| Denali™ Vena Cava Filter System – Femoral and Jugular/Subclavian Delivery Kit (K240257) | Bd | 2024-02-29 |
| APRO 55 Catheter and Alembic Aspiration Tubing (K232971) | Alembic, LLC | 2024-02-29 |
| PowerWire Radiofrequency Guidewire Kit (K232562) | Baylis Medical Technologies, Inc. | 2024-02-28 |
| Intra.Ox™ 2.0 Handheld Tissue Oximeter (K233488) | Vioptix, Inc. | 2024-02-28 |
| Lymphedema Compression (K240011) | Jkh Health Co., Ltd. | 2024-02-23 |
| MYOtherm XP Cardioplegia Delivery System with Cortiva BioActive Surface, MYOtherm XP Cardioplegia Delivery System Uncoated (K240190) | Medtronic | 2024-02-23 |
| Soldier Microcatheter (K232536) | Embolx, Inc. | 2024-02-23 |
| R501 - R502 aortic root cannulae with and without vent line (R501-15: R501-20: R501-26. R502-15; R502-20: R502-26) (K240193) | Sorin Group Italia S.R.L. | 2024-02-22 |
| BraidE Embolization Assist Device (DEN230064) | Rapid Medical Ltd. | 2024-02-21 |
| Cocoon Convective Warming System, Model CWS7000 (K232502) | Care Essentials Pty, Ltd. | 2024-02-21 |
| NaviGo 12F Steerable Intracardiac Catheter Introducer Kit (S12FS-01) (K233708) | Synaptic Medical Corporation | 2024-02-16 |
| S-Patch (S-Patch ExL) (K233906) | Wellysis Corp. | 2024-02-16 |
| VasQ (K240119) | Laminate Medical Technologies , Ltd. | 2024-02-16 |
| FreedomFlow Orbital Circumferential Atherectomy System (H6004/5Fr 3-Sphere Configuration) (K233483) | Cardio Flow Inc., | 2024-02-15 |
| EPi-Ease Epicardial Access Device (EAS) (K233959) | AtriCure, Inc. | 2024-02-13 |
| Easi-Vue® embolic microspheres System (K234123) | Abk Biomedical, Inc. | 2024-02-13 |
| Neteera 130H-Plus Vital Sign Monitoring Sensor (K231733) | Neteera Technologies , Ltd. | 2024-02-09 |
| VenaCore Thrombectomy Catheter (46-101) (K234034) | Inari Medical, Inc. | 2024-02-09 |
| SINC Support Catheter (K233350) | Reflow Medical, Inc. | 2024-02-08 |
| EZ Glide Aortic Perfusion Cannulae (EZC21A, EZC21TA, EZC24A, EZC24TA, EZF21A, EZF21TA, EZF24A, EZF24TA, EZS21A, EZS21TA, EZS24A and EZS24TA); OptiSite Arterial Perfusion Cannulae (OPTI16, OPTI18, OPTI20 and OPTI22); EndoReturn Arterial Cannulae (ER21B and ER23B); (K233895) | Edwards Lifesciences | 2024-02-05 |
| Central Monitoring System (MFM-CMS) (K232694) | Edan Instruments, Inc. | 2024-02-05 |
| Indigo® Aspiration System - Lightning® Flash (K240030) | Penumbra, Inc. | 2024-02-02 |
| WATCHMAN TruSteer Access System (M635TU90050) (K240018) | Boston Scientific Corporation | 2024-02-01 |
| CardioCurve Steerable Sheath Small Curl, 40cm (CC-1040S ); CardioCurve Steerable Sheath Medium Curl, 40cm (CC-1040M ); CardioCurve Steerable Sheath Large Curl, 40cm (CC-1040L ); CardioCurve Steerable Sheath Small Curl, 61cm (CC-1061S); CardioCurve Steerable Sheath Medium Curl, 61cm (CC-1061M ); CardioCurve Steerable Sheath Large Curl, 61cm (CC-1061L); CardioCurve Steerable Sheath Small Curl, 71cm (CC-1071S ); CardioCurve Steerable Sheath Medium Curl, 71cm (CC-1071M ); CardioCurve Steer (K240004) | Circa Scientific, Inc. | 2024-01-31 |
| MightySat -OTC (K214115) | Masimo Corporation | 2024-01-31 |
| CentriMag™ Acute Circulatory Support System (K234118) | ABBOTT MEDICAL | 2024-01-26 |
| Arm-type Fully Automatic Digital Blood Pressure Monitor (K231303) | Joytech Healthcare Co. , Ltd. | 2024-01-26 |
| Distal Access Catheter (K231218) | Accumedical Beijing , Ltd. | 2024-01-19 |
| LifeSPARC System (K233736) | Cardiacassist, Inc. | 2024-01-19 |
| Cleaner™ Pro Thrombectomy System; Cleaner™ Pro Aspiration Catheter with Handpiece; Cleaner™ Pro Aspiration Canister (K232679) | Argon Medical Devices, Inc. | 2024-01-19 |
| Radial Compression Device (K232577) | Ningbo Dizegens Medical Science Co.,Ltd | 2024-01-18 |
| Celect Platinum Vena Cava Filter Set for Femoral Vein Approach (IGTCFS-65-1-FEM-CELECT-PT); Celect Platinum Vena Cava Filter Set for Jugular Vein Approach (IGTCFS-65-1-JUG-CELECT-PT); Celect Platinum Vena Cava Filter Set for Femoral and Jugular Vein Approach (IGTCFS-65-1-UNI-CELECT-PT); Günther Tulip Vena Cava Filter Set for Femoral Vein Approach (IGTCFS-65-1-FEM-TULIP); Günther Tulip Vena Cava Filter Set for Jugular Vein Approach (IGTCFS-65-1-JUG-TULIP); Günther Tulip Vena Cava Filter (K233680) | William Cook Europe Aps | 2024-01-18 |
| exGraft ePTFE Vascular Grafts, exGraft Carbon ePTFE Vascular Grafts (K233783) | Peca Labs, Inc. | 2024-01-17 |
| Cerenovus Large Bore Catheter; Cerenovus Aspiration Tubing Set (K233988) | Cerenovus, Inc. | 2024-01-17 |
| CLEWICU System (K233216) | Clew Medical , Ltd. | 2024-01-13 |
| GORE® PROPATEN® Vascular Graft (K232312) | W. L. Gore & Associates, Inc. | 2024-01-09 |
| Teleport XT Microcatheter (K231608) | OrbusNeich Medical (Shenzhen) Co., Ltd. | 2024-01-07 |
| Lifetech Cardio Temporary Pacemaker (K232721) | Shenzhen Lifetech Cardio Medical Electronics Co., Ltd. | 2024-01-07 |
| Dayspring (K223228) | Koya Medical, Inc. | 2024-01-04 |
| Pulse Oximeter(Model OHT60,OXH78) (K230277) | Cofoe Medical Technology Co., Ltd. | 2024-01-04 |
| Pursuant Health Kiosk (G1.D5) (K230996) | Pursuant Health | 2024-01-04 |
| TriSalus TriGuideTM Guiding Catheter (K233858) | Trisalus Life Sciences | 2023-12-27 |
| Distal Access Catheter (K233205) | Shanghai Heartcare Medical Technology Co., Ltd. | 2023-12-22 |
| CPM System (K231086) | Analog Devices, Inc. | 2023-12-22 |
| ElastiMed SACS (K232300) | Elastimed , Ltd. | 2023-12-22 |
| Reusable Blood Pressure Cuff (K233276) | Suzhou Minhua Medical Apparatus Supplies Co., Ltd. | 2023-12-21 |
| Bearing nsPVA Express™ (K233813) | Merit Medical Systems, Inc. | 2023-12-21 |
| Pediarity™ (K231531) | Hinlab, Inc. | 2023-12-21 |
| SureFlex HD Steerable Sheath, VersaCross HD Steerable Sheath (K231227) | Baylis Medical Company, Inc. | 2023-12-20 |
| HP PTA Balloon Dilatation Catheter (K231402) | Kossel Medtech (Suzhou) Co., Ltd. | 2023-12-20 |
| Cogent™ Hemodynamic Monitoring System; Cogent™ HMS (K232048) | Icu Medical | 2023-12-20 |
| Blood Pressure Monitor (K233130) | Guangdong Transtek Medical Electronics Co., Ltd. | 2023-12-20 |
| IntelliVue Patient Monitor MX750 (866471), IntelliVue Patient Monitor MX850 (866470), IntelliVue 4-Slot Module Rack FMX-4 (866468) (K231671) | Philips Medizin Systeme Boeblingen GmbH | 2023-12-19 |
| JETi™Hydrodynamic Thrombectomy System (K232458) | ABBOTT MEDICAL | 2023-12-19 |
| GORE® ACUSEAL Vascular Graft (K233551) | W. L. Gore & Associates, Inc. | 2023-12-19 |
| ClotTriever Sheath (K233815) | Inari Medical, Inc. | 2023-12-18 |
| FlexCath Cross Transseptal Solution (K233691) | Acutus Medical, Inc. | 2023-12-17 |
| Digital Blood Pressure Monitor (Model: YB-800) (K231478) | Wenzhou Yosun Medical Technology Co.,Ltd | 2023-12-15 |
| Medline ReNewal Reprocessed ViewFlex Xtra ICE Catheter (K232130) | Surgical Instrument Services and Savings, Inc. | 2023-12-15 |
| Masimo Stork (K223721) | Masimo Corporation | 2023-12-15 |
| Cardio Q50, Cardio Q70 (K231160) | Bionet Co., Ltd. | 2023-12-15 |
| Auryon Atherectomy Catheter 1.5 mm XL, Hydrophilic Coating (EXM-4010-H000), Auryon Atherectomy Catheter 0.9 mm XL, Hydrophilic Coating (EXM-4011-H000), Auryon Atherectomy Catheter 1.5 mm XL (EXM -4010-0000), Auryon Atherectomy Catheter 0.9 mm XL (EXM-4011-0000) (K233668) | Eximo Medical, Ltd. | 2023-12-15 |
| MedHealth DVT compression Devices MHH900S/MHH900E (K231801) | Medhealth Medical Limited | 2023-12-14 |
| VersaCross Connect™ Transseptal Dilator (K233647) | Baylis Medical Company, Inc. | 2023-12-14 |
| Millipede 088 Access Catheter (K233648) | Perfuze, Ltd. | 2023-12-14 |
| CASE V7.0 Cardiac Testing System and CardioSoft V7.0 Cardiac Testing System (K231870) | Ge Medical Systems Information Technologies, Inc. | 2023-12-13 |
| Intri24 Introducer Sheath (52-101) (K233646) | Inari Medical, Inc. | 2023-12-12 |
| Wrist Blood Pressure Monitor (K232815) | Zhuhai Yueja Medical Device Technology Co., Ltd. | 2023-12-11 |
| FARADRIVE™ Steerable Sheath (K233248) | Boston Scientific Corporation | 2023-12-11 |
| 10F Sheath and Dilator Set (K233432) | Argon Medical Devices, Inc. | 2023-12-08 |
| SimpleSense-BP, SimpleSense-BP Software Application (K232053) | Nanowear, Inc. | 2023-12-08 |
| DLP Silicone Coronary Artery Ostial Cannulae (K231206) | Medtronic, Inc. | 2023-12-07 |
| QT ECG (QTERD100) (K233521) | QT Medical, Inc. | 2023-12-06 |
| LINQ II Insertable Cardiac Monitor (K233562) | Medtronic, Inc. | 2023-12-06 |
| Electronic Blood Pressure Monitor (K232814) | Zhuhai Yueja Medical Device Technology Co., Ltd. | 2023-12-05 |
| Electronic Blood Pressure Monitor, model: HTD6602US (K223170) | Hetaida Technology Co., Ltd. | 2023-12-05 |
| Cosine-10TM Diagnostic Catheter (K233397) | Medtronic, Inc. | 2023-12-02 |
| Slinky Catheter (K231179) | Anoxia Medical, Inc. | 2023-12-01 |
| Medline ComfortTemp Patient Warming System (K231211) | Medline Industries, LP | 2023-12-01 |
| Radical the Dude 7F Guide Catheter (K231393) | Maduro Medical, Inc. | 2023-11-30 |
| Wrist Pulse Oximeter (K230587) | Beijing Choice Electronic Technology Co., Ltd. | 2023-11-30 |
| 14F iSLEEVE Introducer Set (K233503) | Boston Scientific Corporation | 2023-11-30 |
| Blood Pressure Cuff (1201D1,12L2D1,1202D1,12L3D1,1203D1,1204D1,1205D1,1206D1,1207D1-1#,1207D1-2#,1207D1-3#,1207D1-4#,1207D1-5#,1201B1,12L2B1,1202B1,12L3B1,1203B1,1204B1,1205B1,1206B1,1207B1-1#,1207B1-2#,,1207B1-3#,1207B1-4#,1207B1-5#,1201W2,12L2W2,1202W2,12L3W2,1203W2,1204W2,1205W2,1206W2 and 1207W2) (K232772) | Shenzhen Plinma Technology Co. , Ltd. | 2023-11-29 |
| CEREGLIDE 92 Intermediate Catheter (K230726) | Cerenovus, Inc. | 2023-11-29 |
| XO Cath Microcatheter (E20-090-S, E20-110-S, E20-130-S, E20-150-S, E20-175-S, E20-220-S, E20-090-B, E20-110-B, E20-130-B, E20-150-B, E20-175-B, E20-220-B, E26-090-S, E26-110-S, E26-130-S, E26-150-S, E26-175-S, E26-220-S, E26-090-B, E26-110-B, E26-130-B, E26-150-B, E26-175-B, E26-220-B,) (K231821) | Transit Scientific, LLC | 2023-11-29 |
| Digital Blood Pressure Monitor (K231250) | Guangdong Genial Technology Co., Ltd. | 2023-11-28 |
| Blood Pressure Monitor (K232713) | Guangdong Transtek Medical Electronics Co., Ltd. | 2023-11-28 |
| ABPMpro (K231104) | Somnomedics GmbH | 2023-11-27 |
| NeuTrace EP Mapping System v.2.1 (K233160) | Anumana, Inc. | 2023-11-25 |
| Blood pressure monitor (K232621) | Guangdong Transtek Medical Electronics Co., Ltd. | 2023-11-22 |
| Carnation Ambulatory Monitor (K233110) | Bardy Diagnostics, Inc. | 2023-11-22 |
| Fogg System Patient Monitoring Cables (K222712) | Fogg System Company, Inc. | 2023-11-22 |
| IntelliVue Patient Monitor MX100 (867033), IntelliVue Multi-Measurement Module X3 (867030) (K230604) | Philips Medizin Systeme Boeblingen GmbH | 2023-11-22 |
| Digital Blood Pressure Monitor (Arm Type) (K231245) | Guangdong Genial Technology Co., Ltd. | 2023-11-22 |
| CARDIPIA ECG / Model: CARDIPIA400H, CARDIPIA800H (K230834) | Trismed Co., Ltd. | 2023-11-21 |
| High Pressure Tubing (K232388) | Ningbo Dizegens Medical Science Co.,Ltd | 2023-11-21 |
| INFINITI™ Ambi Angiographic Catheter (K232573) | Cordis US Corp | 2023-11-21 |
| Masimo W1 (K232512) | Masimo Corporation | 2023-11-17 |
| SENDERO Microcatheter (K231600) | Okami Medical, Inc. | 2023-11-17 |
| Edwards Algorithm for Measurement of Blood Hemoglobin (K230612) | Edwards Lifesciences, LLC | 2023-11-17 |