FDA 510(k) clearances — page 361
clearances on record, most recent first.
Clearances — page 361
36,001–36,100 of 176,542- K141812 — MYGAIT STIMULATION SYSTEM
- K141826 — FLASHPAK STERILIZATION CONTAINER SYSTEM
- K141934 — PHYSICA KR KNEE SYSTEM
- K142024 — BRIGHTMATTER NAVIGATION SYSTEM
- K142217 — Reliance Interspinous Plate System
- K143018 — Kangaroo Enteral Feeding Tube Extension Set with ENFit Small Bore Connectors
- K143043 — Tanning Lamp
- K143132 — IS4000 8mm Harmonic ACE Curved Shears
- K143353 — Hahn Tapered Implant System
- K143372 — AWARE
- K143480 — Euphora Rapid Exchange Balloon Dilatation Catheter
- K150010 — Cedic Oral/Luer Enteral ENFit Transition Connector for Medication Port
- K150060 — J2A Dental Implant System, J2C Dental Implant System
- K150165 — GC85A
- K150227 — Disposable Blood Pressure Cuff Guard
- K150413 — QB1 System Powered Muscle Stimulator & Transcutaneous Electrical Nerve Stimulator
- K150438 — Force Fiber OrthoTape suture
- K150510 — Total Bilirubin
- K150545 — Arm-Type Fully Automatic Digital Blood Pressure Monitor (BP-1305, BP-1307, BP-1326, BP-1318, BP-1319, BP-1211, BP-1312, BSP-11, BSP-12, BSP-13)
- K150747 — EzDent-i /E2/Prora View
- DEN140030 — SpaceOAR System
- K141997 — CRIT-LINE IV SYSTEM
- K142745 — 125mL CT Syringe
- K143288 — Sensititre Susceptibility plates
- K143336 — Biomet Microfixation OmniMax MMF System
- K143338 — Argulated Locking Plates
- K143459 — Silk Road Acccess Catheter
- K150253 — Disposable Suction Irrigation, 330mm, Disposable Suction Irrigation, 450mm
- K150263 — K-Pack II Needle-21G x 2
- K150631 — St. Jude Medical MediGuide Enabled Livewire Steerable Electroohysiology Catheter, Livewire Electrophysiology Catheter
- K141181 — NUVE FOR WRINKLES, DPL NUVE FOR WRINKLES
- K141757 — ALERE I STREP A
- K141785 — MICRO THERMX MICROWAVE ABLATION SYSTEM AND ACCESSORIES
- K141991 — SINGLE USE PRELOADED SPHINCTEROTOME V (DISTAL WIREGUIDED); SINGLE USE SP
- K142218 — Coalition AGX Plate and Coalition AGX Spacer
- K142723 — ADVIA Centaur Cortisol (COR) Assy
- K142781 — ImmuLisa Enhanced SS-A (Ro) Antibody ELISA, ImmuLisa Enhanced SS-B (La) Antibody ELISA, ImmuLisa Enhanced Sm Antibody ELISA, ImmuLisa Enhanced RNP Antibody ELISA
- K142818 — Phasix Mesh
- K143165 — Herbert/Whipple Bone Screw System, Herbert/Whipple Bone Screw System, Herbert Cannulated Bone Screw System, Herbert Mini Bone Screw
- K143567 — NexSite HD Hemodialysis Split Tip Catheter for long term use (24cm), NexSite HD Hemodialysis Split Tip Catheter for long term use (28cm), NexSite HD Hemodialysis Split Tip Catheter for long term use (32cm), NexSite HD Hemodialysis Split Tip Catheter for long term use (36cm), NexSite HD Hemodialysis Split Tip Catheter for long term use (40cm), NexSite HD Hemodialysis Split Tip Catheter for long term use (55cm)
- K150175 — HeatLux Pro I
- K150234 — Myriad Prostate Caddy¿ Immobilization Rectal Balloon Item #9901,3301
- K150325 — Range/Denali/Mesa Spinal System
- K150527 — Xcela Power Injectable PICC
- K141527 — DEPUY SYNTHES VARIABLE ANGLE LOCKING HAND SYSTEM
- K143036 — Ebony PTA 0.035 Peripheral Dilatation Catheter
- K143324 — IDS-iSYS CTX-I Calibration Verifiers
- K143365 — Eminent Foot Plate System
- K143695 — CENTRAL MONITORING SYSTEM
- K143697 — Biomet Proximal Humerus Plating System
- K150529 — Site-Rite Prevue Ultrasound System, Site-Rite Prevue+ Ultrasound System
- K150551 — GORE SEAMGUARD Reinforcement
- K143032 — eMotion Faros ECG Mobile
- K150192 — Scenium
- K140110 — FLEXTIP PLUS EPIDURAL CATHETER; FLEXBLOCK CONTINOUS PERIPHERAL NERVE BLOCK CATHETER KIT/SET
- K141085 — WestTec Procedure Facemask; WestTec Surgical Facemask
- K141322 — ADVANCE ENFORCER 35 FOCAL FORCE PTA BALLOON CATHETER
- K141385 — DEPUY SYNTHES INJECTABLE POLYMER SYSTEM (IPS)
- K142420 — Patient Positioning Devices
- K142426 — EBI External Implant System
- K142677 — MALDI Biotyper CA System
- K142709 — samaritan PAD 450P
- K143108 — HealthGuard-15
- K143180 — F3
- K143517 — Voyant Open Sealer-Divider Device
- K143609 — Gyrus ACMI - EZDilate 3-Stage Balloon Dilatation Catheter
- K143641 — NuVasive NVM5 System
- K150150 — 1717SGN / 1717SCN Digital Flat Panel X-ray Detector
- K150291 — TYRX Neuro Absorbable Antibacterial Envelope
- K150366 — SOFIA 6F Catheter
- K141847 — AVANCE FOAM DRESSING KITS
- K141961 — GENADYNE SPIRO FOAM DRESSING KIT
- K142294 — FlexiMarc Marker
- K142449 — Headway 27 Microcatheter
- K142822 — PLIASURE Polyglycolide Synthetic Absorbable Suture
- K142865 — Nellcor Bedside SpO2 Patient Monitoring System
- K143361 — Mammo Workstation
- K143409 — SOMATOM Definition AS Open (VA48)
- K150052 — TRUE METRIX AIR Self-Monitoring Blood Glucose System, TRUE METRIX AIR PRO Professional Blood Gulcose Monitoring System
- K150196 — DD cubeX2
- K150478 — A35 Diagnostic Ultrasound System
- K150485 — AVERT Contrast Modulation System
- K150491 — ER36 Series OAE Test System
- K140213 — DISPOSABLE ENDOSCOPIC CANNULA
- K141715 — GLOVE PORT
- K141833 — STYLET, 23CM, SKULL-MOUNT PATIENT TRACKER, NON-INVASIVE PATIENT TRACKER, TRACER POINTER, TOUCH-N-GO POINTER, NAVIGATION
- K142117 — INVISION TOTAL ANKLE REVISION SYSTEM
- K142706 — Modified ONFLEX Mesh
- K142798 — PASS LP Spinal System
- K142892 — Powder-free Clear Vinyl Patient Examination Gloves
- K142907 — Baha 5 Sound Processor
- K143014 — F5
- K143073 — Affinity NT Oxygenator, Affinity NT Oxygenator with Trillium Biosurface, Affinity NT Oxygenator with Carmeda Biosurface
- K143083 — Bio-Medicus Pediatric Cannula and Introducers
- K143104 — Visalys Core, Visalys PL-Core, Visalys PL-Core-C, Visalys PL-Core-X
- K143443 — VEGA Knee System, Columbus Total Knee System
- K143473 — Short SureLock All-Suture Anchor, 1.4mm with (1) size 0 UHMWPE suture with needles, Short SureLock All-Suture Anchor, 1.4mm with (1) size 2-0 UHMWPE suture with needles
- K143533 — FIBERGRAFT BG PUTTY BONE GRAFT SUBSTITUTE
- K150503 — Echo Bi-Metric Microplasty Line Extension
- K150573 — ebb Complete Tamponade System
Data sourced from openFDA. This site is unofficial and independent of the FDA.