FDA 510(k) clearances — page 484
clearances on record, most recent first.
Clearances — page 484
48,301–48,400 of 176,542- K103770 — SAME/VARIOUS DISTRIBUTORS/ WE MAY PRIVATE LABEL
- K110125 — 2.4 MM VA-LCP VOLAR RIM DISTAL RADIUS SYSTEM
- K110139 — CURVE IMAGE
- K110177 — HELENA SYSTEM
- K110675 — EASYRA UREA NITROGEN AND CREATININE REAGENTS
- K110787 — TRIPORE TDD (HA), TRIPORE TDD (BP90), TRIPORE TDD (BP15)
- K110838 — IFUSE IMPLANT SYSTEM
- K111024 — JETPACK 2.0
- K101827 — OSTEOSCAF
- K102804 — SPI TITANIUM BASE FOR CAD/CAM
- K102859 — RETCAM 3 OPTHALMIC IMAGING SYSTEM
- K103317 — RESUSCITATION UNIT 105
- K103833 — NEOPIP PATIENT CIRCUIT WITH PEEP
- K110112 — CELL-TISSUE CONVERTER (CTC) SYRINGE WITH NEEDLE
- K110210 — SATURN 8000-GS
- K110436 — FDI GLUCOSE CONTROL SOLUTION FOR AVIVA
- K110452 — SOF-FORM II, UNILENS, UNISITE, SIMULVUE, AQUAFLEX, LL-38, BAYVUE AQUAFLEX MTO, UNILENS 38, UNISOFT, SIMULVUE 38 LLBI 2,
- K110461 — SELECTRA CS LEAD INTRODUCER SYSTEM
- K110515 — UCP DRUG SCREENING TEST CUPS
- K110626 — JETSTREAM NAVITUS SYSTEM; JETSTREAM G3 SF SYSTEM; JETSTREAM G3 SE SYSTEM; JETSTREAM G3 L SYSTEM
- K110768 — COMPUTED DENTAL RADIOGRAPHY
- K110833 — CRE BALLOON DILATATION CATHETER
- K110844 — SYMBIA.NET
- DEN110012 — APTIMA TRICHOMONAS VAGINALIS ASSAY
- K090277 — NATUS SLEEPWORKS, MODEL 104017
- K093581 — DISCOVERY MODEL CT590 RT AND OPTIMA MODEL CT580 CT SYSTEMS
- K102034 — BLUE SKY BIO DENTAL IMPLANT SYSTEM
- K102480 — INJECTION PIPETTE; HOLDING PIPETTE; BIOPSY PIPETTE; DENUDING PIPETTE; PARTIAL ZONA DISSECTION (PZD) PIPETTE; ASSISTED HA
- K103277 — 3M ATTEST 1491 SUPER RAPID READOUT BIOLOGICAL INDICATOR; 3M ATTEST 490 AUTO-READER
- K110029 — CONSERVE BIO FOAM SHELL
- K110148 — WEXLER VASCULAR CLAMP SERIES
- K110219 — POWDER FREE VINYL PATIENT EXAMINATION GLOVES
- K110338 — POWDER-FREE VINYL PATIENT EXAMINATION GLOVES
- K110434 — TRIXEL CO2 LASER
- K110487 — FLEXIBLE CARDIAC COIL
- K110521 — EVERON CENTRAL DISPLAY STATION (CDS)
- K110779 — SPACELABS SMART DISCLOSURE SYSTEM
- K110815 — PARIETEX OPTIMIZED COMPOSTIE MESH
- K110816 — PARIETEX OPTIMIZED COMPOSITE MESH (PCO-OSX REFERENCES)
- K100344 — DIMENSION VISTA LOCI CA 15-3 FLEX REAGENT CARTRIDGE, DIMENSION VISTA LOCI 7 CALIBRATOR, MODELS: K6456 AND KC605
- K103362 — AOI CRANIAL HELMET
- K103729 — INFILL INTERVERTEBRAL BODY FUSION DEVICE
- K110136 — RESPICHAMBER VALVED HOLDING CHAMBER
- K100183 — MODEL MC-180MA MULTI-FREQUENCY BODY COMPOSITION ANALYZER
- K102418 — REVERSE MEDICAL REPORT GUIDE CATHETER SYSTEM
- K103042 — ATMOS E 201 THORAX AND ATMOS S 201 THORAX
- K103091 — LANX SPINAL FIXATION SYSTEM
- K103524 — VOYAGER TRANSPORT INCUBATOR WITH MASIMO PULSEOX, VOYAGER TRANSPORT INCUBATOR WITH NELLCOR PULSEOX
- K103527 — AVIATOR TRANSPORT INCUBATOR WITH MASIMO PULSEOX, AVIATOR TRANSPORT INCUBATOR WITH NELLCOR PULSEOX
- K103606 — ARTISTE SOLUTION WITH SYS_VB50 UPDATE
- K103662 — CONTINUUM AND TRILOGY INTEGRATED TAPER (IT) ACETABULAR SYSTEMS; LONGEVITY IT HIGHLY CROSSLINKED POLYETHYLENE ELEVATED LI
- K110152 — SPSMEDICAL VAPORIZED HYDROGEN PEROXIDE CHEMICAL INDICATORS
- K110767 — ANGIOSCULPT PTA SCORING BALLOON CATHETER
- K110841 — DIGITAL COLOR DOPPLER ULTRASOUND IMAGING SYSTEM, CONVEX / LINEAR / PHASED ARRAY TRANSDUCER
- K110921 — NITRILE POWDER-FREE EXAMINATION GLOVES TESTED FOR USE WITH CHEMOTHERAPY DRUGS
- K093914 — NEWDEAL COMPRESSION PLATES
- K101468 — 3M BASIC DISPOSABLE SURGICAL GOWN, 3M HP DISPOSABLE SURGICAL GOWN, 3M REINFORCED DISPOSABLE SURGICAL GOWN, 3M DISPOSABLE
- K101867 — VICOR PD2I ANALYZER
- K102085 — POWDER FREE VINYL PATIENT EXAMINATION GLOVES, CLEAR (NON-COLORED)
- K102847 — DISPOSABLE ENDOMETRIAL SUCTION CURETTE
- K103582 — KELYNIAM CUSTOM SKULL IMPLANT (CSI)
- K110240 — SMITH & NEPHEW, INC. SURESHOT DISTAL TARGETING SYSTEM V2.1
- K110319 — EVERCROSS 0.035 OTW PTA DILATATION CATHETER
- K110368 — NOVABONE PUTTY - BIOACTIVE SYNTHETIC BONE GRAFT
- K110547 — OPTERTRAK LOGIC PSC TIBIAL INSERT
- K110705 — APNEA RISK EVALUATION SYSTEM (ARES)
- K110887 — INJECTION GOLD PROBE BIPOLAR ELECTROHEMOSTASIS CATHETER
- K101201 — STRAIGHT ABUTMENT, 4.2, 4.6, 5.0, 6.4, IMPLANT 6.0, IMPLANT 7.0, IMPLANT 8.0 MODEL: 002061, 002062, 002063, 002064,
- K101412 — EVA TPN BAG
- K103015 — ODRC-DYNAMIC HIP SCREW SYSTEM
- K103336 — MPS450 MULTIPARAMETER SIMULATOR
- K103556 — IPS E.MAX CAD CRYSTALL / CONNECT AND IPS E.MAX CAD CRYSTAL / ADD-ON CONNECT (FOR CAD-ON TECHNIQUE)
- K103784 — DBX DEMINERALIZED BONE MATRIX PUTTY
- K103795 — DBX DEMINERALIZED BONE MATRIX PUTTY
- K110259 — ARCHITEX SPACE MAINTENANCE SYSTEM
- K110742 — ONESTEP ADULT MULTI-FUNCTION ELECTRODE
- K100321 — DIMENSION VISTA LOCI CA 125 FLEX REAGENT CARTRIDGE,AND DIMENSIONS VISTA LOCI 6 CAL, MODEL#'S K6455, AND KC604
- K102943 — CORELEADER ALGI-FIBER WOUND DRESSING MODEL ADW 05050
- K103200 — PROPEP DELIVERY DEVICE
- K103565 — MEDVOXEL HEARTPRO SOFTWARE APPLICATION
- K110023 — INFUSION ADAPTER C100
- K110334 — WALDO PATIENT MONITOR
- K110366 — SYNGO.CT CARDIAC FUNCTION
- K101072 — TRITANIUM PERI-APATITIE ACETABULAR SOLID-BACKED SHELL, TRITANIUM PERI-APATITE
- K101332 — AMC-20 PORTABLE DENTAL CART MODEL AMC-20
- K110101 — TAPER OXINIUM FEMORAL HEAD
- K110763 — LATARJET CORTICAL SCREW SET
- DEN100020 — DENV DETECT IGM CAPTURE ELISA
- K092269 — CANNABINOID ASSAY AND THE RANDOX CANNABINOID CALIBRATOR/ CONTROL SET
- K101377 — SMITH & NEWPHEW ULTRABRAID II SUTURE
- K101581 — INTUITIVE SURGICAL DA VINCI S SURGICAL SYSTEM WITH DA VINCI CONNECT & DA VINCI ONSITE, MODEL IS2000
- K101742 — THERMO SCIENTIFIC CEDIA COCAINE OFT ASSAY
- K101744 — THERMO SCIENTIFIC CEDIA CANNABINOIDS OFT ASSAY
- K101745 — THERMO SCIENTIFIC CEDIA AMPHETAMINE OFT ASSAY
- K101746 — THERMO SCIENTIFIC CEDIA PHENCYCLIDINE (PCP) OFT ASSAY
- K101752 — THERMO SCIENTIFIC CEDIA MULTI-DRUG OFT CALIBRATORS
- K101753 — THERMO SCIENTIFIC CEDIA METHAMPHETAMINE OFT ASSAY
- K101754 — THERMO SCIENTIFIC CEDIA OPIATE OFT ASSAY
- K101805 — HYDROFIX VASO SHIELD
- K101888 — SCENARIA WHOLE-BODY X-RAY CT SYSTEM
Data sourced from openFDA. This site is unofficial and independent of the FDA.