FDA 510(k) clearances — page 1059
clearances on record, most recent first.
Clearances — page 1059
105,801–105,900 of 176,637- K944969 — STERI-LUB LUBRICATION GEL
- K945221 — SUTTER MODEL 6000 HAND CPM DEVICE
- K945406 — SSV PHONATE(TM) SHILEY SPEAKING VALVE
- K945407 — SSVO PHONATE(TM) SHILEY SPEAKING VALVE WITH OXYGEN PORT
- K945449 — UNICATH LLU ANGIOGRAPHIC SYSTEM
- K945451 — HI DENSE, GLASS IONOMER SILVER REINFORCED RESTORATIVE
- K945729 — DYNAMICAIRE(TM) SLEEP SURFACE, ZONEAIR(TM) SLEEP SURFACE
- K945802 — DERMAGRAN WOUND CLEANSER WITH ZINC
- K945869 — R&D PART NOS. 5443, 5322, 5448, 5492
- K945871 — R&D PART NOS. 5339, 5510, 5514
- K946015 — IVALON EXTERNAL SPONGE
- K946030 — DERMASSIST(TM) HYDROGEL SATURATED GAUZE DRESSING
- K946031 — DERMASSIST(TM) HYDROGEL SATURATEED NON WOVEN DRESSING
- K946194 — WEE BAG O'MERCURY
- K946203 — JAI POWDERFREE LATEX EXAMINATION GLOVES
- K950092 — CYPRESS MEDICAL PRODUCTS CATHETER (INSERTION) TRAY
- K950109 — CYPRESS MEDICAL PRODUCTS CATHETER (INSERTION) TRAY/WITH OUT CATHETER
- K950241 — OPHTHALMIC SPONGES
- K950252 — CHAMPRO/UNITED ATHLETIC
- K950334 — KARL STORZ TELE-SCRUB
- K950374 — FOSSIL PARTNERS, L.P. (FOSSIL)
- K950381 — OTICON/LOGIC
- K950603 — KARL STORZ VISCOUS FLUID INJECTION SET
- K950636 — OLYMPUS DISPOSABLE BIOPSY FORCEPS
- K921597 — CAVH/CVVH/CAVHD SET MODEL #HT-HF/505
- K932903 — EKG VEST
- K934787 — SILICORE SEMI-FLOATER
- K936295 — COMFIT BLUE POWERED EXAMINATION GLOVES (HYPOALLERGENIC)
- K940037 — I.D. AND SEAKEM GTG AGAROSES
- K940050 — FOCUS EMG
- K940240 — IKAROS
- K941917 — FLUOROPLUA CARDIAC AND/OR INSTAVIEW
- K942020 — SUNGLASSES
- K942208 — 4003 AEROLITE
- K942454 — DATASCOPE 95 AND 97 IAB PUMP CONSOLE
- K942658 — NEOSCREEN ELISA TSH
- K943451 — ULTIMAX POWDER FREE EXAMINATION GLOVES
- K943715 — VISION SYSTEM UPPER G.I. EXDOSCOPE
- K944322 — AT&T IMAGE SOLUTIONS PICASSO STILL-IMAGE PHONE SYSTEM
- K944522 — MORGANSTERN PROSTATE STABILIZATION AND SEEDING KIT
- K944753 — SENSITITRE SUSCEPTIBILITY ENTEROCOCCAL VANCO AMP
- K944896 — MATRICS IMPRESSION MATERIAL , SYSTEM
- K945012 — CATCO NUTRITIONAL CATHETER
- K945178 — TOUCH FOCUS 200MM DEFOCUSING HANDPIECE
- K945648 — ACCU-BEAM C02 LASER HANDPIECE
- K945822 — CAPNO-FLO(TM) REGULATOR
- K945943 — CVD PERIFLOW(TM) BALLOON DILATATION CATHETER
- K946029 — ACS GUIDE WIRES WITH MODIFIED PACKAGE INSERT
- K950193 — PHILIPPE CHARRIOL
- K950248 — LASERSPRAY(TM)
- K950338 — KARL STORZ RHINO-PHARYNGO-LARYNGO-FIBERSCOPE, BIOPSY, GRASPING FORCEPS
- K950503 — MANUAL SURGICAL INSTRUMENT FOR GENERAL USE
- K950505 — 50MM HANDPIECE
- K950574 — NEEDLE/CANNULA
- K921695 — ULTRA COVER ULTRASOUND TRANSDUCER PROBE COVERS
- K940264 — VASOGENICS EECP-MC2
- K941487 — INSTENT ESOPHACOIL ESOPHAGEAL PROSTHESIS
- K942828 — MAKAR FULL AND HALF FACE SHIELD
- K943193 — COAT-A-COUNT(R) ESTRADIOL-6
- K943194 — IMMULITE(R) ALLERGY FOOD PANEL FP5E
- K943546 — FUKUDA SANGYO MODEL SPIROANALYZER ST-180
- K944062 — LAPRASCOPIC GRASPER
- K945114 — VISITEC SCLERAL PLUG
- K945266 — OPTUS LAPAROSCOPES AND OPERATING LAPAROSCOPES
- K945862 — ENDCUP
- K946022 — HICHEM LDH/L REAGENT KIT
- K950347 — LEVEEN NEEDLE ELECTRODE(TM)
- K950500 — BASIC REUSABLE TROCAR SYSTEM
- K935116 — EMIT IIC BARBITURATE ASSAY
- K935191 — EMIT IIC PHENCYCLIDINE ASSAY
- K935323 — EMIT IIC COCAINE METABOLITE ASSAY
- K935352 — EMIT(R) IIC AMPHETAMINE ASSAY
- K940158 — EMIT IIC CANNABINOID ASSAY
- K940548 — MIC PERCUTANEOUS ENDOSCOPIC JEJUNAL FEEDING TUBE
- K941762 — INTERGRATED MONITORING ARCHIVING AND COMMUNICATIONS SYSTEMS (IMACS)
- K942145 — NON-UNIFORM ATTENUATION CORRECTION SYSTEM
- K943439 — ABUSIGN DOA4
- K943736 — CVPRO CARDIOVASCULAR PATCH
- K944325 — LIFESIGN, CARE POINT, VITALSIGN, ACCUSIGN
- K944541 — HANDYPACK 911SC
- K944697 — AURA FLEX FT4 200 TEST PACK, FT4 CALIBRATOR PACK
- K944851 — MICRO MINI PRIMO AGC, MICRO-MINI PRIMO S-AGC
- K945408 — 340-CHLORIDE FOR DISCRETE RANDOM ACCESS ANALYZER
- K945550 — ABUSIGN(TM) THC, DOA-THC, ACCUSIGN(TM) THC, DOA-THC, DIOSIGN(TM) THC, DOA-THC
- K945609 — ABUSIGN(TM) COC, DOA-COC, ACCUSIGN(TM) COC, DOA-COC, DIOSIGN(TM) COC, DOA-COC
- K945993 — VAPOFIL
- K946063 — TOTAL CHOLESTEROL AND HDL CHOLESTEROL PANEL
- K946064 — TOTAL CHOLESTEROL CASSETTE
- K946065 — TOTAL CHOLESTEROLM HDL CHOLESTEROL AND TRIGLYCERIDES PANEL
- K946066 — TOTAL CHOLESTEROL, HDL CHOLESTEROL AND GLUCOSE PANEL
- K946067 — TOTAL CHOLESTEROL, HDL CHOLESTEROL, TRIGLYCERIDES AND GLUCOSE PANEL
- K946120 — HEMAGEN ENA SS-B KIT (EIA METHOD)
- K946121 — HEMAGEN ENA SS-A KIT (EIA METHOD)
- K946122 — HEMAGEN ENA SCL-70 KIT (EIA METHOD)
- K946123 — HEMAGEN ENA SM KIT (EIA METHOD)
- K946124 — HEMAGEN ENA JO-1 KIT (EIA METHOD)
- K946153 — DIGOXIN FLEX(TM) REAGENT CARTRIDGE
- K946163 — RADIAS TOTAL T4 ENZYME IMMUNOASSAY
- K946183 — CLINITEK ATLAS AUTOMATED URINE CHEMISTRY ANALYZER
- K946381 — SUNGLASSES
Data sourced from openFDA. This site is unofficial and independent of the FDA.