FDA 510(k) clearances — page 761
clearances on record, most recent first.
Clearances — page 761
76,001–76,100 of 176,637- K021440 — BONESOURCE HAC
- K021455 — RAPIDO GUIDING CATHETER, 6F MODEL# 6776; RAPIDO GUIDING CATHETER, 8F MODEL# 6775, 6777, 6778, 6779, 6780, 6781, 6782,
- K021617 — C.T.M. POWER CHAIR, MODEL HS-2800
- K021725 — DISETRONIC D-TRON INSULIN INFUSION PUMP
- K022101 — MEDTEXX POWDERFREE NITRILE RUBBER EXAMINATION GLOVES, GREEN COLOUR
- K022246 — MODIFICATION TO SYMPHONY GRAFT DELIVERY SYSTEM
- K022317 — DANA DIABECARE II INSULIN PUMP & SUPERLINE-EASYRELEASE, SOFT-RELEASE-ST, & SOFT-RELEASE-R INFUSION SETS
- K022476 — RELYX RMGIP
- K012687 — VANGUARD REPROCESSED DIAGNOSTIC ELECTROPHYSIOLOGY CATHETERS
- K012693 — MISTRAL CRITICAL CARE JET VENTILATOR AND ACCESSORIES
- K013093 — PALL ULTIPOR ANESTHESIA BREATHING SYSTEM
- K020040 — LATEX PRE-POWDERED EXAMINATION GLOVES WITH PROTEIN CLAIM
- K021341 — NORMED BONE TRANSPORT DISTRACTION DEVICE
- K021342 — NORMED BI-DIRECTIONAL/MULTIDIRECTIONAL JAW DISTRACTOR
- K021352 — DAYTON WATER SYSTEMS ULTRAPURE WATER TREATMENT SYSTEMS FOR HEMODIALYSIS
- K021450 — CLINPRO PROPHY POWDER
- K021452 — STERILE SENSICARE ADVANTIX POWDER FREE POLYURETHANE MEDICAL/DENTAL EXAMINATION GLOVE
- K021456 — ER150/M2
- K021457 — FLEX SPAN TEMPORARY CROWN & BRIDGE MATERIAL
- K021486 — HERPESELECT 2 ELISA IGG, MODEL ELO920G
- K021503 — UNINHIBITED
- K021507 — PLUS PIVOT LINK UNIVERSAL SYSTEM
- K021510 — UNI-T UNI-THREAD SPINAL SYSTEM
- K021540 — RUSCH EDGAR TUBE
- K021549 — CONTOURED ARTICULAR PROSTHESIS (CAP) FEMORAL HEAD RESURFACING SYSTEM
- K021853 — DISPOSABLE VINYL EXAMINATION GLOVES, YELLOW COLOR, POWDER FREE WITH VITAMIN E
- K021950 — TOP GLOVE MEDICAL (THAILAND) POWDERED LATEX EXAMINATION GLOVES
- K021954 — BD PHOENIX AUTOMATED MICROBIOLOGY SYSTEM-CLINDAMYCIN 0.125-8.0MCG/ML
- K021971 — CERALOY
- K021995 — ESCAPE CONTROL MODULE
- K022019 — PERIFIX CATHETER CONNECTOR
- K022024 — NITRILE POWDER-FREE MEDICAL EXAMINATION GLOVE (GREEN)
- K022160 — XIA SPINAL SYSTEM
- K022162 — STRYKER T4 URETHANE HOOD; STRYKER T4 URETHANE ZIPPER TOGA; STRYKER T4 URETHANE PULLOVER TOGA
- K022168 — ENVOY
- K022193 — DINAMAP PROCARE SERIES MONITOR, MODELS 100N, 200N, 300N, 400N
- K022203 — ABBOTT LIFECARE PCA 3 INFUSER, MODEL 12384
- K022232 — CLINIQA LIQUID-QC HCG CONTROL LEVEL 1, 2, AND 3
- K022310 — ADVANTAGE WINDOWS X-RAY/MR FUSION
- K012688 — VANGUARD REPROCESSED DIAGNOSTIC ELECTROPHYSIOLOGY CATHETERS
- K021387 — POLAR WAND
- K011891 — PANAG
- K013728 — TRACH VOX
- K013763 — WU'S 4-WHEELED NEO SCOOTER, WT-L4
- K014070 — EPOCH HIP PROSTHESIS, MODEL 4075 SERIES
- K020042 — HYCARE LATEX EXAMINATION GLOVE, POWDER FREE
- K020227 — SELICOR, MODELS A100 & D100
- K020665 — HI-OX
- K021041 — WA RUBBERMATE LATEX POWDER-FREE EXAM GLOVES
- K021231 — NMP22 BLADDERCHEK KIT, NMP22 CONTROL KIT
- K021264 — TRZ-CG POWER POSITIONING SYSTEM WITH CENTER-OF-GRAVITY SHIFTING POWER TILT, RECLINE, AND POWER ELEVATING SEAT
- K021436 — TTECH MODEL 200E + TENS DEVICE
- K021442 — OEMEDIC INTERNATIONAL INC. BESMED SINGLE USE ADULT, CHILD, INFANT MANUAL RESUSCITATOR WITH MASK & RESERVOIR
- K021482 — QUANTA LITE SLA (SOLUBLE LIVER ANTIGEN) ELISA
- K021969 — CHROLOY
- K022029 — QUINCKE SPINAL NEEDLE
- K022125 — PROVOX FREEHANDS HME, MODEL 7710
- K022141 — VERDICT-II
- K022296 — MODIFICATION TO EN-BLOC BIOPSY SYSTEM
- K022303 — PHILIPS M2424 DIAGNOSTIC ULTRASOUND SYSTEM &PHILIPS 21315 DIAGNOSTIC ULTRASOUND TRANSDUCER
- K022355 — QUICKTOX MULTIPLE DRUG DIPCARD COC/MET/THC/AMP/PCP/BZO/BAR/MTD/TCA, MODEL QT61
- K012644 — REPROCESSED TROCARS AND CANNULAS
- K013263 — FRED HUTCHINSON CANCER RESEARCH CENTER ENZYME ANTI-SR PROTEIN ANTIBODY TEST
- K020222 — WISORB MALLEOLAR SCREW
- K020337 — READI-STRAND; MODEL PSSTRAND
- K020434 — MICROPLEX COIL SYSTEM (MCS)
- K020657 — ACCULASER PRO LOW LEVEL LASER THERAPY DEVICE
- K021194 — RAICHEM CRP HIGH SENSITIVITY TEST SYSTEM
- K021408 — RESORBABLE CRANIAL CLAMPS
- K021429 — HERPESELECT 1 ELISA IGG, MODEL EL0910G
- K021604 — MAYFIELD RADIOLUCENT SKULL PINS, MODEL 4-0-A-2020
- K021653 — CODMAN BACTISEAL EVD CATHETER SET
- K021757 — CRPEX-BR C-REACTIVE PROTEIN LIT ASSAY, CRPEX-BR CRP CALIBRATOR SET
- K021780 — ADVANTAGE SIM 6.0
- K021842 — ADMIRA SEAL
- K021881 — ENDIUS TITLE SPINAL FIXATION SYSTEM
- K022121 — PSG INPUT BOX, MODEL JE-912AK
- K022130 — BD VACUTAINER PLUS PST II TUBE
- K022161 — MODIFICATION TO COULTER LH 750 HEMATOLOGY ANALYZER, MODEL 6605632
- K022174 — MODIFICATION TO CARDEON AEGIS CATHETER
- K022200 — PENTRA 120/PENTRA 120 RETIC OPTIONS SPS, MODEL PENTRA 120
- K011329 — ECCOVISION ACOUSTIC DIAGNOSTIC IMAGING ACOUSTIC PHARYNGOMETER
- K020882 — SHARPOINT ULTRAPLUG EXTENDED WEAR PLUG
- K021602 — FOSSA URETERAL STONE SWEEPER
- K021638 — ILT ADVANCING MECHANISM, MODEL A115AMI
- K021641 — XTD THROMBECTOMY CATHETER, XX CM
- K021965 — CHROLOY SOLDER
- K021968 — CERALOY SOLDER
- K022116 — ELPH INJECTION SYSTEM
- K022164 — ZETA DIAGNOSTIC RETINAL IMAGING SYSTEM
- K014119 — WU'S 3-WHEELED NEO SCOOTER, WT-M3
- K020046 — MULTIGAS UNIT, MODEL AG-920RA
- K021061 — MODIFICATION TO CD HORIZON SPINAL SYSTEM
- K021316 — ULTRA N-GENEOUS HDL CHOLESTEROL REAGENT 1/REAGENT2; ULTRA N-GENEOUS HDL CHOLESTREOL CALIBRATOR
- K021327 — ORTHOPILOT HTO MODULE
- K021330 — MAGNETOM TRIO QUADRATURE TX/RX HEAD COIL
- K021336 — NOVABONE-RESORBABLE BONE GRAFT SUBSTITUTE
- K021504 — TUTTNAUER EHS SERIES TABLE-TOP AUTOCLAVE, MODEL 2540
- K021660 — K-ASSAY LP(A) ASSAY
- K021713 — STAT PROFILE PHOX PLUS C ANALYZER
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