| Happy Ring Health Monitoring System (K240236) | Happy Health, Inc. | 2024-09-24 |
| EchoGo Heart Failure (2.0) (K240013) | Ultromics Limited | 2024-09-23 |
| Millipede 088 Access Catheter; Millipede 070 Aspiration Catheter; Perfuze Aspiration Tube Set (K242504) | Perfuze, Ltd. | 2024-09-20 |
| HiCardi+ H100 (K232670) | MEZOO Co., Ltd. | 2024-09-20 |
| Stethophone (K240901) | Sparrow Acoustics, Inc. | 2024-09-19 |
| Arrow® Nitinol Wire (K241784) | Teleflex Medical | 2024-09-18 |
| Super Sheath Introducer Sheath S-3N5/1005 S-3N7/1006 S-3W5/1007 S-3W7/1008 (K241230) | Togo Medikit Co., Ltd. | 2024-09-17 |
| Medline ReNewal Reprocessed St. Jude Medical Response Electrophysiology Catheter, Supreme Electrophysiology Catheter (401150, 401206, 401207, 401210, 401211, 401212, 401222, 401223, 401226, 401227, 401228, 401260, 401261, 401271, 401305, 401306, 401309, 401310, 401311, 401312, 401317, 401353, 401357, 401381, 401392, 401399, 401400, 401425, 401430, 401433, 401434, 401435, 401436, 401438, 401441, 401442, 401443, 401444, 401445, 401448, 401449, 401450, 401451, 401453, 401466, 401468, 401 (K241156) | Surgical Instrument Service and Savings, Inc. | 2024-09-14 |
| RT Carbon ECG Leads (K240087) | Ivy Biomedical Systems, Inc. | 2024-09-13 |
| Quantum Perfusion Blood Oxygenator VT75-E1, Quantum Perfusion Blood Oxygenator VT75-E2 (K231982) | Qura S.R.L | 2024-09-12 |
| VitalFlow Set with Balance Biosurface (K240880) | Medtronic, Inc. | 2024-09-12 |
| Selectra 3D Lead Delivery System (443624-443629, 451789-451791); Selectra Slitter Tool (383119); Selectra Accessory Kit (375518) (K240787) | Biotronik, Inc. | 2024-09-12 |
| Pounce XL Thrombectomy System (PTS-1011-7F135) (K241362) | Surmodics,Inc. | 2024-09-11 |
| Medline ReNewal Reprocessed Siemens ACUSON AcuNav 8F Ultrasound Catheter (for Siemens Systems) (10135936); Medline ReNewal Reprocessed Siemens ACUSON AcuNav 8F Ultrasound Catheter (for GE Systems) (10135910) (K234064) | Surgical Instrument Service and Savings, Inc. | 2024-09-10 |
| Option ELITE Vena Cava Filter System (352506070E 352506100E) (K242612) | Argon Medical Devices, Inc. | 2024-09-10 |
| Nordica PV Cryo Mapping Catheter (K233900) | Synaptic Medical Corporation | 2024-09-06 |
| SafeCross Vascular Introducer System (4001) (K240600) | East End Medical I, LLC | 2024-09-06 |
| Indigo® Aspiration System – Aspiration Catheter 6X (K242319) | Penumbra, Inc. | 2024-09-03 |
| ShapeIT (SI014135) (K241611) | Imds Operations B.V. | 2024-09-03 |
| ODI-Tech (K241393) | Odi Medical AS | 2024-08-30 |
| VascuChek Kit, VascuChek Transceiver, VascuChek Clinical Probe, VascuChek Charger (VC-KIT-01, VC-TRX-01, VC-CP-01, VC-CH-01); VascuChek Kit, VascuChek Transceiver, VascuChek Surgical Probe, VascuChek Charger (VC-KIT-01, VC-TRX-01, VC-SP-01, VC-CH-01) (K241583) | Remington Medical, Inc. | 2024-08-30 |
| RHYTHMIA HDx™ Mapping System (K241227) | Boston Scientific Corporation | 2024-08-29 |
| Fogarty Thru-Lumen Embolectomy Catheter (K240078) | Edwards Lifesciences, LLC | 2024-08-28 |
| OxiWear (K233827) | Oxiwear, Inc. | 2024-08-28 |
| Disposable Syringe (Kit); Nemoto Disposable Syringe (Kit) (K242212) | Nemoto Kyorindo Co., Ltd. | 2024-08-27 |
| ulricheasyINJECT Max 2M (XD 10140); ulricheasyINJECT Max 3 (XD 10150); ulricheasyINJECT Max 3 (XD 10180) (K241850) | Ulrich GmbH & Co. KG | 2024-08-26 |
| TriClip Steerable Guide Catheter (K241538) | ABBOTT MEDICAL | 2024-08-26 |
| Morph DNA Steerable Introducer Sheath (K242169) | Biocardia | 2024-08-23 |
| Introducer Sheath Kits (K242248) | Beijing Demax Medical Technology Co.,Ltd | 2024-08-22 |
| Single-use Sterile High-pressure Angiographic Syringes and Accessories (K241109) | Shenzhen Boon Medical Supply Co., Ltd. | 2024-08-22 |
| Glidewire GT-R (K240859) | Terumo Corporation | 2024-08-21 |
| Blood Pressure Monitor (TMB-2092-G) (K241351) | Guangdong Transtek Medical Electronics Co., Ltd. | 2024-08-21 |
| HeartKey® Rhythm (K233755) | B-Secur Limited | 2024-08-16 |
| Sapphire NC ULTRA Coronary Dilatation Catheter (K233499) | OrbusNeich Medical (Shenzhen) Co., Ltd. | 2024-08-16 |
| Mecun SpO2 sensor (K231979) | Shenzhen Mecun Medical Supply Co., Ltd. | 2024-08-16 |
| Sapphire ULTRA Coronary Dilatation Catheter (K233505) | OrbusNeich Medical (Shenzhen) Co., Ltd. | 2024-08-15 |
| Catapult Guide Sheath (K240957) | Contract Medical International, GmbH | 2024-08-14 |
| CROSSLEAD Tracker (K241510) | Asahi Intecc Co., Ltd. | 2024-08-14 |
| EnSite™ X EP System (K242016) | ABBOTT MEDICAL | 2024-08-09 |
| Masimo W1 (K240229) | Masimo Corporation | 2024-08-08 |
| SMARxT Tubing and Connectors (K233702) | LivaNova USA, Inc. | 2024-08-08 |
| Sphere-9Dx Diagnostic Catheter (AFR-00009) (K233433) | Medtronic | 2024-08-07 |
| Abiomed 14Fr Low Profile Introducer Kit (K241708) | Abiomed, Inc. | 2024-08-06 |
| Samsung ECG App v 1.3 (ECG) (K240909) | Samsung Electronics Co., Ltd. | 2024-08-02 |
| Acumen Assisted Fluid Management (AFM) Software Feature (K233984) | Edwards Lifesciences, LLC | 2024-08-02 |
| TLAB® Transvenous Liver Biopsy System (TF-18C) (K241145) | Argon Medical Devices, Inc. | 2024-08-01 |
| Infinity CentralStation Wide (K240312) | Draeger Medical Systems, Inc. | 2024-08-01 |
| VenaTech® LP Vena Cava Filter System and VenaTech® Convertible Vena Cava Filter System (K240578) | B.Braun Medical, Inc. | 2024-07-31 |
| ValvuloPro Valvuloplasty Balloon Catheter (K240967) | Dongguan TT Medical, Inc. | 2024-07-31 |
| Accusafe Transseptal Guidewire (GTR31180, GTR31230) (K240246) | Synaptic Medical Corporation | 2024-07-26 |
| STAR Apollo™ Mapping System (K240509) | Rhythm AI, Ltd. | 2024-07-26 |
| Intra-Operative Positioning System (IOPS®) Viewpoint (Simple Curve Catheters); Intra-Operative Positioning System (IOPS®) Viewpoint (Double Curve Catheters) (K241243) | Centerline Biomedical, Inc. | 2024-07-24 |
| AITRICS-VC (K240756) | Aitrics Co., Ltd. | 2024-07-23 |
| NAVOYCDS (K240558) | Algodx AB | 2024-07-22 |
| VasoGuard (V10, V8, V6, V4, V2) (K233976) | Corvascular Diagnostics, LLC | 2024-07-19 |
| Quantum Perfusion Hybrid System (K241206) | Spectrum Medical S.R.L. | 2024-07-18 |
| ICHOR 7F Embolectomy System (ICH-7F) (K233917) | Ichor | 2024-07-18 |
| ACIST RXi System (016616); ACIST Navvus II Catheter (016675_ (K233904) | Acist Medical Systems, Inc. | 2024-07-17 |
| Finesse Injectable™ PTA Balloon Dilatation Catheter (K241740) | Summa Therapeutics | 2024-07-16 |
| VersaCross Connect™ Transseptal Dilator (K241720) | Baylis Medical Company, Inc. | 2024-07-12 |
| Infinity Gateway Suite (K233834) | Draeger Medical Systems, Inc. | 2024-07-12 |
| Oscar Peripheral Multifunctional Catheter system (K241711) | Biotronik, Inc. | 2024-07-11 |
| Drivewire 24 Guidewire (K233791) | Rapid-Medical , Ltd. | 2024-07-11 |
| Sterling™ MONORAIL™ PTA Balloon Dilatation Catheter (H74939031404020 ); Sterling™ MONORAIL™ PTA Balloon Dilatation Catheter (H74939031406020); Sterling™ MONORAIL™ PTA Balloon Dilatation Catheter (H74939031408020); Sterling™ MONORAIL™ PTA Balloon Dilatation Catheter (H74939031410020); Sterling™ MONORAIL™ PTA Balloon Dilatation Catheter (H74939031412020); Sterling™ MONORAIL™ PTA Balloon Dilatation Catheter (H74939031415020); Sterling™ MONORAIL™ PTA Balloon Dilatation Catheter (H749390314 (K241683) | Boston Scientific Corporation | 2024-07-10 |
| Affinity Fusion Oxygenator with Integrated Arterial Filter and Balance Biosurface (BB811); Affinity Fusion Oxygenator with Integrated Arterial Filter and Cardiotomy/Venous Reservoir with Balance Biosurface (BB841); Affinity Fusion Oxygenator with Integrated Arterial Filter and Balance Biosurface NON STERILE (BB811-NS) (K240666) | Medtronic Perfusion Systems | 2024-07-10 |
| Advisor™ HD Grid X Mapping Catheter, Sensor Enabled™ (K241372) | ABBOTT MEDICAL | 2024-07-09 |
| RhythmStar System (K233584) | RhythMedix, LLC | 2024-07-08 |
| Upper Arm Electronic Blood Pressure Monitor (K241129) | Shenzhen Goodlymed Technology Co., Ltd. | 2024-07-03 |
| Next Generation Aspiration Catheter; Balt Aspiration Tubing Set (K234083) | Balt USA, LLC | 2024-07-02 |
| Next Generation Access Catheter (K234074) | Balt USA, LLC | 2024-07-02 |
| Fogarty Fortis Arterial Embolectomy Catheter (K241330) | Edwards Lifesciences | 2024-07-02 |
| Reprocessed Super Torque and Super Torque Plus Diagnostic Angiographic Catheters (K231015) | Innovative Health, LLC | 2024-07-01 |
| Pulse Oximeter (AOJ-70A); Pulse Oximeter (AOJ-70B); Pulse Oximeter (AOJ-70C); Pulse Oximeter (AOJ-70D); Pulse Oximeter (AOJ-70E) (K232989) | Shenzhen AOJ Medical Technology Co., Ltd. | 2024-07-01 |
| NUVISION™ Ultrasound Catheter; NUVISION™ NAV Ultrasound Catheter (K241540) | Biosense Webster, Inc. | 2024-06-28 |
| Cordis BRITECROSS Support Catheter (K233637) | Cordis US Corp | 2024-06-28 |
| Patient Monitor (RespArray) (K240320) | Edan Instruments, Inc. | 2024-06-28 |
| Swan-Ganz Pacing Probe and Catheters; Swan-Ganz Bipolar Pacing Catheter (D97120F5); Swan-Ganz Bipolar Pacing Catheter (D97130F5); Swan-Ganz Pacing Thermodilution TD Catheter (D200F7); Chandler Transluminal V-Pacing Probe (D98100) (K233983) | Edwards Lifesciences | 2024-06-27 |
| EsoCool Thermal Regulation Catheter (K233357) | Nuvaira, Inc. | 2024-06-27 |
| Auryon Atherectomy Catheter 1.7mm; Auryon Atherectomy Catheter 1.7mm, Hydrophilic Coating (K241553) | Eximo Medical, Ltd. | 2024-06-27 |
| ALN Optional Vena Cava Filter (FB.010500, FF.010995, FJ.120096, FB.HOOK, FF.HOOK, FJ.HOOK) (K241507) | Aln S.A.R.L. | 2024-06-26 |
| WVSM Pro (Series) (500-0030-XX) (K233354) | Athena Gtx, Inc. | 2024-06-26 |
| NeoBeat, NeoBeat Mini (K232111) | Laerdal Medical AS | 2024-06-25 |
| ASAHI Veloute; ASAHI Veloute C3; ASAHI Tellus; ASAHI Tellus C3 (K241158) | Asahi Intecc Co., Ltd. | 2024-06-25 |
| Venowave VW5 (K232640) | Thermabright | 2024-06-25 |
| eCARTv5 Clinical Deterioration Suite (“eCART”) (K233253) | Agilemd, Inc. | 2024-06-21 |
| Tempus ECG-AF (K233549) | Tempus AI, Inc. | 2024-06-21 |
| Merge Hemo, Model RCSV2 (K233326) | Merge Healthcare Incorporated | 2024-06-21 |
| Therm-X (Home); Therm-X (AT) (K240125) | Zenith Technical Innovations | 2024-06-21 |
| MINAMO blue; MINAMO viola (K240387) | Asahi Intecc Co., Ltd. | 2024-06-21 |
| Nimbl (model PD08-N1) (K234155) | Tactile Medical | 2024-06-21 |
| Pulse Oximeter (MD300C228) (K232975) | Beijing Choice Electronic Technology Co., Ltd. | 2024-06-21 |
| DeepRhythm Platform (K232161) | Medicalgorithmics S.A. | 2024-06-20 |
| XO Constrain™ Percutaneous Transluminal Angioplasty Constraining Catheter (K232258) | Transit Scientific, LLC | 2024-06-17 |
| Multi-parameter detector (K231116) | Zhongshan Jinli Electronic Weighing Equipment Co., Ltd. | 2024-06-15 |
| Electronic Blood Pressure Monitor (Model: PG-800B30, PG-800B38, PG-800B39, PG-800B45, PG-800B46, PG-800B47, PG-800B48, PG-800B53, PG-800B55, PG-800B56, PG-800B57, PG-800B58, PG-800B61) (K240729) | Shenzhen Pango Medical Electronics Co., Ltd. | 2024-06-14 |
| Disposable High-pressure Extension Lines (K230668) | Precision Medical Plastics , Ltd. | 2024-06-14 |
| FMD Peripheral Guide Wire F-18 Flex 400 (CSU415400259) (K240460) | FMD Co., Ltd. | 2024-06-13 |
| Agilis™ NxT Steerable Introducer Dual-Reach™ (I-V2-MED) (K241370) | ABBOTT MEDICAL | 2024-06-13 |
| Affinity NT Oxygenator and Uncoated Cardiotomy/ Venous Reservoir (541); Affinity NT Oxygenator with Balance Biosurface and Uncoated Cardiotomy/Venous Reservoir (541B) (K241352) | Medtronic, Inc. | 2024-06-12 |
| MEDIBLU ECG SYSTEM (K233266) | Mediblu Medical, LLC | 2024-06-12 |