| Rebellion; Phantom Multi-Bite Kerrison Rongeur (K221818) | Morpheus AG | 2022-10-07 |
| SuperCheck Pro Blood Glucose Monitoring System (K213061) | Ok Biotech Co., Ltd. | 2022-10-07 |
| Disposable Sterile Syringe with permanently attached needle; Auto-disable Syringe for Fixed-dose Immunization (K220057) | Shinva Ande Healthcare Apparatus Co., Ltd. | 2022-10-07 |
| Pre-Formed Blue (K221575) | Lake Region Medical | 2022-10-07 |
| Forehead Thermometer, models AOJ-F101, AOJ-F102, AOJ-F103, AOJ-F104 AOJ-F105, AOJ-F106, AOJ-F107 (K221170) | Shenzhen AOJ Medical Technology Co., Ltd. | 2022-10-07 |
| PURE Laser (K222369) | Endymed Medical, Ltd. | 2022-10-07 |
| Endoscopic Clean Connecting Tubes, Endoscopic CO2 Source Tubing (K221310) | Changzhou Endoclean Medical Device Co., Ltd. | 2022-10-07 |
| Electrically Powered Wheelchair, Joy Rider (K220156) | Tung Keng Enterprise Co., Ltd. | 2022-10-07 |
| Miha Bodytec II (K221498) | Miha Bodytec GmbH | 2022-10-07 |
| iCare IC200 (K220852) | Icare Finland OY | 2022-10-06 |
| ProSomnus EVO [PH] Sleep and Snore Device, ProSomnus EVO [PH] Sleep and Snore Device with Patient Monitoring (K221889) | Prosomnus Sleep Technologies | 2022-10-06 |
| InfaTherm Disposable Infant Warming Mattress (K221653) | International Biomedical | 2022-10-06 |
| Tibial baseplate, Tibial insert (K222700) | United Orthopedic Corporation | 2022-10-06 |
| b-ONER MOBIO Total Knee System (K222431) | B-One Ortho, Corp. | 2022-10-06 |
| Gemini Sterilization Wrap (K220365) | Medline Industries, LP | 2022-10-06 |
| Perfit FS Dental Zirconia Fully Sintered Block (K222686) | Vatech Acucera, Inc. | 2022-10-06 |
| Genius AI Detection 2.0 (K221449) | Hologic, Inc. | 2022-10-06 |
| ArtFx Corpectomy Cages (Espinax and Distractania Corpectomy Cages) (K211892) | Arftx Medical, LLC | 2022-10-06 |
| NuCath Wedge Pressure Catheter (K213666) | Pfm Medical, Inc. | 2022-10-06 |
| A&D Medical UM-212BLE Blood Pressure Monitor (K212168) | A&D Company, Ltd. | 2022-10-06 |
| Garion Image-Intensified Fluoroscopic X-Ray System, Mobile (K222080) | Sg Healthcare Co, Ltd. | 2022-10-06 |
| PRIMA TT Glenoid (K222427) | Lima Corporate S.P.A. | 2022-10-06 |
| Coag-Sense Prothrombin (PT) / INR Monitoring System for Patient Self-Testing (K212779) | Coagusense, Inc. | 2022-10-05 |
| Flexible Ureterorenoscope (Model: US31E-12-EU, US31E-12-US) (K222737) | Shanghai AnQing Medical Instrument Co., Ltd. | 2022-10-05 |
| VISIONAIR (K221892) | Pacificmd Biotech, LLC | 2022-10-05 |
| FaSet Fixation System (K222515) | Dio Medical Corporation | 2022-10-05 |
| Colibrí System (K220546) | Copan Wasp Srl | 2022-10-05 |
| Arthrex ACL TightRope®, PCL TightRope®, and TightRope® II (K221128) | Arthrex, Inc. | 2022-10-05 |
| Surtron 80 D, Surtron 160, Surtron 200, Surtron Flash 160 HF, Surtron 400 HP (K220138) | Led Spa | 2022-10-05 |
| Cornisol (K221759) | Aurolab | 2022-10-05 |
| ClearCorrect System (K220140) | Clearcorrect, LLC | 2022-10-05 |
| Sterile Hypodermic Syringes for Single Use with Safety Needles (K221073) | Sichuan Prius Biotechnology Co., Ltd. | 2022-10-04 |
| POLYVUE (polymacon) Soft (hydrophilic) Contact Lens, POLYVUE COLOR (polymacon) Soft (hydrophilic) Contact Lens (K221517) | INTEROJO, Inc. | 2022-10-04 |
| HemosIL Liquid Anti-Xa (K213464) | Instrumentation Laboratory CO | 2022-10-04 |
| Sterile Safety Hypodermic Needles for Single Use (K221080) | Sichuan Prius Biotechnology Co., Ltd. | 2022-10-04 |
| INDIGO Aspiration System (CAT RX Aspiration Catheter and Separator 4) (K220683) | Penumbra, Inc. | 2022-10-04 |
| CD HORIZON™ ASTUTE™ SPINAL SYSTEM; CD HORIZON™ Growth Rod Conversion Set; CD HORIZON™ SPINAL SYSTEM; CD Horizon™ Fenestrated Screw Set; COLORADO 2™ SPINAL System; GDLH™ POSTERIOR SPINAL SYSTEM; SHILLA™ Growth Guidance System; TENOR™ SPINAL SYSTEM (K221646) | Medtronic Sofamor Danek USA, Inc. | 2022-10-04 |
| TriVerse Total Knee Replacement System (K222380) | Signature Orthopaedics Pty, Ltd. | 2022-10-04 |
| Sterile Hypodermic Syringes for Single Use with Needles (K221068) | Sichuan Prius Biotechnology Co., Ltd. | 2022-10-04 |
| Sterile Hypodermic Needles for Single Use (K221066) | Sichuan Prius Biotechnology Co., Ltd. | 2022-10-04 |
| Sterile Hypodermic Syringes for Single Use (K221079) | Sichuan Prius Biotechnology Co., Ltd. | 2022-10-04 |
| Hailie Sensor NF0107 & NF0108 (K221994) | Adherium (Nz), Ltd. | 2022-10-04 |
| Route 92 Medical Full Length 070 Access System (K222743) | Route 92 Medical, Inc. | 2022-10-04 |
| ROSA® Knee System (K221928) | Orthosoft D/B/A Zimmer Cas | 2022-10-04 |
| SILO TFX MIS Sacroiliac Joint Fixation System (K221047) | Aurora Spine, Inc. | 2022-10-03 |
| PCA Syringe Sets (K212262) | Baxter Healthcare Corporation | 2022-10-03 |
| Aurolase Therapy, Laser Delivery Device (LDD) (K202953) | Nanospectra Biosciences, Inc. | 2022-10-03 |
| ONVOY Acetabular System (K213842) | Globus Medical, Inc. | 2022-10-03 |
| Disposable Safety Lancets (K221778) | Suzhou Kyuan Medical Apparatus Co., Ltd. | 2022-10-03 |
| Varixis Elbow System (K213014) | Auxein Medical Private Limited | 2022-10-03 |
| Arthrex 2.4 mm Volar Distal Radius Plate System (K222267) | Arthrex, Inc. | 2022-10-03 |
| Lianfa Safety Lancet (Five Models: NPA, PA, PA2, TPA, and APA) (K222376) | Shandong Lianfa Medical Plastic Products Co. , Ltd. | 2022-10-03 |
| Electronic Sphygmomanometer (Model: LT-P30) (K220220) | Zhuhai Linte Medical Instrument Co., Ltd. | 2022-10-03 |
| Freestyle Lancing Device II, Autolet, Autolet Lite, Unilet Lancets (K221613) | Owen Mumford, Ltd. | 2022-10-03 |
| Elastic Traction System (K222354) | Micro-Tech (Nanjing) Co., Ltd. | 2022-10-03 |
| Velano Vascular Blood Collection Adapter (K201237) | Velano Vascular | 2022-10-03 |
| Disposable Nitrile Examination Glove (K222937) | Jiangsu Cureguard Glove Co., Ltd. | 2022-10-01 |
| DoubleChek DC-1001 (K212316) | Nasogastric Feeding Solutions, Ltd. | 2022-09-30 |
| Ultrasonic Surgical System (K210567) | Miconvey Technologies Co., Ltd. | 2022-09-30 |
| Air Compression Leg Massager (Models: S9036C, S9036B and S9036A) (K222206) | Shenzhen Dongjilian Medical Tech Co., Ltd. | 2022-09-30 |
| Safety Lancet (K222090) | Ningbo Medsun Medical Co., Ltd. | 2022-09-30 |
| e-Ortho Shoulder Software v1.1 (K220758) | FH Industrie | 2022-09-30 |
| Autosuture EEA Stapler / circular stapler with DST Series Technology / EEA Autosuture Circular Stapler with DST Series Technology / DST Series EEA Stapler / DST EEA (K221003) | Covidien | 2022-09-30 |
| AugMENTA Penile Implant (K200073) | Augmenta, LLC | 2022-09-30 |
| AMSCO 600 Steam Sterilizer, V-PRO maX 2 Low Temperature Sterilization System, V-PRO s2 Low Temperature Sterilization System, V-PRO 60 Low Temperature Sterilization System, RAS 12 Rack, RAS 12 Long Rack, RAS Cycle of the AMSCO 7052HP and 7053HP Single Chamber Washer Disinfector (K222849) | Steris | 2022-09-30 |
| 8mm Monopolar Curved Scissors (K210478) | Iconocare Health | 2022-09-30 |
| QIR Suite (K211611) | Casis Cardiac Simulation & Imaging Software | 2022-09-30 |
| Shield System (K222625) | Radiaction , Ltd. | 2022-09-30 |
| Arthrex 3.5 mm Locking Compression Plates (K222244) | Arthrex, Inc. | 2022-09-30 |
| Unscented Menstrual Tampon (K222046) | Suzhou Borage Medical Technology Co., Ltd. | 2022-09-30 |
| uDR 380i Pro (K222339) | Shanghai United Imaging Healthcare Co., Ltd. | 2022-09-30 |
| OFNat Lubricant (L15) (K221243) | Suretex Limited | 2022-09-30 |
| Mg-PSZ Ceramic Femoral Head (K220336) | Theken Companies | 2022-09-30 |
| EmbedMed (K220366) | 3D Lifeprints UK , Ltd. | 2022-09-30 |
| Nitrile Powder Free Blue Patient Examination Gloves, Non-Sterile (K221378) | Tec Gloves Industry (M) Sdn.Bhd. | 2022-09-30 |
| Kerecis Oral (K213904) | Kerecis | 2022-09-30 |
| Blood Pressure Monitor(Model:Y30001) (K213023) | Zhangzhou Easepal Medical Science and Technology Co., Ltd. | 2022-09-30 |
| SpineAR SNAP (K213034) | Surgical Theater, Inc. | 2022-09-29 |
| CogNet QmTRIAGE (K220080) | Medcognetics, Inc. | 2022-09-29 |
| Consona N9, Consona N9 Pro, Consona N9 Super, Consona Nova, Consona N9S, Consona NI, Consona NT, Nuewa N9, Recho N9, Consona N9 Exp, Consona N9 Elite, Resona N9, Consona N9T, Consona N8, Consona N8 Pro, Consona N8 Super, Consona OR, Consona N8S, Consona OI, Consona OT, Consona N8 Exp, Consona N8 Elite, Consona N8T, Consona N7, Consona N7 Pro, Consona N7 Super, Consona VR, Consona N7S, Consona VI, Consona VT, Consona N7 Exp, Consona N7 Elite, Consona N7T Diagnostic Ultrasound System (K221300) | Shenzhen Mindray Bio-Medical Electronics Co., Ltd. | 2022-09-29 |
| CureSight-CS100 (K221375) | Novasight , Ltd. | 2022-09-29 |
| Digital Radiography CXDI-Elite, Digital Radiography E1 (K222687) | Canon, Inc. | 2022-09-29 |
| GM85 (K222353) | Samsung Electronics Co., Ltd. | 2022-09-29 |
| Anteralign™ LS Spinal System with Titan nanoLOCK™ Surface Technology MAZORX Stealth(TM) Edition (K222383) | Medtronic Sofamor Danek USA, Inc. | 2022-09-29 |
| ReFlow System Mini (K221918) | Anuncia Medical, Inc. | 2022-09-29 |
| iFuse TORQ® Implant System (K222605) | SI-BONE, Inc. | 2022-09-29 |
| Smith & Nephew, Inc. Plates and Screws Systems: EVOS, Peri-Loc, D-Rad, TC-100, VLP Mini-Mod, Compression Hip Screw (CHS), CONQUEST FN, and cannulated screws (K213126) | Smith & Nephew, Inc. | 2022-09-29 |
| InnovaBurn (K213716) | Triad Life Sciences, Inc. | 2022-09-29 |
| Surgical Gown (Sterile); Surgical Gown (Non-sterile) (K221637) | Allmed Medical (Hubei) Protective Products Co., Ltd. | 2022-09-29 |
| S.I.N. Instrument Kits (K222005) | S.I.N. - Sistema DE Implante Nacional S.A. | 2022-09-29 |
| INNOVANCE VWF Ac (DEN200067) | Siemens Healthcare Diagnostics Products GmbH | 2022-09-29 |
| Consona N6, Consona N6 Pro, Consona N6 Super, Consona AR, Consona N6S, Consona AE, Consona AT, Consona N6 Exp Diagnostic Ultrasound System, Consona N6 Elite, Consona N6T Diagnostic Ultrasound System (K221496) | Shenzhen Mindray Bio-Medical Electronics Co., Ltd. | 2022-09-29 |
| Ghost Spacer System (K213417) | Life Spine, Inc. | 2022-09-29 |
| CORE-SPORT (K220081) | Incore Co., Ltd. | 2022-09-28 |
| InnovaMatrix PD (K211902) | Triad Life Sciences, Inc. | 2022-09-28 |
| SYSTEM 1E Liquid Chemical Sterilant Processing System, SYSTEM 1 endo Liquid Chemical Sterilant Processing System, Model P6800, SYSTEM 1 endo Liquid Chemical Sterilant Processing System, Model P6900, S40 Sterilant Concentrate (K222615) | STERIS Corporation | 2022-09-28 |
| AGILON XO Shoulder System (K222482) | Implantcast GmbH | 2022-09-28 |
| IPL Hair Removal Device (K222316) | Shenzhen Goodwind Technology Development Co., Ltd. | 2022-09-28 |
| BriefCase (K222329) | Aidoc Medical , Ltd. | 2022-09-28 |
| Pocket Fetal Doppler (Models CONTEC10C and CONTEC10CL) (K220245) | Contec Medical Systems Co.,Ltd | 2022-09-28 |