FDA 510(k) clearances — page 52
clearances on record, most recent first.
Clearances — page 52
5,101–5,200 of 175,620- K242362 — Lightning Viewer
- K242529 — Tigon Medical All-Suture Anchors (ASA)
- K242530 — HF-Etchant Hydrofluoric Acid Etching Gel
- K242534 — HandPICO Fractional Laser Handpiece Tip
- K242572 — TopCEM-Try in Veneer Try-in Gel
- K242599 — aprevo® Digital Planning
- K242628 — Scooter (PS30)
- K242644 — SENDERO MAX Delivery Catheter
- K242688 — Finiff System
- K242923 — SimpleSnip Endoscopic Suture Cutter (SC500160); SimpleSnip Endoscopic Suture Cutter (SC500230)
- K242929 — Fas Aligner System
- K242953 — KIDS Arterial Filters
- K243024 — Cellbrick Knee Spacer
- K243040 — LED Light Therapy Mask (SKB-1818P,SKB-1918,SKB-1918P,SKB-1918PLUS,SKB-2318L,SKB-2318P,SKB-2318PRO,IN-FM002, SKB-2418)
- K243149 — Microliter Dosing Syringe (9, 20, 25, 37.5, 50 and 100 microliter models)
- K243293 — Zimmer® Persona® Personalized Knee System
- K243308 — Bonebridge Osteosynthesis Plating System (SALGINA 2.5mm Distal Radius System, CASCELLA 3.5mm Superior Clavicle System, LEPORELLO 3.5mm Olecranon Syste)
- K243607 — Moda-flx Hemodialysis System Cartridge (102121-001 )
- K243629 — Momcozy Wearable Breast Pump (BP311); Momcozy Wearable Breast Pump (BP223); Momcozy Wearable Breast Pump (BP324); Momcozy Wearable Breast Pump (BP334); Momcozy Wearable Breast Pump (BP430)
- K243671 — ExcelsiusGPS® Instruments
- K243675 — InkSpace Imaging Small Body Array
- K243759 — BIOFIRE Blood Culture Identification 2 (BCID2) Panel (RFIT-ASY-0147 (30 pack) RFIT-ASY-0148 (6 pack))
- K243911 — HPR Cordless Hygiene Handpiece
- DEN240014 — ARC-EX System
- K232813 — Therapy EC, Therapy XT
- K240348 — Quantum Mitohormesis (QMT) (M2101)
- K240885 — Shadow Catheter
- K241168 — System 83 Revolve Endoscope Washer/Disinfector
- K241322 — Electric Breast Pump (LD-208L, LD-3010L, LD-2010L, LD-3010, LD-2010)
- K241637 — Echo Intracranial Base Catheter
- K241768 — Broadway 8 Catheter
- K241778 — Hudson RCI Comfort Flo® CubCannula
- K242063 — LibAirty Airway Clearance System
- K242270 — OrthoNext Platform System
- K242370 — Medline Microdissection Needle (4cm) (140936 (ESE104A)); Medline Microdissection Needle (3cm) (140937 (ESE103A))
- K242467 — IQ-UIP
- K242700 — Radiant Renewal Skincare Lid (HD-59A, HD-59B, HD-59C, HD-59D, HD-70, HD-72, HD-72A, HD-73A, HD-73B, HD-116, HD-116A, HD-53A, HD-53B)
- K242819 — IPD Dental Implant Abutments
- K242892 — Cristaline Aligners Z FLX
- K242908 — UV Phototherapy Device (Group A: SQ308PCHFD, SQ308PCQFD, SQ308PCPFD, SQ308PCNFD, SQ308PCMFD); UV Phototherapy Device (Group B: SQ308PHTFF, SQ308PHSFF, SQ308PHRFF, SQ308PHZFG, SQ308PPUFF, SQ308PPVFF, SQ308PPWFG)
- K242954 — Integrity V500 (Integrity, Integrity with VEMP)
- K243071 — Bovine Dermis Collagen Dermal Matrix
- K243094 — Quickdent Dental Implant System
- K243169 — The Sensititre 18-24 hour MIC or Breakpoint Susceptibility System with Ceftobiprole in the dilution range of 0.008-16 ug/mL
- K243171 — Yushan X-Ray Flat Panel Detector
- K243361 — Nutrifit
- K243430 — Micro-current Facial Beauty Device (AM-810B, AM-810W, AM-812B, AM-812W)
- K243440 — Electric Wheelchair (HC820N)
- K243595 — OviTex PRS (Long-Term Resorbable)
- K243652 — Monoject Enteral Syringe with ENFit Connector (401SE); Monoject Enteral Syringe with ENFit Connector (403SE); Monoject Enteral Syringe with ENFit Connector (406SE); Monoject Enteral Syringe with ENFit Connector (412SE); Monoject Enteral Syringe with ENFit Connector (435SE); Monoject Enteral Syringe with ENFit Connector (460SE)
- K243688 — Saige-Dx (3.1.0)
- K243705 — Saige-Density (2.5.0)
- K243725 — BD Vaginal Panel
- K240763 — FirstFit Surgical Kit
- K240765 — Porous Biologic Scaffold
- K240959 — Respiratory Muscle Trainer
- K241040 — Amethyst HP PTA OTW 0.035 Catheter
- K241058 — Lyka® PORT Needle Free Access Device (4170Y)
- K241095 — ARTSMedia Semen Wash Medium
- K241132 — ARTSMedia Oocyte Aspiration Medium (502020, 502050, 502100)
- K241395 — Active System; Avenue8
- K242216 — GENTAFIX® (1, 3, 3MV)
- K242424 — Bluebird Single-Use Respiratory Effort Belt
- K242535 — Single-use Flexible Cystoscope (CY-E2E01, CY-E2E01R, CY-E2F01, CY-E2F01R, CY-E2G01, CY-E2G01R, CY-S2E01, CY-S2E01R); Digital Video Monitor (DVM-D1, DVM-D2)
- K242662 — Falcon/Xpress (Falcon/Xpress)
- K242787 — Tens & Ems Device (TU1080)
- K243128 — Klockner Kits
- K243609 — EquivaBone Osteoinductive Bone Graft Substitute (EquivaBone )
- K243615 — Physica Porous Femoral Components
- K243625 — Xpert MRSA/SA SSTI
- K243720 — 3Delta UNlimited
- K223093 — Aptiva APS IgG Reagent; Aptiva APS IgM Reagent
- K240798 — Cntrl+ Bladder Support Pessary
- K241036 — Autoclave Indicator Tape; EO Indicator Tape
- K241556 — Cardiac Workstation (5000); Cardiac Workstation (7000)
- K241616 — ALLONUS Tech Prosthetics
- K241801 — Tornus ES
- K242146 — BIOBRANE Temporary Wound Dressing; BIOBRANE Glove
- K242297 — Reform Pedicle Screw System
- K242413 — VizionFocus (mififilcon A) Silicone Hydrogel Soft (hydrophilic) Daily Disposable Contact Lens; VizionFocus Color (mififilcon A) Silicone Hydrogel Soft (hydrophilic) Daily Disposable Contact Lens
- K242558 — Halyard Black Nitrile Powder-Free Exam Gloves with Textured Grip Technology, Tested for Use with Chemotherapy Drugs, Fentanyl Citrate, Simulated Gastric Acid and Fentanyl in Simulated Gastric Acid
- K242783 — Roche Digital Pathology Dx
- K242815 — POCKET TENS (EP-300)
- K242816 — Quantium
- K242869 — prodisc® L Instruments
- K242987 — Thulium Fiber Laser (FiberLAZE+, FiberLAZE)
- K243336 — Lucitone Digital Print Denture System
- K243365 — Healgen Accurate Muti-Drug Urine Drug Screen Cup; Healgen Accurate Home Muti-Drug Urine Test Cup
- K243664 — Sentinel Camera
- K232839 — Eye Secret 38 UV Aspheric (polymacon) and Air Light 38 UV Aspheric (polymacon) Soft (hydrophilic) Contact Lens for Daily Wear
- K240676 — ULTIMUS Series Ultrasound Diagnostic System
- K240793 — MSKai
- K240809 — LUOFUCON® Silver Collagen Dressing
- K240873 — TEMBO Embolic System
- K240937 — AIM (N/A)
- K242003 — XABO Ventricular Catheter, XABO Peritoneal Catheter, XABO Catheter Set
- K242015 — TOPAZ Mobile X-ray System (Models : TOPAZ-32D, TOPAZ-40D)
- K242307 — ACHIEVE Partial Knee System
- K243066 — Dental Implants and Abutments
- K243471 — Extraction Basket
Data sourced from openFDA. This site is unofficial and independent of the FDA.