| CATALYSTEM Femoral Stems (K250571) | Smith & Nephew, Inc. | 2025-03-28 |
| ImagingRing m (Version 2.0); Loop-X (Version 2.0); Loop-X Mobile Imaging Robot (Version 2.0) (K234067) | Medphoton GmbH | 2025-03-28 |
| Synthes Graphic Case & Tray System (K241927) | Synthes GmbH | 2025-03-28 |
| Bullsai Confirm (K243520) | Turing Medical Technologies, Inc. | 2025-03-28 |
| Flexi-Seal AIR (with ENFit Connector) (K243228) | Convatec | 2025-03-28 |
| Access Toxo IgG (K242022) | Beckman Coulter, Inc. | 2025-03-28 |
| PBC Separator with Selux AST System (K244044) | Selux Diagnostics, Inc. | 2025-03-28 |
| INNOVANCE Antithrombin (K242952) | Siemens Healthcare Diagnostic Products GmbH | 2025-03-28 |
| Makani Science™ Respiration Monitoring System (K233953) | Makani Science, Inc. | 2025-03-28 |
| Nurochek-Pro System (K243426) | Headsafe Mfg Pty, Ltd. | 2025-03-27 |
| iTotal® Identity™ Cruciate Retaining 3DP Porous Knee Replacement System (K243768) | Restor3D, Inc. | 2025-03-27 |
| MallyaD injection pen adapter (MallyaD) (K250555) | Biocorp Production | 2025-03-27 |
| HyperSuture White/Green Extension Line (K242201) | Threadstone, LLC | 2025-03-27 |
| StarFormer (M008-3T) (K241785) | Fotona D.O.O. | 2025-03-27 |
| Salix Central (K243038) | Artrya Limited | 2025-03-27 |
| HydroMID 5F Dual Lumen Midline Catheter - Basic Kit (70006102); HydroMID 5F Dual Lumen Midline Catheter - Max Barrier Kit (70006104); HydroMID 5F Dual Lumen Midline Catheter - Mobile Max Barrier Kit (90006104) (K244059) | Access Vascular, Inc. | 2025-03-27 |
| 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 |
| Levina Pelvic Floor Muscle Stimulator (RS-48) (K241862) | Zmi Electronics , Ltd. | 2025-03-27 |
| AI-Rad Companion Organs RT (K242745) | Siemens Healthcare GmbH | 2025-03-27 |
| V5med Lung AI (K242919) | V5med, Inc. | 2025-03-27 |
| Urology Videoscope System (Single-use Flexible Ureteroscope: SUV-1A-B, SUV-1A-P, SUV-2A-B, SUV-2A-P, SUV-2B-B, SUB-2B-P, SUV-2C-B, SUV-2C-P;Single-use Flexible Cystoscope: SUV-1D-B, SUV-1D-P; Endoscopic Image Processor: HDVS-S100A, HDVS-S100D.) (K243708) | Scivita Medical Technology Co., Ltd. | 2025-03-27 |
| HC Biologics Osteopoint Spinal Fixation System (K250092) | HC Biologics, LLC | 2025-03-27 |
| Belzer MPS® (UW Machine Perfusion Solution) (BMPS-001) (K243840) | Bridge TO Life | 2025-03-26 |
| NM-01/CPT neurometer (NM-01/CPT) (K240189) | Mde Orvosbiológiai Kutató, Fejleszto, | 2025-03-26 |
| AC3™ Range™ Intra-Aortic Balloon Pump (K250542) | Arrow International, LLC | 2025-03-26 |
| Rayvolve LN (K243831) | AZmed | 2025-03-26 |
| SnapshotGLO (KB100) (K242669) | Kent Imaging, Inc. | 2025-03-26 |
| Arthrex Humeral Plating System and Cerclage Button (K243995) | Arthrex, Inc. | 2025-03-26 |
| EarliPoint System (K243891) | Earlitec Diagnostics | 2025-03-26 |
| Power Wheelchair (YH-E6011,YH-E6013A) (K250134) | Ningbo Youhuan Automation Technology Co., Ltd. | 2025-03-26 |
| SB Knife Jr2 (MD-47702 and MD-47702L) (K241855) | Sb-Kawasumi Laboratories, Inc. | 2025-03-26 |
| Ice Cooling IPL Hair Removal Device (UI06S PR, UI06S PN, UI06S WH) (K250194) | Shenzhen Ulike Smart Electronics Co., Ltd. | 2025-03-26 |
| Electrically powered wheelchair (K244003) | Kunshan Hi-Fortune Health Products Co., Ltd. | 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 |
| AERO MIS Facet Fusion System (K243865) | Aurora Spine | 2025-03-24 |
| AxTiHA® Stand-Alone ALIF System (K250603) | Innovasis | 2025-03-24 |
| LMNT O2 (K250125) | Xplr , Ltd. | 2025-03-24 |
| Sonopet iQ Ultrasonic Aspirator System (5500-050-000) (K243930) | Stryker Instruments | 2025-03-24 |
| TIDAL Fusion Cage System (K242356) | Restor3D, Inc. | 2025-03-24 |
| SonoTAP and SonoTAP II (K243525) | PAJUNK GmbH Medizintechnologie | 2025-03-24 |
| Innovasis Navigation Instruments (K250182) | Innovasis, Inc. | 2025-03-24 |
| Klassic Knee System - Revision Tibial Baseplate (K243991) | Total Joint Othopedics, Inc. | 2025-03-24 |
| UltraCor™ Twirl™ Breast Tissue Marker (K243642) | Bard Peripheral Vascular, Inc. | 2025-03-24 |
| Alinity m BKV (K241921) | Abbott Molecular, Inc. | 2025-03-24 |
| 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 |
| Glean Urodynamics System Male Delivery System (GUS-1000-M); Glean Urodynamics System Female Delivery System (GUS-1000-F); Glean Urodynamics System Uroflowmeter (UFM-1000 (Uroflowmeter)) (K243052) | Bright Uro, Inc. | 2025-03-24 |
| VERAFEYE System VERAFEYE Imaging Catheter & VERAFEYE Imaging System (K242893) | Luma Vision Limited | 2025-03-24 |
| CaseMONO™ Culture (CMON); CaseMONO™ w/HEPES (WHMO); CaseBioscience® HTF (HTFC); CaseBioscience® HTF w/HEPES (HHTF) (K242107) | Casebioscience, Inc. | 2025-03-21 |
| Rayvolve PTX-PE (K243808) | AZmed | 2025-03-21 |
| FloTrac sensors; FloTrac Jr sensors; Acumen IQ sensors; VolumeView sensors (K242909) | Edwards Lifesciences, LLC | 2025-03-21 |
| Autoclavable Cassette (Glidewell HT™ Implant Guided Surgical Kit, Glidewell HT™ Implant Surgical Kit, Glidewell™ Prosthetic Kit) (K242564) | Prismatik Dentalcraft, Inc. | 2025-03-21 |
| REMI Remote EEG Monitoring System (K243185) | Epitel | 2025-03-21 |
| BD Vacutainer® Multiple Sample Luer Adapter (K243649) | Becton, Dickinson and Company | 2025-03-21 |
| V-GRAD (K241833) | Vitromed GmbH | 2025-03-21 |
| Navigator™ HD Ureteral Access Sheath Set 11/13 F x 28cm (M0062502210); Navigator™ HD Ureteral Access Sheath Set 11/13 F x 36cm (M0062502220); Navigator™ HD Ureteral Access Sheath Set 11/13 F x 46cm (M0062502230); Navigator™ HD Ureteral Access Sheath Set 12/14 F x 28cm (M0062502240); Navigator™ HD Ureteral Access Sheath Set 12/14 F x 36cm (M0062502250); Navigator™ HD Ureteral Access Sheath Set 12/14 F x 46cm (M0062502260); Navigator™ HD Ureteral Access Sheath Set 13/15 F x 28cm (M006 (K250517) | Boston Scientific Corporation | 2025-03-21 |
| Signos Glucose Monitoring System (K250106) | Signos, Inc. | 2025-03-21 |
| FiAPC plus probes (K243451) | Erbe Elektromedizin GmbH | 2025-03-21 |
| Natural Cycles (K250561) | Natural Cycles Nordic AB | 2025-03-21 |
| GoLIF! Lumbar Interbody Fusion System (K250186) | Getset Surgical, SA | 2025-03-21 |
| Philips Holter Analysis System (K241890) | Philips Medizin Systeme Böblingen GmbH | 2025-03-21 |
| Consolidated Operating Room Equipment (CORE) 2 Console (K243958) | Stryker Instruments | 2025-03-21 |
| Medical Laser System Incanto / Evoline Platinum /Evoline (K243630) | Solar LS Cjsc | 2025-03-21 |
| Arisure® Closed Male Luer with Spike Adapter (YM060) (K240761) | Yukon Medical, LLC | 2025-03-21 |
| Porous Biologic Scaffold (K250556) | Ventris Medical | 2025-03-21 |
| ARVIS Surgical Navigation System (K243980) | Kico Knee Innovation Company Pty Limited | 2025-03-21 |
| IntelliSep Test (CV-ICG-048) (K250513) | Cytovale, Inc. | 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 |
| EHL Probe (SCDG-AS); EHL Probe (SCDG-BS); EHL Probe (SCDG-CS) (K243032) | Guangzhou Potent Medical Equipment Joint-Stock Co., Ltd. | 2025-03-21 |
| Electrohydraulic Lithotriptor (TCS-B3-II) (K242888) | Guangzhou Potent Medical Equipment Joint-Stock Co., Ltd. | 2025-03-21 |
| ChecQ (AC100) (K241065) | Dentis Co., Ltd. | 2025-03-21 |
| FX CorAL 40 (F00009214); FX CorAL 50 (F00009215) (K242053) | Fresenius Medical Care Renal Therapies Group, LLC | 2025-03-21 |
| Catamaran SI Joint Fusion System (K250403) | Tenon Medical | 2025-03-21 |
| brAIn™ Shoulder Positioning (K243292) | Avatar Medical | 2025-03-20 |
| HPM38 (polymacon) Daily Wear Soft (hydrophilic) Contact Lens (HPM38) (K241884) | Hunan Haipuming Technology Co., Ltd. | 2025-03-20 |
| Revogene (K243922) | Meridian Bioscience, Inc. | 2025-03-20 |
| Vent Creativity Knee v1.0 (Hermes) (K241961) | Vent Creativity | 2025-03-20 |
| Joylux Intimacy Gel (PG3100) (K242958) | Joylux, Inc. | 2025-03-20 |
| RootMend MRR (K243988) | Riverpoint Medical, LLC | 2025-03-20 |
| Endoscopic Water Pump (K241704) | Hangzhou AGS MedTech Co., Ltd. | 2025-03-20 |
| EXPD 114; EXPD 114G; EXPD 114P; EXPD 114PG (K242770) | DRTECH Corporation | 2025-03-20 |
| Starlight Imaging Catheter (K243016) | Spectrawave, Inc. | 2025-03-20 |
| Tesera-k PL System and Tesera-k XL System (K242771) | Kyocera Medical Technologies, Inc. | 2025-03-20 |
| Knee+ (K243975) | Pixee Medical | 2025-03-20 |
| Ameda GLO Wearable Breast Pump (Model W8S) (K250463) | Shenzhen TPH Technology Co., Ltd. | 2025-03-20 |
| iSLEEVE Introducer Set (K250468) | Boston Scientific | 2025-03-20 |
| ViaOne Epicardial Access System (K243928) | Cardiovia , Ltd. | 2025-03-20 |
| AVIEW (K243689) | Coreline Soft Co., Ltd. | 2025-03-19 |
| AcuPebble Ox (200) (K243092) | Acurable Limited | 2025-03-19 |
| Medical Diode Laser Systems (GBOX-6H, GBOX-10D , GBOX-12D, GBOX-15D, VELAS Pro-30B15D, VELAS II-6H, VELAS II-15D) (K241791) | Gigaalaser Company , Ltd. | 2025-03-19 |
| CORIS System (DEN240018) | Nanosonics Limited | 2025-03-19 |
| IPL Hair Removal Device (M8011, M8012, M8013, M8015, M8021, M8022, M8023, M8025, M7011, M7012, M7021, M7023) (K250131) | Mustech Electronics Co., Limited | 2025-03-19 |
| Broncho Videoscope System (Single-use Broncho Videoscope (SBV-1A-B, SBV-1A-P, SBV-1B-B, SBV-1B-P, SBV-1C-B, SBV-1C-P); Full HD Visualization Endoscopic Image Processor (HDVS-S300A, HDVS-S300B, HDVS-S300C, HDVS-S300D); Endoscopic Image Processor (HDVS-S100A, HDVS-S100D)) (K250210) | Scivita Medical Technology Co., Ltd. | 2025-03-19 |
| PeekMed web (K250042) | Peek Health, S.A. | 2025-03-19 |
| DSPS-Prominent® baseplate, MR (113820); DSPS-Prominent® baseplate (113120); DSPS-Prominent® Cradle-I (113140); DSPS-Prominent® Cradle-II (113150); DSPS-Prominent® Cradle-III (113160); DSPS-Prominent® Cradle-IV (113170); DSPS-Prominent® Cradle-VI (113180); DSPS-Prominent® Cradle-VII (113260); Mask DSPS®-PROSCVRL set/5 (113760); Mask DSPS®-PROSC set/5 (113770); Mask DSPS®-PROSCVR set/5 (113780); Mask DSPS®-PROSCL set/5 (113790); Mask DSPS®-PROSHVRL set/5 (113890); Mask DSPS®-PROSH set (K250429) | Macromedics BV | 2025-03-19 |
| 1NEED Pro (K243472) | Campomats S.R.L. | 2025-03-19 |
| IPL Hair Removal Device (BE965A, BE965B, BE965C) (K250171) | Shenzhen Yang WO Electronic Co., Ltd. | 2025-03-19 |
| Luer-Split MAJ-2092 (K241842) | Olympus Medical Systems Corporation | 2025-03-19 |