FDA 510(k) clearances — page 462
clearances on record, most recent first.
Clearances — page 462
46,101–46,200 of 175,770- K100163 — NUTRISAFE 2 FEEDING TUBES MODEL 362.XXX. 1362.XXX
- K101774 — MONARCH III IOL DELIVERY SYSTEM; MONARCH III P CATRIDGE; MONARCH III HANDPIECE (H4)
- K103434 — 3B FLEX-LITE
- K103757 — IMMUNOFIXATION ELECTROPHORESIS TEST USING INTERLAB G26 INSTRUMENT
- K110003 — MTF NEW BONE VOID FILLER
- K110407 — INVISIPORT
- K111492 — ZIMMER PATIENT SPECIFIC INSTRUMENTS PLANNER MODEL 2.5, ZIMMER PATIENT SPECIFIC INSTRUMENTS
- K111597 — DISPOSABLE STIMULATING ELECTRODE
- K111978 — SULCUS BLUE
- K103115 — PRODIGY DIABETES MANAGEMENT SOFTWARE
- K110153 — SFC VERTEBRAL BODY REPLACEMENT
- K110646 — BEAMMED SUNLIGHT MINIOMNI BONE SONOMETER
- K110993 — FEMCHEC PRESSURE MANAGEMET DEVICE
- K111200 — MAC-LAB SYSTEM, CARDIOLAB SYSTEM, COMBOLAB SYSTEM, SPECIALSLAB SYSTEM
- K111264 — CORNERSTONE (R) PSR CERVICAL FUSION SYSTEM
- K111543 — VIRTUOSO (TM) SYSTEM FOR IHC HER2 (4B5)
- K112019 — BENCOX ID STEM, BENCOX METAL HEAD, BENCOX BIPOLAR CUP
- K112051 — LUNGPOINT PLANNING AND VIRTUAL BRONCHOSCOPIC NAVIGATION (VBN) SOFTWARE
- K112335 — BANTAM CATHETER (280MM BALLOON LENGTHS)
- K112646 — SONOACE R7 DIAGNOSTIC ULTRASOUND SYSTEM
- K102063 — HEALTH-E-CONNECT SYSTEM
- K110694 — CONCORDE BULLET SPINAL SYSTEM
- K111875 — RELIEVA SPIN SINUS DILATION SYSTEM
- K111994 — SMITH & NEPHEW CANNULATED SCREWS AND WASHERS
- K112017 — RAUMEDIC ICP MONITORING SYSTEM
- K112254 — APEX KIRSCHNER WIRES AND STEINMANN PINS
- K112615 — AEQUALIS ASCEND MODULAR REVERSE SHOULDER SYSTEM
- K112629 — ONSET ACCESS CATHETER SYSTEM
- K112652 — SURESIGNS VS2+ -SURESIGNS VSI
- K102316 — GLUCOSE SHEPHERD BLOOD GLUCOSE MONITORING SYSTEM
- K102772 — DIMENSION MYCOPHENOLIC ACID (MPAT) FLEX REAGENT CARTRIDGE, DIMENSION MYCOPHENOLIC ACID CALIBRATOR (MPAT CAL)
- K110471 — BABI PLUS INFANT NASAL CANNULA SYSTEM
- K110687 — RELIEVA STRATUS PRO MICROFLOW SPACER (FRONTAL)
- K110780 — ELITECH CLINICAL SYSTEMS BILIRUBIN TOTAL 4+1, ELITECH CLINICAL SYSTEMS ELICAL 2, ELITECH CLINICAL SYSTMES ELITROL I & II
- K110836 — CLS BREVIUS STEM WITH KINECTIV TECHNOLOGY
- K111320 — GLOBALCARDIO
- K111404 — HUIBAO BODY FAT SCALE
- K111419 — OSTEOMED HAND FUSION SYSTEM
- K111532 — MONTBLANC SURGICAL CONTRA-ANGLE AND STRAIGHT HANDPIECE
- K111640 — PRECISION FLOW(R) - HELIOX
- K111784 — VENUS SWAN SYSTEM
- K111859 — ICEEDGE 2.4 CRYOABLATION NEEDLE,ICEEDGE 2.4 CRYOABLATION NEEDLE MULTIPACK
- K112115 — MECTACER BIOLOX(R) DELTA FEMORAL HEADS
- K112263 — MONOPOLAR CURVED SCISSORS TIP COVER ACCESSORY
- K112446 — TOMOTHERAPY TREATMENT SYSTEM
- K112460 — MULTIPLE
- K112635 — U BY KOTEX SLEEK UNSCENTED MENSTRUAL TAMPONS
- K112756 — FORTIFY(TM) AND FORTIFY(TM)-R CORPECTOMY SPACERS
- K112772 — ORTHOLOC(TM) BONE SCREWS
- K101592 — ERASE HAND- HELD CONTROLLER; ERASE SINGLE USE ELECTRIC CATRIDGE SYSTEM
- K103485 — SENOGRAPH DS, SENOGRAPH ESSENSTIAL
- K103625 — OXYLOG 3000 PLUS WORKSTATION, OXYLOG 3000 PLUS BASIC DEVICE
- K103643 — ASCOT HOME MEDICAL MONITORING SYSTEM (HMMS)
- K110531 — ENDOFLIP ECD
- K110579 — ARCHITECT B12 REAGENTS, ARCHITECT B12 CALIBRATORS, AND ARCHITECT B12 CONTROLS
- K111266 — EASYLOCK OSTEOSYSTEM
- K111343 — CROSSTEX ISOFLUID PLUS SURGICAL EARLOOP MASK-BLUE, CROSSTEX ISOFLUID PLUS FOGFREE SURGICAL EARLOOP FACE MASK-BLUE, CROSS
- K111371 — ON CALL CHOSEN BLOOD GLUCOSE MONITORING SYSTEM
- K111566 — DRYVIEW CHROMA IMAGING SYSTEM
- K111647 — C2 NERVEMONITOR SYSTEM WITH ACCESSORIES
- K112037 — RANGE SPINAL SYSTEM (MESA AND DENALI)
- K112571 — XL EXTRACTION CATHETER
- K112579 — WILDCAT 5F GUIDEWIRE SUPPORT CATHETER
- K110819 — SINGHMED ROOLIP MANIPULATOR
- K111447 — ZIMMER PERIARTICULAR SCREWS
- K111740 — AMERIWATER MRO PORTABLE REVERSE OSMOSIS SYSTEM - SINGLE PATIENT, 1 TO 3 STATION
- K111848 — EXETER X3 RIMFIT ACETABULAR CUP
- K112007 — CARTO 3 EP NAVIGATION SYSTEM, VERSION 2.2
- K112173 — SPEACELABS MULTIGAS MODULE
- K112715 — CANDELA GENTLEMAX FAMILY OF LASERS
- K103487 — FORA PNC100 DIGITAL PREGANCY TEST, TD-5301 PREGANCY TEST
- K103651 — CARDIOMED
- K110063 — SOVEREIGN SPINAL SYSTEM
- K110870 — APLIO DIAGNOSTIC ULTRASOUND SYSTEM; APLIO DIAGNOSTIC ULTRASOUND SYSTEM; APLIO DIAGNOSTIC ULTRASOUND SYSTEM
- K111206 — TECO DIAGNOSTICS SALIVA ALCOHOL TEST
- K111378 — OXIMETRY INTERFACE KIT
- K111551 — OEC(R) 9800, OEC(R) 9800 PLUS
- K111583 — FLAATZ 560
- K111662 — VENOTRAIN CURAFLOW
- K111905 — INTELLIVUE GUARDIAN SOFTWARE MODEL 866009, INTELLIVUE CL SP02 POD MODEL 865215, INTELLIVUE CL NBP POD MODEL 865216
- K112116 — DIGITAL CLINICAL THERMOMETER MODEL V901US
- K112456 — ADAPT(TM) UNIVERSAL BALLOON OPEN ACCESS PORT
- K112703 — SHAKER DIGITAL THERMOMETER
- K102871 — SILVER CARE ANITBACTERIAL TOOTHBRUSH
- K103675 — CHIENMAX VIETNAM CO. LTD POWDER FREE BLUE NITRILE EXAMINATION GLOVE
- K110308 — PROSTHETIC SYSTEM
- K110318 — EXCELLAGEN
- K110672 — ETWO SKIN TREATMENT SYSTEM
- K111169 — PROTRACTION FACE MASK, REVERSE PULL FACE MASK MODEL KM-PVS, KM-PIS, KM-PVM, KM-PIM, MODEL KM-FMS, KM-FML, KM-FMF
- K111357 — STRAUMANN NARROW NECK CROSSFIT (NNC) 03.3MM DENTAL IMPLANT SYSTEM
- K111606 — PINNACLE PRECISION ACCESS SYSTEM
- K111644 — MOBICATH TRANSSEPTAL NEEDLE
- K111735 — REVERSE SHOULDER PROSTHESIS MONOBLOCK HEMI ADAPTER
- K111899 — ARMADA 35/35LL PTA CATHETER
- K112228 — VITEK 2 STREPTOCOCCUS LEVOFLOXACIN
- K101273 — DYNAMIC ECG SYSTEM MODEL TLC5000
- K102673 — RHEUMATOID FACTOR IMMUNOLOGICAL TEST SYSTEM
- K103327 — DISCOVERY MR750W 3.0T
- K110140 — NEUROVISION NERVE LOCATOR MONITOR
- K110165 — FREERIDER MODEL LUGGIE MODEL 168-4IT
Data sourced from openFDA. This site is unofficial and independent of the FDA.