FDA 510(k) clearances — page 1223
clearances on record, most recent first.
Clearances — page 1223
122,201–122,300 of 175,890- K910200 — LASER-35
- K910518 — GLOVE-N-GEL AMNIOTOMY KIT
- K910577 — EDWARDS-WALLACE BOURNE HALL CATHETER
- K910663 — BOVIE MODEL X-10, X-10I, ELECTROSURGICAL GENERATOR
- K910788 — CMI TENDER TOUCH VE #303TT AND 404TT
- K910802 — POWER SCAN 1000
- K910941 — LIFELINER SURGICAL GLOVE
- K911174 — NHS 2009SP HEARING AID
- K911182 — NNHS 2050 SERIES (2055W-2054PP) HEARING AIDS
- K911275 — POSICAM SYSTEM MODEL 6.5 POSICAM-HZ SYSTEM
- K911387 — CT SYTEC 4000
- K911633 — PERRY(R) ENCORE CHEMOTHERAPY GLOVE
- K911899 — RAICHEM SPIA C4 REAGENT
- K911900 — RAICHEM SPIA C3 REAGENT
- K905571 — ELECTRO-NERVE STIMULATOR TENS MODEL,INF 4150/A
- K905658 — SYSTEMATE CREATININE (EPOS APPLICATION) #65413
- K910553 — ROCHE APOLIPOPROTEIN STANDARD
- K910678 — TRO-GARD
- K910682 — ROBICSEK PROBE/RETRACTOR
- K910754 — MODEL 43100A SERIES DEFIBRILLATOR, MODIFICATION
- K910882 — PROPAQ 102EL, 104EL AND 106EL
- K910896 — DISPOSABLE ANESTHESIA BREATHING CIRCUIT
- K910903 — INFLATE-A-CUFF #7014
- K911060 — IMMUNOMATRIX THEOPHYLINE ASSAY SYSTEM
- K911141 — HEMOCUE(R) B-GLUCOSE MICROCUVETTE/PHOTOMETER
- K911204 — QUALTEX SKIN STAPLE EXTRACTOR
- K911389 — ANTIMICROBIAL SUSCEPTIBILITY TEST PANEL (IMIPENEM)
- K911390 — ANTIMICROBIAL SUSCEPT. TEST PANEL(TRIMETHOPRIM)
- K911391 — ANTIMICROBIAL SUSCEPT. TEST PANEL (CEFTIZOXIME)
- K911392 — ANTIMICROBIAL SUSCEPTIBILITY TEST PANEL (CEFOTETAN
- K911775 — OMNICATH IMPLANTED CATHETER AND DEPOT
- K911895 — QUALTEX SUTURE BOOTIES
- K911898 — RAICHEM(TM) SPIA(TM) HAPTOGLOBIN REAGENT
- K904738 — PYLORI STAT TEST KIT
- K905049 — QUIDEL HELICOBACTER PYLORI POSTIVE/NEGATIVE CONTR
- K905087 — TRIOS 02
- K905114 — A.P.GRAPH III(TM) CARDIOVASCULAR ANALYZER
- K905182 — OSCOR MEDICAL CORP. PERMANENT PACING PAD
- K905300 — PERMANENT PACING LEAD
- K905468 — PYLORI-G FIAX TEST KIT
- K910450 — CARD GUARD-3000 ECG TELEPHONE ADAPTER
- K910551 — ROCHE REAGENT FOR APOLIPOPROTEIN A-1
- K910552 — ROCHE REAGENT FOR APOLIPOPROTEIN B
- K910595 — MODEL 5311B A-V PACING SYSTEM ANALYZER
- K910620 — CARDIOCAP DR-124 RECORDER
- K910645 — DISPOSABLE PATIENT CABLE
- K910679 — GENESIS I AUTOMATED CELL COUNTER
- K910731 — DISPOSABLE RETRACTABLE NEEDLE SYRINGE
- K910813 — MET-ETCH
- K910834 — QBC AUTOREADER
- K910861 — PERCUTANEOUS INTROD W/SIDEPORT/THREE-WAY STOPCOCK
- K911140 — BARD(R) ENDOCARDIAL BALLOON ARRAY
- K911266 — MODIFIED PK TP CONTROL
- K911579 — STARKEY TRILOGY PROGRAM HEAR AID CC/CE MODELS
- K911848 — IMMUNOWELL RNP/SM ANTIBODY TEST
- K911849 — IMMUNOWELL SJOGRENS SYNDROME A (RO)ANTIBODY TEST
- K911850 — IMMUNWELL SJOGREN`S SYNDROME B (LA) ANTIBODY TEST
- K911851 — IMMUNOWELL SM ANTIBODY TEST
- K903394 — GLOBALCARE MICRO 11 AND MICROCARE (TENS)
- K905038 — OLYMPUS PK-TP ABSORBENT KIT
- K905480 — SPIROSCOPE
- K905782 — FHT (FECAL HEME TEST)
- K910067 — PTI STERNAL CLOSURE WIRE SUTURE
- K910496 — CARBON DIOXIDE LASER SYSTEMS W/ARTHOGUIDE CO2 DEL.
- K910500 — HOWMEDICA KINEMAX PLUS TOTAL KNEE SYSTEM
- K910515 — FREEDOM MARK III SURGICAL HELMET SYSTEM
- K910564 — VERSACATH(TM0 MAINLINE(TM) WITH INTRODUCTION TRAY
- K910653 — TOUCHLESS II INTERMITTENT CATHETER
- K910721 — BIOTROL PROTEIN MULTILEVEL STANDARDS
- K910951 — OPTHLAMIC FRAMES
- K911132 — MULTIPLE, SURGICAL DRAPE PACK
- K911332 — SPECTACLE FRAME
- K911566 — CLEARBLUE EASY
- K901932 — VARIAN ELECTRONIC PORTAL IMAGING SYSTEM
- K905235 — VDR SINUSOIDAL PERCUSIONATOR FAMILY/RELATE ACCESS
- K905635 — OHMEDA MODULUS CD ANESTHESIA SYSTEM
- K910241 — STATIM CASSETTE AUTOCLAVE
- K910790 — MENTOR LUBRICATING JELLY
- K910847 — OHMEDA 7810 ANESTHESIA VENTILATOR
- K910911 — MOSS P.E.G. TRAY
- K910971 — Z XT RADIATION THERAPY TREATMENT TABLE
- K911037 — SAFETY NEEDLE SHEATH, MODIFICATION
- K911774 — ALADAN LATEX MEDICAL GLOVE
- K910661 — MODEL 205 SHOCK-TRODE
- K910964 — HOT BIOPSY FORCEPS
- K911160 — MENTOR(R) WET-FIELD(R) II AC COAGULATOR, 22-1305
- K904332 — MSTIM-2000 EMS
- K904344 — SLEEPER MASK SYSTEM
- K910317 — UNI-SEM(TM)
- K910320 — SERIM PERACETIC ACID REAGENT STRIPS
- K910415 — SUNGLASSES
- K910432 — HAPSET HYDROXYLAPATITE BONE GRAFT PLASTER
- K910499 — IMMUNODIAGNOSTIC ASSAY SYSTEM HERPES SIMPLEX VIRUS
- K910684 — CIBA CORNING ACS FT4 IMMUNOASSAY
- K910737 — SRI T3 IMMOENZYMETRIC ASSAY
- K910930 — ACS THERAPEUTIC DRUG MONITORING CONTROL SET I LE.1
- K911082 — REAL TIME X-RAY IMAGING SYSTEM
- K911109 — OPHTA SIL (R), LACHRYMAL INTUBATION SETS
- K911167 — ACS THERAPEUTIC DRUG MONIT CONTR, SET I, LEVEL II
- K911168 — ACS THERAPEUTIC DRUG MONIT CONTR, SET I, LEVEL III
Data sourced from openFDA. This site is unofficial and independent of the FDA.