FDA 510(k) clearances — page 196
clearances on record, most recent first.
Clearances — page 196
19,501–19,600 of 176,479- K201315 — PERFORM Humeral System Stem
- K201333 — SABER .035 PTA Dilatation Catheter
- K201506 — Talos®-C Cervical Intervertebral Body Fusion System, Talos®-C (HA) Cervical Intervertebral Body Fusion System
- K201570 — PF4 Enhanced assay
- K201779 — HotDog Temperature Management Controller
- K201859 — Porcine Mineral Collagen Composite Moldable
- K201959 — DePuy Synthes 2.7mm VA LCP Clavicle Hook Plate System
- K202143 — Dynex Micro
- K202187 — FLEX Vessel Prep System
- K202297 — Aline Ablation Intelligence
- K193212 — DSM Biomedical Dental Bone Graft Plus
- K200135 — RGK Daily Range Wheelchairs
- K200845 — Navigation Module of the Momentum System
- K201145 — X-Pac Expandable Lumbar Cage System
- K201330 — Tigereye CTO-Crossing Catheter
- K201407 — CD Horizon Spinal System
- K201450 — Straight T Clear Dental Aligner
- K201731 — Diode Laser Body Sculpture System
- K201738 — SubNovii Advanced Plasma Technology
- K201909 — RxSight Contact Lens
- K201944 — DePuy Synthes 2.4mm Ti Self-Tapping MatrixMANDIBLE Screws (26-40mm)
- K202008 — Disposable Vinyl Glove
- K202156 — DIAMOND-5A/6A/8A
- K202242 — HS Fiber
- K192423 — MINT Product Family
- K192653 — Perseus
- K192730 — CALCIUM-CRESOLPHTHALEIN, GLUCOSE, UREA/BUN-UV
- K192822 — Benesta Hysteroscope
- K193409 — Vista Rinse, Vista Rinse Plus
- K193462 — ClotTriever Thrombectomy System
- K193664 — SubQKath Catheter and Needle Set
- K200027 — Blood Collection Needle with/without Holder, Safety Blood Collection Needle with/without Holder, Luer Access Device-holder with Preattached Multiple Sample Adapter
- K200708 — Vivid iq
- K200851 — Vivid T8, Vivid T9
- K201090 — Structur CAD
- K201252 — Spectralis HRA+OCT and variants
- K201539 — Keeogo Dermoskeleton System
- K201551 — KetoSens BT Blood B-Ketone Monitoring System
- K201578 — DePuy Synthes Variable Angle Locking Patella Plating System
- K201829 — SensiCare PI Evolution Surgical Glove (Tested for Use with Chemotherapy Drugs)
- K201948 — AcroDTI Visualizer
- K202153 — Responsive Arthroscopy Suture Anchor System
- K202256 — 3Shape Implant Studio
- K201194 — Acuity 200 (fluoroxyfocon A) Rigid Gas Permeable Contact Lens
- K201470 — Disposable Medical Face Mask
- K202014 — Magnetom Aera, Magnetom Skyra, Magnetom Prisma/Prisma fit
- K202252 — ASAHI Corsair Armet 18 Microcatheter (Model: CSAR060-18N), ASAHI Corsair Armet 18 Microcatheter (Model: CSAR090-18N), ASAHI Corsair Armet 18 Microcatheter (Model: CSAR110-18N), ASAHI Corsair Armet 18 Microcatheter (Model: CSAR135-18N),
- K202328 — CD Horizon Spinal System
- K202354 — Surgical Mask-Model Number CW01
- K201841 — EyeBOX
- K190561 — NICU V'02
- K192524 — Lumipulse G CA15-3
- K192538 — BD Syringe NRFit Lok and BD Syringe NRFit Slip
- K193341 — iCTmotor (WL-1)
- K193439 — MEBO Wound Dressing
- K193655 — MSLS6QF TENS/PMS Device
- K200835 — 3M Tegaderm CHG Chlorhexidine Gluconate Gel Pad
- K201134 — Arthrex NanoScope System
- K201225 — Neodent Implant System - GM Helix Implants 7.0
- K201517 — Plain Surgical Mask
- K201537 — Protective Face Mask for Medical Use
- K201721 — TruLift Expandable Spacer System
- K202197 — Astopad Patient Warming System
- K202238 — SIGNA Artist
- K202335 — Ambra ProViewer
- K192111 — Biodegradable Nitrile Examination Powder Free Glove, Green
- K192452 — Lyograft
- K193599 — BOUNDER 300 Power Wheelchair, BOUNDER Plus 300 Power Wheelchair, BOUNDER 450 Power Wheelchair, BIG BOUNDER 600 Power Wheelchair, BIG BOUNDER 1000 Power Wheelchair
- K200102 — MIS Dental Implant System
- K200212 — Reprocessed Advisor HD Grid Mapping Catheter, Sensor Enabled
- K200641 — HaloGUARD Protective Disc with CHG
- K201074 — Delta III Lithotripter
- K201203 — Cliq Aspirator
- K201211 — 3MP Color LCD Monitors C32S+, C32SP+; 3MP Monochrome LCD Monitors G32S+, G32SP+
- K201336 — DePuy Synthes Tibial Nail Advanced, Depuy Synthes Locking Screws Medullary Nails, 4.0 and 5.0mm
- K201522 — Arthrex Syndesmosis TightRope XP Buttress Plate Implant System
- K201591 — Flat Panel Detector
- K201769 — Cavetto [MAX] Cervical Cage System
- K201900 — 3D GraftRasp System
- K201966 — 7D Surgical FlashLock 1, 7D Surgical Flex Rod Connector - 5.5 mm - 150 mm, 7D Surgical Flex Array
- K202176 — Symetrex LTHD Catheter, Symetrex LTHD Catheter with Sideholes
- K202235 — ArtPIX DRF
- K202499 — Diamond Digital Sleep Orthotic (DDSO)
- K192704 — Endofresh Digestive Endoscopy System
- K192830 — Bright Temporary C&B
- K193405 — Simplant Digital Guide
- K193618 — ExactechGPS System
- K200462 — EtchPro Etching Gel
- K200503 — ATL Anchors
- K200516 — OCT-Camera ID 21101A3
- K200812 — VeriSight Intracardiac Echocardiography (ICE) Catheter, VeriSight Pro ICE Catheter
- K200827 — LOCATOR R-Tx
- K200833 — RX-1 Rhythm Express Remote Cardiac Monitoring System
- K201277 — Oral-B Dry Mouth Oral Rinse
- K201552 — ApolloVue S100 Image System
- K201677 — Arthrex Mesh Plates
- K201765 — SmartHDM-510 System
- K202124 — Aesculap PAS-Port Proximal Anastomosis System
- K202169 — Quantum PureFlow Centrifugal Blood Pump CP37, Quantum PureFlow Centrifugal Blood Pump CP22
- K202182 — ZOOM (71, 55, 45, 35) Reperfusion Catheters; ZOOM Aspiration Tubing
Data sourced from openFDA. This site is unofficial and independent of the FDA.