FDA 510(k) clearances — page 299
clearances on record, most recent first.
Clearances — page 299
29,801–29,900 of 175,699- K163605 — LEDEX WL070+
- K163620 — Reprocessed Kendall SCD Express Compression Sleeves, Reprocessed Kendall SCD Comfort Compression Sleeves
- K153587 — Taps for Resorbable Screws
- K161091 — STIMPOD NMS460 Nerve Stimulator
- K161274 — Bondiloxs Topical Hemostatic Granules
- K161412 — F&P Brevida Nasal Pillows Mask
- K161904 — GEO Bone Screw System
- K162121 — Siconus SI Joint Fixation System
- K162197 — EndoClot
- K162432 — Multi-Link X2 ECG Cable and Lead Wire System
- K162651 — Breast BI 7 MR Coil Mammavention 3T
- K162817 — Noddle(TM)
- K162895 — Elecsys Troponin T Gen 5 STAT Assay, Elecsys Troponin T Gen 5 STAT CalSet, Elecsys PreciControl Troponin, Elecsys Troponin T Gen 5 CalCheck 5
- K163156 — SurgiCase Orthopaedics, SurgiCase Connect, SurgiCase Guides
- K163254 — Acuity 18 (enflufocon A) Rigid Gas Permeable Contact Lens
- K163310 — NovaBone IRM
- K163657 — Quantum Workstation
- K161514 — Precision Thin Reciprocating Blade, 0.010in.
- K162455 — Humelock Reversed Shoulder
- K162663 — WELL LIFE Rx Wireless TENS/EMS Stimulator, model WR-2603/2603A, WR-2604/2604A and WR-2605/2605A
- K163231 — Chameleon PTA Balloon Catheter
- K163554 — hema-screen ER XCEL Enhanced Readability Fecal Occult Blood Test
- K153128 — Kolplast Cervical Sample Collection Kit
- K160965 — SuperLine
- K161106 — PANPAC DISPOSABLE VACUUM CURETTES
- K161328 — Cantab Mobile
- K161762 — DynaMatrix/Dynamatrix Plus
- K162164 — GingiKnit+, GingiBraid+, and Shortcut with GingiBraid+ Non-Impregnated Retraction Cord
- K162489 — RED Light Device
- K162511 — LELO RESPECT HEX Natural Rubber Latex Condom
- K162775 — Legion Cone System
- K162864 — OsteoVation Impact
- K163519 — RX DC
- K163534 — Lumipulse G FSH-N Calibrators
- K163541 — Magseed Magnetic Marker System
- K163546 — Lumipulse G Progesterone-N Calibrators
- K161217 — VITEK 2 Gram Negative Ceftriaxone (<=0.25->=64 ug/mL)
- K161902 — Meridian M110 Fetal Monitoring System
- K162173 — Elecsys CYFRA 21-1 CalCheck 5
- K162323 — Tooth Shade Resin Material
- K162336 — Contour Next EZ Blood Glucose Monitoring System
- K162500 — Ostial Sprit Cannulae
- K162532 — WellDoc BlueStar, WellDoc BlueStar Rx
- K162694 — Ayers Rock Cervical interbody fusion system
- K162754 — FREND Vitamin D Test System
- K162884 — SpineGuard DSG Zavation Screw System
- K163176 — Exilis XP II
- K163205 — 48CH Head Coil
- K163521 — Lumipulse G LH Calibrators
- K163533 — EzDent-i; E2; ProraView
- K163544 — Lumipulse G Prolactin
- K163635 — ACUSON S1000/S2000/S3000 Diagnostic Ultrasound Systems
- K160178 — Lympha-Flow(LF1200)
- K161204 — ENDOCAM Flex HD Camera System 5521
- K161281 — Dentalis Bio Solution Implants
- K161517 — Mortara Surveyor Patient Monitor
- K162057 — ConceptoMed Luer-Jack Slip 10ml
- K162201 — Desara TV, Desara Blue TV
- K162261 — CERAMAGE UP
- K162387 — U-IGNITE Bladeless Trocar
- K162765 — Venus Velocity Diode Laser System
- K162810 — InSeca ARC Stylus, Aerin Console
- K162885 — SPY Phi Open Field Handheld Fluorescence Imaging System
- K163128 — Epic Pro
- K163479 — R2P Metacross RX
- K160991 — Neo GBR System
- K162179 — osteo-WEDGE II ® Open Wedge Bone Locking Plate System
- K162805 — Akros Fibulink Syndesmosis Repair Kit
- K163015 — Liquichek Tumor Marker Control-Level 1; Liquichek Tumor Marker Control-Level 2; Liquichek Tumor Marker Control-Level 3; Liquichek Tumor Marker Control- Trilevel MiniPak
- K163120 — EPIQ 5 Diagnostic Ultrasound System; EPIQ 7 Diagnostic Ultrasound System; Affiniti 50 Diagnostic Ultrasound System; Affiniti 70 Diagnostic Ultrasound System
- K163252 — Mammomat Fusion with Stereotactic Biopsy
- K151857 — Love Alchemy's Love Lotion
- K161508 — Ceruloplasmin
- K161841 — D2P
- K161971 — Bindex BI-2
- K162083 — RII Multi-function Infrared Thermometer, Model TH52Z
- K162208 — DxC 700 AU Clinical Chemistry Analyzer, AU IgG Reagent
- K162483 — Symbia Intevo Bold
- K162767 — Sentinel BreastScan II System
- K162818 — Nitrile Powder Free Examination Glove with Low Dermatitis Potential Claim and Tested for Use with Chemotherapy Drugs (Blue)
- K162819 — Nitrile Powder Free Examination Glove with Colloidal Oatmeal USP Tested for Use with Chemotherapy Drugs
- K161036 — Hospira Extension Set, Hospira Primary Set
- K161463 — SureClip(TM) Repositionable Hemostasis Clip
- K161504 — Cook Turbo-Flo HD Acute Hemodialysis Catheter Set/Tray
- K162086 — MultiStim ECO
- K162181 — Protek Duo Venous Dilator Set, Protek Solo Venous Dilator Set
- K162253 — Trapper Exchange Device
- K162490 — Disc-FX System
- K162887 — PrismaSATE
- K162931 — Ingenia 1.5T CX and Ingenia 3.0T CX R5.3
- K162946 — 8ch Knee-Foot SPEEDER
- K162969 — LIAISON® CMV IgG and LIAISON® CMV IgG Serum Control Set
- K163013 — Quantib Brain 1.2
- K163116 — Ingenia 1.5T, Ingenia 1.5T S and Ingenia 3.0T R5.3
- K163141 — NAMIC ClearaCIL Contrast Injection Lines
- K163142 — SpeedStitch Suture Passer; SpeedStitch Suture Cartridges, White Suture, Blue Cobraid, Black Cobraid, Mixed Pack; SpeedStitch Needle Loader and Unloader
- K163444 — Spectre guidewire
- K163456 — DuraGen Secure Dural Regeneration Matrix
- K163457 — NeuraGen 3D Nerve Guide Matrix
- K163490 — StatStrip Xpress 2 Glucose Hospital Meter System
Data sourced from openFDA. This site is unofficial and independent of the FDA.