FDA 510(k) clearances — page 438
clearances on record, most recent first.
Clearances — page 438
43,701–43,800 of 175,770- K121113 — BIOPSY SCIENCES, INC. HYDROMARK BREST BIOSY SITE MARKER
- K121198 — BW685, BW685S
- K121306 — SMARTSTITCH M-CONNECTOR ULTRA SMARTSTITCH SUTURE DEVICE HANDLE SMARTSTITCH SUTURE DEVICE HANDLE
- K121347 — PRESSON ELECTRODE
- K121529 — BLACK NITRILE POWDER-FREE EXAMINATION GLOVES
- K111781 — GYMFORM DUAL FLEX BELT MODEL WB-162
- K111939 — M/29TM - PRESSURE INJECTABLE
- K112010 — AEROCHAMBER PLUS FLOW-VU ANTI-STATIC VALVED HOLDING CHAMBER (VHC)
- K112748 — SLIMPLICITY SOLO ANTERIOR CERVICAL PLATE SYSTEM
- K113349 — HUMAN CH50 REAGENT PACK FOR USE ON THE SPAPLUS, HUMAN CH50 CALIBRATOR SET FOR USE ON THE SPAPLUS, HUMAN CH50 CONTROLS FO
- K113421 — MINICAT
- K113819 — MONGOOSE ANGIOGRAPHIC CATHETER
- K120424 — MEDSOURCE IV ADMINSTRATION SET
- K120650 — POISE PERSONAL LUBRICANT
- K120969 — AC LENS BRANDED CONTACT LENS CASE
- K121746 — RANDOX MICROALBUMIN CONTROL LEVEL 1 AND CONTROL LEVEL 2 (LIQUID)
- K121794 — LIQUICHEK URINE CHEMISTRY CONTROL
- K121838 — LIEBEL-FLARSHEIM DIRECT DIGITAL IMAGING SYSTEM
- K121856 — ULTRAVERSE 014 AND 018 PTA BALLOON DILATATION CATHETERS LINE EXTENSION
- DEN120011 — PROTEUS INGESTION CONFINMATION SYSTEMS
- K112872 — STATIM 2000 G4 CASSETTE
- K120263 — VOLUX 21C, DIGITAL EXTRAORAL SOURCE X-RAY SYSTEM
- K120474 — GYRUS ACMI TELESCOPE STORAGE-STERILIZATION TRAY
- K120584 — POWER FREE STRETCH VINYL PATIENT EXAMINATION GLOVES
- K120639 — PERFORMAX PEDIATRIC SE TOTAL FACE MASK
- K120773 — NELLCOR BEDSIDE SPO2 PATIENT MONITORING SYSTEM
- K121133 — CARESENS N VOICE BLOOD GLUCOSE MONITORING SYSTEM
- K121426 — AYNERGETICS DISPOSABLE SPETZLER-MALIS STANDARD BIPOLAR FORCEPS
- K121449 — DIRECTPATH
- K121471 — LIGHTSCALPEL FAMILY OF HANDPIECE TIPS FOR CO2 SURGICAL LASERS
- K121807 — V5MS TRANSDUCER
- K113610 — ANA-SCREEN WITH MDSS
- K120305 — THINKINGNET, THINKINGPACS/RIS - PROPRIETARY NAME FRO THINKINGNET, THINKINGARCHIVE (OR NUPAX) - THE MANAGEMENT AND ARCHIV
- K120374 — SEVIIN REVERSE SHOULDER
- K121407 — OXYBAND WOUND DRESSING
- K121650 — S-SCAN
- K112674 — NAVIS TORQUER
- K113621 — SMARTDRIVE WHEELCHAIR POWER-ASSIST
- K120195 — SAFETY SUBCUTANEOUS TISSUE INFUSION SET
- K120302 — MECHANICAL WHEELCHAIR
- K120468 — NCIRCLE(R) NITINOL TIPLESS STONE EXTRACTOR NGAGE(R) NITINOL STONE EXTRACTOR
- K120582 — HEATLUX
- K120649 — AUTOSURE VOICE 3 PLUS BLOOD GLUCOSE MONITORING SYSTEM
- K120726 — FLIGHT 60 VENTILATOR
- K120807 — SYNTHES MULTILOC HUMERAL NAILING SYSTEM
- K120937 — SUNFLOWER WARNER
- K121030 — SACKS HOLDINGS INC.'S CONTACT LENS STORAGE CASE
- K121096 — VENUS LUMBAR INTERVERTEBRAL BODY FUSION CAGE SYSTEM
- K121125 — FLEXSTENT BILIARY SELF-EXPANDING STENT SYSTEM
- K121601 — SYNTHES 2.7/3.5MM VARIABLE ANGLE LCP ANKLE TRAUMA SYSTEM-ANTEROLATERAL DISTAL TIBIA PLATE
- K111454 — ILUMINAGE DIODE LASER
- K112331 — BIOPURE PORTABLE RO SYSTEMS
- K120138 — BD MAX MRSA ASSAY, BD MAX INSTRUMENT
- K120244 — SPECTRASHIELD 9500 SURGICAL N95 RESPIRATOR
- K120338 — ATLANTIS IN ZIRCONIA FOR DENTSPLY ANKYLOS IMPLANT, ATLANTIS LATER ABUTMENT IN ZIRCONIA
- K120514 — CARDIOPACS
- K120530 — DENTIN DENTAL IMPLANTS SYSTEM: RAPID, CLASSIC, PRESTIGE, ONE PIECE, DENTIN DENTAL ABUTMENT SYSTEM / DENTIN RESTORATION S
- K120636 — SYNAPSE 3D CARDIAC TOOLS
- K120733 — SIMPLANT GO
- K120739 — AEQUALIS ADJUSTABLE MODULAR REVERSE SHOULDER SYSTEM
- K121464 — BLUE POWER FREE NITRILE EXAMINATION GLOVE
- K121680 — CD HORIZON SPINAL SYSTEM
- K121683 — ACCULIF TL CAGE
- K103577 — TRINON Q & Q3 IMPLANT SYSTEM
- K112634 — NATROX TOPICAL OXYGEN DELIVERY SYSTEM WITH IODP
- K113056 — ORANGE COLORED CONDOMS ORANGE SCENT
- K113262 — ACE CHOLESTEROL REAGENT, ACE HDL-C REAGENT, ACE LDL-C REAGENT-C, ACE-TRISLYCERIDES REAGENT
- K120177 — SPINAL ELEMENTS CERCLAGE SYSTEM
- K120634 — U-RIGHT TD-3124 BLOOD PRESSURE MONITORING SYSTEM
- K120884 — PERICAM PSI
- K120941 — CONSTANT CARE LILAH HOME HEALTH MONITORING SYSTEM
- K120966 — DEPUY PULSE LUMBAR CAGE SYSTEM
- K121060 — SPINE FRONTIER INDUS ACP SYSTEM
- K121107 — FORTIFY INTEGRATED CORPECTOMY SPACERS, (FORTIFY I AND FORTIFY I-R)
- K121122 — DETECTABUSE LIQUID CONTROL, DETECTABUSE STAT-SKREEN LIQUID CONTROL
- K121336 — MODIFIED SURGIQUEST AIRSEAL OPTICAL TROCAR & CANNULA SYSTEM WITH INTEGRATED INSUFFLATOR DPIS 2000
- K121506 — UTB BLUE POWDER FREE NITRILE
- K121629 — COOK CELECT PLATINUM VENA CAVA FILTER SET FOR FEMORAL APPROACH COOK CELECT PLATIUM VENA CAVA FILTER SET FOR JUGULAR APPR
- K121669 — WARMAIR MODEL 135 HYPERTHERMIA SYSTEM (CONTROLLER AND BLANKETS)
- K121871 — AIRSTRIP REMOTE PATIENT MONITORING (RPM) REMOTE DATA VIEWING
- K113435 — ACE CARBON DIOXIDE(CO2-LC) REAGENT, ACE DIRECT BILIRUBIN REAGENT, ACE TOTAL BILIRUBIN REAGENT, ACE MAGNESIUM REAGENT
- K120285 — K SERIES CPAP SYSTEM WITH HEATED HUMIDIFER
- K121448 — ONCENTRA, ONCENTRA EXTERNAL BEAM, ONCENTRA BRACHY
- K121609 — ASTHMAPOLIS SYSTEM
- K111785 — FREEDOM(R) STEMMED TIBIAL COMPONENTS
- K111949 — AC WOUND TREATMENT SYSTEM
- K112318 — CLEARPATH 24
- K113080 — TUBALGATOR
- K113200 — VITEK 2 AST-GN PIPERACILLIN/TAZOBACTAM
- K113459 — ANTEPLEGIA CATHETER ANTEGRADE CARDIOPLEGIA CATHETER AORTIC ROOT CANNULA ANTEGRADE CATHETER WITH DURAFLO COATING
- K113512 — BIOMET MICROFIXATION MANDIBULAR FRACTURE/ RECONSTRUCTION DEVICES AND PREBENT PLATES SYSTEM
- K113582 — ARCHSTENT BILIARY SYSTEM
- K113767 — MOUNTED MEDICAL OXYGEN SYSTEM
- K113775 — FLASH-C PTCA BALLOON DILATATION CATHETER- 4.0MM X 14MM X 135CM -4.0MM X 19MM X 135CM- 4.5MM X 14MM X 135CM-4.5MM X 19MM
- K120193 — ANY VIEW PATIENT MONITORS
- K120218 — TEK USA E-GENERATOR INTEGRATED LED HANDPIECE (HIGH & LOW SPEED AIR TURBNINE DENTAL HANDPIECE)
- K120260 — ICTA
- K120459 — STEERABLE GUIDING SHEATH, MODEL ADELANTE DESTINO
- K120520 — EXACTRAC ROBOTICS NOVALIS ROBOTICS
- K120581 — SC TIP CLEANER
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