophilic guidewire (K222690) | Artiria Medical SA | 2023-04-24 |
| CONNEQT PULSE (K221742) | Atcor Medical | 2023-04-21 |
| SUPERPLAST Double-Occluder, SUPERPLAST Vascular Probe (K220981) | Fehling Surgical Instruments, Inc. | 2023-04-20 |
| BASHIR Endovascular Catheter Ref. No. 7201, BASHIR S-B Endovascular Catheter, Ref. No. 7101 (K222095) | Thrombolex, Inc. | 2023-04-20 |
| Tubing and Accessories Sets for Extracorporeal Membrane Oxygenation (ECMO) with Balance™ Biosurface (K223168) | Medtronic, Inc. | 2023-04-19 |
| Terumo Advanced Perfusion System 1 (K221895) | Terumo Cardiovascular Systems Corporation | 2023-04-18 |
| ClotTriever BOLD Catheter (K230494) | Inari Medical, Inc. | 2023-04-18 |
| Anivia SG1000 Pump Console (K230698) | Apmtd, Inc. | 2023-04-18 |
| Tigertriever 21 Revascularization Device, Tigertriever 17 Revascularization Device, Tigertriever 13 Revascularization Device (K230429) | Rapid Medical Ltd. | 2023-04-17 |
| Masimo Rad-G with Temperature (K213676) | Masimo Corporation | 2023-04-16 |
| N9+ (K223785) | Nonagon , Ltd. | 2023-04-14 |
| Dragonfly OpStar™ Imaging Catheter (K230411) | ABBOTT MEDICAL | 2023-04-14 |
| Quantum PureFlow Standard Heat Exchangers (HX11W-S2, HX11W-S1M and HX11W-S2M) (K223879) | Quara S.R.L. | 2023-04-13 |
| Stratus Infusion Catheter (K222185) | Intervene, Inc. | 2023-04-13 |
| Task Force CORE (K223332) | Cnsystems Medizintechnik GmbH | 2023-04-12 |
| POT PTCA Balloon Dilatation Catheter (K230705) | Brosmed Medical Co., Ltd. | 2023-04-11 |
| Route 92 Medical Full Length 070 Reperfusion System and Aspiration Tubing Set (K223530) | Route 92 Medical, Inc. | 2023-04-11 |
| ENROUTE® Transcarotid Neuroprotection System (K230402) | Silk Road Medical | 2023-04-11 |
| APRO 70 Catheter and Alembic Aspiration Tubing (K230695) | Alembic, LLC | 2023-04-10 |
| Arm Blood Pressure Monitor/Automatic Wireless Smart Blood Pressure Monitor (K222887) | Famidoc Technology Company Limited | 2023-04-10 |
| Cleaner Plus™ Thrombectomy System, Cleaner Plus™ Aspiration Catheter, Cleaner Plus™ Handpiece with 65cm Maceration Wire, Cleaner Plus™ Handpiece with 135cm Maceration Wire, Cleaner Plus™ Aspiration Canister (K223176) | Argon Medical Devices, Inc. | 2023-04-10 |
| Memo 3D Semirigid Annuloplasty Ring; Memo 3D ReChord Semirigid Annuloplasty Ring; Memo 4D Semirigid Annuloplasty Ring (K230318) | Corcym S.r.l. | 2023-04-07 |
| CARESCAPE Canvas 1000, CARESCAPE Canvas Smart Display, CARESCAPE Canvas D19, F2 Frame (F2-01) (K223531) | GE Healthcare Finland Oy | 2023-04-06 |
| RayFlow (K222023) | Hexacath | 2023-04-06 |
| Affinity Fusion™ Oxygenator System (K230640) | Medtronic, Inc. | 2023-04-06 |
| Reveal LINQ Insertable Cardiac Monitor, LINQ II Insertable Cardiac Monitor, AccuRhythm AI ECG Classification System (K223630) | Medtronic, Inc. | 2023-04-05 |
| D·Kaptain PTA High Pressure Balloon Dilatation Catheter (K214009) | Dk Medical Technology Co., Ltd. | 2023-04-05 |
| Reprocessed NRG Transseptal Needle (K213584) | Innovative Health, LLC | 2023-04-04 |
| Kendall SCD SmartFlow Controller, Cardinal Health Element Sleeves, Kendall SCD Express Sleeves, Kendall SCD Express Foot Cuff, Kendall SCD Sequential Compression Comfort Sleeves, Kendall SCD SmartFlow Controller Tubing Assembly (K230028) | Cardinal Health200, LLC | 2023-04-03 |
| SpO2 Extension Cable (K222370) | Beijing Rongrui-Century Science & Technology Co., Ltd. | 2023-04-02 |
| ROVO Mechanical Thrombectomy Device (K220780) | 2mg, Inc. | 2023-03-31 |
| Aspirex™ Thrombectomy System (K230356) | C.R. Bard, Inc. | 2023-03-31 |
| Maestro Microcatheter (K230636) | Merit Medical System, Inc. | 2023-03-30 |
| Stethophone v1 (K222871) | Sparrow Acoustics, Inc. | 2023-03-29 |
| Triever16 Curve (K223419) | Inari Medical | 2023-03-23 |
| AccurSound Electronic Stethoscope AS-101 (K221805) | Heroic Faith International , Ltd. | 2023-03-23 |
| POLARSHEATH™ Steerable Sheath 12F (UPN:M004CRBS3150), POLARMAP™ Circular Mapping Catheter (UPN:M004CRBS7210), POLARMAP™ EP Electrical Cable (UPN:M004CRBS62000), SMARTFREEZE™ Esophageal Temperature Sensor (ETS) Cable: -SMARTFREEZE™ Esophageal Temperature Sensor (ETS) Cable (UPN: M004CRBS6310), -SMARTFREEZE™ 16 PIN Esophageal Temperature Sensor (ETS) Cable (UPN: M004CRBS6320), -SMARTFREEZE™ CIRCA Esophageal Temperature Sensor (ETS) Cable (UPN: M004CRBS6340), SMARTFREEZE™ Pressure Sensor (K223824) | Boston Scientific Corporation | 2023-03-22 |
| CardioSTAT® ECG Test Solution (K223049) | Icentia, Inc. | 2023-03-22 |
| Arise™ UHP Dilatation Catheter (K230191) | Creagh Medical, Ltd. | 2023-03-22 |
| Meritrans ECO Reusable Pressure Transducer, Meritrans ECO Domes (K221782) | Merit Medical Pte. , Ltd. | 2023-03-17 |
| Ablacath™ Mapping Catheter (K223666) | Ablacon, Inc. | 2023-03-17 |
| Alio (K223073) | Alio, Inc. | 2023-03-17 |
| InThrill Thrombectomy System (K223613) | Inari Medical, Inc. | 2023-03-17 |
| ONE-CUF (K230145) | Ge Medical Systems Information Technologies, Inc. | 2023-03-14 |
| HeartBuds Electronic Stethoscope (K212906) | Heartbuds, LLC | 2023-03-14 |
| RevCore™ Thrombectomy Catheter. (K223609) | Inari Medical, Inc. | 2023-03-14 |
| Aristotle 14 Guidewire; Aristotle 18 Guidewire; Aristotle 24 Guidewire; Volo 14 Guidewire; Zoom Wire 14 Guidewire (K220398) | Scientia Vascular, LLC | 2023-03-10 |
| CEREGLIDE 71 Intermediate Catheter; Cerenovus Aspiration Tubing Set (K221934) | Cerenovus, Inc. | 2023-03-09 |
| CPS Locator 3D Delivery Catheter (K230363) | CenterPoint Systems, LLC | 2023-03-09 |
| Vassallo GT 018 Hybrid (K223432) | Filmecc Co., Ltd. | 2023-03-09 |
| CEREGLIDE 71 Intermediate Catheter (K221930) | Cerenovus, Inc. | 2023-03-09 |
| Essenz HLM (K221373) | Livanova Deutschland, GmbH | 2023-03-09 |
| AutoPulse NXT Resuscitation System (K221700) | Zoll Circulation, Inc. | 2023-03-09 |
| Pulse Oximeter (K220101) | Beijing Choice Electronic Technology Co., Ltd. | 2023-03-08 |
| Protrieve Sheath (K230331) | Inari Medical, Inc. | 2023-03-07 |
| Radical-7 Pulse CO-Oximeter and Accessories, Rad-97 and Accessories (K212161) | Masimo Corporation | 2023-03-06 |
| Abdominal Aortic and Junctional Tourniquet - Stabilized (AAJT-S) (K221661) | Compression Works, Inc. | 2023-03-03 |
| Aspira Pleural Drainage System (K212696) | Merit Medical Systems, Inc. | 2023-03-03 |
| Electronic Sphygmomanometers (K222394) | Qingdao Yasee Medical Device Co., Ltd. | 2023-03-03 |
| Artix AX (K223436) | Inari Medical | 2023-03-02 |
| 6F Wallaby Long Sheath (K222603) | Wallaby Medical, Inc. | 2023-03-02 |
| OPTRELL™ Mapping Catheter with TRUEref™ Technology (K230253) | Biosense Webster, Inc. | 2023-03-02 |
| Peel-Away Introducer (405104, 405108, 405112, 405116, 405118, 405119, 405120, 405122, 405124, 405128, 405129, 405136, 405144, 405145, 405146, 405147, 405149, 405153, 405154, 405254, 405269, 405270, 405404, 405408, 405412, 405416, 405418, 405420, 405422, 405424, 405428) (K230283) | ABBOTT MEDICAL | 2023-03-01 |
| ProTrack Pigtail Wire (K213898) | Baylis Medical Company, Inc. | 2023-03-01 |
| VIOLA (K230248) | Vascular Graft Solutions, Ltd. | 2023-02-28 |
| Handheld Pulse Oximeter (K213431) | Shenzhen Witleaf Medical Electronics Co., Ltd. | 2023-02-26 |
| Symphony Thrombectomy System (K223216) | Truvic Medical, Inc. | 2023-02-23 |
| OXY-1 System (K223161) | Abiomed, Inc. | 2023-02-23 |
| Everion+ System (K213863) | Biofourmis Singapore Pte., Ltd. | 2023-02-23 |
| Introducer Sheath Kits (K222184) | Beijing Demax Medical Technology Co.,Ltd | 2023-02-21 |
| Excipio LV Thrombectomy Device (K223897) | Contego Medical, Inc. | 2023-02-17 |
| APRO 70 Catheter and Alembic Aspiration Tubing (K223545) | Alembic, LLC | 2023-02-17 |
| CARTO® 3 EP Navigation System with CARTOSOUND™ 4D Version 7.4 (K223733) | Biosense Webster, Inc. | 2023-02-16 |
| Passeo-35 Xeo Peripheral Dilatation Catheter (K222065) | Biotronik, Inc. | 2023-02-16 |
| NUVISION™ NAV Ultrasound Catheter (K223766) | Biosense Webster, Inc. | 2023-02-16 |
| ZEUS System (K222389) | iRhythm Technologies, Inc. | 2023-02-15 |
| SC HONKYTONK PTCA Balloon Dilatation Catheter (K223022) | Sino Medical Sciences Technology, Inc. | 2023-02-15 |
| Cobra Catheter System (K223891) | Endovascular Engineering | 2023-02-15 |
| Arm Blood Pressure Monitor (K222869) | Andon Health Co, Ltd. | 2023-02-15 |
| Indigo® Aspiration System – Lightning Bolt Aspiration Tubing (K223186) | Penumbra, Inc. | 2023-02-13 |