FDA 510(k) clearances — page 962
clearances on record, most recent first.
Clearances — page 962
96,101–96,200 of 175,890- K945410 — IRT LOCKING SYRINGE
- K962139 — SAFESKIN
- K962518 — NITRILE COPOLYMER PATIENT EXAMINATION GLOVES
- K963465 — PELVIC HOLDER
- K963771 — CHLOROPRENE EXAM GLOVES
- K963949 — KSEA UNIMAT PLUS
- K963959 — OSTEONICS MODULAR ACETABULAR CUP (HA-COATED VERSION)
- K964059 — MICADENT
- K964828 — VIREX II 128 GERMICIDAL CLEANER AND DEODORANT
- K960839 — FILM SCANNER 300
- K962049 — C-REACTIVE PROTEIN (CRP) AGGLUTINATION LATEX KIT
- K962583 — CAT SCOOTER WITH DS60 VONYTOLLRT
- K962864 — THB CAL STANDARD FOR IL CO-OXIMETERS/OXIMETERS
- K963228 — REPLIDERM WOUND DRESSING
- K963641 — STREPTOCOCCUS MIC PANEL
- K963807 — TOMTEC ECHO-SCAN
- K963826 — ENDOCARE CRYCARE CRYOSURGICAL SYSTEM
- K963859 — QLVA PLUS
- K963861 — LASERSHARE PRINT SPOOLER AND/OR SOFTWARE
- K963888 — C-ARM TABLE IVS-100
- K963896 — MOBILE CT PROSPEED FAMILY
- K963939 — SYNERMED DIRECT BILIRUBIN REAGENT KIT
- K963953 — IMIG-MRI
- K964072 — MONOCRYL (POLIGLECAPRONE 25) SUTURE, UNDYED
- K964124 — PHILIPS COMPUTED RADIOGRAPHY
- K964203 — PIPERACILLIN/TAZOBACTAM 4
- K964212 — QUINIDINE ENZYME IMMUNOASSAY
- K964250 — LINX NETWORKING SYSTEM
- K964270 — UNIVERSAL REAGENT FACTOR V DEFICIENT PLASMA
- K964442 — VALPROIC ACID ASSAY FOR THE TECHNICON IMMUNO 1 SYSTEM
- K964459 — UNIVERSAL REAGENT FACTOR X DEFICIENT PLASMA
- K964721 — VITROS IMMUNODIAGNOSTICS PRODUCTS TOTAL T4 REAGENT PACK (GEM.1005) TOTAL T4 CALIBRATORS (GEM.C005)
- K954642 — HYDRO-SELECT GUIDEWIRE
- K955791 — SURGIFLATOR-20 PIM
- K961318 — 1ST RESPONSE DISPOSABLE MANOMETER
- K962185 — HYDRASOFT (EAST) AND HYDRASOFT TORIC(EAST) (METHAFILCON B) DAILY WEAR SOFT HYDROPHILIC CONTACT LENS
- K962538 — BARD COAGULATING RESECTOR MODEL (3552XX; XX=01,02,03,04,05 OR 06)
- K962572 — SCIMED CHOICE PT VISION PTCA GUIDE WIRE
- K962894 — SYNTHES HIGH TIBIAL OSTEOTOMY (HTO) SYSTEM
- K963307 — GDC PATIENT RETURN ELECTTRODE MODEL 45021
- K963749 — HIGH PRESSURE INJECTION LINES
- K963993 — RUSCH SIMPLASTIC FOLEY CATHETERIZATION SET
- K964289 — EYE FIXATION SPECULUM
- K964316 — PLASTIC SUNGLASSES
- K964554 — PERSONAL TELEMEDICINE MODULE
- K954610 — MODEL 430-07 ENDOCARDIAL PACING LEAD
- K960101 — ISLAND BIOSURGICAL BOLSTER
- K960643 — ADVANTAGE MAPF HIP FEMORAL COMPONENT
- K961859 — NOVUS STANDARD AND PEDIATRIC VALVES
- K962050 — THERATEST EL-RFSCR
- K962230 — CELSITE PORT WITH PRECONNECTED CATHETER
- K962283 — EEG ELECTRODES
- K962296 — STREPTOLEX-STAT
- K962641 — MAXIMA FORTE HOLLOW FIBER OXYGENATOR WITH PLASMA RESISTANT FIBER
- K962917 — MULTIDEX HYDROPHILIC WOUND DRESSING GEL
- K963094 — CYNOSURE PHOTOGENICA LP DERMATOLOGICAL VASCULAR LESION LASER
- K963127 — ELECSYS FT3
- K963296 — INCSTAR TOXOPLASMA IGG ALISA ASSAY (CAT.#7565)
- K963297 — INCSTAR TOXOPLASMA IGG FAST ELISA ASSAY (CAT.#7560)
- K963539 — SIGMA DIAGNOSTICS WASH CONCENTRATE
- K963633 — VENTNET; CENTRAL MONITORING STATION
- K963747 — REACH STIM-U-DENT PLAQUE REMOVERS WITH MICRODENT/REACH FLOSS STIKS WITH MICRODENT/REACH FLOSS PICS WITH MICRODENT ETC.
- K963884 — SOMNUS DISPOSABLE MULTIPLE ELECTRODE COAGULATING PROBE MODEL 350
- K963910 — HEART NEBULIZER #100609
- K963934 — ACCESS TROPONIN I REAGENTS ON THE ACCESS IMMUNOASSAY ANALYZER MODEL NUMBERS: 33320, 33325 AND 33329
- K963973 — DEPUY CANNULATED CROSS PIN SCREW SYSTEM
- K964007 — ACROMED CABLE/WIRE PEDICLE SCREW
- K964100 — VISION-SCIENCES MODEL SS-U32 ENDO SHEATH FOR USE WITH THE VSI S-F100 FLEXIBLE FIBEROPTIC SIGMOIDOSCOPE AND VSI S-V100
- K964111 — LITHOVAC SUCTION/ASPIRATION PROBE
- K964323 — CHROMOPRINT CHROMATIC ALGINATE IMPRESSION MATERIAL
- K964345 — ETHICON ABSORBABLE POLY (L-LACTIDE/GLYCOLIDE) SURGICAL SUTURE, UNDYED
- K964558 — VITROS IMMUNODIAGNOSTICS PRODUCTS/TSH REAGENT PACK (GEM. 1001)/TSH CALIBRATORS(GEM.C001)
- K964687 — N LATEX CRP MONO REAGENT
- K964693 — ELECSYS FSH ASSAY
- K964705 — SOLDER GPY
- K964706 — SOLDER 650
- K964707 — SOLDER 585
- K964708 — SOLDER 615
- K964713 — SOLDER GPW
- K964829 — ELECSYS CALCHECK FSH
- K964830 — ELECSYS CALCHECK LH
- K964835 — COVERAGE SPRAY HBV
- K961687 — EVITA 4
- K962212 — KARL STORZ FRIMBERGER VARIOGUIDE
- K962968 — PROC APC ASSAY, PROC CONTROL PLASMA
- K963062 — IMMAGE SYSTEM DIGOXIN (DIG) REAGENT/BECKMAN DRUG CALIBRATOR 2
- K963707 — NELLCOR PURITAN BENNETT NPB-40 HANDHELD PULSE(NPB-40)
- K963733 — NICCHECK I
- K963849 — MANAN D BAG
- K964068 — CARBAMAZEPINE ASSAY FOR THE TECHNICON IMMUNO 1 SYSTEM
- K964158 — JEL-40 (CODE NAME RD-0430)
- K964173 — C-MOUNT OBJECTIVE LENS F = 17 MM, STEAM-STERILIZABLE: MODEL 85 261.172, C-MOUNT OBJECTIVE LENS F = 21 MM, STEAM-STERILIZ
- K964328 — SYNTHES (USA) SYNTHES MMFS-ADJUSTABLE SAGITTAL SPLIT PLATE
- K964355 — ONTRAK TESTCUP 5 (MODIFICATION)
- K964415 — N-ASSAY TIA RHEUMATOID FACTOR TEST KIT
- K964418 — N-ASSAY TIA RHEUMATOID FACOTR MULTI-CALIBRATOR SET
- K964535 — VIREX TB READY-TO-USE DSINFECTANT CLEANER & DEODORANT
- K964610 — TRIAD II DISINFECTANT CLEANER AND DEODORANT
- K964613 — VIREX II 256 GERMICIDAL CLEANER AND DEODORANT
- K964640 — CANTROL IRON/TIBC CONTROLS, LEVEL 1 AND LEVEL 2 PRODUCT NUMBERS: LEVEL 1: IIBC-91 AND LEVEL 2: IIBC-92
Data sourced from openFDA. This site is unofficial and independent of the FDA.