FDA 510(k) clearances — page 87
clearances on record, most recent first.
Clearances — page 87
8,601–8,700 of 176,479- K240257 — Denali Vena Cava Filter System Femoral and Jugular/Subclavian Delivery Kit
- K240268 — Accu-Joint Hemi Implant
- DEN230024 — Technozym ADAMTS13 Activity
- K231845 — Dental unit Model: Mare
- K232562 — PowerWire Radiofrequency Guidewire Kit
- K232613 — CT Cardiomegaly
- K232885 — Dawn Diode Laser System
- K233488 — Intra.Ox 2.0 Handheld Tissue Oximeter
- K233830 — OsteoCool 2.0 RF Ablation System
- K222400 — Coresculpt & Magsculpt
- K232522 — ARK Levetiracetam II Assay
- K232607 — 4CIS SARA SPINE SYSTEM, 4CIS VERTU SPINE SYSTEM, 4CIS WILL PEDICLE SCREW SYSTEM, aBle SPINAL FIXATION SYSTEM, aBle Xt SPINAL FIXATION SYSTEM
- K233435 — Peace N Quiet (0.7.0)
- K233623 — Praxiject SP 0.9% NaCl
- K233879 — Vasoview Hemopro 3 Endoscopic Vessel Harvesting System (VH-6000), Vasoview Hemopro 3 Endoscopic Vessel Harvesting System with Vasoshield (VH-6001), Vasoview Hemopro 3 Power Adapter (VH-6020)
- K233972 — Camber Sacroiliac (SI) Fixation System
- K234014 — Obsidian® NOW
- K230693 — BIS Advance Monitoring System
- K230782 — TENS device-HeadaTerm 2 (Model: YF-HT2)
- K231822 — GOLFF Sterile Anti-Fog Solution
- K232084 — Stellaris Elite vision enhancement system
- K232628 — VADER® Pedicle System
- K232752 — Stone Extraction Balloon (VDK-BAL-23-11/13/15-B,VDK-BAL-23-15/18/20-B,VDK-BAL-23-9/12/15-B,VDK-BAL-23-10/13/16-B,VDK-BAL-23-8.5/11.5/15-B,VDK-BAL-23-12/15/18-B,VDK-BAL-23-11/13/15-C,VDK-BAL-23-15/18/20-C,VDK-BAL-23-9/12/15-C,VDK-BAL-23-10/13/16-C,VDK-BAL-23-8.5/11.5/15-C,VDK-BAL-23-12/15/18-C)
- K233560 — Powder Free Nitrile Examination Glove Blue with Low Dermatitis Potential Claim, Tested for use with Chemotherapy Drugs, Fentanyl and Gastric Acid
- K233675 — FMS VUE Fluid Management and Tissue Debridement System
- K234133 — Dexcom G7 Continuous Glucose Monitoring System
- DEN230025 — MIRA Surgical System
- K230423 — Electronic Peak Flow Meter
- K231601 — FLC Kappa, FLC Lambda,FLC Control Level 1, FLC Control Level 2
- K231679 — CONTOUR® PLUS BLUE Blood Glucose Monitoring System
- K232075 — StatStrip Glucose Hospital Meter System
- K232174 — rainbowTM Multi-Layer Block / bright 3-Layer / bright Mono
- K232228 — Multi-drug Urine Test Cup, Multi-drug Urine Test Dip Card, Accurature Multi-drug Urine Test Cup, Accurature Multi-drug Urine Test Dip Card
- K232536 — Soldier Microcatheter
- K232800 — Navigation Tracking Instruments
- K233576 — Konmed Incontinence Stimulation Electrode (Vaginal Probe: KM-503, KM-504, KM-505, KM-506, KM-507, KM-5013 +1 more
- K233590 — Overjet Charting Assist
- K233709 — Exceed Unlimited
- K233722 — RADspeed Pro
- K233754 — AIO Breathe
- K233784 — ENSO (Model 2)
- K233995 — Ivotion Base Print
- K240011 — Lymphedema Compression
- K240190 — MYOtherm XP Cardioplegia Delivery System with Cortiva BioActive Surface, MYOtherm XP Cardioplegia Delivery System Uncoated
- K240201 — PathLoc SI Joint Fusion System
- K240212 — COGNiTiON Staple System
- K240213 — Iconix Knotless Anchor
- K214037 — Ergo-Flex Technologies Back on Trac (BOTGEN1) and Cervi-Trac
- K223826 — NanoDrop Lancet
- K231875 — Vaginal Tactile Ultrasound Imager
- K231876 — MultiPulse HoPLUS
- K232074 — Serafin®
- K232163 — Lotus Single Lumen Ovum Aspiration Needle; Lotus Double Lumen Ovum Aspiration Needle
- K232831 — Quiver Aspiration Pump
- K233544 — MESHEET
- K233640 — Segmental Plating System (SPS) +4 more
- K233749 — Revolution Ascend Sliding
- K233775 — Vivatmo pro
- K233996 — Ulthera System (UC-1 Control Unit PRIME)
- K240173 — Treace Medical Systems (TMC) Plating System
- K240174 — 1688 4K Camera System with Advanced Imaging Modality
- K240193 — R501 - R502 aortic root cannulae with and without vent line (R501-15: R501-20: R501-26. R502-15; R502-20: R502-26)
- K240313 — Oligio X
- DEN230064 — BraidE Embolization Assist Device
- K231561 — Pulmonary Function Tester, Model: A9
- K231753 — Oneday Implant Abutment
- K232148 — X-Guide Surgical Navigation System
- K232265 — BLUEPRINT Patient Specific Instrumentation
- K232502 — Cocoon Convective Warming System, Model CWS7000
- K233199 — ROSA® Shoulder System
- K233325 — Visionary Optics Scleral Contact Lens (roflufocon D, roflufocon E, hexafocon A, hexafocon B, tisilfocon A, fluoroxyfocon A)
- K233439 — HD60 Series Ultrasound Diagnostic System
- K240194 — ProCinch, QuadCinch
- K231896 — Diode Laser Therapy System
- K233150 — NET BRAND Osteosynthesis Nailing System
- K233194 — TS Abutment System
- K233454 — ONLINE TDM Methotrexate
- K233471 — Reprocessed HARMONIC 1100 Shears, 5mm Diameter, 20cm length (HAR1120) +1 more
- K233760 — Mjolnir Pro. (Multielectrode plasma)
- K240146 — BD Prevue II Peripheral Vascular Access System
- K230235 — Medline Luer Lock Syringes
- K231453 — SnapHammer Hammertoe Correction System
- K231513 — Oral Matrix
- K231657 — AGILON® XO Shoulder Replacement System
- K231985 — Disposable Grounding Pad
- K232043 — Endoscopic Video Image Processor (RP-IPD-V2000A, RP-IPD-V2000B, RP-IPD-V2000C, RP-IPD-V2000D), Single-Use Video Gastroscope (RP-GI-G02A, RP-GI-G02B), Single-Use Video Colonoscope (RP-GI-C02A, RP-GI-C02B)
- K232087 — Dental LT Comfort Resin
- K232420 — Zenition 30
- K232645 — Airgle Room Air Purifier
- K232771 — Montage Flowable Settable, Resorbable Bone Paste
- K233652 — Contour Hand/Wrist (Q7000232)
- K233658 — Biowy Tym Tube (TT)
- K233708 — NaviGo 12F Steerable Intracardiac Catheter Introducer Kit (S12FS-01)
- K233906 — S-Patch (S-Patch ExL)
- K234005 — Access CK-MB
- K240119 — VasQ
- K240137 — Cranial LOOP, Cranial LOOP L and Cranial LOOP XL Cranial Bone Fixation System
- K240148 — SCIg60 Infusion System
- K222917 — Breathing circuit bacterial/viral filter
- K223493 — PBC Separator with Selux AST System
Data sourced from openFDA. This site is unofficial and independent of the FDA.