FDA 510(k) clearances — page 211
clearances on record, most recent first.
Clearances — page 211
21,001–21,100 of 175,699- K192132 — SeaSpine Beachside System
- K192473 — Exsomed Wrist Plating System
- K192528 — CO2 Laser Therapy System
- K193009 — Promisemed Heel Blood Lancet
- K193083 — M.U.S.T. Sacral Illiac Screw and Pelvic Trauma System
- K193107 — TriSalus Infusion System
- K193160 — Glidesheath Slender Tibial Pedal Kit
- DEN180014 — WOUNDCHEK Bacterial Status
- K182819 — Decanting Device
- K183622 — NasalCEASE and BleedCEASE
- K190009 — Sunmas TENS & PMS (Model SM9187, SM9180L, SM9180S)
- K190588 — Integra TITAN Reverse Shoulder System
- K190659 — Ureteral Stent Open Tip/Closed Tip/Intraoperative Tip, Ureteral Stent via Ureterorenoscope Open Tip/Closed Tip, Pediatric Ureteral Stent Open Tip/Closed Tip, Mono J Urinary Diversion Ureteral Stent Open Tip/Closed Tip, Multiloop Ureteral Stent Open Tip/Closed Tip
- K190876 — mCare®Powder-free Nitrile Blue Examination Gloves with Chemotherapy Drugs Labeling Claimed
- K190987 — Uroject12 Syringe Lever
- K191088 — Checkme O2 Pulse Oximeter
- K191656 — Zipbond
- K191722 — Vital Navigation System
- K192038 — Emprint Visualization Application
- K192374 — Cardinal Health Level 3 Surgical Mask with Anti-Fog Foam Strip
- K192394 — Hi-Fatigue Bone Cement
- K192666 — Promisemed Blood Lancet, VeriFine Safety Lancet, VeriFine Mini-Safety Lancet
- K193040 — Resorbable Mesh Device
- K190710 — EliA SymphonyS Immunoassay
- K192105 — Innonix Antiviral Child's Face Mask
- K192186 — I-Portal Neuro Otologic Test Center, I-Portal Video Nystagmography System, I-Portal Portable Assessment System - Nysragmograph
- K192365 — Shoulder Innovations Total Shoulder System
- K192782 — ASAHI CROSSWALK Peripheral Support Catheter
- K193034 — AXS Infinity LS Plus Long Sheath
- K190577 — World Knee Total Knee Systems
- K190811 — Optimus NEURO System - Sterile Kit
- K190955 — Hypotension Decision Assist
- K191032 — fMRI Hardware System
- K191428 — ECG Cable
- K191673 — Upper Arm Blood Pressure Monitor
- K191911 — 3Shape Splint Design
- K191987 — Orapeutic
- K192079 — EOSedge
- K192379 — Hi-Fatigue G Bone Cement
- K192438 — Rhythmia HDxTM Mapping System
- K192468 — Male, Nelaton-tip Ready-to-Use Hydrophilic Catheter; Femal, Nelaton-tip Ready-to-Use Hydrophilic Catheter; Pediatric, Nelaton-tip Ready-to-Use Hydrophilic Catheter Intermittent Catheter; Male, Tapered-Tip Tiemann Ready-to-Use Hydrophilic Catheter; Male, Olive-Tip Tiemann Ready-to-Use Hydrophilic Catheter
- K192519 — Multi-modality workstation
- K192791 — Diagnostic Ultrasound System
- K192945 — 7D Surgical System Cranial Biopsy and Ventricular Catheter Placement Application
- K182892 — TRAUS Dental Handpieces
- K190911 — Physica KR Liner and SMR Reverse Humeral Liner
- K191426 — FiberTak Button
- K191502 — Heraeus Peripheral Guidewire
- K191961 — OrthoGold
- K192026 — Peridot Intervertebral body fusion System
- K192271 — Access PCT, Access PCT Calibrators
- K192320 — HealthCXR
- K192367 — Ion Endoluminal System
- K192376 — Simplexa VZV Swab Direct, Simplexa VZV Positive Control Pack
- K192396 — Streamline MIS Spinal Fixation System
- K192417 — ARIX Cannulated Screw System
- K192738 — ETEST Delafloxacin (DFX) (0.002-32 µg/mL)
- K192745 — DePuy Synthes Trauma Screws
- K192764 — NeuroOne Cortical Electrode
- K192907 — Advocate PTA Catheter
- K192919 — Pinnacle Duofix HA Acetabular Cup Prosthesis
- K192946 — DePuy Corail AMT Hip Prosthesis
- K181845 — Pivot System Sterilization case
- K190494 — Infant Incubator
- K190529 — SOZO
- K190590 — Allwin Ovum Pickup Needles (ACE Single Lumen Ovum Pickup Needle, OVUMPICK Double Lumen Ovum Pickup Needle, ACE-FL Single Lumen Ovum Pickup Needle with Flushing Line, ACE-M Manual Single Lumen Ovum Pickup Needle)
- K191851 — VS3-IR
- K192248 — Cortina [MAX] Lumbar Cage System
- K192329 — Blue Latex Examination Powder Free Gloves
- K192788 — ADVIA Centaur Cortisol (COR)
- K182712 — DEXIS CariVu 3-in-1 by KaVo
- K190760 — Cadwell Bolt Software
- K171899 — Revitalair 430F
- K190331 — Applied Medical Laparoscopic Linear Cutter
- K190512 — SmartBand EMR Kit, SmartBand EMR Pack, SmartSnare
- K190518 — Color Liquid, Vita Liquid
- K190697 — PREVENA PLUS Incision Management System (No Ag); PREVENA PLUS DUO Incision Management System (No Ag)
- K190977 — Navina Smart System, Navina Classic System
- K191028 — KLS Martin Individual Patient Solutions
- K191075 — Healy
- K191103 — Parkell Desensitizer Gel
- K191236 — 3M Attest Steam Chemical Integrators
- K191734 — MatriStem UBM Pericardial Patch
- K191746 — SMR TT Augmented Glenoid System
- K191754 — Hair Growth System
- K191903 — BruxZir GT (Gum Tissue) Color
- K192122 — Trevo Trak 21 Microcatheter
- K192126 — AMIStem-P Short Neck
- K192157 — 6450 Ultrasound system
- K192207 — Trevo NXT ProVue Retriever
- K192242 — Synergy Platform, Synergy, Infinity, VersaHD
- K192260 — everX Flow
- K192270 — LEva Pelvic Digital Health System
- K192336 — Navigated Anterolateral Disc Prep Instruments
- K192508 — Medsynapse Ris Pacs & Medsynapse VNA
- K192603 — Spes Medica Subdermal Needle Electrodes
- K192675 — VariAx Foot
- K192777 — ADVIA Centaur CA 15-3 assay
- K192843 — INNOVITA HCG Pregnancy Rapid Test Strip, INNOVITA HCG Pregnancy Rapid Test Cassette, INNOVITA HCG Pregnancy Rapid Test Midstream
- K192877 — Senhance Surgical System
Data sourced from openFDA. This site is unofficial and independent of the FDA.