FDA 510(k) clearances — page 32
clearances on record, most recent first.
Clearances — page 32
3,101–3,200 of 175,620- K252239 — InVision 3T Recharge Operating Suite
- K252326 — InterSpace GV Hip Spacer
- K244016 — iPETcertum (v1.0)
- K250246 — uMR Jupiter
- K250434 — trophon2
- K250934 — Respiree Cardio- Respiratory Monitor System
- K251411 — Chemfort Female Luer Lock Adaptor
- K252113 — PRADO Lumbar Interbody Fusion System
- K252141 — AltiVate Reverse® Glenoid
- K250950 — CUTIVA Topical Skin Adhesive (RM1700); CUTIVA PLUS Skin Closure System (RM1739)
- K251087 — Blood Volume Analyzer (200)
- K251113 — iHealth Compare Wireless Blood Pressure Monitor(BP-300C);iHealth Compare Pro Wireless Blood Pressure Monitor(BP-300CV);iHealth Compare S Wireless Blood Pressure Monitor(BP-300V);iHealth Wireless Blood Pressure Monitor(BPX1);iHealth Blood Pressure Monitor(KD-595);iHealth Track Pro Connected Blood Pressure Monitor(KN-550LT);Semi Automatic Blood Pressure Monitor(KD-388N);Arm Blood Pressure Monitor(KD-553);Arm Blood Pressure Monitor(KD-557BR);Arm Blood Pressure Monitor(KD-558);Arm Blood Pr
- K251122 — Terragene® Bionova® BT20 Biological Indicator
- K251223 — HnX-P1, HnX-PB
- K251762 — Quantum Perfusion Centrifugal Blood Pump CP20NG with Integrated Sensors (CP20V-NG)
- K243427 — QuickSleeper 5
- K243448 — Equinoxe® Shoulder System
- K243458 — HydroPICC 4Fr Single Lumen Marked catheter, 130 cm guidewire - Basic Kit (70001301); HydroPICC 4Fr Single Lumen Marked catheter, 70 cm guidewire - Basic Kit (70001302); HydroPICC 4Fr Single Lumen Marked catheter - Maximal Barrier kit (70001304); HydroPICC 5Fr Dual Lumen Marked catheter, 130 cm guidewire - Basic Kit (70002301); HydroPICC 5Fr Dual Lumen Marked catheter, 70 cm guidewire - Basic Kit (70002302); HydroPICC 5Fr Dual Lumen Marked catheter - Maximal Barrier kit (70002304); Hydr
- K243462 — Diazyme Colorimetric Lithium Assay
- K243483 — Access hsTnI
- K243496 — MycoMEIA Aspergillus Assay
- K243841 — Sparta Infusion Set for Insulin
- K250315 — RONAVIS FX (FX-001)
- K250381 — Deepsight NeedleVue LC1 Ultrasound System
- K250495 — MINI VP1 (PL67_F); MINI VP1 (PL61_F)
- K250508 — AK 98 Dialysis Machine (955607)
- K250541 — Self-Forming Magnet (Flexagon Plus OTOLoc)
- K250790 — INNOVISION-DXII
- K250941 — Revolution Vibe
- K251252 — NOBILCAM IMPAK Disc
- K251652 — Strauss Surgical Cystoscopes & Hysteroscopes (STS-2040-302ASA HD-endoscope, STS-2040-302AA HD-endoscope, STS-2040-302BA HD-endoscope, STS-2040-302BSA HD-endoscope, STS-2040-302ESA HD-endoscope, STS-2040-302CA HD-endoscope, STS-2029-302AA HD-endoscope, STS-2029-302BA HD-endoscope, STS-2040-298DSA-RWF-endoscope, STS-2040-298ASA-RWF-endoscope, STS-2040-300GSA-RWF-endoscope, STS-2040-303CA-RWF-endoscope, STS-2040-280ASA-OLY-endoscope, STS-2040-280ESA-OLY-endoscope, STS-2040-283BSA-OLY-endo
- K251707 — IPL Hair Removal Device (HCT-1208/HCT-1208B/HCT-1208L)
- K252094 — eZSURE Empty Fluid Container
- DEN240068 — ArteraAI Prostate
- K241461 — Mpact Constrained Liner
- K242728 — BeneVision Central Monitoring System
- K243341 — Genius AI Detection 2.0
- K243455 — cobas Respiratory 4-flex for use on the cobas 5800/6800/8800 Systems
- K243571 — Trabecular Metal Acetabular Revision System, Acetabular Liners and Constrained Liners
- K243656 — U2 Total Knee System PF+ Patella; USTAR II System PF+ Patella
- K244060 — eCO2 3D
- K250477 — NextAR(TM) Spine
- K250597 — REMEX Xcam6
- K250738 — YSIO X.pree
- K250843 — Wearable Breast Pump (Model FS12A); Wearable Breast Pump (Model FS12B)
- K251561 — Biograph Trinion
- K251574 — Sleep Watch
- K241990 — SpineSite Endoscope System
- K242855 — P-CON (polymacon) Soft (hydrophilic) Contact Lenses (Tinted, Color)
- K243534 — Micro Catheter
- K243919 — Voxel Dosimetry (00859873006226)
- K244007 — ArteVu
- K250127 — TSK Syringe
- K250724 — Intraosseous Infusion Needles
- K251060 — CORUS Navigation System-GX
- K251076 — Diode Laser Hair Removal Machine (models: T60A, T60B, T60C, T60D, T60E)
- K251234 — EnSite X EP System
- K251319 — Sterile Nitrile Powder Free Examination Glove Tested for Use with Chemotherapy Drugs and Fentanyl Citrate (Blue); Sterile Nitrile Powder Free Examination Glove Tested for Use with Chemotherapy Drugs and Fentanyl Citrate (Blue) Extended Cuff
- K251361 — Tyber Medical Distal Radius Plating System
- K251706 — TENS and EMS Unit
- K251735 — Stabilis SA Cervical Stand-Alone System (Various PNs)
- K252032 — T65 (9016E061-)
- K252144 — Iconix Speed Anchor; Iconix Speed HA+ Anchor
- K243407 — Forcyte Autograft Harvest Kit
- K243473 — PRORAD ATLAS ULTRAPORTABLE; PRORAD ATLAS ULTRAPORTABLE PLUS
- K250179 — Patient Monitor (CX10, CX12, CX15, UX10, UX12, UX15)
- K250356 — MoMe ARC® Wireless Ambulatory ECG Monitoring and Detection System (32000)
- K250442 — da Vinci Surgical System, IS5000
- K250647 — SImmetry+ System
- K251350 — BD Plastipak Syringe
- K251364 — Sleepiz One+ (2.5)
- K251523 — Cios Spin
- K251664 — Single Use Aspiration Needle (NA-201SX-4021); Single Use Aspiration Needle (NA-201SX-4022)
- K241183 — ISO Abutment
- K243489 — Alinity m EBV (09N43-095)
- K250652 — ECG-AI Low Ejection Fraction (LEF) 12-Lead algorithm (1010)
- K251061 — NAEOTOM Alpha.Peak/NAEOTOM Alpha; NAEOTOM Alpha.Pro; NAEOTOM Alpha.Prime
- K251187 — 3 in 1 TENS UNIT (TC1241, TC2241, TS1241)
- K251220 — NUVENTUS NV.C Prosthetic Components
- K251636 — Spectrum IQ Infusion System with Dose IQ Safety Software (3570009)
- K251640 — SIGMA Spectrum Infusion Pump with Master Drug Library
- K243244 — Heated Breathing Tube
- K243403 — BD Nexiva Closed IV Catheter System
- K250232 — Vathin® Video Bronchoscope System
- K250244 — Compression Therapy Device (LGT-2210DS)
- K250334 — Fusion Craniofacial Implant; Fusion Skull Implant
- K250552 — Hi-Torque Command 14 ST Guide Wire and Hi-Torque Command 14 MT Guide Wire
- K250859 — TransForm McCarthy Mitral Annuloplasty Ring (TF)
- K250970 — Marie
- K250989 — Stryker and Serf hip devices
- K251322 — Venue; Venue Go; Venue Fit; Venue Sprint
- K251339 — Medical Diode Laser Hair Removal Device (PZ-606¿, PZ-BDT68-01, PZ-BDT68-02, PZ-BDT68-03, PZ-BDT68-04)
- K251620 — A.L.P.S. Proximal Humerus Plating System
- K251665 — Triathlon® Hinge Knee System
- K252033 — Profoject Disposable Syringe, Profoject Disposable Syringe with Needle
- K252215 — InbellaMAX System
- K243392 — Infusomat® Space Volumetric Infusion Pump Administration Sets
- K243711 — Confocal Microprobe Imaging System (BrightP980); Confocal Microprobe Imaging System (BrightP960); Confocal Microprobe Imaging System (BrightP880); Confocal Microprobe Imaging System (BrightP860); Confocal Microprobe Imaging System (BrightP780); Confocal Microprobe Imaging System (BrightP750); Confocal Microprobe Imaging System (BrightP680); Confocal Microprobe Imaging System (BrightP660); Confocal Microprobe Imaging System (BrightP600); Confocal Microprobe Imaging System (BrightP580);
- K250284 — TSK SELECT Needle
- K250322 — Respond OC Conserving Regulator (130-0800)
Data sourced from openFDA. This site is unofficial and independent of the FDA.