FDA 510(k) clearances — page 787
clearances on record, most recent first.
Clearances — page 787
78,601–78,700 of 175,825- K012110 — DRI ECSTASY ENZYME IMMUNOASSAY
- K012174 — ERIS LAYERING MATERIALS
- K012203 — CLAY-PARK LABS, INC. - LUBRICATING JELLY
- K012220 — TAO EMBRYO TRANSFER CATHETER SYSTEM
- K012321 — POINT 4 FLOWABLE
- K012430 — MULTI-METER GLUCOSE CALIBRATION VERIFICATION MATERIAL, MODEL RNA GL3
- K012646 — TERUMO 30 GAUGE HYPODERMIC NEEDLE
- K012754 — EZ SET INFUSION SET
- K002339 — AEMS V, EMS-1000, MODEL TS-140500 AND AEMS VI, EMS-1000 PLUS, MODEL TS-140600
- K003924 — MAVIDON MEDICAL ELECTRODE JELLY
- K011025 — FORTAFLEX SURGICAL MESH
- K011072 — GELFLEX TRITON HW SOFT BIFOCAL CONTACT LENS AND THE GELFLEX TRITON SOFT BIFOCAL CONTACT LENS
- K011744 — HP-5, BATTERY OPERATED, REAR WHEEL DRIVE, POWER WHEELCHAIR
- K011746 — MB 11
- K011946 — THE SPIN SNAP-OFF SCREW
- K012096 — DISPOSABLE VITRECTOMY LENS
- K012161 — FLEX-NAILS
- K012196 — ULTRACELL ABSORBENT STICK
- K012252 — QUIK-CHECK OVULATION PREDICTOR
- K012319 — RANDOX HUMAN ASSSAYED DRUG CONTROL
- K012365 — VAXCEL DIALYSIS CATHETER
- K012399 — MODIFICATION TO ELECSYS FSH II CALSET
- K012445 — EMS SWISS LITHOCLAST MASTER (A.K.A. SWISS LITHOCLAST ULTRA)
- K010772 — ISI-2500 CCD C-ARM, ISI-2500 PLUS CCD C-ARM
- K010918 — LIFEPAK 12 DEFIBRILLATOR/MONITOR SYSTEM
- K011698 — STRAUMANN GBR SYSTEM
- K011759 — RADIUS NEXT GENERATION GUIDEWIRE
- K011762 — HI-WAVE; POUR-PLUS
- K012231 — AVANTE MICRO CRYSTAL SYSTEM
- K012307 — LUXACORE/LUXACORE DUAL
- K012316 — PERMACEM / PERMACEM DUAL
- K012347 — PROTEGE SELF-EXPANDING NITINOL STENT WITH STARPORT DELIVERY TECHNOLOGY
- K012362 — MODIFICATION TO VASCULAR CLOSURE DEVICE
- K012374 — MODIFICATION TO: LOFRIC PLUS SINGLE USE URINARY CATHETER
- K012538 — TUBING AND CONNECTORS WITH TRILLIUM BIOPASSIVE SURFACE
- K012560 — GE LOGIQ A100 MP, MODEL 2272413
- K012567 — MODIFICATION TO: REAADS ANTI-PHOSPHATIDYLSERINE IGG/IGM SEMI-QUANTITATIVE TEST KIT
- K001853 — SYRINGE MANAGEMENT SYSTEM, MODEL SMS-1
- K010372 — LIGHTLAS 532 PHOTOCOAGULATOR
- K010418 — DRIED GRAM-NEGATIVE AND GRAM-POSITIVE MIC/COMBO PANELS
- K011073 — CRYOPLAN SYSTEM
- K011604 — PROSTATE SPECTROSCOPY AND IMAGING EXAM (PROSE) SOFTWARE OPTION FOR MRI
- K011749 — LATEX POWDERED PATIENT EXAMINATION GLOVE, 200 MICROGRAMS OR LESS
- K011811 — MONARCH INFLATION SYRINGE; UNIVERSAL FLUID DISPENSING SYRINGE
- K011817 — BRIDGE FX
- K011856 — RADIOGRAPHIC MARKERS
- K011941 — EXCILON AMD ANTIMICROBIAL SPONGE MODEL #7088
- K012129 — ORTHO DEVELOPMENT ORION-I EMF SYSTEM
- K012224 — SINGLE ACTION BIOPSY NEEDLE, MODEL RCBS: XX GAUGE, XX LENGTH, XX THROW
- K012303 — JEL-20
- K012305 — MODIFICATION TO: TRINICA ANTERIOR CERVICAL PLATE SYSTEM
- K012310 — MODIFICATION TO:HL168D BLOOD PRESSURE MONITOR
- K012533 — MODIFICATION TO OSI MEDICAL DOLPHIN STAND-ALONE PULSE OXIMETER AND ACCESSORIES
- K012757 — ITI DENTAL IMPLANT SYSTEM
- K010785 — KSEA DION-GRACIA SET
- K011660 — WECK CARDIAC PACING WIRES
- K011991 — MODIFICATION TO MEDRAD SPECTRIS MR INJECTOR
- K012020 — RESPIEVENTS SOFTWARE IS EVENT DATA PROCESSING SOFWARE FOR A PC
- K012038 — JAS URIC ACID LIQUID REAGENT
- K012104 — SNOW LOTUS POWDER-FREE LATEX SURGEON'S GLOVES
- K012422 — K-ASSAY D-DIMER CONTROLS
- K010635 — INTERLOK / HA COPELAND RESURFACING HEADS
- K010755 — BAYER DIAGNOSTICS ADVIA CENTAUR TOXOPLASMA IGM ASSAY
- K011333 — CERCON CERAM
- K011339 — QUEST EXERCISE STRESS SYSTEM, MODEL CONFIGURATION 14
- K012053 — DIAMEDIX IS-ANTI-CARDIOLIPIN SCREEN TEST SYSTEM
- K012058 — STAT PROFILE PHOX PLUS L ANALYZER
- K012117 — VALIDATE CHEM 1 CALIBRATION VERIFICATION TEST SET, MODEL 10001
- K012118 — VALIDATE CHEM 2 CALIBRATION VERIFICATION TEST SET, MODEL 10002
- K012119 — VALIDATE CHEM 3 CALIBRATION VERIFICATION TEST SET, MODEL 10003
- K012120 — VALIDATE CHEM 4 CALIBRATION VERIFICATION TEST SET, MODEL 10004
- K012122 — VALIDATE CHEM 5 CALIBRATION VERIFICATION TEST SET, MODEL 10005
- K012163 — POLYTITER SYSTEM
- K012243 — MCC URICHECK ASSAYED LIQUID URINE MULTICONSTITUENT CONTROL
- K012276 — TEMP 3
- K012291 — HUMAN IGG SUBCLASS LIQUID REAGENT KITS, PRODUCT CODE LK001.TA
- K012295 — HUMAN IGG SUBCLASS LIQUID REAGENT KITS, PRODUCT CODE NK001.T
- K012311 — IMMULITE 2000 GENTAMICIN, MODELS L2KGE2 (200 TESTS), L2KGE6 (600 TESTS)
- K012312 — IMMULITE 2000 TOBRAMYCN, MODELS L2KTC2 (2002 TESTS), L2KTC6 (600 TESTS)
- K012451 — PROPAQ ENCORE MODELS 202, 204, 206; PROPAQ CS MODELS 242, 244, 246
- K012478 — MODIFICATION TO: I-STAT PORTABLE CLINICAL ANALYZER
- K003552 — ITI DENTAL IMPLANT SYSTEM
- K010735 — SPEEDYBELL
- K011575 — 22MM SITESELECT BREAST BIOPSY DEVICE MODEL SSD022
- K012216 — NIROYAL BILIARY PREMOUNTED STENT SYSTEM
- K012280 — TITANIUM COMPRESSION ANCHOR SYSTEM MODEL VERSION 2
- K012455 — WELCH ALLYN DURASHOCK BLOOD PRESSURE SYSTEM
- K012461 — SIEMENS INFINITY MIB II DUO PROTOCOL CONVERTER
- K012553 — GSIBP BLOOD PRESSURE CUFF
- K010547 — VERTEX SEALAND L/C ORTHODONTIC SEALANT
- K010796 — AIA-PACK BRCA, ST AIA PACK BRCA
- K011069 — AQUASENS FLUID MONITORING SYSTEM
- K011491 — HELIOSEAL CLEAR CHROMA
- K011565 — INFANT OXYGEN TREATMENT HOOD
- K011667 — HORIZONS INTERNATIONAL POLYPECTOMY SNARES
- K011765 — SUNMAX BLUE NITRILE POWDER-FREE EXAMINATION GLOVE
- K011784 — MODIFICATION TO ENVOY PATIENT MONITOR
- K011801 — FUTURA TOPCAP NON GAMMA-2
- K012048 — POWDER FREE NEOPRENE EXAMINATION GLOVES, NON STERILE
- K012156 — IMAGINE H.E.
Data sourced from openFDA. This site is unofficial and independent of the FDA.