FDA 510(k) clearances — page 1312
clearances on record, most recent first.
Clearances — page 1312
131,101–131,200 of 175,890- 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
- K892838 — IRON SYSTEM PACK REAGENTS
- K893117 — GLUCOMETER QA BLOOD GLUCOSE MTR/GLUCOFILM TEST ST
- K893125 — BECKMAN EPSILON(TM) IGE REAGENT KIT
- K893199 — PHACO-INJECTOR(TM) INTRAOCULAR LENS IMPLANT INSTR
- K893737 — DIRECTIGEN 1-2-3 INFECTIOUS MONONUCLEOSIS TEST
- K884759 — SHOWER STRETCHER W/WHEELS
- K890171 — INLINE AUTOTRANSFUSION SYSTEM
- K890351 — ORTHORALIX SD/ORTHORALIX SD CEPH
- K890443 — CASPAR SCALP CLIP, APPLIER
- K890499 — BIVONA VENTILATOR ISOLATOR SYSTEM
- K890845 — PREMISE SERIES BED
- K890874 — BIOCHEM 520 BREATH INDICATOR
- K891180 — TRANSESOPHAGEAL ULTRASOUND ACCESSORIES KIT
- K891282 — MIC-100 WITH CRYOPROBES
- K891690 — KODAK EKTASCAN IMAGE MANAGER
- K891769 — MAGNISCAN 5000 MR SYSTEM
- K891990 — RUBEOLA IGG CLIN-ELISA TEST SYSTEM, CAT. #4600
- K892052 — SARNS MEDICAL CART
- K892058 — ISL QC 2000
- K892516 — CANDELA PLDL-1 PULSED DYE LASER
- K892808 — KINETIC MODEL 700
- K892857 — HARVESTING TUBE
- K892866 — AUTOMATIC CRANIAL DRILL (PERFORATOR)
- K892877 — CRADLE, HOSPITAL BED CLOTHING
- K893707 — AUTO SUTURE SURGIPORT DEPTH GUIDE AND SKIRT
- K893709 — COHERENT MARIE ARGON PHOTOCOAGULATOR
- K890424 — ENTERAL FEEDING CONTAINER
- K891600 — ARGEDENT 88, DENTAL ALLOY FOR PORCELAIN)
- K892220 — LAMINARIA TENT
- K892264 — ORALCHEK SUPER-SOFT BRUSH
- K892456 — KULZER TRANSLUX EC
- K892624 — PATIENT EXAMINATION GLOVES (LATEX)
- K892625 — PATIENT EXAMINATION GLOVES (LATEX)
- K892768 — PATIENT EXAMINATION GLOVES (POLY)
- K892910 — ARGELITE 76SF+ DENTAL ALLOY
- K892923 — LATEX PATIENT EXAMINATION GLOVES
- K892945 — PATIENT EXAMINATION GLOVES
- K892961 — PATIENT EXAMINATION GLOVES
- K892965 — LATEX EXAM GLOVES (MFG. BROADLAND RUBBER INDUST.)
- K893047 — JASONTEX LATEX EXAMINATION GLOVES
- K893098 — VINYL EXAM GLOVES (MFG. TOPLAS INDUSTRIAL CO.)
- K893166 — LATEX EXAMINATION GLOVES
- K893266 — LATEX EXAMINATION GLOVES
- K893345 — ARGELITE 50 (DENTAL ALLOY FOR PORCELAIN APPLI.)
- K893381 — ARGENCO 71 TYPE II DENTAL GOLD ALLOY
- K893382 — ARGENCO 63 TYPE III DENTAL GOLD ALLOY
- K893383 — ARGENCO 75 TYPE III DENTAL GOLD ALLOY
Data sourced from openFDA. This site is unofficial and independent of the FDA.