FDA 510(k) clearances — page 964
clearances on record, most recent first.
Clearances — page 964
96,301–96,400 of 176,637- K963831 — SHEATHES (NON-LATEX)
- K963866 — AMBIDERM (WHITE POW LATEX EXAM GLOVES W/ PROTEIN)
- K963868 — IMMAGE IMMUNOCHEMISTRY SYSTEM IMMUNOGLOBULIN G (IGG), A (IGA) AND M (IGM)
- K964004 — GLUCOMETER ENCORE BLOOD GLUCOSE TEST STRIPS
- K964010 — IMMAGE IMMUNOCHEMISTRY SYSTEM APOLIPOPROTEIN A-1 REAGENT (APA)/ IMMAGE IMMUNOCHEMISTRY SYSTEM APOLIPOPROTEIN B REAGENT
- K964174 — MINERAL TRIOXIDE AGGREGATE (MTA)
- K964260 — IMMAGE IMMUNOCHEMISTRY SYSTEM KAPPA LIGHT CHAIN (KAP) REAGENT IMMAGE IMMUNOCHEMISTRY SYSTEM LAMDA LIGHT CHAIN (LAM) REAG
- K964372 — CARDIAC T TROPONIN T RAPID ASSAY
- K964520 — PARASCAN SCANNING DEVICE
- K964523 — RECOVER INFANT HEEL WARMER (5100)
- K964526 — LIBERTY RECTAL PELVIC FLOOR EXERCISER
- K964626 — EDGE/VISTA SYSTEM ENHANCEMENT PACKAGE
- K964628 — NITRILE POWDER-FREE EXAMINATION GLOVES
- K964629 — VINYL PATIENT EXAMINATION GLOVES
- K964630 — GLUCOMETER ELITE BLOOD GLUCOSE METER
- K964647 — NORTH AMERICAN SCIENTIFIC (NASI) 1-125 RADIONUCLIDE BRACHYTHERAPY SOURCE
- K964656 — TEFGEN GUIDED TISSUE MEMBRANE
- K964747 — SOMATOM PLUS 4 CT SCANNER
- K964810 — DERMADAM
- K964812 — NIMA NEEDLELESS INJECTIONSITE MASTER ADAPTER AND I.V. SET
- K964859 — SCIMED 5 FRENCH IMPULSE ANGIOGRAPHIC CATHETERS
- K964862 — TROPONIN-I TEST SYSTEM
- K964931 — WHITE CORE
- K964944 — ROUND DENTAL BUR
- K964981 — TEMPFIL C&B
- K965026 — PFINGST PRESSURE PASTE
- K965202 — VACUTAINER BRAND SAFETY-LOK BLOOD COLLECTION SET
- K965213 — STRATUS MYOGLOBIN GLUOROMETRIC ENZYME IMMUNOASSAY
- K970054 — TANDEMRX
- K970147 — ELECSYS CALCHECK PROLACTIN
- K970148 — ELECSYS CALCHECK ESTRADIOL
- K970254 — SEIRIN PYONEX ACUPUNCTURE NEEDLES
- K970260 — SEIRIN JR ACUPUNCTURE NEEDLES
- K962246 — RIGID FIBER OPTIC LAPAROSCOPE
- K962718 — FEMEXAM TESTCARD
- K962737 — AMBIDERM (COLOR POW LATEX EXAM GLOVES W/ PROTEIN)
- K963023 — ULTRASOUND GASTROSCOPE GF TYPE UM30P
- K964148 — PATIENT EXAMINATION GLOVES; CHLORINATED POWDERFREE NITRILE EXAMINATION GLOVES
- K964315 — REMEL STAPH LATEX KIT
- K964487 — IMIPENEM ANTIMICROBIAL SUSCEPTIBILITY TEST DISC
- K964489 — CEFACLOR ANTIMICROBIAL SUSCEPTIBILITY TEST DISC
- K964490 — AZTREONAM ANTIMICROBIAL SUSCEPTIBILITY TEST DISC
- K964491 — NORFLOXACIN ANTIMICROBIAL SUSCEPTIBILITY TEST DISC
- K964492 — CIPROFLOXACIN ANTIMICROBIAL SUSCEPTIBILITY TEST DISC
- K964495 — CEFEPINE ANTIMICROBIAL SUSCEPTIBILITY TEST DISC
- K964672 — SUTURE APPLICATOR
- K964701 — MITRAFLEX PIGMENTED WOUND DRESSING
- K964722 — DELTA N95 RESPIRATOR
- K964723 — RACAL N95 RESIRATOR
- K964899 — KENDALL CURITY URETERAL CATHETER
- K964927 — STABILIZER SOFT TISSUE ANCHOR, 8MM MODEL TA1008, ANCHOR INSERTER/SUTURE ORGANIZER, 8MM MODEL AI1008, STABILIZER DRILL, 8
- K964964 — POWDER-FREE VINYL PATIENT EXAMINATION GLOVES
- K970021 — RUSCH SUPRAPUBIC TRAY
- K953175 — AS/3 ESTPR MODULE
- K954003 — COBE HEMODYNAMIC RECIRCULATION MONITOR
- K960534 — METALLIC SPHERICAL CMC IMPLANT
- K960659 — CERAMIC SPHERICAL CMC IMPLANT (SUBJECT TO MARKETING APPROVAL)
- K961498 — RESCH ARTHROSCOPIC AND PERCUTANEOUS SCREW FIXATION SYSTEM (A.S.F.)
- K962335 — MLC FIT
- K962603 — MASIMO SET MS-1 PULSE OXIMETER & THE LNOP SERIES OF SENSORS & CABLES
- K962708 — TITANIUM CD HORIZON SPINAL SYSTEM
- K963125 — M AND R REUSABLE ELECTRODES (MULTIPLE)
- K963139 — OLYMPUS TRANSFERRIN IMMUNOTURBIDIMETRIC REAGENT
- K963302 — TAYMAN MEDICAL, INC. STEPPING & STABILIZING SYSTEM
- K963680 — TARGET MYOGLOBIN TEST
- K963741 — LEIBINGER LUHR SMALL CRANIOMAXILLOFACIAL BONE SCREWS
- K964139 — SYSMEX CA-6000
- K964401 — KENDALL-LTP DISPOSABLE TEMPERATURE PROBES (DTP1,DTP2,DTP3,DTP4)
- K964493 — OFLOXACIN ANTIMICROBIAL SUSCEPTIBILITY TEST DISC
- K964496 — CEFIXIME ANTIMICROBIAL SUSCEPTIBILTY TEST DISC
- K964497 — CERALAS DIODE LASER SYSTEM (CERALAS D15)
- K964501 — SULBACTAM/AMPICILLIN ANTIMICROBIAL SUSCEPTIBILITY TEST DISC
- K964512 — CEFTIZOXIME ANTIMICROBIAL SUSCEPTIBILITY TEST DISC
- K964521 — DEPUY DUPONT PHANTOM SUTURE ANCHOR
- K964614 — ULTRAFERA WOUND DRESSING
- K964623 — TITANIUM CD HORIZON ANTERIOR SPINAL SYSTEM
- K964655 — UHMWPE HIP AND KNEE COMPONENTS - PACKAGING CHANGE
- K964786 — ANCHORLOK RL SOFT TISSUE ANCHOR SYSTEM
- K965007 — ORATEC INTERVENTIOUNS ELECTROSURGICAL PROBES
- K965038 — GORE-TEX SOFT TISSUE PATCH PLUS/DUALMESH PLUS BIOMATERIAL/MYCROMESH PLUS BIOMATERIAL/DUALMESH PLUS BIOMATERIAL WITH HOLE
- K965169 — STABLELIN ENZYME LINEARITY TEST SET C (ITEM NO. 003)
- K970009 — LYFO(TM) DIFFERENTIAL DISK-BACITRACIN
- K970176 — HCG CONTROLS
- K960037 — SUGITA AVM MICROCLIP
- K962105 — PLANNED SOPHIED CLASSIC
- K964735 — DENTINSENSE
- K965006 — AT 62 EEG (A.K.A THE A; PHA-THETA TRAINER)
- K953976 — SAFE MICRO
- K960850 — ACCESS CHLAMYDIA ASSAY
- K961024 — BIOSIGN MONO-PLUS WB,BIOSIGN MONO WB,MONO-PLUS WB,ACCUSIGN MONO WB
- K961730 — RAPID GRAM-POSITIVE ID SYSTEM
- K961968 — BBLCRYSTAL GRAM-POSITIVE ID SYSTEM
- K962653 — MICROGYN RESECTION LOOP, COAGULATING ELECTRODE, CISS SHEATH ELECTRODE, LOOP ELECTRODE KIT AND COAGULATING ELECTRODE KIT
- K963104 — 9.5 FR.- FLEXI-CATH INTRA-AORTIC AND CONTROL SYSTEM
- K963645 — HERPES GROUP IGG ELISA TEST SYSTEM
- K963673 — IMMAGE IMMUNOCHEMISTRY SYSTEM TDM (CAR,PHE,PHY, & THE) REAGENTS
- K964245 — PRECISE, TYNMPANETTE, AND XACTO IMPRESSION KITS
- K964419 — MIRACLE - EAR (ITE/ITC/CIC)
- K964485 — PORTPRO ELECTRONIC PORTAL IMAGING SYSTEM
- K964494 — SLEEPWIZARD
Data sourced from openFDA. This site is unofficial and independent of the FDA.