FDA 510(k) clearances — page 1120
clearances on record, most recent first.
Clearances — page 1120
111,901–112,000 of 175,890- K925321 — A-DEC 2146 DUO UNIT
- K925322 — A-DEC 2147 DOCTOR'S UNIT
- K925323 — A-DEC 2183 DUO UNIT, CUSP
- K925324 — A-DEC 2184 DUO UNIT
- K925325 — A-DEC 2185 DOCTOR'S UNIT
- K931965 — MEDIX PHOTOTHERAPY LAMP
- K932321 — LAPAROSCOPY OPTICS
- K932418 — SUNBRONZE TANNING LAMPS
- K932623 — QUANTIMETRIX BLOOD GLUCOSE CONTROLS
- K932846 — TENCEL X-RAY DETECTABLE SPONGES/LAP PADS
- K933692 — SIGMA CO2 ACID REAGENT
- K933896 — PHX TECHNOLOGIES CORP., MONOPOLAR ELECTROCAUTERY PROBE TIP CLEANER
- K933897 — PHX TECHNOLOGIES CORP., 5MM DISPOSABLE SUCTION-IRRIGATION CANNULA CLEANER
- K934191 — NEW BLUE MAX BALLOON DILATATION CATHETER
- K934339 — LOC GUIDE WIRE EXTENSION
- K934433 — VANTAGE DIALTAION CATHETER
- K934641 — I-STAT CONTROL LEVELS 1,2,3
- K934961 — SPINPRO HDL PRECIPITATING REAGENT
- K935182 — EMDS ALKANINE PHOSPHATASE (ALP) TEST
- K935183 — EMDS MAGNESIUM (MG) TEST
- K925539 — SUNGLASSES
- K930331 — SPECTACLE FRAME
- K930893 — MITEK SUPER QUICKANCHOR, MODIFICATION
- K932172 — MEDTRONIC MODELS 4057M,4058M,4557M, PACING LEADS
- K932537 — SCIMED MAVERICK PTA CATHETER
- K932757 — SECURODRIP (TM) I.V. ARMBOARD
- K933392 — ELIAS CARDIOLIPIN IGM ANTIBODIES
- K933393 — ELIAS CARDIOLIPIN IGG ANTIBODIES
- K933814 — PHOTOSTRESS RECOVERY TESTER
- K933943 — FEP RINGED GORE-TEX STRETCH VASCUALR GRAFT WITH REMOVABLE RINGS
- K934248 — ALPHA-DENT TISSUE CONDITIONER AND TEMPORARY RELINER
- K934301 — SPECTACLE FRAMES
- K934374 — SUNGLASSES (NON-PRESCRIPTION)
- K934403 — SUNGLASSES
- K934463 — SPECTACLE FRAME
- K934726 — FEP RINGED GORE-TEX VASCULAR GRAFT
- K934797 — FINE OPTICS
- K934837 — SUNGLASSES
- K934852 — COOL KIDS HIP SHADES
- K934858 — FRAME SPECTACLE
- K923729 — URETERAL CATHETER
- K931196 — APEC GLUCOSE ANALYZER
- K932068 — PERITEMP PF 4005 HEATER
- K932304 — MICRO EIA FOR AMPHETAMINE METABOLITES
- K933328 — DAMOR CREME
- K933929 — LAB-SITE(R) SAFETY CANNULA
- K933977 — AIRCAST EDEMAFLOW SYSTEM
- K934267 — DAMOR CREAM SATURATED DRESSING
- K934376 — STC DIAGNOSTICS AUTO-LYTE BARBITURATES EIA
- K934534 — TROCAR W/CANNULA, O RING, ADAPTER, AND ADAPTER SLEEVE MODIFICATION
- K934801 — SPINPRO HDL PRECIPITATING REAGENT
- K934898 — GLUCOMETER QA BLOOD GLUCOSE METER MODIFICATION
- K934900 — GLUCOMETER ENCORE QA BLOOD GLUCOSE METER MODIFICATION
- K923788 — SPACE LABS MODEL 90560
- K924016 — SYMBIOSIS REUSABLE ARTHROSCOPIC SURGICAL INST.
- K925643 — RX FIT MEDICAL STOCKINGS
- K925921 — MODIFIED SITE DISPOSABLE DIAPHRAGM CASSETTE
- K926381 — OCUSYSTEM IIE
- K926549 — ENDOCATH ELECTROPHYSIOLOGY CATHETER
- K931556 — ARGENCO M
- K931629 — CARAPACE ANGIOGRAPHY TRAYS
- K931824 — CARAPACE INSTRUMLENT AND INSTRUMENT SETS
- K933831 — PERMASOFT SOFT RELINE MATERIAL BY NU-DENT, INC.
- K934064 — REFLOTRON HEMOGLOBIN TEST TABS
- K934351 — APTT-ES REAGENT
- K934497 — CBC-STK(TM) HEMATOLOGY CONTROL/MULTIPLE
- K934584 — SPECTROLYSE FACTOR VII:C
- K920703 — GASTROINTESTINAL FEEDING TUBE
- K922998 — ENFUSE ENTERAL FEEDING TUBE
- K924626 — NOVAMETRIX MODEL 510
- K925588 — NORTEC STER SALINE-O.9% SODIUM CHLOR FOR DEV IRRI
- K925593 — NORTEC STERILE WATER FOR DEVICE IRRIGATION
- K925735 — EEG ANALYZER
- K925755 — DE LUXE
- K930776 — COBAS CORE TSH EIA
- K932109 — PROFILOMAT
- K932206 — SYNELISA ANA PROFILE
- K932389 — 8100 ANESTHETIC AGENT MONITOR
- K932438 — MODEL IPM-1 IMPEDANCE PULSE MONITOR
- K932608 — COBAS(R) CORE T3 EIA
- K932715 — CIBA CORNING ACS ESTRADIOL IMMUNOASSAY
- K932747 — CIBA CORNING ACS FREE T3 IMMUNOASSAY
- K934355 — ELECTROMEDICS BLOOD HEAT EXCHANGER
- K934473 — LACTOFERRIN MICROASSAY SYSTEM
- K934660 — R AND D BATTERIES, INC. PART NUMBERS 5310, 5063 & 5211
- K934747 — R & D BATTERIES, INC. PART NUMBERS 5296, 5479, 5351, & 5470
- K935016 — COCAINE METABOLITE EIA ASSAY MODIFICATION
- K915620 — ENDOWASH
- K921134 — FRESENIUS POLYSULFONE DIALYZERS
- K924461 — STREP A NEGATIVE CONTROL
- K925858 — OE 1.5 SI
- K931626 — CARAPACE STERILE COTTON BALLS
- K931849 — PARAPREP
- K932176 — BIOSIL MEDICAL GRADE SILICONE SHEETING
- K932406 — NUCLITRYP(TM)(I125)-HUMAN PANCREA CATH TRY RAD KIT
- K932479 — B-HCG HUMAN SERUM CONTROLS
- K932719 — RITTER MODEL 158 AND 159 EXAM LIGHTS
- K933048 — LAERDAL(TM) POCKET MASK, MODIFICATION
- K934441 — KING SYSTEMS HME
- K934623 — ENDOSCOPIC VIDEO SYSTEM AND ENDOSCOPIC VIDEO CAMERA
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