| SMARTeZ™ Elastomeric Infusion Pump (498111, 498121, 498131, 498141) (K242152) | Epic Medical Pte. , Ltd. | 2024-10-07 |
| LUOFUCON® Extra Silver Gelling Fiber Dressing Plus (Prescription use),LUOFUCON® Silver Antimicrobial Gelling Fiber Dressing Plus (OTC use) (K240485) | Huizhou Foryou Medical Devices Co., Ltd. | 2024-10-07 |
| DEKA Infusion System, DEKA Administration Set (K242693) | Deka Research and Development Corporation | 2024-10-07 |
| Pangea Platform; Pangea Femur Plating System; Pangea Humerus Plating System; Pangea Tibia Plating System (K242445) | Stryker GmbH | 2024-10-06 |
| BPS Wrist Fracture System (K242343) | Orthonovis, Inc. | 2024-10-04 |
| IdentiTi™ II Interbody System (K242364) | Alphatec Spine, Inc. | 2024-10-04 |
| Bladeless Trocar; Bladed Trocar; Hasson Trocar (K241052) | Advamedix, GmbH | 2024-10-04 |
| Zeta Cranial Navigation System (ZNS131-US) (K242351) | Zeta Surgical, Inc. | 2024-10-04 |
| EchoSolv AS (K241245) | Echo IQ, Ltd. | 2024-10-04 |
| AuST Steerable Sheath (K242106) | CenterPoint Systems, LLC | 2024-10-04 |
| Power Wheelchair (K241854) | Anhui Jbh Medical Apparatus Co., Ltd. | 2024-10-04 |
| LVivo Software Application (K240553) | Dia Imaging Analysis, Ltd. | 2024-10-04 |
| Electroporation System (N3000) (K240376) | Surgnova Healthcare Technologies (Zhejiang) Co., Ltd. | 2024-10-04 |
| Treace Medical Concepts (TMC) Screw Fixation System (K242671) | Treace Medical Concepts, Inc. | 2024-10-04 |
| Upper Arm Electronic Blood Pressure Monitor (FC-BP103, FC-BP106, FC-BP113, FC-BP120, FC-BP121, FC-BP130, FC-BP131) (K242721) | Shenzhen Finicare Co., Ltd. | 2024-10-04 |
| UMED REPROCESSED AIRCAST VENAFLOW FOOT CUFF; UMED REPROCESSED KENDALL SCD EXPRESS SLEEVE; UMED REPROCESSED AIRCAST ELITE CALF CUFF 3040 3050; UMED REPROCESSED CTC VP 501 CALF CUFF; UMED REPROCESSED CTC VP 520 FOOT CUFF (K241746) | United Medical Resources, LLC | 2024-10-04 |
| Video Ureteroscope System (K241434) | Hunan Vathin Medical Instrument Co., Ltd. | 2024-10-04 |
| Lunit INSIGHT DBT v1.1 (K242652) | Lunit, Inc. | 2024-10-04 |
| Disposable Powered Articulating Endoscopic Linear Cutter Stapler & Reloads (30mm series); Disposable Powered Articulating Endoscopic Linear Cutter Stapler & Reloads (45mm series); Disposable Powered Articulating Endoscopic Linear Cutter Stapler & Reloads (60mm series) (K242679) | Fengh Medical Co., Ltd. | 2024-10-04 |
| GripTract-GI Endoscopic Tissue Manipulator Lower GI Models (K242325) | Actuated Medical, Inc. | 2024-10-04 |
| Endoscopic Injection Needles (K240675) | Promisemed Hangzhou Meditech Co., Ltd. | 2024-10-04 |
| BioSieve™ Fentanyl FIA Home Test Kit; BioSieve™ Fentanyl FIA Pro Test Kit; BioSieve™ Toxismart Reader (K241869) | Vivachek Biotech (Hangzhou) Co., Ltd. | 2024-10-04 |
| Single use flexible ureteroscope (UR-D1); Single use flexible ureteroscope (UR-D2); Single use flexible ureteroscope (UR-F1); Single use flexible ureteroscope (UR-F2) (K240074) | Shenzhen Besdata Technology Co., Ltd. | 2024-10-04 |
| TroCare TroKit Laparoscope Lens Wiper (CP000626) (K241796) | TroCare, LLC | 2024-10-04 |
| QUADSENSE (K241298) | Eventum Orthopaedics, Ltd. | 2024-10-04 |
| Curlin 8000 Ambulatory Infusion System; Enterprise Solution (ES) Software; Curlin 380-series Administration Sets (K242660) | Zevex, Inc. | 2024-10-03 |
| Exactech® TRULIANT® Knee System (K240393) | Exactech, Inc. | 2024-10-03 |
| OBSIDIO™ Conformable Embolic (K242507) | Boston Scientific | 2024-10-03 |
| Injectable Root Canal Bioceramic Sealer (i-MTA SP) (K241977) | Longly Biotechnology (Wuhan) Co., Ltd. | 2024-10-03 |
| Additive Manufacturing Zirconia Customized Restoration (K240586) | Hangzhou Thales Medtech Co., Ltd. | 2024-10-03 |
| Pulse Oximeter (WS20A) (K240808) | Hunan Accurate Bio-Medical Technology Co., Ltd. | 2024-10-03 |
| Icona Hip Stem (K241472) | Corin U.S.A. Limited | 2024-10-03 |
| Lantern® Hip (K242616) | Orthalign, Inc. | 2024-10-03 |
| Rest Assure System (K233497) | Somnomed, Inc. | 2024-10-03 |
| VitruvianScan (v1.0) (K241925) | Perspectum, Ltd. | 2024-10-02 |
| MammoScreen BD (K241561) | Therapixel | 2024-10-02 |
| RejuvaKnee™ Collagen Meniscus Implant (K242302) | Collagen Matrix, Inc. | 2024-10-02 |
| Versana Premier; Versana Premier Lotus; LOGIQ F (K242005) | GE Medical Systems Ultrasound and Primary Care Diagnostics | 2024-10-02 |
| Interwedge® Standalone Lateral (K241487) | Foundation Surgical Group, Inc. | 2024-10-02 |
| 8F Modified Sheath System (K240529) | Route 92 Medical, Inc. | 2024-10-02 |
| Anovo Surgical System (model 6N) (K241907) | Momentis Surgical , Ltd. | 2024-10-02 |
| ARTFX Lumbar PEEK Cages (K240889) | Artfx Medical | 2024-10-02 |
| Ceramic Etchant (HF-5 and HF-9) (K240153) | Liaoning Upcera Co., Ltd. | 2024-10-02 |
| REMEDY Stemmed Knee Spacer System with All-Poly Tibial Component (K242377) | Osteoremedies, LLC | 2024-10-02 |
| NxTAG® Respiratory Pathogen Panel (K242613) | Luminex Molecular Diagnostics, Inc. | 2024-10-02 |
| Arthrex Virtual Implant Positioning (VIP) System Software (K241097) | Arthrex, Inc. | 2024-10-02 |
| MuscleView (K241331) | Springbok, Inc. | 2024-10-01 |
| Crown HT (K242277) | Sprintray, Inc. | 2024-10-01 |
| Esperance 3+ Aspiration Catheter System (K240917) | Wallaby Medical | 2024-10-01 |
| Pocguide Multi-Drug Test Panel, Pocguide Multi-Drug Test Panel OTC (K242498) | Aicheck Biotech, Inc. | 2024-10-01 |
| LungVision (K240943) | Bodyvision Medical , Ltd. | 2024-10-01 |
| Electric wheelchair (YHWL002, YHWL003) (K240331) | Yongkang Youha Electric Appliance Co., Ltd. | 2024-10-01 |
| Disposable Endoscope Valves Set (AF series) (K241285) | Alton (Shanghai) Medical Instruments Co., Ltd. | 2024-10-01 |
| GM85 (K242651) | Samsung Electronics Co., Ltd. | 2024-10-01 |
| The Sensititre 20 - 24 hour Haemophilus influenzae/Streptococcus pneumoniae (HP) MIC or Breakpoint Susceptibility System with ceftriaxone in the dilution range of 0.015 - 2 ug/ml. (K241967) | Thermo Fisher Scientific | 2024-10-01 |
| Definium Pace Select ET (K242678) | Ge Hualun Medical Systems Co. , Ltd. | 2024-10-01 |
| LUXEN 5G (K241151) | Dentalmax Co., Ltd. | 2024-09-30 |
| Kem Medical Lead-free Chemical Indicators for Steam Sterilization (K241836) | Kem Medical Products Corporation | 2024-09-30 |
| Wondfo 2019-nCoV Antigen Test (Lateral Flow Method) (K241317) | Guangzhou Wondfo Biotech Co., Ltd. | 2024-09-30 |
| MSFX MIKRON SPINAL FIXATION SYSTEM (K241657) | Mikron Makina Sanayi VE Ticaret Ltd. Sti. | 2024-09-30 |
| AQUABEAM Robotic System (AB2000) (K241952) | Procept Biorobotics | 2024-09-30 |
| OcuCool (DEN230011) | Recensmedical, Inc. | 2024-09-30 |
| Numen™ Coil Embolization System; NumenFR™ Detachment System (K242154) | MicroPort NeuroTech (Shanghai) Co., Ltd. | 2024-09-30 |
| CrossFAST™ Integrated Microcatheter Guide Extension System (CFM55) (K242276) | Vantis Vascular, Inc. | 2024-09-30 |
| YSI 2900C Biochemistry Analyzer (K210933) | Ysi, Inc. | 2024-09-30 |
| EasyCare Tx 2 (K241939) | Resmed Corp | 2024-09-27 |
| AMC Health CareConsole (K233446) | Amc Health | 2024-09-27 |
| Shockwave Intravascular Lithotripsy (IVL) System with the Javelin Peripheral Intravascular Lithotripsy (IVL) Catheter (K242213) | Shockwave Medical, Inc. | 2024-09-27 |
| Optima Coil System (OptiBlock Line Extension) (K242582) | Balt USA, LLC | 2024-09-27 |
| ShortCut (DEN240017) | Pi-Cardia, Ltd. | 2024-09-27 |
| ACTIVO (K242206) | Daeju Meditech Engineering Co., Ltd. | 2024-09-27 |
| Elvie Stride 2 (K242125) | Chiaro Technology, Ltd. | 2024-09-27 |
| Sourcerer (K241513) | Brain Electrophysiology Laboratory Company, LLC | 2024-09-27 |
| encevis (2.1) (K240993) | Ait Austrian Institute of Technology GmbH | 2024-09-27 |
| HIGHERDOSE Red and Infrared Light Mask (MK66-L) (K241933) | Shenzhen Kaiyan Medical Equipment Co., Ltd. | 2024-09-27 |
| ClotTriever XL Catheter (41-102) (K242557) | Inari Medical, Inc. | 2024-09-27 |
| CAC (gated) Algorithm (K240369) | BunkerHill Health | 2024-09-27 |
| Aulisa Temperature Module (TM0002) (K240220) | Taiwan Aulisa Medical Devices Technologies, Inc. | 2024-09-27 |
| Halyard Purple Nitrile* Powder-Free Exam Gloves, Low Dermatitis Potential, Tested for Use with Chemotherapy Drugs, Fentanyl Citrate, Simulated Gastric Acid and Fentanyl in Simulated Gastric Acid (K241909) | O&M Halyard, Inc. | 2024-09-27 |
| JBS-LVO (K241480) | JLK, Inc. | 2024-09-27 |
| iCare ST500 (TA04) (K241447) | Icare Finland OY | 2024-09-27 |
| Hudson RCI® Comfort Flo Nasal Cannula; Hudson RCI® Comfort Flo Plus Cannula (K240163) | Medline Industries, LP | 2024-09-27 |
| AllTest Multi-Drug Urine Test Panel; AllTest Multi-Drug Rapid Urine Test Panel (K242540) | Hangzhou AllTest Biotech Co., Ltd. | 2024-09-27 |
| trophon Wireless Ultrasound Probe Holder (K241536) | Nanosonics Limited | 2024-09-27 |
| Secret Line up (FC1938E80 FC1950E90 FC1960E100 FC1970E120 FC1990E150 FC19100E150 FC19100E280 FC19100E420 FC2038E80 FC2050E90 FC2060E100 FC2070E120 FC2090E150 FC20100E170 FC2138G80 FC2150G90 FC2160G100 FC2170G120 FC2190G150 FC21100G170 FCL18100C160 FCL1938E80 FCL1950E90 FCL1960E100 FCL1970E120 FCL1990E150 FCL19100E160 FCL2138G80 FCL2150G90 FCL2160G100 FCL2170G120 FCL2190G150 FCL21100G160 FCRL1870C162 FCRL18100C185 FCRL1970E162 FCRL19100E185 FCHL1960E90 FCHL1970E120 FCHL19100E160 FCW1938 (K242571) | Hyundae Meditech Co., Ltd. | 2024-09-27 |
| TearRepair Liquid Skin Protectant (K241916) | Optmed, Inc. | 2024-09-27 |
| ID Free Personal Lubricant (K240745) | Westridge Laboratories, Inc. | 2024-09-27 |
| cryo-GO Vitrification Device (K241341) | Fujifilm Irvine Scientific | 2024-09-26 |
| Cannulated PsiFGuard (K241895) | Spineguard | 2024-09-26 |
| Protean Fragment Plating System (K241815) | Skeletal Dynamics, Inc. | 2024-09-26 |
| CrossWise RF Transseptal Access System (Models: CW-1085S, CW-1085A, CW-1012W, CW-1012C); CrossWise RF Adapter Cable (Model CW-1002) (K241414) | Circa Scientific, Inc. | 2024-09-26 |
| BioButton System (K241101) | Biointellisense, Inc. | 2024-09-26 |
| Any-Com (K241147) | Mediclus Co., Ltd. | 2024-09-26 |
| Affixus Tibial and Antegrade Femoral Nailing System (K241651) | Zimmer, Inc. | 2024-09-26 |
| Permatage Settable Bone Putty (K241027) | Orthocon, Inc. | 2024-09-26 |
| myAir (K241216) | Resmed Corp | 2024-09-26 |
| Microwave Ablation Generator (KY-2000A, KY-2100A) (K241827) | Canyon Medical, Inc. | 2024-09-26 |
| Verifine® Pen Needles (K242632) | Promisemed Hangzhou Meditech Co., Ltd. | 2024-09-26 |
| Accelerate Arc System (K240854) | Accelerate Diagnostics, Inc. | 2024-09-26 |
| MOLLI 2 System (K234149) | Molli Surgical, Inc. | 2024-09-26 |