FDA 510(k) clearances — page 878
clearances on record, most recent first.
Clearances — page 878
87,701–87,800 of 175,890- K984107 — RDI DIRECT LDL CHOLESTEROL TEST
- K984113 — MS400
- K984132 — IMMULITE C-REACTIVE PROTEIN, MODELS LKC1, LKC5
- K984137 — QUANTA LITE CELIAC SCREEN (TISSUE TRANSGLUTAMINASE/GLIADIN) ELISA
- K984158 — P.F.C. MODULAR PLUS OFFSET TIBIAL TRAY
- K984303 — VITROS CHEMISTRY PRODUCTS MAGNETIC HDL-CHOLESTEROL REAGENT
- K984320 — BIOABSORBABLE INTERFERENCE SCREWS
- K984354 — MECHANICAL WHEELCHAIR
- K984367 — ACTIVX
- K984448 — BIRCOLL BALLOON DISSECTOR
- K984459 — DEPUY PROFILE FEMORAL HIP WITH POROCOAT
- K984529 — HEMOCHEK SAMPLE COLLECTION KIT
- K990059 — OSTEONICS SPINAL SYSTEM-EXPANDED INDICATIONS
- K990161 — ABBOTT LIQUID CSF CONTROL, MODEL #'S 1E98-01, 1E99-01
- K990162 — ABBOTT LIQUID AMMONIA CONTROL, MODEL #'S 1E93-01,1E94-01,1E95-01
- K972065 — AURORA
- K972616 — ONCOLOGY PLUS POWDER FREE LATEX EXAMINATION GLOVES (PROTEIN CONTENT LABELING)
- K981359 — GT LEGGIERO
- K982095 — LACTOSORB MENISCAL REPAIR DEVICE
- K982242 — INVACARE CPAP
- K982384 — MERCATOR
- K982500 — CHAIT CECOSTOMY CATHETER
- K982506 — VERRUCA-FREEZE CRYOSURGERY DELIVERY SYSTEM
- K982540 — MERCATOR ATRIAL HIGH DENSITY ARRAY CATHETER MODELS, 7005, 7006, 7007, MERCATOR ATRIAL HIGH DENSITY ARRAY DEPLOYMENT KIT,
- K982819 — ENDIUS SPINE ENDOSCOPE
- K983100 — KAVO KEY LASER 1242
- K983988 — SYNTEC-TAICHUNG NON-STERILE TITANIUM ALLOY MINI-PLATE
- K972615 — CHEMO PLUS POWDER FREE BLUE LATEX EXAMINATION GLOVES (PROTEIN CONTENT LABELING)
- K982090 — PACEART HOME TRAK PLUS EASI EVENT RECORDER SYSTEM
- K982178 — VAGABOND SOFT RESTRAINT SYSTEM
- K982488 — BICON BONE SCREW SYSTEM
- K983145 — TEXTURED POWDER-FREE LATEX EXAM GLOVES WITH ALOE VERA AND PROTEIN CONTENT LABELING CLAIM (50 MICROGRAMS OR LESS)
- K983281 — APOB
- K983799 — MEDTRONIC PS MEDICAL NIVEAU DRAINAGE SYSTEM, MEDTRONIC PS MEDICAL NIVEAU DRAINAGE SYSTEM POLE CLAMP, MEDTRONIC PS MEDICL
- K983809 — KLS MARTIN INTRAORAL ZURICH RAMUS DISTRACTOR
- K983912 — VISTAKON (LENEFILCON A)CONTACT LENS CLEAR AND VISIBILITY TINT WITH UV BLOCKER
- K983992 — NICHOLS ADVANTAGE THYROGLOBULIN AUTOANTIBODIES (TGAB) ASSAY
- K984013 — PLANMECA INTRACAM STATION
- K984260 — PINNACLE R/O OR REDIFOCUS INTRODUCER R/O (COMPRISED OF A SHEATH & DILATOR)
- K984288 — VITROS CHEMISTRY PRODUCTS PHBR SLIDES
- K990149 — ABBOTT LIQUID PEDIATRIC CHEMISTRY CONTROL, MODEL # 4E37-01, 4E38-01
- K990150 — ABBOTT LIQUID LIPIDS CHEMISTRY, MODEL #'S 3E18-01, 3E19-01
- K981954 — VARIOUS DENTAL IMPLANTS WITH VARIOUS ABUTMENTS
- K982264 — FIRSTSAVE BIPHASIC MODELS 9200 AND 9210
- K982432 — PILLOW MASKER, C2007M, C2008M,CE2000, WONDER EAR, MINI WONDER EAR, PT-2SM, PT-3SM, PT-3LFM, PT-3HFM, PT3CM, PT5-SM, PT5-
- K982568 — BLADDERMANAGER PCI 5000 MODEL 1002
- K983782 — ELECTROSURGICAL DISPERSIVE ELECTRODE
- K983832 — INTERACOUSTICS MODEL MT 10, HANDHELD IMPEDANCE AUDIOMETER
- K983905 — KODAK DIGITAL SCIENCE 3600 DISTRIBUTED MEDICAL IMAGER, KODAK DIGITAL SCIENCE 1200 DISTRIBUTED MEDICAL IMAGER, MODEL 3600
- K984045 — RF CONTROL FOR IMMUNOTURBIDIMETRIC ASSAYS
- K984069 — ENTAXIS NASAL PACKING
- K984127 — POWDER FREE LATEX EXAMINATION GLOVES, NON-STERILE
- K984252 — IMATION TRIMATIC DIGITAL SYSTEM
- K984257 — MEDRAD PHASED ARRAY NEUROVASCULAR COIL
- K984273 — FOCUS DAILIES VISITINT (NELFILCON A) ONE-DAY CONTACT LENS
- K984274 — MAGNETIC RESONANCE DIAGNOSTIC DEVICE, VERSION 5.0 OPERATING SYSTEM SOFTWARE
- K984605 — POWDER-FREE NITRILE PATIENT EXAMINATION GLOVE, WHITE (NON COLORED)
- K990017 — ABBOTT IMMUNOASSAY-MCC (LIQUID) CONTROL, MODEL NUMBER 6E20-10
- K990061 — VITROS IMMUNODIAGNOSTIC PRODUCTS AFP RANGE VERIFIERS
- K983796 — 6004 NIBP MONITOR WITH TEMPERATURE
- K983920 — EMS PEEP VALVES- ADJUSTABLE
- K984181 — THE APTUS (AUTOMATED) APPLICATION OF THE VZV IGG ELISA TEST SYSTEM
- K984232 — MODIFICATION OF EMIT D.A.U. OPIATES ASSAY
- K984317 — THE APTUS (AUTOMATED) APPLICATION OF THE TOXOPLASMA IGG ELISA TEST SYSTEM. AN ENZYME LINKED IMMUNOSORBENT ASSAY (ELISA)F
- K984321 — VITROS IMMUNODIAGNOSTIC PRODUCTS VITAMIN B12, REAGENT PACK 1/2, FOLATE REAGENT PACK 3, ANF CALIBRATORS
- K984577 — DRAGER OXYLOG 2000
- K982114 — LOPRO SILICONISED LOW PROTEIN POWDERFREE LATEX EXAMINATION GLOVES
- K982652 — ALLEGIANCE PORTA-WARM MATTRESS
- K982771 — GYRUS HYSTEROSCOPIC RESECTOSCOPE
- K983593 — OVUM PICK-UP ASPIRATION NEEDLES
- K983743 — BISURE LAPAROSCOPIC BIPOLAR FORCEPS
- K983744 — MCAS (MODULAR CLIP APPLIER SYSTEM)
- K983787 — SYNTHES PROXIMAL TIBIA PLATING SYSTEM
- K983828 — NITRIKLEEN- NITRILE EXAMINATION GLOVE POWDER FREE
- K983998 — POWDER FREE LATEX EXAMINATION GLOVES
- K984046 — BIOMEDICS 55 (OCUFILCON D) UV BLOCKING SOFT (HYDROPHILIC) CONTAC LENS
- K984200 — STABILIZER SOFT TISSUE ANCHOR, 5 AND 8MM; ANCHOR INSERTER, 5 AND 8MM; STABILIZER DRILL, 5 AND 8MM, NONSTERILE; STABILIZE
- K984243 — TELEX TINNITUS-COMPANION
- K984259 — PROSTHETIC (POLYMACON) HYDROPHILIC CONTACT LENS FOR DAILY WEAR (CLEAR AND TINTED)
- K984362 — ENLIGHT LV
- K984377 — SYNTHES SPINE CERVIFIX SYSTEM
- K990132 — DATEX-OHMEDA ANESTHESIA VAPORIZER, MODEL D-TEC
- K982006 — MICOMED - HALM ZIELKE INSTRUMENTATION
- K982332 — STERIS TEN SIXTEEN STEAM STERILIZER
- K982532 — PARIETEX
- K982997 — FREQUENCY 55 UV (METHAFILCON A) HYDROPHILIC CONTACT LENS FOR DAILY WEAR (CLEAR AND TINTED WITH UV BLOCKER)
- K983217 — ROWE DUAL-CHECK VALVE
- K983647 — ECHO-COAT ULTRASOUND NEEDLES
- K983727 — BIOSONIC ULTRASONIC SCALER SYSTEM
- K983926 — MPS GRAVITY FLOW CONTROL SET
- K984122 — WAKO L-TYPE UIBC, WAKO UIBC CALIBRATOR
- K984147 — LOVYTEX SND BHD POWDER-FREE POLYMER COATED LATEX EXAMINATION GLOVES
- K984217 — ENLIGHT-2
- K984331 — ODI ULTIMATE COMPRESSION HIP SCREW
- K984348 — TIMX LOW BACK SYSTEM
- K984350 — VSP SYSTEM
- K984425 — MODIFICATION OF PRECISET SERUM PROTEINS CALIBRATOR
- K984484 — LC MICROHYBRID
- K984517 — CYNOSURE ERASURE LASER
- K982515 — POWER-DRIVE, WISAP MODEL #7688PD/7688PD1
Data sourced from openFDA. This site is unofficial and independent of the FDA.