FDA 510(k) clearances — page 207
clearances on record, most recent first.
Clearances — page 207
20,601–20,700 of 175,699- K192530 — Surefil one Self-adhesive Composite Hybrid
- K193295 — Parcus Knotless PEEK and PEEK CF Push-In Suture Anchor
- K193504 — HardyDisk AST Cefiderocol 30ug (FDC30)
- K190837 — Internal Hex Implant System
- K190954 — Fundus Camera
- K191093 — Isopure Dry Acid Dissolution System
- K191109 — Spectra Q
- K191322 — E-EEGX, N-EEGX
- K192161 — FastFit EMS System
- K192502 — Anatomic PEEK Cervical Fusion System, Anatomic PEEK PTC Cervical Fusion System, Capstone Spinal System, Capstone PTC Spinal System, Capstone Control Spinal System, Capstone Control PTC Spinal System, Clydesdale Spinal System, Clydesdale PTC Spinal System, Cornerstone PSR Cervical Fusion System, Crescent Spinal System, Crescent Spinal System Titanium, Divergence Anterior Cervical Fusion System (For Stand-Alone Interbody Device Only), Divergence-L Anterior/Oblique Lumbar Fus
- K192684 — HydroPearl Microspheres
- K192993 — SCARLET AL-T
- K193574 — Q-Rad System
- K193606 — Y-Knot OneStep Anchor
- K191149 — CARESCAPE B650
- K191229 — TrapIt
- K191425 — Hydro-Temp Neonatal Skin Temperature Probe Cover
- K192564 — Disposable Gold Cup EEG Electrodes
- K192985 — Medline Glide-On 3G Vinyl Examination Gloves
- K193370 — Nexxt Matrixx System
- K193566 — ZELTIQ CoolSculpting System
- K193569 — PIVO(TM)
- K192098 — EzMobile
- K193222 — Tyber Medical Anatomical Plating System
- K193045 — geko W-2
- K193548 — Mirage Hydrophilic Guidewire, X-pedion Hydrophilic Guidewire
- K181089 — SureLead Cable System
- K190306 — AMD Ritmed AssureWear VersaGown
- K190871 — Bio-TackS Orthodontic Mini Implant
- K192182 — C015
- K192211 — SoundBite Console, SoundBite Active Wire 18
- K192302 — Mahurkar Acute Single Lumen Catheter, Mahurkar Acute Dual Lumen Catheter, Mahurkar Acute Triple Lumen Catheter, Mahurkar Acute High Pressure Triple Lumen Catheter
- K192415 — Study Watch with Irregular Pulse Monitor
- K192495 — Black Diamond Navigation Instruments
- K192547 — MAGLUMI 2000 HCG/ß-HCG
- K192563 — Altera gas Sampling Lines
- K192583 — PicoLazer Laser System
- K192606 — SAC2 - Electrode Cream
- K192635 — Powder Free Nitrile Patient Examination Gloves, Non-Sterile (Orange)
- K192761 — Asimov-MKS Imaging System
- K192926 — RxSight Insertion Device
- K193007 — LiNA OperaScope with HDMI cable and on-board LCD - 6 units, LiNA OperaScope Recording Module
- K193182 — Evis Exera III Duodenovideoscope Olympus TJF-Q190V
- K193507 — Merit ONE Snare System
- K193509 — AcQGuide Flex with AcQCross QX, AcQGuide Mini with AcQCross QX
- K193543 — CoLink Plating System, Fracture and Correction System, CoLink Mini Plating System, CoLink View Plating System, CoLink Afx Plating System
- K193547 — CustomizedBone Service
- K193570 — Dental Pain Eraser
- K193590 — CareSens S Fit BT Blood Glucose Monitoring System
- K191095 — Maxxi Snore Sensor
- K191538 — Resectr Tissue Resection Device
- K191802 — Electric Breast Pump
- K191831 — MobiliT Cup
- K192357 — INNOVO
- K192750 — AcTiFlip Naked, AcTiFlip Cinch, AcTiFlip WHIP, GFS Ultimate Hip
- K192869 — SherpaPak Lung Preservation System , SherpaPak Liver Transport System
- K192942 — ALLthread Titanium Suture Anchor
- K192956 — Auto Positioning
- K193488 — GlideScope BFlex 3.8 Single-Use Bronchoscope
- K193500 — Stellar M22 for Intense Pulsed Light (IPL) and Laser System
- K193611 — Viveve 2.0 System
- K181005 — ClenchGuard
- K183284 — INTRAcel RF Microneedle System
- K190028 — UNO 30
- K190981 — NEX-D2 Posterior Fixation System
- K191125 — ADAS 3D
- K191266 — VitalScan ANS
- K191275 — AllInCath 035M PTA Balloon Dilatation Catheter
- K192004 — Eko Analysis Software
- K192251 — Livento Press, Soprano 10, Soprano
- K192454 — Wattson Temporary Pacing Guidewire
- K193225 — KDR AU-DDR System Advanced U-Arm with Dynamic Digital Radiography, KDR AU System Advanced U-Arm with Static Digital Radiography
- K193493 — ADVIA Centaur Total IgE (tIgE)
- K193503 — Arthrex SwiveLock Suture Anchor
- K190316 — Icare ic200
- K191020 — G210 InviCell Plus with SignipHy pH monitoring
- K192115 — SABLE Expandable Spacer
- K192429 — Dental Pain Eraser
- K192800 — Streamline TL Spinal Fixation System
- K192920 — Oragene®Dx
- K193188 — MiiS Horus Eye Anterior Camera
- K193478 — XTRAC Momentum Excimer Laser System
- K191717 — Route 92 Medical Sheath System
- K192409 — Midwest Rhino XE and Air Motor M
- K192544 — Erchonia Emerald
- K193645 — nva, nvp, and nvt
- K183074 — TENS and EMS Stimulator, TENS Stimulator
- K190878 — Trach- Vac Endotracheal Tube (SFTVPU) Subglottic Suction Tube with Salter Flex-Tip and Salter ThinCuff, Trach- Vac Endotracheal Tube (SFTVVC) Subglottic Suction Tube with Salter Flex-Tip and Salter ThinCuff
- K191221 — Cybird LED Curing Light
- K191678 — IP Converter
- K191692 — KardioScreen
- K192307 — Nihon Kohden NKV-550 Series Ventilator System
- K192315 — Medline Green Ambidextrous Power-Free Nitrile Examination Gloves with Colloidal Oatmeal USP (Tested for Use with Chemotherapy Drugs)
- K192966 — FlowMet
- K192995 — OsteoRemedies Hip Spacer System
- K193011 — CD Horizon Fenestrated Screw Set
- K193372 — Univers Revers Modular Glenoid System (Augemented baseplates)
- K193452 — MotoBAND CP Implant System
- K193465 — CorticaLINK Spinal Fusion Platform
- K191052 — HyaloGYN Vaginal Moisturizing Suppositories
Data sourced from openFDA. This site is unofficial and independent of the FDA.