FDA 510(k) clearances — page 2
clearances on record, most recent first.
Clearances — page 2
101–200 of 176,428- K260031 — THERMEO® I MSI
- K260250 — QCA 10 Electrocardiograph (QCARD-10); QCA 10W Electrocardiograph (QCARD-10W)
- K261225 — CAS-One IR
- K262015 — Elucid FFR-IQ (B.1)
- K262213 — Power Mobility Scooter (MA03)
- K262241 — Electric Wheelchair (0080)
- K262553 — MOBILITY SCOOTER (YQ-401,YQ- 401A,YQ-403,YQ-403A)
- K262721 — Spinalogic Bone Growth Stimulator
- K262726 — NeckTune SA Cervical Cage
- K263048 — Syngo Carbon Space (VA4)
- K263073 — Fast Absorbing PGLA
- K260474 — Liora Monofilament Scaffold
- K260619 — VITEK 2 AST-Streptococcus Cefepime (<=0.06 >=4 µg/mL)
- K261543 — Phasix ST Parastomal Hernia Mesh
- K262052 — Tri Stage Venous Cannulae
- K262649 — Alians Forearm
- K252139 — Kentrospine Viktr-MIS® Pedicle screw system
- K260945 — Ultima System (UL-800) +3 more
- K254058 — DistaSense(TM) (v1)
- K254210 — REBOHIL (BGM-1, BGM-2, BGM-3, BGM-4, BGM-5)
- K254230 — CapsoView (CVV); CapsoCloud (CLD)
- K254252 — UNIDRIVE SIII System +1 more
- K254255 — S-Patch CardioAI
- K254291 — easyEndo E-Lite Single Use Powered Endoscopic Staplers +2 more
- K254297 — Tempus ECG-MR
- K260023 — TumorSight Risk
- K260055 — syngo.CT Brain Quantification
- K260140 — Aevice Wheeze Detection Module
- K261262 — Altis Full Face Mask
- K261336 — Xpert Respiratory Panel
- K261372 — Profoject LOR Syringe
- K261977 — Braun Aura 9 (6042)
- K261992 — 3M Attest Steam Chemical Integrator (1243A, 1243B, 1243RE, 1243RES)
- K262196 — Invisalign System
- K262215 — Profoject Safety Sliding Blood Collection Set
- K262548 — EPIQ Inspira Series Diagnostic Ultrasound System; Affiniti Series Diagnostic Ultrasound System
- K262975 — Arthrex Beaming System
- K262983 — EsTemp Implant
- K263182 — EVO X30 Diagnostic Ultrasound System +8 more
- K254199 — PicoreMax (PicoreMax)
- K254303 — KARL STORZ SUPRALOOP
- K260114 — Align® Cover and Pad Guidance Tool
- K260214 — STA® - Liquid Anti-Xa
- K260313 — MD-6000S Bladder Scanner
- K260949 — Disposable Belts for Polysomnography (CNSAC)
- K261078 — Electric Scooter (FNS01,FNS03)
- K261345 — Pediatric Nailing Platform Femur
- K262149 — corra® cervical plating system
- K262168 — QIAstat-Dx BCID GN Plus AMR Panel
- K262183 — Hair Growth Helmet (TK-176, TK-600, TK-500, TK-282, TK-500A, TK-282A, TK-126, TK-60)
- K262252 — MPa Max adhesive
- K262618 — Arthrex Spine Compression FT Screw
- K262955 — OsseoFit Stemless Shoulder System
- K263010 — ISIS Headboxes, ISIS Neurostimulator, ISIS Xpert Plus, ISIS Xpert, ISIS Xpress
- K254289 — Portable Oxygen Concentrator (OX-1A-E, OX-1B)
- K260117 — Everslide
- K260597 — VIRTUE QA
- K260995 — DynaNail Helix® Fixation System
- K261418 — Liquick X-treme, Liquick X-treme Plus
- K261453 — G7® Acetabular System
- K261637 — Single-use Flexible Bronchoscope
- K261874 — Syneris PACS v.1.0.1.0
- K261892 — ProRib Fixation System
- K262067 — iFuse Granite Onyx Implant System
- K262144 — DIAMED Handpiece; DIAMED Airmotor; DIAMED Airmotor Handpiece
- K262156 — Anti-HCV Next
- K262207 — Cemented Plus Abutment
- K262254 — Hair Growth Comb (X-GC01)
- K262353 — BTL-299-F
- K262582 — Electric wheelchair (GP100)
- K263049 — SABER-C System
- K243223 — Multiple therapy aesthetic treatment device (BHS 202 UNYQUE)
- K253762 — ErgoSteel (ES0001/696)
- K254168 — Actolind® (06.3637. Actolind® Gel Plus)
- K254240 — Echo-2
- K261125 — BodyTom 64 (NL4100); OmniTom Elite (NL5000)
- K262299 — Instant-View® hCG Combo II Cassette Test
- K262390 — BoneXpert
- K262442 — HipStudio Analysis
- K263054 — BIOFIRE Respiratory Panel 2.1 (RP2.1)
- K253509 — TriSalus TriNav Advance Infusion System
- K254280 — F.A.S.T Screw
- K260416 — ZYLOX Hippo PTA Balloon Dilatation Catheter
- K260512 — Disposable Ureteral Access Sheath
- K260940 — BellaTek Bars
- K261368 — Rapid Platform (R6.7)
- K261725 — OtoCompanion (Version 1.0)
- K262108 — FAMA Male Latex Condoms Aqueous Lubricant (Ultra-thin) +8 more
- K262109 — Access NT-proBNP
- K262547 — KARL STORZ TIPCAM1 Rubina
- K262982 — Core·it Dual
- K241973 — SmartIPL_NI System
- K252723 — Dynamis Pro Family
- K261859 — Electric Scooter (FDB08, FDB08A, FDB12)
- K253146 — Hyperdrive 35 Guidewire
- K253419 — Triever Duo Catheter
- K254095 — 25G Huber Needle
- K254160 — VacHeal Negative Pressure Wound Therapy System
- K254171 — Mesh Nebulizer (4 models)
- K254179 — Drainage Catheter
Data sourced from openFDA. This site is unofficial and independent of the FDA.