FDA 510(k) clearances — page 1310
clearances on record, most recent first.
Clearances — page 1310
130,901–131,000 of 175,890- K893603 — REMOVE ADHESIVE REMOVER
- K893611 — BARD PLAQUE ELECTRODE ARRAY
- K893617 — MOBILE C-ARM
- K893642 — MODIFIED ENDOGUIDE
- K893659 — ELECTROSURGERY ANALYZER RF302
- K893675 — VISTA MR 2055 HP SYSTEM AND 2055 UPGRADES
- K893732 — ASPEN DISPOSABLE BIPOLAR CORD
- K893739 — VISTA MR 2055 HP SYSTEM AND 2055 UPGRADES
- K893754 — CEFIXIME, 5 MCG SENSI-DISC ANTIMIC SUSCEP TEST DIS
- K893763 — MODELS 1113 AND 1114 PACEMAKER LEADS
- K893782 — PATIENT EXAMINATION GLOVES W/CORN STARCH POWDER
- K893813 — FLOOR STANDING, OPERATING AND EXAMINING LIGHT
- K893870 — ADAMS BREAST IMPLANT PROTECTOR
- K893896 — QUANTITATIVE ASSAY FOR DET. OF IGG IGM ANTI-DSDNA
- K893901 — LATEX EXAMINATION GLOVES
- K893902 — 4 X 4 STERILE GAUZE SPONGE TRAY
- K893906 — GOLD CLASS GRANDTEX/MULTIPLE(MFG:ZHUHAI GOLD CLASS
- K893939 — ISOLATION MASKS
- K893951 — PHARMACIA CAP SYSTEM IGE RIA AND FEIA
- K893969 — DECUBITUS CARE PAD
- K894017 — POWER PODIATRY CHAIR/TABLE #414, #416 & #417
- K894034 — MODIFIED LABELING OF SURGICAL GLOVES
- K894039 — QUIDEL TOTAL IGE TEST QUANTITATIVE VERSION
- K894040 — IMPLANTABLE PACING LEADS W/IS-1 CONN., UNIPOLAR
- K894284 — GOWN, OPERATING, SURGICAL
- K892955 — PATIENT EXAMINATION GLOVES (LATEX)
- K882384 — DELUXE CONTACT LENS HOLDER (HARD & SOFT) #283
- K883809 — NEWPORT VENTILATOR MODEL E150
- K884625 — DPX BONE DENSITOMETER FOR TOTAL BODY BONE DENSITY
- K884925 — THE GREAT WALL CONDOM
- K884927 — BE #1100 MOISTURE TRAP & BE #1102/50 DISP CANISTER
- K884969 — BIO-MATE(TM) EPIDURAL CATHETER
- K885015 — COI 72 HR COLLAGEN SHIELD
- K885107 — THROMBOSTIN IFA*
- K885115 — IMD 7GX
- K885295 — IMX RUBELLA IGM, MICROPART. ENZYME IMMUNOASSAY
- K885297 — IMX RUBELLA IGG, MICROPARTICLE ENZYME IMMUNOASSAY
- K890031 — IMX TOXO IGG ANTIBODY ASSAY
- K890032 — IMX TOXO IGM ANTIBODY ASSAY
- K890092 — HI STANDARD MAGNETIC RESONANCE DIAGNOSTIC DEVICE
- K890360 — GREER DERMAPIK SYSTEM
- K890533 — ITEM #352/#CS352* CONTACT LENS CASES
- K890610 — VIRONOSTIKA(TM) ANTI-CMV IGM MICROELISA SYSTEM
- K890731 — MEDSURG EPIDURAL TRAY/19 GA/BUL TIP/17GA TUO 1002
- K890732 — MEDSURG EPIDURAL TRAY/BULLET TIP/17 GA TUOHY 1002E
- K890733 — MEDSURG EPIDURAL TRAY/19 GAGE OPEN END TUOHY 1012
- K890782 — GRIESHABER SOFT TIP NEEDLE (20 & 19 GAUGES)
- K890931 — PATIENT EXAMINATION GLOVE
- K891063 — SURFLO(R) WINGED INFUSION SET
- K891087 — TERUMO SURFLO(R) I.V. CATHETER
- K891146 — TERUMO SURFLO(R) INJECTION PLUG
- K891164 — SAMUELS - MICRO -SCLER CATHETER
- K891352 — MARLOW ANAL SPECULUM
- 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
Data sourced from openFDA. This site is unofficial and independent of the FDA.