FDA 510(k) clearances — page 11
clearances on record, most recent first.
Clearances — page 11
1,001–1,100 of 176,428- K253393 — Single-use Balloon Dilatation Catheter (AG-5251-083018 AG-5251-085518 AG-5251-088018 AG-5251-083019 AG-5251-085519 AG-5251-088019 AG-5251-083021 AG-5251-085521 AG-5251-088021 AG-5251-083024 AG-5251-085524 AG-5251-088024 AG-5251-103018 AG-5251-105518 AG-5251-108018 AG-5251-103019 AG-5251-105519 AG-5251-108019 AG-5251-103021 AG-5251-105521 AG-5251-108021 AG-5251-103024 AG-5251-105524 AG-5251-108024 AG-5251-123018 AG-5251-125518 AG-5251-128018 AG-5251-123019 AG-5251-125519 AG-5251-128019
- K253404 — CLEAR Aspiration System
- K253560 — Enhanced Boundary for PCCT
- K260394 — Hydrophilic coated intermittent nalaton catheter for single use-ready to use (NCR)
- K260669 — Endoform Dermal Template
- K260937 — Smart Electric Wheelchair (R1-Std-BK, R1-Pro-BK, R1-Ultra-GK, R1-Ultra-WK)
- K260998 — Ceribell Neurology Review Software
- K261023 — Microdacyn Wound Irrigation Solution
- K261055 — AMSCO 700 Steam Sterilizer
- K261260 — HD Camera Head OLYMPUS CH-S200-08-LB
- K261772 — Target Xtra Detachable Coil
- K261866 — Concerto Versa Detachable Coil
- K253180 — Microlife Digital Peak Flow Meter, Model PF200B (PF200B)
- K253199 — CURASYS 2 (EMDN0003)
- K253211 — AQUABEAM Robotic System
- K261004 — Codman® Distal Peritoneal Catheter, Barium Open End (82-1682) +1 more
- K253148 — RX-1 Sleep
- K253176 — TearView
- K253421 — Perfusion Measurement Platform v1
- K254011 — Flow Water-Based Personal Lubricant
- K254287 — Medline Reusable Blood Pressure Cuff
- K260316 — CMN Capillary Function with Oncology Virtual Expert
- K261075 — Manual Wheelchair (MS01); Manual Wheelchair (MA01)
- K261076 — Caregiver-assisted wheelchair (MS02); Caregiver-assisted wheelchair (MA02)
- K261279 — DeltaNEC Interbody System
- K261342 — Urocross Expander System (UES-2018-C1)
- K261950 — Health Line Tearaway Introducer
- K260369 — Dynamis Robotic Surgical System
- DEN250025 — Syncron-E
- K250806 — Dental Implant System
- K251232 — MegaGen Zygoma Dental Implant System
- K251559 — InstaTRU Instant Biological Indicator for Steam (IBI-05)
- K252066 — inspired Heated Breathing Circuit (510-008) +3 more
- K252839 — ZywieZ3 Sensor & Adhesive
- K252982 — CONDUIT ZERO-P VA Secured Spacer System
- K253050 — RadOncAI
- K253058 — Portable DR Imaging System
- K253080 — AND Medical Femoral Nail System (PFNA01); AND Medical Femoral Nail System (PFNA02)
- K253110 — Sol-Glide Safety Needle; Sol-Glide Safety Needle with Syringe
- K253116 — 3D MAC Titanium Cranial Plate (TCP) System
- K253126 — Wrist Blood Pressure Monitor (XW-05)
- K253131 — Curing Light (M-Cure 6)
- K253187 — SteriBest® Sterilization Tray System
- K253521 — ECMT-100 WMD
- K253678 — MAMMOMAT B.brilliant (11372950)
- K253776 — Implantmed Plus II & Piezomed Plus II Module
- K253812 — Power Wheelchair (W5915B, W5915C, W5915D)
- K253824 — Powder Free Nitrile Examination Gloves Non-Sterile Black
- K254169 — SmartSpectra Vital Signs Monitor 1.0
- K254254 — Momcozy Wearable Breast Pump (BP311, BP311-A, BP311-B, BP311-C, BP311-D)
- K260178 — Pelvic Muscle Trainer (KM510, KM516B)
- K260190 — ARTHUR
- K260280 — NOVEOS Specific IgE (sIgE) +5 more
- K260636 — Remanufactured LigaSure XP Maryland Jaw Sealer/Divider Without Nano-coating
- K260729 — Vascular Assist Occlusion Triage (VAOT) (v1.0)
- K260820 — VIVIX-S 4386W (FXRD-4386WA)
- K260946 — LED Light Therapy Mask (K9C-TK, K9C-K, K9P-YK, K9P-K, FM-03BK, FM-09K)
- K261099 — Blood Volume Analyzer (200)
- K261246 — SRGC-06
- K261651 — Precice Max System and Precice Ankle Salvage System
- K261665 — CORUS Navigation System-GN
- K261701 — Hemolase Fiber (Hemo-R-0.40-2.5/Hemo-R-0.60-2.5/Hemo-R-0.40-1.8/Hemo-R-0.60-1.8)
- K261707 — MEMO 4D Curve Semirigid mitral annuloplasty ring
- K261713 — Synapse PACS (7.6.0)
- K252399 — Portable Oxygen Concentrator
- K253045 — Socko Vimax Spinal Fixation System
- K253055 — Sine Monitoring Parkinsons Disease Tremor Dyskinesia Apple Watch (SMPDTDAW)
- K253155 — Fule Metallic Lockable Intramedullary Nail Systems
- K253255 — Non-Sterile Ultrasound Gel Sterile Ultrasound Gel
- K253333 — Assisted Reproduction Laser System (Model ILS-400M)
- K253634 — CoolSeal Generator® (CSL-200-90)
- K260006 — INOSS System
- K260428 — RIVOS EUS Access Device (M00553900)
- K260538 — Momcozy Wearable Breast Pump (BP420, BP420-A, BP420-B, BP420-C, BP420-D )
- K260867 — Nitrile Powder Free Examination Gloves Tested for Use with Chemotherapy Drugs and Fentanyl Citrate (Blue) +1 more
- K260916 — FLEXI-PORT Power Injectable Implantable Port
- K261544 — Hydro Irrigation System
- K261570 — PICOSURE WORKSTATION
- K261631 — Amplatzer TorqVue Exchange System
- K261638 — Bonvadis®
- K261672 — twiist Automated Insulin Delivery (AID) System
- K253001 — KT Airway Clearance Device II (KT-3); KT Airway Clearance Device II (KT-5)
- K253046 — HERA Interlocking Intramedullary Nailing System
- K253069 — Lipoprotein (a) Molarity Assay
- K253137 — FUJIFILM Endoscope Model EB-840S; FUJIFILM Endoscope Model EB-840T
- K253159 — Prophecy Incompass Surgical Planning System
- K253231 — Laser Hair Growth System (Laser Cap 128, Laser Helmet 272, Laser Helmet 352, Laser Helmet 552, Laser Helmet 500)
- K253264 — myAblation Guide (VC10A)
- K253374 — LimiFlex® Dynamic Sagittal Tether Instrument Set
- K253723 — BOSS
- K254025 — LED Neck Beauty Mask (ZLD-66A,ZLD-90E,ZLD-130,ZLD-180H)
- K260425 — TENS / EMS DEVICE (FT-247 Series) (FT-247, FT-237)
- K260693 — VicorderCS (VCS-SYS-1100)
- K260831 — Z1 Hip System
- K260844 — ACUSON Sequoia Diagnostic Ultrasound System +3 more
- K260899 — Laser Hair Growth Device (F21151, F21152, F21153, F21154, F21155, F21156, F21157, F21158, F21159)
- K260958 — I.T.S. Clavicle Plates with Angular Stability +11 more
- K261683 — Augment Off-Axis Instrument System
- K261833 — NEUROMARK System (NMK00301)
- K253059 — Tournicare ARMA Automatic Blood Pressure Monitor (ARMA-08)
Data sourced from openFDA. This site is unofficial and independent of the FDA.