FDA 510(k) clearances — page 1230
clearances on record, most recent first.
Clearances — page 1230
122,901–123,000 of 176,637- K911525 — TOKUSO LIGHT BOND
- K911558 — ANTIMICROBIAL SUSCEPT. TEST PANEL NITROFURANTOIN
- K911578 — CHOLESTECH L.D.X. LIPID ANALYZER, MODIFICATION
- K911596 — VISION BG MONITOR
- K911652 — MIRCOLINE SCREEN FOR COCAINE
- K911701 — G-FLOSS & G-FLOSS II
- K911712 — STRATUS(R) AUTOMATED SAMPLE HANDLER
- K911792 — FIRST CHOICE(TM), MODIFICATION
- K911803 — HI CHEM AQUEOUS MULTIANALYTE LINE STAND, MODIFIED
- K911941 — CEDIA(R) DIGOXIN R' ASSAY
- K902607 — DANTEC MAGNETIC STIMULATOR MAG 2 (MAG 2)
- K904889 — TENS CONDUCTIVE MEDIA PAD
- K905397 — PB3200 INTRA-ARTERIAL BLOOD GAS MONITORING SYSTEM
- K910142 — SPARK KIT(R), MODIFICATION
- K910601 — PATHFINDER
- K910629 — AP-860PA NIBP MODULE
- K910770 — 504US PULSE OXIMETER
- K900576 — MODIFIED AEROCHAMBER WITH MASK
- K904234 — MENS-O-MATIC I
- K904235 — MENS-O-MATIC 2000
- K904258 — MICRO DERM
- K904260 — MENS-O-MATIC 3000
- K904288 — MENS-O-MATIC 1XS AND MENS-O-MATIC 2XS
- K904430 — MENS FREEDOM MICRO
- K905404 — MEDTRONIC SULLIVAN NASAL CPAP SYSTEM
- K910194 — COMPANION 318 NASAL CPAP DIAGNOSTICS SYSTEM
- K910281 — INTRAVASCULAR IMAGING SYSTEM/MODIFIED
- K910587 — MINISCOPE
- K910637 — MENTOR(R) SUR-E-TROL(R)
- K910662 — PS OMNIFIT NORMALIZED HIP STEM SERIES
- K910907 — PUMP VAC PLUS
- K911039 — INVOTEC EAR DRAPE
- K911108 — OPHTA SIL (R), PUNCTAL PLUGS AND INSERTERS
- K911369 — QUALTEX LIGHT HANDLE AND LIGHT HANDLE COVER
- K911913 — PRECISION GLIDE - ENHANCED SURGICAL BLADE
- K911921 — DISPOSABLE ISOLATION GOWN
- K905590 — UCEZ - STERILE LENS FOG REDUCTION DEVICE
- K910180 — BACTI-SWAB
- K910181 — HITT BY HEMOCHRON(R)
- K910440 — DOCUMENT REFLECTANCE II LINEARITY TEST SET
- K910646 — SUPERSERUM REAGENT (SSR)
- K910671 — MODEL GS-4700 COMMON DUCT STONE REMOVING KIT
- K911145 — BORRELIA BURGDORFERI POLYVAL IGG/IGM ANTIBODY TEST
- K902853 — GRAVITY PLUS CONTROLLER/COMPOUNDER
- K904237 — RAPID IMMOBILIZATION DEVICE OR R.I.D. SYSTEM
- K904264 — MODEL SW-103 SOLITANS STIMULATOR
- K905471 — TROCAR ACCESS SHEATH
- 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
Data sourced from openFDA. This site is unofficial and independent of the FDA.