FDA 510(k) clearances — page 753
clearances on record, most recent first.
Clearances — page 753
75,201–75,300 of 176,637- K021443 — 56 SERIES JET NEBULIZER
- K022391 — MODIFICATION TO KPS-1, KIDNEY PERFUSION SOLUTIION
- K022774 — IQ 200 SYSTEM
- K022907 — ANSPACH POWERED KERRISON SYSTEM (PKS)
- K022913 — NXSTAGE PREMIXED DIALYSATE
- K022942 — CRANIOCUT
- K022987 — LAXTEX EXAMINATION GLOVES, POWDERED CONTAINS 180 MCGM OR LESS OF TOTAL WATER EXTRACTABLE PROTEIN PER GRAM
- K023245 — BLOOD FLOW ANALYZER (BFA), MODEL 408-100-01
- K021200 — COMPAS
- K021451 — DURACON CS TIBIAL INSERT
- K021688 — NICALERT
- K022043 — SMART PLUG, MODEL 500; SMARTPLUG FORCEPS, MODEL 502; PUSH ROD, MODEL 503
- K022204 — VKS KNEE SYSTEM
- K022346 — CLEANTEXX MINT FLAVOUR BLUE COLOUR POWDER-FREE BARRIER PRO COPOLYMER EXAMINATION GLOVES
- K022370 — FRAMELOCK; FRAMELOCK ACCESSORIES
- K022378 — PLASMALITE PULSED LIGHT SYSTEM
- K022381 — PROFILE 1320 LASER SYSTEM
- K022384 — XENON FIBEROPTIC LIGHT SOURCE, MODEL 1300 XSBP
- K022430 — ISO FUNCTIONAL
- K022756 — NIPRO BIO-FLEX CATHETER
- K022862 — TRANSCURE, MODEL 2910
- K022895 — ELCAM STOPCOCKS AND MANIFOLDS
- K022969 — UNIVERSAL CERAMIC SOLDER
- K023005 — AQUILLA MODULAR WHEELCHAIR
- K023069 — TIMEX DIGITAL ORAL THERMOMETERS; TIMEX ACCUCURVE ORAL THERMOMETER
- K023092 — BD K-4000 MICROKERATOME SYSTEM
- K023099 — AROX 45-JBP; AROX 53-JBP; MEROX 45-JBP; MEROX 53-JBP
- K023116 — CORDIS OPTEASE PERMANENT VENA CAVA FILTER, MODELS 466-F200A, 466-F200B
- K023133 — MODIFICATION TO EBI VUELOCK ANTERIOR CERVICAL PLATE SYSTEM
- K023204 — MODIFICATION TO EBI OMEGA21 SPINAL FIXATION SYSTEM
- K023235 — MULTIPLE PRIVATE LABELS VINYL EXAMINATION GLOVES, POWDER-FREE
- K023249 — ALCON LADARWAVE CUSTOMCORNEA WAVEFRONT SYSTEM
- K023260 — 1.2MM OSTEOMED AUTO-DRIVE SCREW SYSTEM
- K023314 — MICROFIX
- K023318 — I-FLOW ELASTOMERIC PUMP WITH BOLUS
- K023324 — MODIFICATION TO EBI XFIX DFS SYSTEM
- K012816 — DYNAREX IODOFORM PACKING STRIPS, MODELS 3411, 3412, 3413, 3414
- K013921 — PORGES SILICONE DOUBLE LOOP URETERAL STENT, MODEL # AJ4X / BJ1X / BJ2X
- K021351 — BIOSTEON CROSS PIN
- K021815 — SMITH & NEPHEW IMAGE SURGICAL INSTRUMENTS FOR TRAUMA APPLICATIONS
- K021835 — BRENNEN MEDICAL SURGICAL MESH, GLUCAMESH/GLUCATEX
- K021856 — PORGES URETERAL CATHETERS, MODELS ACN6XX, ACN5XX, AC5B, AC5C07, ACP5XX, ACP2XX, ACP3XX, ACP4XX, ACP6XX
- K022403 — GMRS PRESS FIT STEMS WITH PUREFIX HA
- K022595 — WILSON-COOK CYSTOTOME
- K022651 — HOFFMANN 30 DEGREE PELVIC DOUBLE BALL JOINT
- K022670 — CARRAKLENZ AND ULTRAKLENZ
- K022824 — ECHO-VIEW 5.X, EASY-VIEW 2.X, OMNI VIEW 2.X, CARDIO-VIEW 1.X, LV ANALYSIS 1.X & SURGICAL VIEW 1.X
- K022924 — SHERPA MOBILITY SYSTEM (MANUAL WHEELCHAIR)
- K023085 — RX 90 FEMORAL STEM AND RX 90 LATERALIZED FEMORAL STEM
- K023186 — OPTETRAK TOTAL KNEE SYSTEM OFFSET TIBIAL TRAY
- K023203 — OSSTAPLE
- K023211 — NEXGEN COMPLETE KNEE SOLUTION CRUCIATE RETAINING (CR)-FLEX FEMORAL COMPONENTS
- K023250 — LINICAL PROTEIN 2 CALIBRATION VERIFIERS LEVELS A-E FOR THE BECKMAN-COULTER IMMAGE
- K023270 — SAS STREPALERT
- K023291 — COBRA COOLED CARDIAC SURGICAL PROBE, MODEL 1596X
- K020054 — SANARUS INDICA MARKER SYSTEM
- K021889 — SURGIFORM AUGMENTATION MATERIAL (S.F.A.M.)
- K021936 — MOIST PUNCTAL PLUG SYSTEM
- K022327 — NOVUS SPECTRA
- K022338 — OPTICAL INTEGRITY GENERAL SHAPED FIBER
- K022351 — DIODENT DENTAL LASER SYSTEM
- K022357 — TRANSEND 300 ES GUIDEWIRE, MODEL 46-814 & TRANSEND 300 FLOPPY GUIDEWIRE, MODEL 46-815
- K022637 — BD-3000 MICROKERATOME SYSTEM, MODEL K-3000 MICROKERATOME
- K022754 — S&T SINGLE USE MICRO ANASTOMOSIS CLAMP
- K023065 — CYCLOSPORINE (CSA) FLEX REAGENT CARTRIDGE
- K023136 — OLEEVA FABRIC
- K023376 — EB-1830T3, VIDEO BRONCHOSCOPE
- K022016 — POLYMER COATED POWDERFREE LATEX EXAMINATION GLOVE
- K022314 — SANARUS VISICA TREATMENT SYSTEM
- K022566 — POWDER-FREE LATEX EXAMINATION GLOVE (GREEN) WITH NATURAL WATER SOLUBLE VITAMIN E AND PROTEIN CONTENT LABELING (50 MICRO
- K022668 — ADVIA 120 HEMATOLOGY SYSTEM COMPLETE BLOOD COUNT (CBC) METHOD
- K012537 — REPROCESSED IMAGING CATHETERS
- K013805 — KOWA AUTOMATED TONOMETER KT-500
- K020839 — QUANTUM, MODELS SR, HR, DL; VASCULIGHT, MODELS SR, HR, VS, VX, DL
- K020936 — 10F X 18CM PEDIATRIC ASH SPLIT CATH XL, MODEL ASPC18P-XL; 10F X 24CM PEDIATRIC ASH SPLIT-CATH XL, MODEL ASPC24P-XL
- K020964 — NEICH NM ADVANCE CATHETER SHEATH INTRODUCER
- K021087 — HIPPOCRAT ELECTRONIC STETHOSCOPE, MODEL DR300; SOUNDS EASY AUSCULTATION SOFTWARE
- K021446 — OEMEDIC INTERNATIONAL INC. BESMED SILICONE ADULT, CHILD, INFANT MANUAL RESUSCITATOR WITH MASK AND RESERVOIR
- K021752 — FP(HEXAFOCON A)RGP CONTACT LENS SPHERICAL/ASP(HEXAFOCON A)RGP CONTACT LENS ASPHERICAL
- K021910 — COMFORT DREAMRIDER SCOOTER, LY-EW402
- K021937 — TGDC-01 PRA
- K022117 — MAJESTIK (TM) SHIELDED ANGIOGRAPHY NEEDLE, MODEL STAN18T71W-25, MAJESTIK (TM) SHIELDED ANGIOGTAPHY NEEDLE, SRAN18T71WR-5
- K022280 — STOCKERT CORONARY PERFUSION CANNULAE
- K022286 — ENCIRCLE LOCALIZATION DEVICE
- K022336 — BALDUR BRAND VINYL POWDERED EXAMINATION GLOVES, SUN FLOWER GLOVES CO., LTD
- K022369 — COMFORT WINDJOY SCOOTER, MODEL LY-EW302
- K022390 — HITACHI ALTAIRE
- K022398 — REUSABLE BRONCHIAL BIOPSY FORCEPS
- K022415 — BONE INJECTION GUN (B.I.G.) FOR PEDIATRICS, MODEL 1ST
- K022492 — PULPDENT SEMI-GEL ETCH
- K022493 — EMS 400
- K022545 — GLUCOBALANCE DATA MANAGEMENT SOFTWARE, MODEL 555020
- K022562 — VARIOUS BRANEMARK SYSTEM IMPLANTS-IMMEDIATE FUNCTION INDICATION
- K022585 — KIMAX QMA
- K022620 — SHEATHLESS ACCESSORY KIT, MODELS XRIK24, XRIK28, XRIK32, XRIK36, XRIK40 AND XRIKRT
- K022692 — VOXELPLUS PACS
- K022710 — SMARTPACS
- K022716 — MED-LOGICS MICROKERATOME BLADE, MODEL 7020CLB
- K022728 — AUDIOTRAVELLER, MODEL AA222
- K022757 — SPIFE CK KIT, MODEL 3332, 3333
Data sourced from openFDA. This site is unofficial and independent of the FDA.