FDA 510(k) clearances — page 755
clearances on record, most recent first.
Clearances — page 755
75,401–75,500 of 175,825- K022038 — SPI ONETIME DENTAL IMPLANT
- K020585 — ZIP OPEN FORCEPS WITH ELECTROSURGICAL CUT
- K021151 — AMMONIA ASSAY FOR THE ADVIA INTEGRATED MODULAR SYSTEM
- K021202 — ULTRAQUIET
- K021311 — SYNTHETIC ABSORBABLE SEEDING SPACERS MADE OF POLYDIOXANONE MATERIAL
- K021582 — BACTEC MGIT 960 PZA KIT
- K020017 — MEDX 1000 SERIES
- K020073 — MEDICAL ADMINISTRATOR
- K020114 — 3D KNEE
- K020704 — ROCHE ONLINE GENTAMICIN
- K020735 — SOF-PACH REUSABLE NEUROSTIMULATION ELECTRODES
- K020926 — EXTENSION SET, MODELS 1911-512
- K021075 — MECHANICAL DAILY USE WHEELCHAIR
- K021185 — NERVUS MONITOR
- K021191 — AUTOALIGN
- K021199 — PRIMECHAIR
- K021224 — ENDOCERVICAL BLOCK NEEDLE
- K021385 — ATAC PAK BUN REAGENT
- K021525 — TOPCUT
- K021581 — HEMOSORB
- K021610 — QAB2A IGM ELISA KIT HRP
- K021611 — QAB2A IGG ELISA KIT HRP
- K021624 — RNA GL4 GLUCOSE CALIBRATION VERIFICATION CONTROL, MODEL RNA CVC GL4
- K021676 — CYPRESS MEDICAL PRODUCTS, LP DISPOSABLE VAGINAL SPECULUM, NON-METAL
- K021678 — HEMADERM COTAINING HEMADEX CLOTTING BEADS
- K021697 — GLUCOSE CONTROL SOLUTION FOR BD LATITUDE
- K021874 — ABBOTT Q2 PLUS S02/CONTINUOUS CARDIAC OUTPUT COMPUTER, LIST NUMBER 56711
- K021927 — PLATELET CONCENTRATE SEPARATION KIT FOR CELSEP CENTRIFUGE SYSTEM
- K021970 — THE TRABECULAR METAL MONOBLOCK CUP, MODELS 00-7259-0XX-28 (ZIMMER CAT. #) AND 02-293-28XX1 (IMPLEX PART #)
- K021998 — HORIZONS CYTOLOGY BRUSH
- K022001 — MPOWER, MODEL 712 SERIES
- K022053 — HYDRAGEL 7 LIPOPROTEIN(E), PN 4114 & HYDRAGEL LIPOPROTEIN(E) 15/30 PN 4134
- K022109 — EIZO, MODEL FC-2091
- K012193 — AMC ANTIMICROBIAL PIN/WIRE SLEEVE
- K013873 — COBRA CARDIAC ELECTROSURGICAL SYSTEM
- K013892 — LUTZ NEEDLE
- K014019 — NEUROTECH MEDISTIM PLUS, TYPE 291
- K014020 — NT MEDITENS PLUS, TYPE 290
- K020433 — FT101 FOREHEAD THERMOMETER; FT101 INFRARED DIGITAL THERMOMETER
- K020792 — ACETAMINOPHEN ASSAY FOR THE ADVIA INTEGRATED MODULAR SYSTEM
- K020794 — SALICYLATE ASSAY FOR THE ADVIA INTEGRATED MODULAR SYSTEM
- K020921 — NO-POKES NEEDLE SAFETY DEVICE
- K021243 — ILT TORQUER, MODEL 114TR1
- K021335 — MONARCH SPINE SYSTEM
- K021616 — DELIGHT DENTAL ER: YAG LASER SYSTEM
- K021817 — AARON A950 HIGH FREQUENCY ELECTROSURGICAL GENERATOR, AARON A950 ELECTROSURGICAL GENERATOR, 240V
- K021882 — CRPEX-HS CRP CALIBRATOR SET, CATALOG NO: 1510
- K021959 — DOLPHIN MEDICAL STAND-ALONE PULSE OXIMETER, MODEL 2100
- K022087 — DISPOSABLE POWDER FREE VINYL SYNTHETIC EXAM GLOVES WITH ALOE VERA, GREEN COLOR
- K020668 — ALOKA SSD-1000 DIAGNOSTIC ULTRASOUND SYSTEM, MODELS ASU-1003, UST-9121, UST-9124
- K021601 — MICHEALTH ET 1100/ET 1200 INFARED EAR THERMOMETER
- K021899 — CONCENTRIC BALLOON GUIDE CATHETER, MODEL 90072
- K021903 — KODAK X-OMAT CASSETTE/LEADLESS FOR DENTAL USE
- K013418 — AM-BIO EXTENDED RANGE SERIES DIALYZER, MODELS WET AND DRY
- K013434 — VP-2000/1000
- K013634 — BIOTEQUE 3 IN 1 HEMODIALYSIS BLOOD TUBING PACK
- K014297 — ENDOVIVE INITIAL PLACEMENT GASTROSTOMY KIT; ENDOVIVE LOW PROFILE BUTTON REPLACEMENT GASTROSTOMY TUBE; SECURI-T INITIAL P
- K020456 — EASI 12 LEAD ALGORITHM
- K020527 — HORIZON PHACOEMULSIFICATION SYSTEM, MODEL HZN-2030
- K021149 — AURORA DS
- K021170 — TSRH SPINAL SYSTEM
- K021207 — STARLIGHT
- K021394 — DIAMEDIX IS-RHEUMATOID FACTOR TEST SYSTEM
- K021473 — BAIR HUGGER TEMPERATURE MANAGEMENT SYSTEM
- K021497 — CYPRESS ULTRASOUND SYSTEM
- K021901 — WALLGRAFT TRACHEOBRONCHIAL ENDOPROTHESIS WITH UNISTEP PLUS DELIVERY SYSTEM
- K021908 — PROVEN MODULAR POSTERIOR STABILIZED FEMORAL
- K021914 — MICROPLEX COIL SYSTEMS (MCS)
- K022050 — CGS-31A MULTISLICE UPGRADE KIT FOR AQUILION CT SCANNER. TSX-101A (AQUILION ADVANCE MULTI)
- K013909 — S7 ELITE CP AP SYSTEM
- K021488 — SURECAN SAFETY HUBER NEEDLE INFUSION SETS
- K020475 — CHAD THERAPEUTICS OXYPENUMATIC CYPRESS MODEL 511
- K020818 — POWDER-FREE LATEX EXAMINATION GLOVES WITH COLORANTS
- K021007 — ULTRA PRESERVE WITH ALOE VERA (GREEN) NATURAL RUBBER LATEX EXAMINATION GLOVE MADE FROM ALLOTEX AN ENZYME TREATED NATURAL
- K021119 — POWDERED BROWN LATEX SURGICAL GLOVES, STERILE WITH EXPIRATION DATE LABELING CLAIM & PROTEIN CONTENT LABELING CLAIM
- K021179 — DISPOSABLE GUIDEWIRE, MODELS G-205-3545S & G-205-3545A
- K021253 — ULTRASONIC TIPS WITH DIAMOND COATING
- K021358 — EMBRYO BIOPSY MEDIUM
- K021428 — CLINITEK ATLAS PRO 12 REAGENT PAK SYSTEM
- K021730 — GLOVCO BRAND POWDER-FREE NITRILE EXAMINATION GLOVES (PURPLE)
- K022018 — RHIGENE ANA ELISA TEST SYSTEM, MODEL K7560
- K002741 — BROWNE TST SINGLE USE BOWIE DICK/INTEGRATOR TEST PACK
- K012600 — CLEARMEDICAL/NELLCOR OXISENSOR II, ADULT, MODEL D-25/D-25L
- K012609 — CLEARMEDICAL/NELLCOR OXISENSOR II, NEONATAL/ADULT, MODEL N-25
- K012622 — CLEARMEDICAL/NELLCOR OXISENSOR II, PEDIATRIC, MODEL D-20
- K013768 — POWERED MUSCLE STIMULATOR
- K020431 — FIBIOCORE
- K020484 — CARESIDE LDH
- K020852 — POLY-CHEM GLUCOSE
- K021084 — LIGHT SABER SPINAL NEEDLE
- K021094 — INTROCAN SAFETY IV CATHETER
- K021159 — POWDERED LATEX SURGIACAL GLOVES, STEERILE WITH EXPIRATION DATE LABELING CLAIM
- K021261 — SEEDNET SYSTEM AND SEEDNETGOLD SYSTEM, MODELS GP6T5, GP5T5, GP5T3, HP5T5 & HP5T3
- K021332 — WIENER LAB. CK-NAC UV UNITEST, WIENER LAB. CK-NAC UV AA, WIENER LAB. CK-NAC UV AA, WIENER LAB.NAC UV AA LIQUIDA
- K021337 — AART PECTORALIS IMPLANT
- K021366 — MAC-LAB/CARDIOLAB EP/COMBOLAB
- K021407 — COALESCENT SURGICAL U-CLIP - OR OTHER TBD AND ACCESSORIES
- K021453 — HEARTSTREAM XL DEFIBRILLATOR/MONITOR, MODEL #M4735A
- K021827 — MODIFICATION TO ACCU-CHEK ACTIVE SYSTEM
- K021919 — SCS CLARIS SPINAL SYSTEM,REXTENDED OMNIAXIAL CONNECTOR-,MEDIUM, MODEL CO05, SCS CLARIS SPINAL SYSTEM,EXTENDED OMNIAXIALO
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