| AuST Steerable Sheath (K251051) | CenterPoint Systems, LLC | 2025-04-30 |
| Arctic Sun Stat Temperature Management System (K243942) | Medivance, Inc. | 2025-04-30 |
| APRO 45 Catheter and Alembic Aspiration Tubing (K251015) | Alembic, LLC | 2025-04-30 |
| Arm Blood Pressure Monitor (ARM-30A+);Arm Blood Pressure Monitor (ARM-30G2);Arm Blood Pressure Monitor (ARM-30Q);Arm Blood Pressure Monitor (ARM-30E+); (K244000) | Shenzhen AOJ Medical Technology Co., Ltd. | 2025-04-30 |
| APRO 55 Intermediate Catheter (K250962) | Alembic, LLC | 2025-04-29 |
| APRO 55 Swift Catheter and Alembic Aspiration Tubing (K250958) | Alembic, LLC | 2025-04-28 |
| Amulet™ Steerable Delivery Sheath (K250426) | ABBOTT MEDICAL | 2025-04-25 |
| Prelude Wave Hydrophilic Sheath Introducer (K250909) | Merit Medical Systems, Inc. | 2025-04-25 |
| FreedomFlow™ Orbital Circumferential Atherectomy System (H6005/ 4Fr 3-Sphere Configuration) (K250723) | Cardio Flow Inc., | 2025-04-25 |
| PeriCross™ Epicardial Access Kit (K243954) | Circa Scientific, Inc. | 2025-04-24 |
| Arm Blood Pressure Monitor (ARM-30H); Arm Blood Pressure Monitor (ARM-30J); Arm Blood Pressure Monitor (ARM-30K); Arm Blood Pressure Monitor (ARM-90B) (K250116) | Shenzhen AOJ Medical Technology Co., Ltd. | 2025-04-24 |
| Aperta NSE PTA Balloon Dilatation Catheter (K243944) | Goodman Co., Ltd. | 2025-04-22 |
| D·Kutting™ LL Peripheral Scoring Balloon Dilatation Catheter (K242254) | Dk Medical Technology Co., Ltd. | 2025-04-21 |
| CHIKAI Nexus 014 (K243383) | Asahi Intecc Co., Ltd. | 2025-04-21 |
| PeriBeam® Pericardial Membrane (K240775) | Tamabio | 2025-04-18 |
| VitalRhythm (K242129) | Vitalconnect, Inc. | 2025-04-17 |
| FlowGuide (FG60F); GuidionShort (GS60F) (K242337) | Imds Operations B.V. | 2025-04-17 |
| Elfor-L (K243852) | Elfi-Tech , Ltd. | 2025-04-14 |
| Globalcare Blood Pressure Monitor (GUS610) (K250136) | Globalcare Medical Technology Co., Ltd. | 2025-04-08 |
| LiquID .051 LP Guide Catheter Extension (K243691) | Seigla Medical, Inc. | 2025-04-04 |
| JETi Hydrodynamic Thrombectomy System (K243549) | ABBOTT MEDICAL | 2025-04-04 |
| 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 |
| WHOOP ECG (electrocardiogram) Feature (1.0) (K243236) | Whoop., Inc. | 2025-04-04 |
| Masimo W1 (K243305) | Masimo Corporation | 2025-04-03 |
| SION blue PLUS (K243733) | Asahi Intecc Co., Ltd. | 2025-04-02 |
| Aristotle 14 Guidewire; Aristotle 18 Guidewire; Aristotle 24 Guidewire; Zoom Wire 14 Guidewire; Aristotle Colossus Guidewire (K243938) | Scientia Vascular, Inc. | 2025-04-01 |
| SelectSite C304 Deflectable Catheter System (C304); C315 Delivery System (C315) (K250558) | Medtronic, Inc. | 2025-03-27 |
| Crossloop (K241962) | Asahi Intecc Co., Ltd. | 2025-03-27 |
| Edwards eSheath Optima introducer set (K244046) | Edwards Lifesciences | 2025-03-27 |
| AC3™ Range™ Intra-Aortic Balloon Pump (K250542) | Arrow International, LLC | 2025-03-26 |
| Aventus Thrombectomy System (IM-2100) (K250668) | Inquis Medical | 2025-03-25 |
| Bolt Intravascular Lithotripsy (IVL) System (K250225) | Bolt Medical, Inc. | 2025-03-25 |
| VentiV 7Fr -12Fr MP Mechanical Thrombectomy System (VS7-MP60S, VS7-MP90S, VS8-MP60S, VS8-MP90S, VS8-MP100B, VS10-MP100B, VS11-MP60S, VS11-MP90S, VS12-MP100B, 7F-MP60S, 7F-MP90S, 8F-MP60S, 8F-MP100B, 10F-MP100B, 11F-MP60S, 11F-MP90S, 11P-MP60S, 11P-MP90S, 12F-MP100B, V30-ASP) (K250013) | Control Medical Technology, Inc. / Dba Ventiv Scientific | 2025-03-24 |
| VERAFEYE System VERAFEYE Imaging Catheter & VERAFEYE Imaging System (K242893) | Luma Vision Limited | 2025-03-24 |
| FloTrac sensors; FloTrac Jr sensors; Acumen IQ sensors; VolumeView sensors (K242909) | Edwards Lifesciences, LLC | 2025-03-21 |
| Philips Holter Analysis System (K241890) | Philips Medizin Systeme Böblingen GmbH | 2025-03-21 |
| Excelsior XT-27 Microcatheter, Excelsior XT-27 Flex Microcatheter, Excelsior XT-27 Pre-Shaped Microcatheter, Excelsior XT-27 Flex Pre-Shaped Microcatheter (K242289) | Stryker Neurovascular | 2025-03-21 |
| iSLEEVE Introducer Set (K250468) | Boston Scientific | 2025-03-20 |
| ViaOne Epicardial Access System (K243928) | Cardiovia , Ltd. | 2025-03-20 |
| CarbonCool® System (K240933) | Global Healthcare SG Sdn. Bhd | 2025-03-18 |
| Catapult Guide Sheath; 4F; 15cm (US-34015-F-ST-H); Catapult Guide Sheath; 4F; 45cm (US-34045-F-ST-H); Catapult Guide Sheath; 4F; 60cm (US-34060-F-ST-H); Catapult Guide Sheath; 4F; 90cm (US-34090-F-ST-H); Catapult Guide Sheath; 4F; 130cm (US-34130-F-ST-H); Catapult Guide Sheath; 5F; 15cm (US-35015-F-ST-H); Catapult Guide Sheath; 5F; 45cm (US-35045-F-ST-H); Catapult Guide Sheath; 5F; 45cm; Hockey Stick (US-35045-F-HS-H); Catapult Guide Sheath; 5F; 45cm; Multipurpose (US-35045-F-MP-H); Ca (K250439) | Contract Medical International, GmbH | 2025-03-16 |
| KOROT Blood Pressure Monitor (KOROT P3 Accurate) (K250091) | Korot Co., Ltd. | 2025-03-14 |
| Ruby XL System (K250079) | Penumbra, Inc. | 2025-03-14 |
| Turbo-Elite Laser Atherectomy Catheter (K250385) | Spectranetics | 2025-03-13 |
| FlowTriever2 Catheter (K250088) | Inari Medical, Inc. | 2025-03-13 |
| OutFlo Aortic Valve Dilatation Balloon Catheter (K241562) | Disa Medinotec | 2025-03-11 |
| Medline ReNewal Reprocessed Siemens ACUSON AcuNav 10F Ultrasound Catheter (for Siemens Systems) (08255790 ); Medline ReNewal Reprocessed Siemens ACUSON AcuNav 10F Ultrasound Catheter (for GE Systems) (10043342) (K243101) | Surgical Instrument Service and Savings, Inc. | 2025-03-10 |
| Intra-Operative Positioning System (IOPS®) (K243842) | Centerline Biomedical, Inc. | 2025-03-06 |
| CROSSLEAD 0.018inch (K242597) | Asahi Intecc Co., Ltd. | 2025-03-05 |
| Pulse Oximeter ( PO2, PO2A, PO2B) (K242876) | Shenzhen Viatom Technology Co., Ltd. | 2025-02-28 |
| Seclusion Catheter (K243436) | Basis Medical | 2025-02-28 |
| Parafleet SC 014 PTA Balloon Dilatation Catheter; Parafleet SC 018 PTA Balloon Dilatation Catheter; Parafleet SC 035 PTA Balloon Dilatation Catheter (K243704) | Brosmed Medical Co., Ltd. | 2025-02-27 |
| Gelweave™ Vascular Prostheses (K241550) | Vascutek, Ltd. | 2025-02-27 |
| Aventus Thrombectomy System (K250202) | Inquis Medical | 2025-02-26 |
| Makoto Intravascular Imaging System™ (VC-MC10 / TVC-MC10i); Dualpro™ IVUS+NIRS Imaging Catheter (TVC-C195-42); Peripheral 014 Imaging Catheter (TVC-E195-42 ) (K241576) | Infraredx, Inc. | 2025-02-26 |
| Millipede 070 Aspiration Catheter; Perfuze Aspiration Tube Set (K250012) | Perfuze, Ltd. | 2025-02-26 |
| Aulisa Oximeter Module (2nd Gen.) (GA-OM0007, GA-OM0008) (K233963) | Taiwan Aulisa Medical Devices Technologies, Inc. | 2025-02-25 |
| Loss of Pulse Detection (K242967) | Fitbit | 2025-02-25 |
| APRO 70 Swift Catheter and Alembic Aspiration Tubing (K243287) | Alembic, LLC | 2025-02-24 |
| Upper Arm Electronic Blood Pressure Monitor (U87Y series (models including U80Y, U81Y, U82Y,U83Y,U86Y U80N, U81NH), U86E series (including U82E, U80E, U80EH, U81E, U83E, U85E, U80L, U87E ), U81X series (including U81X, U80X, U82X, U83X, U81D, U82D, U83D, U81RH, U82RH) and U83Z series (including U83Z, U80Z, U81Z, U82Z, U85Z, U86Z and U87Z)) (K243115) | Shenzhen Urion Technology Co., Ltd. | 2025-02-21 |
| Unimed Reusable Finger Clip SpO2 Sensors (UXXX-91 Series) (U403-91); Unimed Reusable Finger Clip SpO2 Sensors (UXXX-91 Series) (U410-91) (K243086) | Unimed Medical Supplies, Inc. | 2025-02-20 |
| CER-S (K243312) | Cardiocalm Srl | 2025-02-20 |
| Wrist Digital Blood Pressure Monitor (BSX312, BSX313, BSX315, BSX322, BSX323, BSX353, BSX355) (K241578) | Shenzhen Bsx Technology Electronics Co., Ltd. | 2025-02-19 |
| AViTA Pulse Oximeter (SP62B) (K242455) | Avita Corporation | 2025-02-19 |
| AXS Lift Intracranial Base Catheter (K243593) | Stryker Neurovascular | 2025-02-18 |
| LimFlow V-Ceiver (K242776) | LimFlow, Inc. | 2025-02-14 |
| WARD-CSS (v1.2.x) (K241958) | Ward 24/7 Aps | 2025-02-14 |
| Penumbra System (Reperfusion Catheter RED 72) (K242104) | Penumbra, Inc. | 2025-02-13 |
| OptoMonitor 3 (K241418) | Opsens, Inc. | 2025-02-12 |
| Etiometry Platform (DAV 5.4 RAE 9.2) (K241479) | Etiometry, Inc. | 2025-02-12 |
| Wrist Blood Pressure Monitor (XY-W01A, XY-W01B) (K241634) | Guangdong Xinyu Electronic and Technology Co., Ltd. | 2025-02-11 |
| Electronic Blood Pressure Monitor (K243661) | Hetaida Technology Co., Ltd. | 2025-02-07 |
| CROSSLEAD 0.014inch (K241702) | Asahi Intecc Co., Ltd. | 2025-02-06 |
| Unimed Reusable Finger Clip SpO2 Sensors (U103-125); Unimed Reusable Finger Clip SpO2 Sensors (U403-254); Unimed Reusable Finger Clip SpO2 Sensors (U103-254); Unimed Reusable Finger Clip SpO2 Sensors (U403-125) (K242580) | Unimed Medical Supplies, Inc. | 2025-02-06 |
| Accurate Mini Non-invasive blood pressure monitor (AMB-001) (K242352) | Accurate Meditech, Inc. | 2025-02-05 |
| iCare APP (K243146) | Ihealth Labs, Inc. | 2025-02-03 |
| Arm Blood Pressure Monitor (XY-B01, XY-B02, XY-B03, XY-B05, XY-B07, XY-B08, XY-B09) (K241590) | Guangdong Xinyu Electronic and Technology Co., Ltd. | 2025-02-03 |
| Semi-Floating Temporary Pacing Electrode Catheter, Bipolar, Stainless Steel Electrodes, 115 cm, 4Fr. (006221P); Semi-Floating Temporary Pacing Electrode Catheter, Bipolar, Stainless Steel Electrodes, 115 cm, 5Fr. (006225P); Semi-Floating Temporary Pacing Electrode Catheter, Bipolar, Stainless Steel Electrodes, 125 cm, 6Fr. (006241P); Semi-Floating Temporary Pacing Electrode Catheter, Bipolar, Stainless Steel Electrodes, 125 cm, 7Fr. (006242P); NBIH™ Temporary Pacing Electrode Catheter, (K241334) | C.R. Bard, Inc. | 2025-01-31 |
| Gentuity® HF-OCT Imaging System with Vis-Rx Prime® Micro-Imaging Catheter (K242966) | Gentuity, LLC | 2025-01-31 |
| Rotarex Atherectomy System (K242757) | Bard Peripheral Vascular, Inc. | 2025-01-30 |
| Wrist Blood Pressure Monitor (OHMS11, OHMS12) (K242568) | Shenzhen Zhongkemingwang Telecommunications Software Corp. | 2025-01-30 |
| Aulisa Infant Oximeter Module (2nd Gen.) (GA-OM0018) (K233956) | Taiwan Aulisa Medical Devices Technologies, Inc. | 2025-01-30 |
| Rotatable Connector (5944RL) (K241199) | Shenzhen Launch Electrical Co., Ltd. | 2025-01-23 |
| Vios Monitoring System(TM) Model 2050; Vios Central Station Monitor/Vios Central Server Software 2050 (K241728) | Murata Vios, Inc. | 2025-01-23 |
| Streamline Unipolar Pediatric Temporary Pacing Lead (6491) Streamline Unipolar Temporary Atrial Pacing Lead (6492) Streamline Unipolar Temporary Myocardial Pacing Wire (6494) Streamline Bipolar Temporary Myocardial Pacing Lead (6495) Streamline Unipolar Temporary Myocardial Pacing Lead (6500) (K242705) | Medtronic, Inc. | 2025-01-17 |
| Embozene Color-Advanced Microspheres (K242608) | Varian Medical Systems, Inc. | 2025-01-17 |
| Philips Reusable ECG Lead Sets and Trunk Cables : Model Number,Model Name: 989803170171, OR 3-Lead ECG Trunk Cable, AAMI/IEC; 989803170181, OR 5-Lead ECG Trunk Cable, AAMI/IEC; M1667A, 6 Lead ECG Trunk, AAMI/IEC 2.7m; M1668A,5 Lead ECG Trunk, AAMI/IEC 2.7m; M1669A,3 Lead ECG Trunk, AAMI/IEC 2.7m; M1949A,5+5 ECG Trunk cable AAMI, IEC 2.7m; M1663A,10 Lead ECG Trunk AAMI/IEC 2m; M1665A, 6+4 Lead ECG Trunk AAMI/IEC 2.7m; M1671A, 3 Leadset, Grabber, AAMI, ICU; M1673A, 3 Leadset, Sn (K243545) | Philips Medizin Systeme Böblingen GmbH | 2025-01-17 |
| VersaD Delivery Catheter (K242051) | Unity Medical, Inc. | 2025-01-17 |
| Affera Integrated Mapping System (K243892) | Medtronic, Inc. | 2025-01-17 |
| CloudHRV™ System (100-01-001) (K241217) | Inmedix, Inc. | 2025-01-16 |
| Venera 608 Deep Vein Thrombosis (DVT) Prevention System (K241096) | Suzhou Minhua Medical Apparatus Supplies Co., Ltd. | 2025-01-15 |
| Ventrax™ Delivery System (K242873) | Merit Medical Systems, Inc. | 2025-01-15 |
| Micro Ace Gold Advanced Micro Access System (K242229) | Merit Medical Systems, Inc. | 2025-01-15 |
| BB-613-BPM (K241066) | Biobeat Technologies , Ltd. | 2025-01-14 |
| Zoom System (K242672) | Imperative Care, Inc. | 2025-01-14 |
| Radical the Dude 8F Guide Catheter (K243577) | Maduro Medical, Inc. | 2025-01-14 |
| APRO 70 Swift Catheter (K243297) | Alembic, LLC | 2025-01-14 |
| Arm-type Fully Automatic Digital Blood Pressure Monitor (DBP-62D0L, DBP-62D0B, DBP-61D0, DBP-61D0L, DBP-6293L, DBP-6293B, DBP-6193) (K241431) | Joytech Healthcare Co. , Ltd. | 2025-01-13 |
| Solo Pace Control (K241781) | Solo Pace, Inc. | 2025-01-10 |
| Blood Pressure Monitor (RAK260, RAK262, RAK263, RAK266, RAK268, RAK269, RAK282, RAK283, RAK286, RAK288, RAK289, RAK291, RAK292, RAK293, RAK295, RAK296, RAK297, RAK298) (K242528) | Shenzhen Ruiankang Technology Co., Ltd. | 2025-01-10 |