FDA 510(k) clearances — page 180
clearances on record, most recent first.
Clearances — page 180
17,901–18,000 of 176,479- K203258 — syngo.CT Lung CAD
- K203378 — Pulsehaler
- K203443 — MAGNETOM Vida, MAGNETOM Sola, MAGNETOM Lumina, MAGNETOM Altea
- K210057 — Blue Nitrile Exam Glove, Powder Free
- K210071 — SIS System (Version 5.1.0)
- K210110 — Guidion
- K210616 — Longeviti PMMA Static Cranial Implant
- K210631 — Avitus(r) Bone Harvester
- K210654 — EnCor Breast Biopsy Probe with Rinse Tube
- K201001 — Modulith SLX-F2
- K201896 — ivi N3003 Surgical face Mask, ivi N6006 Surgical mask
- K202708 — Surgical Face Masks
- K203641 — E-Denture Pro
- K203836 — BOMEDENT Apex locator, WISMY Apex locator
- K210058 — Blue Nitrile Exam Glove, Powder Free
- K210226 — PicoSure Workstation
- K210308 — EMPOWR Porous Femur with HAnano SurfaceTM
- K210603 — 3M Bair Hugger Temperature Management System (Model 675)
- K200601 — LumiCare Caries Diagnostic Rinse
- K201590 — EMMA Capnograph
- K202191 — Surgical Mask
- K203505 — DORO QR3 Headrest System (Aluminum)
- K203826 — LaserCap Family of Lasers 300, 224, 120 & 80
- K203827 — REMI
- K210173 — StarGuide
- K203417 — DVT-4000S
- DEN200019 — Oxehealth Vital Signs
- DEN200050 — Portable Neuromodulation Stimulator (PoNS)
- K201197 — TruAbutment DS, TruBase S
- K201426 — MyCRO Band
- K201466 — Tranberg CLS Laser Applicator
- K201634 — RG 3ml Medication Cartridge
- K201734 — AllerBlock Junior
- K201921 — Spacelabs Lifescreen PRO Analyzer
- K201957 — A8, A9 Anesthesia System
- K202547 — Surgivisio system
- K202725 — ETD4000
- K202751 — TandemHeart Pump and Escort Controller
- K202905 — Disposable Face Mask
- K203038 — Toro-L Interbody Fusion System
- K203254 — Lucent 3D Spinal System
- K203259 — FairFix Adjustable Button System
- K203685 — Disposable Surgical Face Mask
- K203788 — DermaV Laser System
- K210205 — DePuy Synthes 3.5/4.5 mm Variable Angle LCP Periprosthetic Proximal Femur Plating System
- K210207 — Humeral Eccentric Reverse Metaphysis
- K210534 — GEO FirstFUSE 1st MTP Joint Arthrodesis Plating System
- K210638 — i-ED COIL System
- K200177 — Low-frequency Multi-function physiotherapy instrument
- K201376 — ANAM Test System
- K201878 — ST-Z5
- K201982 — Air compression therapy system FO-3001; Air compression therapy system FO-3008
- K202073 — NeedleSmart Professional (NS Pro)
- K202083 — Biodegradable Powder Free Nitrile Examination Glove, Blue-White Color with Low Dermatitis Potential Claim and Tested for Use with Chemotherapy Drugs
- K202133 — Disposable Medical Mask
- K202824 — BRS Procedure Face Mask
- K202944 — NEBULAE SRS Laparoscopic Surgical Smoke Removal System
- K203273 — FibroScan® Family of Products (Models: 502 Touch, 530 Compact, 430 Mini+, and 630)
- K203547 — Nalu Neurostimulation System
- K203776 — Surgical Masks, Model SNN200640 & MN112
- K203834 — Arthrex Patella SuturePlates
- K210333 — DiaPaste
- K210566 — LEGION Porous CR Narrow Femoral Components
- K210667 — FIREBIRD SI Fusion System
- K201626 — Safety Subcutaneous Infusion Set
- K202015 — White ENDOSEAL MTA
- K202080 — Biodegradable Powder Free Nitroprene Examination Glove, Low Dermatitis Potential Claim, Teal-Black Color
- K202453 — SAFECARE Multi-Drug Urine Test Cup, SAFECARE Multi-Drug Urine Test Dip-Card
- K202650 — Medical disposable face mask non sterile
- K203133 — ENvizion Medical ENvue ENvizion Medical Enteral Feeding Tube
- K203225 — Aquilion ONE (TSX-306A/3) V10.4 with Spectral Imaging System
- K203560 — STERIZONE VP4 Test Pack
- K203703 — I-Q View
- K210498 — Betta Link Knotless Implant System
- K202186 — TrueRelief Device
- K202483 — MyHomeDoc
- K202917 — LigaSure Exact Dissector, Nano-coated
- K203064 — ICU Health Surgical Mask
- K203205 — Navigated Spine Instruments
- K203391 — TE7/TE5/TE7 Max/TE5 Max/TE9 Diagnostic Ultrasound System
- K203592 — Tigertriever and Tigertriever 17 Revascularization Devce
- K203620 — Aneroid Sphygmomanometer
- K203780 — Harvester SI: Sacroiliac Fixation System
- K210209 — Viz ICH
- K210325 — APOLLO Anterior Cervical Plate (ACP) System
- K210555 — 7D Surgical System - Drill Guide
- K210828 — DIOnavi-Denture02
- K202009 — Probe Cover: JZ-KBT-001, JZ-KBT-002, JZ-KBT-005, JZ-KBT-007, JZ-KBT-008, JZ-KBT-009, JZ-KBT-010, JZ-KBT-015, JZ-KBT-025, JZ-KBT-026
- K202492 — EZ-IO Intraosseous Vascular Access System
- K203289 — Gold Standard Diagnostics Borrelia burgdorferi VlsE-OspC IgG/IgM ELISA Test Kit
- K203292 — Gold Standard Diagnostics Borrelia burgdorferi IgG/IgM ELISA Test Kit
- K203295 — Gold Standard Diagnostics Borrelia burgdorferi IgM ELISA Test Kit
- K203296 — Gold Standard Diagnostics Borrelia burgdorferi IgG ELISA Test Kit
- K203612 — Capture-CMV
- K203737 — Spark Clear Aligner System
- K203052 — Movement and Compressions System (the MAC System)
- K192731 — ZIDA Wearable Neuromodulation System
- K201095 — Sovereign America Surgical Face Mask
- K202081 — Biodegradable DriTek Powder Free Nitrile Examination Glove, Low Dermatitis Potential Claim, Blue
- K202379 — Invacare AVIVA Storm RX Power Chair
Data sourced from openFDA. This site is unofficial and independent of the FDA.