FDA 510(k) clearances — page 32
clearances on record, most recent first.
Clearances — page 32
3,101–3,200 of 176,479- K251336 — VISERA ELITE III Video System Center Olympus OTV-S700 (OTV-S700) +2 more
- K251833 — EMPOWR Acetabular® Liner Extension
- K252271 — Hemoclip
- K252327 — CMORE® CT System; CMORE® CT System Navigated Instruments
- K252452 — PeekMed web
- K252829 — Powered Wheelchair (PL001-9001)
- K252959 — WRISTAR MultiAx Distal Radius Kit
- K253290 — XSTAT P15
- K251006 — NeVasc Aspiration System
- K251702 — IntelliVue Patient Monitor MX750 +2 more
- K252287 — Symani Surgical System
- K252474 — Withings BeamO (SCT02)
- K252560 — Atlas Spine HiRISE Expandable Cervical Corpectomy System
- K252570 — EzSensor HD, EzSensor UHD
- K252573 — KLS Martin Cranial Implants - MR Conditional +6 more
- K251596 — Lunderquist Extra Stiff Wire Guide
- K243131 — Triathlon Pro
- K250264 — SugarBug (1.x)
- K250739 — Primeprint Direct Aligner
- K250819 — Electric Wheelchair (Rollz Motion Electric 2M)
- K251129 — S.I.N. Tapered Pro Conical Zygoma Implant System
- K251295 — ulrichINJECT CT Motion (XD 8000)
- K251391 — BrainsWay Deep TMS System
- K251441 — Inion CPS 1.5 Baby Bioabsorbable Fixation System; Inion CPS 1.5/2.0/2.5 Bioabsorbable Fixation System
- K251853 — Consona N5, Consona N5 Pro, Consona N5 Super, Consona N5 Exp, Consona ER, Consona N5S, Consona EI, Consona EF, Consona N5 Elite, Consona N5 Ultra, Consona N3, Consona N3 Exp Diagnostic Ultrasound System
- K252041 — Fibresolve (with PCCP)
- K252519 — CO2 Laser Therapy System (K106)
- K252564 — Medical Diode Laser Systems (VeinCure)
- K253039 — AUTO KERATO-REFRACTO TONOMETER TRK-3 OMNIA
- K253513 — MultiMatch Flow Chameleon AntiMicrobial Composite
- K250423 — mb-FIX Cranial Stabilization Systems
- K250815 — Hubly Drill (H100)
- K251004 — Dual-Mode Mobile C-Arm (Geelin500A, Geelin500M)
- K251555 — Ultra Compression Screw System
- K251792 — Stereotaxis GenesisX RMN with Navigant Workstation (NWS)
- K252133 — Adaptix Ortho350
- K252418 — Catalyst F1x Shoulder System
- K252469 — MAGNABOND SE; MAGNABOND UNIVERSAL; MAGNABOND UNIVERSAL DCA
- K252515 — Q-Switched Nd:Yag laser (K690)
- K252525 — AIO Breathe
- K252845 — Venus Nova (FP-2001)
- K253074 — Tandem Mobi insulin pump with interoperable technology
- K253265 — BriefCase-Triage
- K253478 — Motive Muscle Stimulator for Lower Back (OT01-1003)
- K250363 — Depth Electrode (17+ models)
- K250375 — Allure Hip Stem and Intramedullary Plugs
- K250376 — ViVY
- K250599 — ExcelsiusGPS Instruments
- K252514 — EVAC-MRI
- K252677 — Polyshield Safety IV Catheters
- K250241 — Cios Select
- K250576 — Flexx Junior (FLX-J00, FLX-J50)
- K250853 — Merit Syringe
- K251303 — Tamburo Thulium Fiber Laser System
- K251410 — VXvue
- K251709 — MedCAD® AccuStride System
- K252664 — GMReis Suture Anchors
- K252740 — Voyant® Open Fusion Device (EB240/Open Fusion)
- K252964 — PRIMED Surgical and Procedure Masks
- K250330 — 3mensio Workstation
- K250392 — ZAP-X Radiosurgery System (ZAP-X)
- K251532 — Acorn 3D Software (AC-SEG-4009); Acorn 3DP Model (AC-101-XX)
- K251626 — Midmark Dental Delivery System
- K252458 — Kyphoplasty Balloon Dilatation Catheters
- K252481 — cobas CMV
- K252484 — cobas HCV
- K252671 — Electric wheelchair (NSDS-01)
- K252698 — NightGuard Aire Max
- K253448 — Sonosite MT Ultrasound System
- DEN240074 — Pulsenmore ES
- K250306 — Chex-All Sterilization Pouches and Tubes
- K250338 — MSS - Humeral reverse liners extension
- K250358 — BD Enteric Bacterial Panel for BD COR System, BD Enteric Bacterial Panel plus for BD COR System, and Enteric Bacterial Panel Diluent for BD COR System
- K250917 — Flexible Ureterorenoscope system (Electronic Endoscope Image Processor, model: SP-TXCLQ12.1, Flexible Ureterorenoscope, model: SP-SNGSYJ 2.0, SP-SNGSYJ 2.2, SP-SNGSYJ 2.5, SP-SNGSYJ 2.8)
- K251041 — GripTract-GI Endoscopic Tissue Manipulator Upper GI Model GT-GS100
- K251381 — Ceribell Instant EEG Headcap (Small: C251, Medium: C252)
- K251547 — DESS Dental Smart Solutions
- K252060 — GREEN
- K252074 — Aplio i900, Aplio i800 and Aplio i700 Software V9.0 Diagnostic Ultrasound System
- K252088 — Firebird SI Navigation System
- K252160 — Persyst 15 EEG Review and Analysis Software (Persyst 15 (P15))
- K252412 — Voyant® Electrosurgical Generator (EA030/Electrosurgical Generator)
- K252427 — Diode Laser Hair Removal Machine (GLD01)
- K252442 — Kii Structural Balloon Access System
- K252777 — Freedom Metaphyseal Cone Implants (Metaphyseal Cones)
- K253501 — Hydro Print Premium Fast Set - 454g (1lb) (052037) +9 more
- K243619 — Niti-S Esophageal Stent; Esophageal TTS Stent
- K250325 — BD Alaris Pump Infusion Set
- K250337 — AiORTA - Plan
- K250632 — Arctx Cool Catheter Set
- K251531 — AIR COMPRESSION BOOTS 1018195,1018196
- K251686 — Tornier Humeral Reconstruction System Max (Tornier HRS Max)
- K251938 — GEN5 and GEN5+ Dental Implant System
- K252046 — Zoom System (Zoom 4S Catheter)
- K252387 — Simplexa COVID-19/ Flu A/B & RSV Direct (MOL4450); Simplexa COVID-19/ Flu A/B & RSV Positive Control Pack (MOL4460)
- K252414 — Q-Renew LLLT Hair Growth Helmet (Q-HLMT-V1)
- K252430 — Freeprint® denture flex
- K252529 — Moses 200 D/F/L Laser Fiber (M0068130100) +2 more
- K252607 — AllTest Urinary Tract Infection Test
- K252752 — ellacor System with Micro-Coring Technology
Data sourced from openFDA. This site is unofficial and independent of the FDA.