FDA 510(k) clearances — page 1318
clearances on record, most recent first.
Clearances — page 1318
131,701–131,800 of 176,637- K891393 — ORGENICS IMMUNOCOMB(TM) CMV IGG ANTIBODY TEST KIT
- K891410 — NASOGASTRIC PH SUCTION CATHETER, ST-5001
- K891456 — HEYER-SCHULTE (CSF) VENTRI ACCESS(RESERV/ANTECHAM
- K891543 — MAGNAVIEW MOBILE MRI VERSION 110 FHM
- K891760 — MAGNETIC RESONANCE SYSTEM, MODEL BMT 1100,MODIFIED
- K891771 — VICTOR MEDICAL OXYGEN THERAPY REGULATOR, MODIFIED
- K892062 — PS3500 ARTHROSCOPIC SURGICAL SYSTEM
- K892117 — GENTLEHALER(R)
- K892266 — PATIENT EXAMINATION GLOVES (LATEX)
- K892289 — PATIENT EXAMINATION GLOVES (LATEX)
- K892364 — KALTOSTAT(TM) WOUND DRESSING
- K892372 — SPIN-CLEAN CLEANING UNIT
- K892408 — NSD 8CS8 - TENS DEVICE
- K892437 — KENDALL KENGUARD URINARY LEG BAGS
- K892439 — KENDALL CURITY STOMACH TUBES
- K892442 — KENDALL CURITY URETHRAL CATHETERS
- K892566 — PATIENT EXAMINATION GLOVES (LATEX)
- K892657 — SENSIMAT
- K892691 — CATHETERS, MALE, FEMALE
- K892859 — THE STAGO VIII DEFICIENT PLASMA KIT
- K892860 — SATURNE 41
- K892881 — DENTAL SANI-SLEEVE STERILE 60MM X 1650MM #1101
- K892882 — DENTAL SANI-SLEEVE STERILE 100MM X 2200MM #1102
- K892942 — BREATH TRACKER
- K893140 — DOCUMENT(TM) TRIGLYCERIDE LINEARITY TEST SET
- K893141 — DOCUMENT(TM) IRON MAGNESIUM LINEARITY TEST SET
- K893142 — DOCUMENT(TM) IRON, MAGNES, TRIGLY LINEAR TEST SET
- K893388 — DEVILBISS MODEL 7351D REVITALIZER CPAP SYSTEM
- K893391 — MI-328, MI-316, MI-388 DIGITAL THERMOMETER
- K893396 — AN ALTERNATIVE DIRECT BONDING ORTHO. SYSTEM
- K893400 — SERUMAX (AUTOMATED SERUM CENTRIFUGATION & STATION)
- K893402 — COMPACT 2052(TM) DUAL COLLECTION BLOOD RECOVERY
- K893416 — URIC ACID REAGENT (PROCEDURE NUMBER 686)
- K893420 — MASTERLAB PFT AND MASTERLAB BODY BOX
- K893422 — CLEARVIEW STREP A
- K893460 — A-PORT IMPLANT VASCULAR ACCESS SYSTEM .6MM/2.29MM
- K893476 — ANGIOTEC SPX SPLIT SCREEN DUAL CHANNEL SCAN CONV.
- K893480 — BYRD EXTRACTOR SET
- K893510 — CRONEX QUANTA V RARE EARTH INTENSIFYING SCREEN
- K893521 — IMLOGIX 1000 IMAGE DISPLAY SYSTEM
- K893523 — FACTOR X DEFICIENT PLASMA
- K893524 — FACTOR IX DEFICIENT PLASMA
- K893525 — FACTOR VIII DEFICIENT PLASMA
- K893533 — FACTOR V DEFICIENT PLASMA
- K893534 — FACTOR XII DEFICIENT PLASMA
- K893535 — FACTOR VII DEFICIENT PLASMA
- K893536 — FACTOR XI DEFICIENT PLASMA
- K893542 — DIASTEMA CLOSING KIT
- K893549 — X-RING SEPARATORS
- K893565 — ARGENCO 68 TYPE IV DENTAL GOLD ALLOY
- K893568 — ARGENCO 56 TYPE IV DENTAL GOLD ALLOY
- K893608 — ACTICHROME ATIII KIT
- K893619 — VISTA MR 2055 HP SYSTEM
- K893634 — MODIFIED STERILIZATION OF TUR APRONS
- K893650 — PLATELET AGGREGATION PROFILER MODEL PAP-4C
- K893652 — RADIOGRAPHIC FLOOR MOUNTED TUBESTAND FM 60
- K893653 — RADIOGRAPHIC CEILING TUBE SUPPORT CTS15
- K893654 — MEMORY CHAIN
- K893669 — CELLMATICS SHLAMYDIA DETECTION SYSTEM
- K893686 — ARGELOY N.P.
- K893702 — TECNOL GAITERS PRODUCT NUMBER 47725-010
- K893783 — ACS ANIMAL PLASMA COAGULATION CONTROL LEVEL I
- K893784 — ACS HUMAN PLASMA COAGULATION CONTROL LEVEL I
- K893787 — LIFECELL RECOVERY CONTAINER
- K893791 — BREATHING MOUTHPIECE
- K893881 — ACCESS TM
- K893897 — SEMI-QUANTITATIVE ASSAY FOR DET. OF IGG AND IGM
- K882818 — SEER
- K884800 — ACTA GENOS ELECTROCARDIOGRAPH
- K884998 — SELBY INSTRUMENTATION
- K885089 — SURGICAL GLOVES
- K885102 — OMNIFIT CERAMIC MORSE TAPER HEAD (1002 SERIES)
- K885192 — APR COLLARED REVISION FEMORAL COMPONENT
- K885349 — SONOMICROMETER, ULTRASONIC DIMENSION SYSTEM, CARD.
- K890292 — PCA-10, 10CC DISP. ANGIOGRAPHY CONTROL SYRINGE
- K890876 — BP-8800 BLOOD PRESSURE MONITOR
- K891062 — TERUMO AV FISTULA NEEDLE SET
- K891403 — HUGH YOUNG II UROLOGICAL TABLE
- K891418 — LATEX EXAMINATION GLOVES, STYLE 510 LX
- K891835 — BUD BRAND PATIENT EXAMINATION GLOVES (VINYL)
- K891855 — WINFIELD LATEX EXAMINATION GLOVES
- K891952 — TRU-TOUCH VINYL EXAM GLOVES (CANADA)
- K892017 — PURAFLEX PATIENT EXAMINATION GLOVES
- K892066 — HORIZON CENTRAL STATION
- K892152 — PATIENT EXAM GLOVES (MFG. NINGBO MEDICAL LATEX)
- K892204 — NIDEK INC. MODELS YC-2000 & 3000 OPHTHALMIC LASERS
- K892209 — APTT BY HEMOCHRON(R)
- K892214 — REVERSE CUTTING CANNULATED CANCELLOUS BONE SCREW
- K892387 — MODIFIED GELMAN ARTERIAL FILTER
- K892426 — NO. 86500 - ENDOSCOPIC JET WASHER
- K892455 — KULZER ADHESIVE CEMENT
- K892504 — 'EXMOOR' SINGLE USE SUCTION TUBE
- K892803 — PHONIC EAR ITE/ITC HRNG AID 901, 902, 903, 906,911
- K892820 — FORCEPS, SURGICAL, GYNECOLOGICAL
- K892932 — BIOPRIME TM KIT
- K892933 — INFRALASE-LASERGUIDE DELIVERY SYSTEM
- K892937 — REUSABLE BOWL AND SPATULA FOR MIXING BONE CEMENTS
- K892976 — SINGLE USE VINYL EXAM GLOVES - COLOR CODED
- K893018 — HPI NON STERILE EXAM GLOVES
- K893135 — GENT-L-KARE STER SUCT CATH TRAY W/14 FR/STER WATER
Data sourced from openFDA. This site is unofficial and independent of the FDA.