FDA 510(k) clearances — page 543
clearances on record, most recent first.
Clearances — page 543
54,201–54,300 of 175,825- K083231 — PANTHERA MECHANICAL WHEELCHAIR, MODELS S2, U2, BAMBINO, MICRO, BT
- K083303 — LANDLEX, MODEL: 402X
- K083398 — CERCOM CEMENT
- K083718 — BEAU RX SCAR CARE GEL
- K083874 — GALAXY
- K080134 — COMPRESSIBLE LIMB AND CIRCULATION THERAPY SYSTEM, MODEL WHF-314 (POWER-Q1000)
- K081279 — PRO-TECH DELIVERY SYSTEM ELECTRODES, MODEL TT-2000
- K081536 — MEDISIZE BLUE, MEDISIZE GREEN, MEDISIZE RED
- K081796 — EASYPLUS MINI R2N SELF MONITORING GLUCOSE TEST SYSTEM
- K081881 — GISH TUBING AND CONNECTORS WITH HA COATING
- K082138 — AIRGENT, MODEL AG7000010
- K082668 — BIO-SCREEN
- K082710 — SAFECHILD ENTERAL FEEDING TUBE AND ACCESSORIES AND FEEDING TUBE EXTENSION SET
- K082810 — ARTHREX BIO-COMPOSITE SUTURE ANCHORS: ARTHREX BIO-COMPOSITE PUSHLOCK, BIO-COMPOSITE TAK AND BIO-COMPOSITE CORKSCREW
- K083176 — PASTURE, MODELS: F550, A520
- K083470 — CARPENTIER- EDWARDS PHYSIO II ANNULOPLASTY, MODEL 5200
- K083489 — JETSTREAM PATHWAY PC ATHERECTOMY SYSTEM, MODEL OV10300
- K083647 — VALO, MODEL 5919
- K083835 — ATTUNE ADJUSTABLE FLEXIBLE ANNULOPLASTY RING MODEL AFR
- K090061 — AIRSTRIP OB
- K081537 — CFS FLEXIBLE
- K081797 — IMAGE STORAGE SYSTEM, MODEL KSS-400
- K081932 — ENDEARE BREAST PUMP
- K082212 — SYRINGE WITH HANDI-FIL
- K082353 — MERCURY SPINAL SYSTEM
- K083151 — EXTREMITY MEDICAL SUTURE ANCHOR
- K083264 — RAYAUTOPLAN 1.0
- K083473 — CLEAR BRAVO
- K083725 — RADPRO ION
- K083826 — LAGUNA POLYAXIAL PEDICLE SCREW SYSTEM
- K083856 — INTRACEPT FLEXIBLE BI-POLAR RF PROBE AND CURVED INSTRUMENT SET, MODELS: FG0018, FG0026
- K090044 — PATLOG, PATLOG PATIENT HANDLING SYSTEM, PATLOG TOPLOG TABLE TOP, MODEL(S) 1.0, 1.0, C
- K080921 — SPIRO-MASTER PC-10 SPIROMETRY SYSTEM
- K081811 — CARE3 PLUS
- K081822 — COULTER 6C CELL CONTROL, MODELS 628027 & A59925
- K082409 — SOLAR LASER ABLATION SYSTEM, MODELS: LU-1083-25, LF-1083, PC-1000, IC-1083, LW-2000, LG-2001, LK-001, PM-1083, TF-1083
- K082882 — A.V. FISTULA BLUNT NEEDLE SET
- K083453 — COSTORSOL
- K083652 — IBOND TOTAL ETCH
- K083795 — CYNOSURE SMARTLIPO MPX LASER
- K083818 — UNIVERSAL ELECTRODES
- K072102 — EPIVISION SL SYSTEM
- K081193 — COBAS INTEGRA 400/800 BILIRUBIN TOTAL
- K081307 — OMNILUX CLEAR-U
- K081499 — HEALTH MANAGER, VERSION 1.1
- K081641 — COULTER LIN-X LINEARITY CONTROL
- K081908 — CLINIQA LIQUID QC URINALYSIS CONTROLS, LEVELS 1 AND 2
- K082511 — MEDIGARD BLOOD COLLECTION DEVICE
- K082518 — DUAL NEEDLE SUTURE PASSER SYSTEM
- K082521 — EASY2CHECK BLOOD GLUCOSE AND BLOOD PRESSURE MONITORING SYSTEM
- K082626 — PAM 3000
- K082728 — VERTEX RECONTRUCTION SYSTEM, VERTEX SELECT RECONSTRUCTION SYSTEM
- K082887 — PM-1000F+PATIENT MONITOR
- K083046 — FORA TELEHEALTH SYSTEM
- K083099 — EASYMAX N SELF MONITORING BLOOD GLUCOSE SYSTEM, MODEL: EPS08008
- K083194 — VIRTUOSAPH (TM) ENDOSCOPIC VEIN HARVESTING DISPOSABLE SYSTEM, MODEL MCVS550
- K083387 — MODIFICATION TO KOWA NONMYD ALPHA-DIII
- K083517 — INTELLIVUE PATIENT MONITOR, MODELS MP2, MP5, MP20, MP30, MP40, MP50, MO60, MP7-, MP80, AND MP90
- K083553 — NASO-LARYNGO-PHARYNGOSCOPE
- K083578 — NORAS CPC MULTIFUNCTIONAL COIL
- K083681 — BIOLAND BLOOD PRESSURE MONITOR
- K081033 — MIROXI
- K081054 — GISH ARTERIAL FILTER WITH HA COATING
- K081377 — NUVASIVE SURGICAL MESH SYSTEM
- K081911 — NON-STERILE, POWDERED NITRILE EXAMINATION GLOVE, BLUE
- K082115 — PHOGLASS FILL, CORE, CEM, SEAL, PRIME AND PHOGLASS PROTECT
- K082337 — MINNIE SUPPORT CATHETER
- K082617 — TRAUSON GENERAL SPINAL SYSTEM (GSS)
- K082716 — A-DEC/W&H ALEGRA AIR-DRIVEN HIGHSPEED HANDPIECE, MODEL TE-97, TE-98, A-DEC/W&H ALEGRA HANDPIECE ATTACHMENT, MODEL HE-43
- K082955 — ETHICON ENDO-SURGERY ARTICULATING HOOK KNIFE, MODEL IN4505
- K082996 — BIOLOX DELTA OPTION CERAMIC HEADS
- K083150 — G-FORCE TENODESIS SCREW
- K083430 — REAL-TIME PCR INTERNAL CONTROL 2B SET
- K083495 — MODIFICATION TO: METHA HIP SYSTEM
- K083537 — MODIFICATION TO MEDWAVES MICROWAVE COAGULATION/ABLATION SYSTEM
- K083839 — AVAULTA SOLO SYNTHETIC SUPPORT SYSTEM, AVAULTA PLUS BIOSYNTHETIC SUPPORT SYSTEM
- K083872 — IMNS MEDACTA NAVIGATION SYSTEM
- K090004 — LEVITRONIX, THORATEC CENTRIMAG BACK-UP CONSOLES
- K080964 — FRESENIUS MODEL 2008T HEMODIALYSIS MACHINE
- K081064 — GIARDIA FECAL ANTIGEN DETECTION LATERAL FLOW KIT, MODEL GL-LF
- K081101 — SPECTRA-SYSTEM ABUTMENTS 2008
- K081378 — DRI METHADONE METABOLITE (100/300) ASSAY, CALIBRATORS AND CONTROLS
- K081396 — SWISSPLANT DENTAL IMPLANT SYSTEM
- K082406 — EXPANDABLE PEEK-OPTIMA IMPLANT
- K082748 — ATRIUM PROLITE S MESH
- K083025 — SYNTHES 4.5 MM VA-LCP CURVED CONDYLAR SYSTEM
- K083149 — ARTERIAL HEALTH PACKAGE (AHP) SOFTWARE
- K083769 — MODIFICATION TO URESTA PESSARY
- K083916 — LCD3090WQXI OR MD304MC 29.8 INCH DIAGNOSTIC IMAGING LCD MONITOR, MODEL L307TD
- K072971 — TOPCON 3D OCT-1000 OPTICAL COHERENCE TOMOGRAPHY SYSTEM FOR MEASUREMENT OF RETINAL THICKNESS
- K080299 — RESPIFIT S, MODEL RS-LR1001004
- K081230 — TRAUSON INTRAMEDULLARY NAIL
- K082089 — PRUMYX CREAM
- K082488 — DIAZYME LP(A) ASSAY
- K082605 — VPAP AUTO WITH HUMIDAIRE 3I
- K083082 — MOORVMS-LDF1 AND MOORVMS-LDF2 LASER DOPPLER PERFUSION AND TEMPERATURE MONITORS
- K083089 — NEWPORT SPINAL SYSTEM
- K083155 — HD CAMERA HEAD OTV-S7PROH-HD-L08E
- K083166 — SPECIALTY COILS FOR THE MAGNETOM ESSENZA
- K083167 — PHENIX CERVICAL INTERBODY DEVICE
Data sourced from openFDA. This site is unofficial and independent of the FDA.