FDA 510(k) clearances — page 1319
clearances on record, most recent first.
Clearances — page 1319
131,801–131,900 of 176,637- K893378 — PROTHROMBIN TIME (PT) BY HEMOCHRON
- K893406 — DESERET PRN ADAPTER
- K893417 — SURGIFRESH SUB-MICRON MASK NO. 901008-000
- K893452 — EXTRA STRENGTH EFFERGRIP DENTURE ADHESIVE CREAM
- K893458 — FIBEROPTIC HEADLIGHT SYSTEM
- K893491 — MODEL M2-150/I-150/M2-150T/M3-150/M2-150,300-300
- K893531 — CUFF SPECULUM
- K893614 — AEROMAT MRS-1000
- K893706 — COLD/HOT FLUID RADIATION PAD NEUTECH
- K893708 — FLUIDIZED AIR BED
- K893772 — TISSUE EMBEDDING MEDIUM
- K882596 — MP TEST
- K884978 — PHARMA-PLAST INSULIN INFUSION SET
- K890125 — SANITARY NAPKIN PADS
- K890864 — HANDTYMP SCREENER MODEL 2000 + 2002 REMOTE TRANS.
- K890930 — PATIENT EXAMINATION GLOVES
- K892213 — ACS COLLOID OSMOTIC PRESSURE CALIBRATOR
- K892309 — PATIENT EXAMINATION GLOVES (LATEX)
- K892480 — PATIENT EXAMINATION GLOVES
- K892506 — PATIENT EXAMINATION GLOVES (LATEX)
- K892687 — CANNULATED BIOPSY FORCEPS
- K892915 — PLEUR-EVAC A-8002--ADULT/PEDIATRIC DUAL COLLECTION
- K893031 — DELTA (TM) ROBOTIC PIPETTOR
- K893206 — SHARPLAN 1075 CO2 LASER
- K893255 — SPECTRUM, VISIBLE LIGHT CURE ORTHODONTIC ADHESIVE
- K893340 — LATEX SURGICAL GLOVES
- K893701 — SLT CONTACT LASER SYSTEM
- K893884 — BACTON TM, BASIC TM, APO B REAGENT
- K893885 — BACTON TM, BASIC TM, APO A-I REAGENT
- K890018 — PACEMAKER LEAD ADAPTER
- K890047 — VASCUCARE PERCUTANEOUS ANGIOSCOPY DELIVERY SYSTEM
- K890505 — USCI GREY/BLACK GUIDE WIRE
- K890639 — RESUBMITTED EBV/IGM-CHECK TEST KIT
- K890794 — DAIG PACEL(TM) FLOW DIRECTED PACING CATHETER
- K890807 — GUIDE WIRE INTRODUCER
- K890819 — HSV-CHECK(TM) TEST KIT
- K890827 — IL1400, BGELECTROLYTE ANALYZER
- K890828 — PERIFLUX PF3
- K890926 — SURECUT BMB BONE MARROW BIOPSY/ASPIRATION NEEDLE
- K891162 — HSV-1 ELISA TEST SYSTEM
- K891457 — DR. VOLKNER'S LAMELLAR TURNING BED(TM)
- K891542 — EBNA-CHECK(TM) TEST KIT
- K891782 — HSV-2 ELISA TEST SYSTEM
- K891923 — AMRESCO PRODUCT NUMBER 7426
- K892005 — SHOCK ADVISORY ADAPTER FOR USE W/LIFEPAK 9
- K892227 — EDENTEC MODEL 2001 MODULAR MEMORY UNIT (MMU)
- K892331 — ENZYMATIC UREA NITROGEN REAGENT SET
- K892818 — REP(TM) LD-2 STAT KIT, CAT. NO. 3078
- K892844 — AST REAGENT (PROCEDURE NUMBER 158)
- K893224 — REP GLYCO-8 KIT, #3208/REP GLYCO-16 KIT, #3207
- K893243 — INTRA AORTIC BALLOON
- K893245 — L30-LB- INFANT LIMB BAND
- K893392 — CPM-1 SYSTEM OXIMETER/CARDIAC OUTPUT COMPUTER
- K893423 — QBC III CENTRIFUGAL HEMATOLOGY SYSTEM
- K893554 — ARGENCO 60 TYPE IV DENTAL GOLD ALLOY
- K893563 — ARGENCO 42 TYPE IV DENTAL GOLD ALLOY
- K893564 — ARGENCO 30 TYPE IV DENTAL GOLD ALLOY
- K893567 — ARGENCO 52 TYPE IV DENTAL GOLD ALLOY
- K893605 — SRI LUTEINIZING HORMONE IMMUNOENZYMETRIC ASSAY
- K893633 — MODEL 5330 EXTERNAL A-V SEQUENTIAL DEMAND PULSE
- K891374 — PATIENT EXAMINATION GLOVES (LATEX)
- K891644 — SAMBORD LATEX PATIENT EXAMINATION GLOVES
- K891702 — PATIENT EXAMINATION GLOVES (LATEX)
- K891912 — AMRESCO UREA NITROGEN (BUN) REAGENTS, PROD # 7123
- K891958 — THE ROYAL GLOVES (PATIENT EXAM GLOVES)
- K892247 — PATIENT EXAMIAINATION GLOVES (LATEX)
- K892414 — QUALITEX LATEX EXAMINATION GLOVES
- K892471 — PATIENT EXAMINATION GLOVES (LATEX)
- K892654 — BIOSTIX (TM)HCG--SIMPLE PREGNANCY TEST
- K892905 — DIRECT BILIRUBIN FOR MANUAL OR AUTOMATED APPLI.
- K892975 — LOW POWDER SINGLE USE LATEX EXAM GLOVES
- K893015 — LATEX EXAMINATION GLOVES
- K893107 — CHAMP-PAQ LATEX PATIENT EXAMINATION GLOVES
- K893179 — WARDEN LATEX EXAMINATION GLOVES
- K893211 — REP SPE-8 KIT, CAT.# 3172/REP SPE-16 KIT CAT.#3171
- K893268 — LATEX EXAMINATION GLOVES
- K893479 — CHOLESTEROL REAGENT SET
- K881196 — AM 706 ELECTROMYOGRAPH, STIM., NEURO., EXTERNAL
- K884884 — OSSICULAR PROSTHESIS: 8 PARTIAL, 3 TOTAL
- K890271 — ALPHA MODEL I ITE HEARING AID
- K890323 — MAX-1 (EXERCISE ELECTROCARDIOGRAPH)
- K890433 — IMPLANT PARALLELING DEVICE (I.P.D.)
- K890476 — ADEL - MODEL 986 INFANT WARMER
- K890728 — STERILE IRRIGATION TRAYS
- K891095 — VIS-DISK HCG (EIA) LYOPHILIZED JPL-044M
- K891096 — VIS-DISK HCG (EIA) JPL-041M
- K891235 — PRIMUS MODEL CLC 330
- K891270 — MICROTRAK EIA AUTOREADER
- K891604 — THE CEN-SLIDE(TM) CENTRIFUGE TUBE
- K891672 — PUL-TRON 100K PROFESSIONAL SPIROMETER
- K891694 — THE SMILE MACHINE
- K891922 — AMRESCO CHOLESTEROL REAGENTS, PROD. # 7325
- K892001 — DEX-CELL HYSTEROSCOPY FLUID DELIVERY DEVICE
- K892121 — SPIRO-LINK REAL TIME SPIROMETRY SYSTEM
- K892224 — D-CHEM(TM) T-UPTAKE TEST KIT FOR T-UPTAKE DETERMIN
- K892259 — JESBERG ESOPHAGOSCOPE
- K892388 — THE TONGUE CLEANER
- K892419 — NPG 2 BASE METAL ALLOY
- K892452 — PALASEAL(R)
- K892454 — KULZER INLAY SYSTEM
Data sourced from openFDA. This site is unofficial and independent of the FDA.