FDA 510(k) clearances — page 432
clearances on record, most recent first.
Clearances — page 432
43,101–43,200 of 175,770- K122378 — NEXTGEN ALTIUS OCT SYSTEM
- K122541 — ORTHOFIX CONTOURS PROIMAL HUMERAL PLATE (PHP)
- K122545 — CG+ ARROW PICC POWERED BY ARROW VPS STYLET
- K122558 — ULTRASAFE PASSIVE NEEDLE GUARD
- K120018 — MINDCHILD MERIDIAN FETAL HEART RATE MONITOR
- K120288 — ORTHOCAD SOFTWARE OPTION
- K120397 — MEB-2300A NEUROPACK EVOKED POTENTIAL AND EMG MEASURING SYSTEM
- K120405 — WALK ON WHEELS HS-3500 ELECTRIC AISLE WHEELCHAIR
- K120450 — SLEEP PROFILER
- K120644 — MERIT HYDROPHILIC GUIDE WIRE
- K120657 — MASIMO SET AND MASIMO RAINBOW SET PULSE OXIMETERS AND SENSORS
- K120968 — POWER-FREE VINYL PATIENT EXAMINATION GLOVES, CLEAR(NON-COLORED)
- K121029 — METS MODULAR DISTAL FEMUR
- K121055 — METS MODULAR TOTAL FEMUR
- K121224 — GENESIS HEALTH TECHNOLOGIES BLOOD GLUCOSE MONITORING SYSTEM
- K121302 — BIOMET MICROFIXATION STERNAL CLOSURE SYSTEM
- K121689 — VITASCAN LT SCANMASTER
- K121917 — PENUMBRA EMBOLECTOMY ASPIRATION SYSTEM
- K122514 — VERIGENE GRAM-POSITIVE BLOOD CULTURE (GC-GP) NUCLEIC ACID TEST
- K122563 — MYOSURE XL ROD LENS HYSTEROSCOPE, MYOSURE XL OUTLFOW CHANNEL
- K122622 — ENDURAMESH
- K110949 — BICERA (TM) RESORBABLE BONE SUBSTITUTE
- K120107 — SCKOONCUP
- K121519 — ISIGHT
- K121614 — NEPHROMAX HIGH PRESSURE NEPHROSTOMY BALOON DILATATION CATHETER
- K121633 — BD VERITOR(TM) SYSTEM FOR THE RAPID DETECTION OF RSV
- K122591 — CLYDESDALE SPINAL SYSTEM
- K113742 — KMC KYPHOPLASTY SYSTEM
- K120235 — MODEL FAMILY OF AEROLASE ND:YAG LASERS: FRIENDLYLIGHT ND: YAG LASERS, FRIENDLYLIGHT NEO, LIGHTPOD ND: YAG LASERS, LIGHTP
- K120281 — DIGNITY POWER INJECTABLE TITANIUM PORT
- K120328 — ORIGINS LIPOHARVESTING SYSTEM
- K121022 — AMERIWATER ALARM PANEL - BASE MODEL AND REMOTE, BASE MODEL & REMOTE WITH CONDUCTIVITY, BASE MODEL & REMOTE WITH RESISTIV
- K121114 — TIGRAN PERIBRUSH
- K121187 — KATALYST LASER PROBES, KATALYST ILLUMINATED LASER PROBES
- K122487 — BIOFIBER SYTURE
- K122506 — SUREFIRE HIGH FLOW ANGIOGRAPHIC CATHETER, ACCESS
- K100645 — AFFINITY PIXIE OXYGENATION SYSTEM WITH CARMEDA BIOACTIVE SURFACE OR BALANCE BIOSURFACE
- K110053 — CORRECTINJECT SAFETY SYSTEM, CATHETER CONNECTOR, FILTER, INFUSION ADAPTOR, SYRINGE KIT
- K111375 — STERRAD (R) CYCLESURE (R) 24 BIOLOGICAL INDICATOR
- K113296 — ZMR HIP SYSTEM KWZ-PROSTHESIS, HIP, CONSTRAINED, CEMENTED OR UNCEMENTED, METAL/POLYMER
- K120825 — SUPRA SCAN DELIVERY SYSTEM
- K121153 — PEEK CUSTOMIZED CRAIAL IMPLANT KIT
- K121439 — METAFIX FEMORAL HIP STEM SIZE 1
- K121575 — OXFORD ANKLE FUSION NAIL(AFN) SYSTEM
- K121625 — LULLABY TM WARMER
- K121694 — IMAGER II ANGIOGRAPHIC CATHETER
- K111128 — LABONACHECK A1C
- K111377 — STERRAD(R) 100NX STERILIZER DUO CYCLE
- K112741 — POWDER FREE VINYL PATIENT EXAMINATION GLOVE
- K113725 — VIRTUOST
- K113841 — IMMUNOCAP ALLERGEN COMPONENTS BUNDLE
- K120737 — TRIA LASER HAIR REMOVAL SYSTEM
- K121078 — VAN GOGH ANTERIOR CERVICAL PLATE SYSTEM
- K121335 — G-DERM POWDER-FREE SYNTHETIC SURGICAL GLOVE
- K121479 — AIM
- K121541 — JAZZ SYSTEM
- K121774 — ROTABLATOR ROTATIONAL ATHERECTOMY SYSTEM WITH PERIPHERAL ROTALINK PLUS
- K121827 — GSI VIEWER WITH VUE OPTION
- K122019 — STREPTOCOCCUS APP. SEROLOGICAL REAGENTS
- K122119 — DX-D FULL LEG FULL SPINE
- K122413 — PATIENT POSITIONING SYSTEM
- K122491 — VIAMO SSA-640A V4.0
- K122579 — VELASHAPE
- K122593 — PRECISION ENDOSCOPIC INFRARED COAGULATOR; MODEL 5100 SINGLE-USE DISPOSABLE MAXI-GUIDE FLEXIBLE LIGHTGUIDE; MODEL 5100-2
- K112693 — NON-STERILE, POWER FREE YELLOW LATEX EXAMINATION GLOVES
- K120277 — VITAL COUGH
- K120384 — PROTECTOR, INJECTOR, CONNECTOR
- K121112 — STRYKER VIDEO URETEROSCOPE
- K121256 — ALCO-SCREEN 02
- K122260 — AYCAN MOBILE
- K122427 — CS ORTHODONTIC IMAGING SOFTWARE CS OMS IMAGING SOFTWARE
- K122569 — LAVA ULTIMATE CAD/CAM RESTORATIVE FOR CEREC LAVA ULTIMATE CAD/CAM RESTORATIVE FOR E4D LAVA ULTIMATE IMPLANT CROWN RESTOR
- K112221 — EUROIMMUN ANTI-SLA/LP ELISA(LGG)
- K112223 — EUROIMMUN ANTI-LKM-1 ELISA(LGG)
- K113393 — POWDER FREE BLACK NITRILE EXAMINATION GLOVES
- K120009 — TESTOSTERONE TEST SYSTEM; CALIBRATOR; AND QUALITY CONTROL MATERIAL (ASSAYED AND UNASSAYED)
- K120012 — INTEGRA JARIT VIDEO ASSISTED THORACIC SURGERY INSTRUMENTS
- K120766 — ENDOSCOPIC DIAGNOSTIC & TREATMENT SYSTEM (MODIFICATION)
- K120776 — ABUTMENT FOR COMPETITIVE IMPLANT NOBEL ACTIVE CONNECTION
- K121492 — UNICEL DXC SYNCHRON SYSTEMS HEMOGLOBIN ALC-(HBA1C-) REAGENT
- K121528 — POWER-FREE NITRILE EXAMINATION GLOVES, PEPPERMINT SCENTED, BLUE COLOR
- K121630 — RANGE SPINAL SYSTEM
- K121801 — QUINTEX CERVICAL PLATING SYSTEM
- K122352 — NUVASIVE PRECEPT SPINAL SYSTEM
- K122387 — VOLUSON P6, VOLUSON P8
- K122462 — ROTH NET RETRIEVER
- K122471 — SOMATOM DEFINITION
- K122515 — C2-9-D ULTRASOUND TRANSDUCER
- K112624 — ELECSYS HE4, ELECSYS HE4 CALSET, ELECSYS PRECICONTROL HE4, ELECSYS HE4 CALCHECK 5
- K113060 — UNITY TOATAL KNEE SYSTEM
- K113731 — ESENSOR RESPIRATORY VIRAL PANEL
- K120126 — BAROSENSE ENDOGASTRIC TUBE AND INTRODUCER BOUGIE
- K120924 — BENCOX MIRABO CUP BENCOX MIRABO INSERT (STANDARD& ELEVATED TYES) BENCOX MIRABO CUP SCREW HOLE PLUG
- K121273 — VISIONS PV .035 DITITAL IVUS CATHETER
- K121316 — LANX SPINAL FIZATION SYSTEM
- K121372 — FULLY AUTOMATIC ELECTRONIC BLOOD PRESSURE MONITOR
- K121573 — INTEGRA CAMINO ICP MONITOR
- K121822 — DELICOT
- K121885 — EARLYSENSE CENTRAL DISPLAY SYSTEM
- K121935 — TAPERSET HIP SMALL STEMS
Data sourced from openFDA. This site is unofficial and independent of the FDA.