FDA 510(k) clearances — page 45
clearances on record, most recent first.
Clearances — page 45
4,401–4,500 of 175,620- K250468 — iSLEEVE Introducer Set
- DEN240018 — CORIS System
- K241791 — Medical Diode Laser Systems (GBOX-6H, GBOX-10D , GBOX-12D, GBOX-15D, VELAS Pro-30B15D, VELAS II-6H, VELAS II-15D)
- K241842 — Luer-Split MAJ-2092
- K242241 — Sunny
- K242486 — Tyber Medical Anatomical Plating System
- K243092 — AcuPebble Ox (200)
- K243443 — EXPD 4343N1; EXPD 4343N; EXPD 4343U1; EXPD 4343NU; EXPD 4343NP; EXPD 3643N1; EXPD 3643N; EXPD 3643U1; EXPD 3643NU; EXPD 3643NP
- K243472 — 1NEED Pro
- K243689 — AVIEW
- K243987 — TriMed Elbow and Forearm System
- K243999 — TriMed Ankle Fixation System
- K250042 — PeekMed web
- K250131 — IPL Hair Removal Device (M8011, M8012, M8013, M8015, M8021, M8022, M8023, M8025, M7011, M7012, M7021, M7023)
- K250171 — IPL Hair Removal Device (BE965A, BE965B, BE965C)
- K250210 — Broncho Videoscope System (Single-use Broncho Videoscope (SBV-1A-B, SBV-1A-P, SBV-1B-B, SBV-1B-P, SBV-1C-B, SBV-1C-P); Full HD Visualization Endoscopic Image Processor (HDVS-S300A, HDVS-S300B, HDVS-S300C, HDVS-S300D); Endoscopic Image Processor (HDVS-S100A, HDVS-S100D))
- K250429 — DSPS-Prominent® baseplate, MR (113820); DSPS-Prominent® baseplate (113120); DSPS-Prominent® Cradle-I (113140); DSPS-Prominent® Cradle-II (113150); DSPS-Prominent® Cradle-III (113160); DSPS-Prominent® Cradle-IV (113170); DSPS-Prominent® Cradle-VI (113180); DSPS-Prominent® Cradle-VII (113260); Mask DSPS®-PROSCVRL set/5 (113760); Mask DSPS®-PROSC set/5 (113770); Mask DSPS®-PROSCVR set/5 (113780); Mask DSPS®-PROSCL set/5 (113790); Mask DSPS®-PROSHVRL set/5 (113890); Mask DSPS®-PROSH set
- K250502 — SafeSource Direct Blue Powder-Free Nitrile Exam Gloves (AMERI-TUFF Series 4000, AMERI-TOUCH Series 5000)
- K240287 — LYHER® Oral fluid Multi-Drug Test Kit (Cube)
- K240933 — CarbonCool® System
- K241729 — Hard Splint & Thermo-Adaptive Splint
- K241783 — FortiVy OsteoVy Lumbar IBF
- K241937 — Klarity SGRT System (ARSG-E1A, ARSG-E3A)
- K242161 — Radlink GPS Pro Imaging
- K242533 — Powder Free Nitrile Patient Examination Gloves, Blue Colored, Non Sterile, Low Dermatitis Potential. Tested for Use with Chemotherapy Drugs and Fentanyl Citrate
- K242683 — QP-Prostate® CAD
- K243553 — QuikClot Control+ Hemostatic Device
- K243556 — Lux HD 35 Detector (Lux HD 35); Lux HD 43 Detector (Lux HD 43)
- K243807 — Single Use Retrieval Basket V FG-V421PR/V422PR/V431P/V432P
- K250413 — Aglaia LED Beauty Device (BP-D2309)
- K250494 — The OsteoCentric Bone Plate and Screw System
- K241975 — SERV MEDICAL CDSS
- K242140 — Air Compression Leg Massager (K-705)
- K243504 — MAIA (AHMACME001)
- K243646 — Ziehm Solo FD
- K243802 — aprevo® anterior and lateral lumbar interbody fusion device, aprevo® anterior lumbar interbody fusion device with interfixation
- K243862 — LVivo Software Application
- K243867 — LAGIS Suction Irrigation System
- K243869 — Horizon® 3.0 TMS Therapy System (Horizon 3.0 Inspire); Horizon® 3.0 TMS Therapy System (Horizon 3.0 with StimGuide Pro); Horizon® 3.0 TMS Therapy System (Horizon 3.0)
- K244056 — DOC Band 3D
- K250379 — SIGNA Prime Elite
- K250498 — BPS Wrist Fracture System
- K250514 — UPT Series Medical RO Water Treatment System
- K250439 — Catapult Guide Sheath; 4F; 15cm (US-34015-F-ST-H); Catapult Guide Sheath; 4F; 45cm (US-34045-F-ST-H); Catapult Guide Sheath; 4F; 60cm (US-34060-F-ST-H); Catapult Guide Sheath; 4F; 90cm (US-34090-F-ST-H); Catapult Guide Sheath; 4F; 130cm (US-34130-F-ST-H); Catapult Guide Sheath; 5F; 15cm (US-35015-F-ST-H); Catapult Guide Sheath; 5F; 45cm (US-35045-F-ST-H); Catapult Guide Sheath; 5F; 45cm; Hockey Stick (US-35045-F-HS-H); Catapult Guide Sheath; 5F; 45cm; Multipurpose (US-35045-F-MP-H); Ca
- K234012 — VITEK COMPACT PRO
- K241765 — PLANET Onco Dose (3.2)
- K241816 — VerteGlide Spinal Growth Guidance System
- K241960 — DeepRESP
- K242010 — Bronchoscope System, The Single-use Bronchoscope (Single-use Bronchoscope: SP-Y-ZQGJ2.8, SP-Y-ZQGJ3.8, SP-Y-ZQGJ4.2, SP-Y-ZQGJ4.8, SP-Y-ZQGJ5.2, SP-Y-ZQGJ5.8; Electronic Endoscope Imaging Processor: SP-TXCLQ12.1)
- K242121 — mBôs (Monogram mBôs TKA System)
- K242244 — Viewer+
- K242323 — Maestro System (REF100)
- K242811 — BodyTom 64
- K243332 — Promisemed Safety Huber Needles
- K243353 — One-Fil Putty
- K243529 — Solution Administration Sets
- K243599 — Arrow Endurance Extended Dwell Peripheral Catheter System (EDC-00818)
- K243838 — NEXXT MATRIXX® SI System
- K243931 — CDC Human Influenza Virus Real-time RT-PCR Diagnostic Panel: Influenza A/B Typing Kit (VER 2); Influenza A Subtyping Kit (VER 4); Influenza B Lineage Genotyping Kit (VER 1.1 and 2); and Influenza A/H5 Subtyping Kit (VER 4)
- K250025 — Porcelain Powder (Enamel/ Modifier,Stain/Glaze,Stain/Glaze-A,Modeling Fluid )
- K250079 — Ruby XL System
- K250091 — KOROT Blood Pressure Monitor (KOROT P3 Accurate)
- K250267 — Visalys® Bulk Fill 1 x 4 g Syringe (15060); Visalys® Bulk Fill 15 x 0.25 g Caps (15062); Visalys® Bulk Flow 1 x 2 g Syringe (15064); Visalys® Bulk Flow 15 x 0.25 g Caps (15066); Visalys® Bulk Flow Intro pack (15067); Visalys® Bulk Intro pack (15068)
- K250401 — AION TempShield
- K250526 — Arthrex 4.75 mm Double Loaded Knotless Corkscrew Suture Anchor
- K241811 — MedCAD® AccuStride System
- K242406 — SiOxC Cream
- K242997 — MY01 Continuous Compartmental Pressure Monitor
- K243487 — CryoFreeze Wart and Skin Tag Remover
- K243735 — Ziehm Vision FD
- K243788 — IceCap product line
- K243993 — Photon Therapy Apparatus (BL-10)
- K244022 — 308nm UV Phototherapy System (UV-K); 308nm UV Phototherapy System (UV-X); 308nm UV Phototherapy System (UV-Y); 308nm UV Phototherapy System (UV-Z)
- K250088 — FlowTriever2 Catheter
- K250113 — neoLaser Laser Surgery Fibers
- K250255 — xvision Spine system
- K250380 — Surgify Halo (54.085.SHD.H1); Surgify Halo (54.140.SHD.H1); Surgify Halo (54.070.NVG.H1); Surgify Halo (54.125.NVG.H1); Surgify Halo (54.000.SEE.H1)
- K250382 — Freedom Total Knee System (All-poly Tibial Plate)
- K250385 — Turbo-Elite Laser Atherectomy Catheter
- K241822 — ReWalk® 7 Personal Exoskeleton (50-20-0005)
- K243746 — Delphi Amplifier
- K243763 — Wireless TENS & EMS Unit
- K243783 — Walking rehabilitation training electric wheelchair (ZW518)
- K243822 — BioFire Warrior Panel; BioFire Warrior Panel Control Kit
- K243849 — 2430TCA with Xmaru W
- K243903 — RCT600
- K243957 — PICOALEX
- K250411 — DANNIK® Laparoscopic Single-Use Poly Specimen Retrieval System
- K250605 — EVOL® ha Hyper C Cervical Interbody Fusion System
- K241562 — OutFlo Aortic Valve Dilatation Balloon Catheter
- K241725 — Better Diagnostics Caries Assist (BDCA) Version 1.0
- K242610 — 8mm Monopolar Curved Scissors (470179)
- K243029 — Origin TT Stem
- K250357 — RemunityPRO Pump for Remodulin® (treprostinil) Injection
- K250374 — iBur 3.0mm Diamond Match Head, Distal Bend (8431-107-030D); iBur 3.0mm Precision Round, Distal Bend (8431-009-030); iBur 4.0mm Precision Round, Distal Bend (8431-009-040); iBur 2.0mm Diamond Round, Distal Bend (8431-012-020D); iBur 3.0mm Diamond Round, Distal Bend (8431-012-030D); iBur 4.0mm Diamond Round, Distal Bend (8431-012-040D); iBur 3.0mm Coarse Diamond Round, Distal Bend (8431-013-030DC); iBur 4.0mm Coarse Diamond Round, Distal Bend (8431-013-040DC); iBur 5.0mm Coarse Diamond R
- K250424 — Arthrex TightRope Soft Button, RT
- K241944 — AGILON® XO Shoulder Replacement System
- K243101 — Medline ReNewal Reprocessed Siemens ACUSON AcuNav 10F Ultrasound Catheter (for Siemens Systems) (08255790 ); Medline ReNewal Reprocessed Siemens ACUSON AcuNav 10F Ultrasound Catheter (for GE Systems) (10043342)
- K243596 — da Vinci SP SureForm 45 Staplers and Reloads (SP1098)
- K243676 — Duet External Drainage and Monitoring System (EDMS)
Data sourced from openFDA. This site is unofficial and independent of the FDA.