FDA 510(k) clearances — page 511
clearances on record, most recent first.
Clearances — page 511
51,001–51,100 of 176,542- K100656 — COMPRESSIBLE LIMB THERAPY SYSTEM MODEL WHF-324 (POWER-Q1000 PLUS)
- K100878 — SELF CATH CATHETER
- K100913 — IQVITALS AND IQVITALS SYSTEM
- K100942 — U-RIGHT EAR THEMOMETER, MODELS TD-1115 AND TD-1118
- K101142 — HEARTWAY LIGHTWEIGHT POWER MOBILITY SCOOTER, S34
- K101143 — HEARTWAY POWER MOBILITY SCOOTER, S11
- K092021 — CRYOVALVE SG PULMONARY HUMAN HEART VALVE (AND CONDUIT)
- K093390 — HEALOS DENTAL BONE GRAFT SUBSTITUTE (ALSO CALLED HEALOS OR HEALOS II) MODEL 6008, 6025
- K093405 — PROPHECY PRE-OPERATIVE NAVIGATION ALIGNMENT GUIDES
- K100150 — CERAMICS2IN1
- K100553 — BLOOD PRESSURE METER MODEL CH-101
- K100824 — MECHANICAL WHEELCHAIR, MODEL DS 202-S
- K092062 — EVERON 1.0
- K100148 — SIMPLEXA INFLUENZA A H1N1 (2009) MODEL MOL2500
- K100524 — POLYTEL(R) APT MODEL: PWA-08-01
- K101011 — HI-TORQUE BALANCE MIDDLEWEIGHT UNIVERSAL
- K090861 — MAMBO, MODEL CS 18XX-XX
- K091556 — HEMOSIL ACUSTAR ANTI-B2 GLYCOPROTEIN-I; IGG, IGM, IGG CONTROLS, IGM CONTROLS
- K091734 — SONIC SHOT GX
- K092454 — VITEK 2 YEAST VORICONAZOLE
- K092528 — BIOMET FORERUNNER LOCKING PLATE SYSTEM
- K092695 — TRANSCORP TRANS-PLATE ANTERIOR CERVICAL PLATE SYSTEM
- K093168 — MEDIFLASH AND ESTEFLASH
- K100154 — FIXCET SPINAL FACET SCREW SYSTEM
- K100232 — LUMINESSE ZR BLANKS
- K100349 — VISTAKON (NARAFILCON B) CONTACT LENS VISIBILITY TINTED WITH UV BLOCKER
- K100363 — ULTRA DCI MODEL 5000
- K100626 — DOPPLER FETAL HEART RATE DETECTOR, MODEL FM-200
- K100686 — CONMED MACROLYTE DISPERSIVE ELECTRODE
- K100750 — AUDIT MICROCV ASO LINEARITY SET, MODEL K721M-5
- K100769 — PENUMBRA SYSTEM SEPARATOR FLEX (026,032,041,054), MODELS PSF026, PSF032, PSF041, PSF054
- K100847 — SYNTHETIC SEEDING SPACER MODEL SS9 X 50-50, SS9 X 55-50, SS9 X 55-150, SS9 X 1CM-30
- K100849 — SYNC-RX SYSTEM, MODEL AS00010
- K101113 — GUARDIAN II NC HEMOSTASIS VALVE
- K101139 — PROSTIVA RF THERAPY MODEL 8929 HAND PIECE
- K092617 — ROYAL GUARD
- K092628 — ENTERAL FEEDING TUBE AND ACCESSORIES, FEEDING TUBE EXTENSION SET
- K092689 — MANUKAPLI WOUND DRESSING
- K093895 — ALLY PLATFORM SYSTEM
- K100194 — OPTICAL INTEGRITY LASERGUARD FIBERS
- K100365 — FARRELL VALVE WITH CORFLO ANTI-IV CONNECTORS MODEL 20-4300AIV
- K100369 — POWDER-FREE NITRILE GLOVES, BLACK
- K100616 — KNOCKOUT SR MEDIUM, KNOCKOUT SR XENOFREE MEDIUM MODEL 10828, 12618
- K100677 — LYMPHA PRESS 201MAX, MODEL 201MAX
- K100699 — POWDER-FREE VINYL PATIENT EXAMINATION GLOVES
- K101169 — DESARA MESH MODEL: CAL-DS01
- K101175 — KFX APPIANFX PEEK FEMORAL IMPLANT WITH INSERTER
- K083798 — IMPIX ALIF LUMBAR IBF, IMPIX ALIF-D LUMBAR IBF, IMPIX TLIF LUMBAR IBF
- K093479 — DISPOSABLE SUCTION AND IRRIGATION SYSTEM
- K093820 — SUBFIX ARTHROEREISIS IMPLANT, MODELS SUT0065, SUT0080, SUT0090, SUT0100, SUT0115
- K093939 — ADVIA CHEMISTRY SALICYLATE REAGENT
- K093992 — TERUMO LAUER LOCK ADAPTER
- K100462 — JETSTREAM G3 L SYSTEM, PV CONSOLE, MODELS PV31400, PV31300, PVCN100
- K100856 — POWDERED VINYL PATIENT EXAMINATION GLOVES, CLEAR (NON-COLORED)
- K101151 — REGENT ANTERIOR CERVICAL PLATE
- K092129 — INTERSURGICAL HEATED WIRE BREATHING SYSTEMS AND HUMIDIFICATION CHAMBERS, MODEL 2026,2026-CH, 2310, 2320, 2330
- K092229 — THYRETAIN TM TSI REPORTER BIOASSAY
- K093218 — FEMEYE TWO
- K094061 — KENSEY NASH ECM SURGICAL PATCH
- K100008 — CARDO MEDICAL CERAMIC HIP SYSTEM
- K100193 — OTOMAG BONE CONDUCTION HEARING SYSTEM
- K100734 — POWDER FREE VINYL PATIENT EXAMINATION GLOVES, CLEAR (NON-COLORED)
- K100735 — POWDER FREE VINYL PATIENT EXAMINATION GLOVES, CLEAR (NON-COLORED)
- K101184 — TITAN TI SUTURE ANCHOR SYSTEM, MODELS 22-9055, 22-9055N, 22-9065, 22-9065N, 22-9022, 22-9005,, 22-9006
- K100203 — HANDHELD PULSE OXIMETER MODEL MD300A/ MD300K2/ MD300M
- K100220 — POLARIS SPINAL SYSTEM
- K100240 — ORTHOPEDIATRICS PEDILOC TIBIA PLATE SYSTEM
- K100953 — MICROLIFE NON-CONTACT INFRARED FOREHEAD THERMOMETER, MODEL FR1DZ1
- K101094 — CLEARJET
- K092602 — FREESTYLE Lite Blood Glucose Monitoring System and Freestyle Freedom Lite Blood Glucose Monitoring System
- K093738 — MRI PATIENT POSITIONING DEVICES
- K093794 — SMART-READ EZTEST-STEAM SCBI AND TEST PACK
- K094046 — LNCS OXIMETRY SENSORS, REPROCESSED LNCS OXIMETRY SENSORS
- K094054 — MODIFCATION TO: NUVASIVE NEUROVISION EMG ENDOTRACHEAL TUBE
- K100010 — HDL CHOLESTEROL (HDLX) ASSAY
- K100047 — SUREFIT DUAL DISPERSIVE ELECTRODE
- K100271 — VARI AX DISTAL RADIUS LINE EXTENSIONS OF XXL PLATES
- K100294 — SYNTHETIC POWDER-FREE VINYL PATIENT EXAMINATION GLOVES
- K100521 — COMFYSLEEVE 1-75 AND LYMPHAPOD SLEEVES, FOR USE WITH LP OPTIMAL AND PLUS
- K100704 — ACCU-CHEK FLEXLINK PLUS INFUSION SET, ACCU-CHECK LINKASSIST PLUS INSERTION DEVICE
- K100788 — COCR RODS
- K090633 — LENSAR LASER SYSTEM
- K092164 — TRANSCRANIAL AND VASCULAR DOPPLER DIAGNOTIC ULTRASOUND TRANSDUCERS, MODEL EMS-9UA
- K093123 — BIOMERIX VENTRAL HERNIA REPAIR MESH, MODEL SM3-TAB
- K093716 — BABI PLUS INFANT NASAL CANNULA SYSTEM
- K100089 — SYNTHES T-PAL SPACER
- K100265 — DIAMOND ANTERIOR CERVICAL PLATE SYSTEM
- K100353 — SPINEWAND SURGICAL DEVICE
- K100433 — IMMULITE 2000 CMV IGM, IMMULITE CMV IGM CONTROLS, AND IMMULITE 200 CMV IGM ADJUSTOR MODEL L2KCM2, L2KCM6, LCMC1, LCMC2,
- K100697 — POWDER FREE VINYL PATIENT EXAMINATION GLOVES, CLEAR (NON-COLORED)
- K100897 — LEGION POROUS + HA TIBIAL BASEPLATES
- K101056 — VARIAX ELBOW SYSTEM
- K091255 — MINXRAY, MODEL: BPD60
- K092116 — EASYCELL CELL LOCATOR
- K092219 — NAVIGATOR CLINICAL GUIDENCE SYSTEM
- K092586 — MALE LATEX CONDOM (STRAIGHT SIDE OR CONTOURED OR FLARED IN SHAPE, EITHER TEXTURED OR NON-TEXTURED , LUBRICATED OR NON-LU
- K092789 — VIRTUOSAPH PLUS ENDOSCOPIC VESSEL HARVESTING SYSTEM
- K093087 — BWF-5 MEDICAL LASER SERIES
- K093114 — THERMO SCIENTIFIC DRI AMPHETAMINES ASSAY
- K093590 — PLANMECA PROMAX 3D MAX
Data sourced from openFDA. This site is unofficial and independent of the FDA.