FDA 510(k) clearances — page 1589
clearances on record, most recent first.
Clearances — page 1589
158,801–158,900 of 175,890- K823368 — DADE ESR KIT
- K823411 — PEDIATRIC URINE COLLECTOR
- K823445 — ALKPHOR SYSTEM
- K823450 — FEMALE EXTERNAL URINARY APPLIANCE
- K823462 — SINGLE VIAL AMYLASE PNP TEST
- K823472 — ULTRA CHEM BAN-UV #65080 & 65081
- K823476 — GAMMADAB LH RADIO-KIT #CA-1508
- K823496 — ARTHROSCOPIC IRRIGATION SETS-2C4030/31
- K823498 — PARA 12
- K823507 — TANDEM-E -IGE IMMUNOEZYMETRIC ASSAY
- K823510 — CURAY ANTERIOR/POSTERIOR RESTORATIVE
- K823520 — FIBROSYSTEM
- K823522 — DILULAB 230
- K823524 — OXYGEN CONCENTRATOR
- K823536 — INTRALIG
- K823548 — COMPRESSION HIP SCREW SIDE-PLATE
- K823557 — REMOVAWELL PLATE LID
- K823570 — CORNING 170 PH/BLOOD GAS ANALYZER
- K823591 — AMEDA HAND BREAST PUMP
- K823603 — FORMED PLASTIC PANTY HOSE AID
- K823604 — ROD W/HOOK TO PULL CLOTHES ON
- K823605 — PORTABLE ELECTRIC CAN OPENER
- K823606 — PLASTIC BREAK RESISTANT MIRROR
- K823607 — CARPET SWEEPER
- K823623 — INFLATABLE HEAVY PLASTIC EXERCISER
- K823627 — LEATHER I VELCRO SHOE FASTENER REPAIR
- K823628 — LEATHER & VELCRO SHOE FASTENER
- K823632 — LONG HANDLED FOLDING HAIRBRUSH
- K823633 — TURNERS FOR KNOBS
- K823634 — CHAIR OR BED LEG EXTENDERS
- K823635 — CUSHIONS FOR WHEELCHAIR ARMS
- K823636 — ARM THROUGH FOR WHEELCHAIR BK-6459-01 &
- K823669 — HEARING AID UNITRON #UE4-H
- K823684 — FILE TYPE K ENDODONTIC
- K823685 — FILE TYPE H (HEDSTROEM) ENDODONTIC
- K823686 — REAMER TYPE K ENDODONTIC
- K823690 — IVFLO-HP & IVFIL-HP
- K823732 — CBM, CORE BUILD-UP MATERIAL
- K823744 — PORCELAIN ARTIFICIAL TEETH
- K822429 — SINGLE VISION POWER LENS
- K822430 — KRYPTOX-ROUND SEGMENT BIFOCAL
- K822431 — SUNGLASS & SAFETY PLANO LENS
- K822541 — VISIOPAL 75
- K822542 — POLYCORE
- K828620 — MULTI IMAGE CAMERA
- K823402 — ULTRACHEM BUN-UV-GEM SAEC APPLI.#65080&
- K821983 — TITAN GEL LDH ISOENZYME KIT
- K822000 — EXTRACORPOREAL BLOOD GAS SYSTEM
- K823271 — DISPOSABLE ADULT VO. VENTILATOR CIRCUIT
- K823281 — MODEL RM 6000, 6100,6200 POLYGRAPH
- K823304 — RIASET PROLACTIN RIA KIT
- K823313 — IN VITRO GAMMACOAT B-HCG RADIO. TEST
- K823341 — TRIGLYCERIDES REAGENT SET TAG-GK
- K823354 — ULTRACHEM ENZYMATIC CHOLESTEROL OXIDASE
- K823371 — DURAPULSE
- K823379 — 125-I FSH RADIOIMMUNOASSAY KIT
- K823380 — 125-I LH RADIOIMMUNOASSAY KIT
- K823387 — SOPHEIA GENTAMICIN EIA KIT
- K823404 — VOLUMERIC CONTROLLER
- K823406 — GUARDIAN 110, VOL. CONTROL DELIV. SYS
- K823459 — PHILLY BOLT ADULT PROCEDURE KIT
- K823481 — BE #16 - MANIFOLD
- K823484 — THERMAL DILUTION CATHETER
- K823528 — GLISLENS
- K823589 — H 12 07
- K823594 — PLASTIC BUILT-UP HANDLE EATING UTENSILS
- K823595 — HEAD SUPPORT FOR WHEELCHAIR
- K823596 — CLAMP ON HOLDER FOR A GLASS OR CUP
- K823600 — SOLID WOOD CONE
- K823601 — WRIST SUPPORT
- K823602 — REGULAR SHOE HORN W/CYLINDRICAL HANDLE
- K823609 — KIT OF WORDS & LTRS TO RE-LEARN-BK4014
- K823610 — BK-4015 ECONOMY COMMUNICATION SHEET
- K823613 — PLASTIC STOP TO HOLD TELEPHONE BUTTON
- K823614 — FLEXIBLE HOLDER TO HOLD PHONE RECEIVER
- K823615 — TELEPHONE ADAPTOR-PERSONS CANT ANSWER
- K823616 — PLASTIC SLIP-ON PEN/PENCIL HOLDER
- K823617 — PLASTIC SLIP-ON POINTS W/RUBBER TIP FOR
- K823618 — PROGRESSIVE RESISTANCE EXERCISE CUFF
- K823619 — PLASTIC ELASTOMER ENCASED IN TERRY CLOTH
- K823620 — PLASTIC ELASTOMER IN CUBE FORM EXERCISE
- K823678 — TELEMETRY DECODER #540-02
- K823858 — VOLUME VENTILATOR
- K821951 — DATASCOPE MODEL 83 IABP SYSTEM
- K822913 — URIC ACID REAGENT
- K828544 — MAXICAMERA 400ZS
- K828545 — MAXICAMERA 500A SMALL FIELD IMAGING SYSTEM
- K822799 — STREPTACOCCUS CO-AGGLUTINATION KIT
- K822424 — CURITY TRANSPARENT FILM DRESSING
- K823239 — SURE & NATURAL MAXISHIELDS
- K823246 — AUSTIN INHALATOR
- K823288 — AMICON DIAFILTERS 20 & 30 HEMOFILTERS
- K823509 — P-S MED. LUMBO PERITONEAL & VENTRICULO-
- K823546 — RENAFLO II
- K823565 — MULTI-LUMEN INTRAVENOUS CATHETER
- K821669 — AMES TDA GENTAMICIN TEST
- K821702 — POWER SUTURE
- K822791 — CORATOMIC #VX5-105 & VX5-205 PULSE GEN.
- K822843 — HTS *1
- K822897 — DSL 1700
Data sourced from openFDA. This site is unofficial and independent of the FDA.