FDA 510(k) clearances — page 867
clearances on record, most recent first.
Clearances — page 867
86,601–86,700 of 176,637- K991839 — ABX PENTRA 120 RETIC AUTOMATED HEMATOLOGY ANALYZER
- K992550 — LIQUICHEK IMMUNOLOGY CONTROL LEVEL 1, 2, 3
- K984214 — CORDIS ENDOVASCULAR TEMPORARY OCCLUSION BALLOON CATHETER
- K984530 — DRX NTX OR, OSTEOMARK NTX DIRECT RESPONSE
- K990648 — KELLER VITAL SIGNS MONITOR, KMS 890+
- K990883 — LAGLOVE BRAND BLUE COLOLRED NITRILE EXAMINATION GLOVE (POWDERED)
- K991632 — FOTONA NOVALIS ER: YAG LASER SYSTEM
- K991634 — FOTONA NOVALIS R RUBY LASER SYSTEM
- K991665 — HDL CHOLESTEROL, PRODUCT NO'S 124-01, CH102-01
- K991701 — MACH-SIGMA HANDPIECE, ULTRAPUSH, MODELS MACH-SIGMA MU (MINI HEAD), MACH-SIGMA SU (STD. HEAD), MACH-SIGMA TU (TORQUE HD)
- K991717 — CARESIDE MG
- K991766 — ECG-GATING SYSTEM FOR AQUILION CT SCANNER, TSX-101A
- K991826 — PLANMED SOPHIE AND SOPHIE CLASSIC
- K991938 — CAPHOSOL ARTIFICIAL SALIVA
- K992051 — RADIFOCUS OPTITORQUE
- K992252 — LIGHT DIAGNOSTICS PNEUMOCYSTIS CARINII DFA, MODEL 31965
- K992365 — AIA-PACK FOLATE ASSAY
- K992422 — ACCUSIGN DOA3,DOA, COC/THC/OPI2000 DOA3; BIOSIGN DOA3, COC/THC/OPI2000; STATUS DS COC/THC/OPI2000
- K992503 — SECHRIST AIR-OXYGEN MIXER, 3500/3500HL SERIES
- K984532 — CADPLAN HELIOS OPTION 6.0
- K990263 — IMMUNOCARD STAT! E. COLI O157:H7
- K990842 — SAS ROTA TEST
- K991316 — TOUCH TEAR IGE MICROASSAY KIT
- K991623 — NIPRO ARTERIAL VENOUS FISTULA NEEDLE, AGULHA PARA FISTULA ARTERIO-VENOSA, AGUJA PARA FISTULA ARTERIO VENOSA
- K991628 — MODIFIED LX-20 CO2 LASER SYSTEM FAMILY, LX-20SA
- K991720 — KRONUS OPTIQUANT THYROGLOBULIN KIT
- K991890 — AUTOSTAT II ANTI-GBM ELISA, HY.TEC ANTI-GMB ELISA
- K991961 — 3M LVR SYSTEM
- K992138 — MICROMEDICS S&T TOTAL OSSICULAR REPLACEMENT PROSTHESIS AND ACCESSORIES
- K992428 — ACCUTOUCH POWDER FREE NATURAL RUBBER LATEX PATIENT EXAMINATION GLOVE
- K990666 — HYDROXYAPATITE (HA) REFLECTION ACETABULAR SHELL, HYDROXYAPATITE (HA) REFLECTION INTERFIT SHELL
- K991284 — ANTERIOR EYE-SEGMENT ANALYSIS SYSTEM
- K991715 — BIOSTINGER-V BIOABSORBABLE MENISCAL REPAIR DEVICE
- K991788 — SALTER LABS PEP DEVICE
- K991790 — ULTIMAX ANKLE FUSION ROD SYSTEM
- K991806 — VHS SUPRACONDYLAR PLATE SYSTEM
- K991877 — MACMED PAEDIATRIC INTRAMEDULLARY NAIL
- K992040 — FLEXISCOPE II ARTHROSCOPES AND ACCESSORIES
- K992229 — MXU-125 OR TMX-125
- K992291 — H20- TETHERED OPTION
- K992406 — VAPR 2.3MM END EFFECT ELECTRODE FOR USE WITH VAPR SYSTEM
- K983618 — DRI-SATE MIXER FOR PREPARATION OF ACIDIFIED DIALYSATE CONCENTRATE
- K984029 — SILGEL STC-S
- K984085 — RITEFLO SPACER
- K990041 — UROSTYM BIOFEEDBACK AND STIMULATION PROBES
- K991216 — HOFFMAN IVF-1
- K991261 — ICSI INJECTION MICROPIPETTE (SPIKED & NON-SPIKED), ICSI HOLDING MICEOPIPETTE, ASSISTED HATCHING/ZONA DRILLING MICROPIPET
- K991426 — MAHE INSTRUMENTS
- K991505 — MICRO-STRIP FOR PHENCYCLIDINE METABOLITES
- K991516 — MICRO-STRIP FOR MARIJUANA METABOLITES
- K991594 — CELSIOR COLD FLUSH, STORAGE AND TRANSPORT SOLUTION FOR HEARTS
- K991845 — PATIENT EXAMINATION GLOVES, NITRILE POWDER FREE, TURQUOISE,NON-STERILE.
- K991846 — PATIENT EXAMINATION GLOVE, NITRILE, POWDERED, TURQUOISE, NON-STERILE
- K991871 — HEWLETT PACKARD MULTI FUNCTION ADULT DEFIB ELECTRODE, MODEL M3501A & M3502A
- K991981 — NITRILE EXAMINATION GLOVES, NON-STERILE, POWDER FREE, DARK BLUE COLOR
- K992002 — AUTOHDL CHOLESTEROL REAGENT SET
- K992017 — DISPOSABLE PVC SYNTHETIC EXAMINATION GLOVES, POWDER FREE
- K992019 — LAGLOVE POWDER FREE LATEX SURGICAL GLOVES WITH PROTEIN CONTENT LABELING CLAIM (50 MICROGRAMS OR LESS)
- K992157 — CHIRON DIAGNOSTICS ACS: 180 FERRITIN ASSAY
- K992362 — FLEXISCOPE IQ 101
- K973707 — ROCHE AMPLICOR CT/NG TEST FOR CHLAMYDIA TRACHOMATIS
- K991028 — CORDIS PALMAZ CORINTHIAN TRANSHEPATIC BILIARY STENT AND ACCESSORIES
- K991747 — QUICKVUE ONE-STEP H. PYLORI II TEST
- K991903 — EXCEL PHOTIC STIMULATOR, MODEL (XLPS-1)
- K991929 — INTRASTENT
- K992275 — FRESENIUS MODIFIED F400 LOW VOLUME HEMOCONCENTRATOR F3000 & MODIFIED F400 LOW VOL HEMOCONCENTRATOR W/TUBING SET F3000TS
- K992289 — VINYL POWDERED EXAM GLOVE / CAT.# 15-020
- K974728 — INTER-OP METASUL ACETABULAR SYSTEM
- K990619 — RUSCH REINFORCED ENDOTRACHEAL (OR TRACHEAL) TUBE- CUFFED AND UNCUFFED MURPHY/MAGILL, STERILE
- K991371 — CARESIDE AMMONIA
- K991566 — SOLUSTAPLE
- K991569 — HOME/COMMERCIAL OXYGEN UNIT BY SYSTEM O2
- K991642 — EYE TRAK TM, COMPUTERIZED ELECTRONYSTAGMOGRAPH (ENG), MODEL ETV-XXXX
- K991652 — HIGH ENDS GRADIENTS/MAGNETOM SYMPHONY SYSTEM
- K992126 — CIRCON SURGIFLEX WAVE TSUNAMI SUCTION-IRRIGATION SYSTEM
- K992387 — ROSSMAX AUTOMATIC WRISTWATCH BLOOD PRESSURE MONITOR, MODEL RM-4100
- K992388 — ROSSMAX AUTOMATIC WRISTWATCH BLOOD PRESSURE MONITOR, MODEL RM-4200
- K990854 — INNERDYNE RADIALLY EXPANDING DILATION, RED DEVICE
- K990942 — DUET II GLUCOSE CONTROL MONITORING SYSTEM
- K991157 — N LATEX STFR REAGENT
- K991565 — TAC-2, TRANSMISSION ATTENUATION CORRECTION AND DST, DST-XL GAMMA CAMERAS AND VISION POWER STATION COMPUTER, FOR USE IN S
- K991629 — GE VIEW APPLICATIONS (CONSISTING OF GE VIEWING STATION AND GE EXTENDED VIEWING STATION) VERSION 1.2C
- K991724 — QUADRATURE LOWER EXTREMITY COIL, MODEL 473PH-64
- K991740 — OPART, MODEL MRT-600
- K991765 — SYNERGY SHOULDER COIL
- K991805 — ASPEN ULTRASOUND WITH FREESTYLE IMAGING OPTION
- K991866 — BILIRUBIN, TOTAL AND DIRECT, PRODUCT NO, 122-01, 122-02, 122-03, 122-04
- K991867 — INORGANIC PHOSPHORUS (IP), PRODUCT NO'S, 112-01, 112-02
- K992318 — MEDTRONIC AVE BRIDGE STENT
- K992438 — INVIGRA PLUS (WITH SPERMICIDAL LUBRICANT)
- K982859 — UC-PLUS SOLUTION UNICONDYLAR KNEE SYSTEM
- K983802 — LMI CAROTID ENDARTERECTOMY SHUNT CATHETER, MODEL #'S CES, CESR, CESB, CESRB, CEST, CESTR, CESTB, CESTRB, CES-SB, CESR-SB
- K984054 — AGC V2 REVISION KNEE SYSTEM
- K984482 — AVE GL-1 GUIDING CATHETER
- K990142 — HT, MODEL HT PB
- K990345 — RABEA DEVICE, MODEL PXXXXXX
- K990680 — DENTEC LD 15 DIODE LASER
- K990770 — BIORC ANCHOR
- K990914 — POLARIS DIODE LASER SYSTEM AND ACCESSORIES
- K991073 — ACIER SUTURES
Data sourced from openFDA. This site is unofficial and independent of the FDA.