FDA 510(k) clearances — page 840
clearances on record, most recent first.
Clearances — page 840
83,901–84,000 of 176,637- K000338 — VITAPORT 3
- K000361 — K-ASSAY AT-III
- K000920 — REAADS IGA ANTI-PHOSPHATIDYLSERINE SEMI-QUANTITATIVE TEST KIT
- K991549 — EMBOSPHERE MICROSPHERES
- K993513 — DELTALOC ANTERIOR CERVICAL PLATE SYSTEM
- K993630 — BIOLOK SCREW
- K000255 — COBE SMARXT OPTIMA XP SURFACE MODIFIED HOLLOW FIBER MEMBRANE OXYGENATOR
- K000649 — SYSMEX AUTOMATED COAGULATION ANALYZER, MODEL CA-1500
- K000762 — MOXIFLOXACIN, 5 UG, BBL SENSI-DISC
- K000964 — STERILE WATER OR O.9% SODIUM CHLORIDE, MODEL AL4100 & AL4109
- K001021 — LILLIPUT PHOSPHOLYPIDIC INERT SURFACE IN OXYGENATION (PH.I.S.I.O.) INFANT HOLLOW FIBRE OXYGENATOR, MODEL D902
- K001118 — MODIFICATION TO LIPOPROTEIN (A) SPQ III ANTIBODY REAGENT SET
- K993410 — DATES-OHMEDA AESTIVA SMARTVENT MRI
- K994023 — HAEMACURE HEMAMYST SURGICAL APPLICATOR SYSTEM H-AS01
- K000297 — ERCHINGER HEMORRHOIDAL LIGATORS: SUCTION LIGATORS, MOD. ERCHINGER, RUDD, MCGIVNEY MOD. ERCHINGER
- K000392 — RESPONSE 2000 HIP STEM
- K000412 — VISION R/F TILTING TABLE
- K000432 — RESPONSE 2000 CEMENTED HIP STEM
- K000443 — REMOTE FETAL MEDICINE ULTRASOUND SYSTEM
- K000452 — SCREENERS METHAMPHETAMINE TEST, DRUGSCREEN DIP METHAMPHETAMINE TEST
- K000496 — EVERSHEARS BIPOLAR SCISSORS
- K000557 — MEDVIZER PACS, MODEL RELEASE 2000
- K000612 — ACCUCORE SINGLE ACTION CORE BIOPSY DEVICE
- K000985 — MATANG POWDERED LATEX PATIENT EXAMINATION GLOVE WITH PROTEIN LABELING CLAIM (50 MICROGRAM OR LESS
- K001016 — GE LOGIQ 700
- K001105 — MOSS MIAMI 6.35MM ROD SYSTEM PEDICLE AND LAMINAR HOOKS
- K001133 — VITRO CHEMISTRY PRODUCTS ECO2 SLIDE & CALIBRATOR KIT 2
- K992597 — LORAD LT-100 LASER TREATMENT SYSTEM
- K000212 — KSEA CHARDONNES MORCELLATION KNIFE
- K000444 — MITYVIEW 4-WAY LATERAL EXPANDER SPECULUM
- K000507 — CAVERMAP SURGICAL AID
- K000867 — POWDER FREE LATEX EXAMINATION GLOVES, PEPPERMINT SCENTED (CONTAINS 50 MCGM OR LESS OF TOTAL WATER EXTRACTABLE PROTEIN GR
- K000956 — MODIFICATION TO SCIMED 6F IMPULSE ANGIOGRAPHIC CATHATERS
- K001123 — KURZ UPPER EYELID IMPLANT SIZERS, MODEL 8000 111
- K001130 — 3D MANUAL COARSE MANIPULATOR MN-188NE
- K001131 — 3D HDRAULIC FINE MICROMANIPULATOR MO-188NE
- K001189 — MODIFICATION TO CONVERTORS SURGICAL GOWNS
- K993492 — DEVILBISS NEBULIZER MODEL 800
- K993871 — BIOSHIELD HEAVY DUTY AND SUPER DUTY EXPRESS STERILIZATION WRAP
- K000195 — CRANIAL DRILL
- K000247 — BAUSCH & LOMB RENU 1 STEP DAILY PROTEIN REMOVER
- K000448 — PACSSTATION
- K000549 — OPART, MODEL MRT-600
- K000650 — BETEL POWDER FREE LATEX EXAM GLOVES
- K000868 — NON-STERILE POWDER-FREE, BLUE NITRILE EXAMINATION GLOVES
- K000875 — ASSAYED QCS 1,2, CAT. NOS. 970200, 970500
- K000953 — DISPOSABLE POWDERED VINYL SYNTHETIC EXAM GLOVES, WHITE COLOR
- K000962 — PICO SMOKERLYZER, MODEL EC-50
- K001102 — PARSET PRIMARY SET WITH CHECK VALVE, MODEL A10002E
- K992732 — STERILE WATER & STERILE 0.9% SODIUM CHLORIDE
- K993356 — COULTER HEMATOLOGY ANALYZERS WITH IRF & MRV ANALYSES
- K994174 — FRIALIT-2 MH-2 ABUTMENT
- K000205 — EMBRYON SINGLE AND DOUBLE LUMEN NEEDLES
- K000222 — UM-L25
- K000340 — HYSTALOG HSG CATHETER
- K000408 — LIFESTYLES, CONTEMPO OR PRIVATE LABEL STRAWBERRY, VANILLA, OR BANANA FLAVORED CONDOM
- K000455 — GETTIG GUARD
- K000474 — VIEW NT
- K000478 — THE CYBERKNIFE SYSTEM FOR STEREOTACTIC RADIOSURGERY/ RADIOTHERAPY V2.1
- K000516 — GE LOGIQ 700
- K000936 — VAPR 2.3MM WEDGE ELECTRODE FOR USE WITH VAPR SYSTEM
- K000961 — AARON 900 HIGH FREQUENCY DESSICCATOR/HANDPIECE
- K001025 — LIFECARD CF COMPACT RECORDER
- K991380 — OIL FOR TISSUE CULTURE
- K992294 — BIOCERAMIC ORBITAL IMPLANT
- K993268 — MALLINCKRODT DAR HEATED WIRE BREATHING CIRCUIT
- K000106 — DEPILASE YAGLASE ND:YAG LASER SYSTEM AND ACCESSORIES
- K000163 — PM 2002 PROLINE/AEC
- K000245 — CSM STRETTA SYSTEM
- K000400 — SCREENERS AMPHETAMINE TEST, DRUGSCREEN DIP AMPHETAMINE TEST
- K000402 — SCREENERS PHENCYCLIDINE (PCP) TEST, DRUGSCREEN DIP PHENCYCLIDINE (PCP) TEST
- K000487 — MEDTRADE PRODUCTS ALGINATE ISLAND
- K000508 — THERMOFLEX SYSTEM
- K000522 — SCREENERS BARBITURATE TEST, DRUGSCREEN DIP BARBITURATE TEST
- K000571 — GE LOGIQ 700
- K000865 — QUIK-CAP
- K000874 — URINE CONTROL 1, CAT. NO. 903600, URINE CONTROL 2, CAT. NO. 904100
- K000876 — SYNERGY ADJUSTABLE TRANSVERSE CONNECTOR ROD, SYNERGY ADJUSTABLE TRANSVERSE CONNECTOR LAMP
- K000945 — PARA 12 PLUS RETICS
- K000991 — MODIFICATION TO TSRH SPINAL SYSTEM
- K001154 — I-STAT MODEL 200 PORTABLE CLINICAL ANALYZER
- K994308 — NUVASIVE TOWNLEY FACET SCREW
- K000043 — DRG AURICA ELISA TESTOSTERONE KIT
- K000137 — ENHANCED COMPENSATING FILTER
- K000224 — FLUROPERM 60-OK, PARAGON HDS-OK
- K000398 — SHIELD VON WILLEBRAND FACTOR ACTIVITY ELISA, MODEL FVWF 200
- K000406 — RHINOSCAN MODEL SRE2000/ SRE2100 WITH ACOUSTIC RHINOMETRY MODULE
- K000458 — URINE BENZODIAZEPINES (BENZ) SCREEN FLEX REAGENT CARTRIDGE, CATALOG NO. DF 92A
- K000603 — SPIFE CHOLESTEROL PROFILE KIT
- K000895 — STAT PROFILE PHOX PLUS ANALYZER
- K990034 — WILSON-COOK COLONIC Z-STENT
- K991755 — MEDLINE TENDER WET WOUND DRESSING
- K991818 — ACRYDERM SILVER ANTI-MICROBIAL WOUND DRESSING, MODELS 1041, 1042, 1043, 1044, 1045
- K991908 — IDEMSA HEMOPHAN HOLLOW FIBER DIALYZERS
- K993677 — MEDTRONIC CLEARVIEW INTRAVASCULAR ARTERIOTOMY SHUNT
- K994289 — SUTUREGROOVE
- K000126 — MASIMO SET RADICAL PULSE OXIMETER WITH SATSHARE, MASIMO LNOP-ADT-ADULT/PEDIATRIC DISPOSABLE SENSOR, MASIMO LNO-PDT-PEDIA
- K000223 — NITRILE PATIENT EXAMINATION GLOVES, POWDER-FREE
- K000238 — HSV-1 & HSV-2 DIFFERENTIATION IMMUNOBLOT IGG, MODEL IB0900G
- K000241 — RADIOTHERAPEUTICS RF 3000 RADIOFREQUENCY GENERATOR
Data sourced from openFDA. This site is unofficial and independent of the FDA.