FDA 510(k) clearances — page 855
clearances on record, most recent first.
Clearances — page 855
85,401–85,500 of 175,890- K992528 — BIOCHECK IGE ELISA, MODEL BC-1035
- K992763 — SYSMEX AUTOMATED COAGULATION ANALYZER, MODEL CA-500
- K992928 — CD HORIZON SPINAL SYSTEM
- K992947 — CANNULATED SMARTSCREW MODELS 224540C, 224570C
- K992963 — I3RAD 125 I BRACHYTHERAPY SEED, MODEL I125-0401
- K990378 — STATVIEW SYSTEM
- K992124 — AVANTI POLAR LIPIDS VDRL ANTIGEN SLIDE TEST KIT WITH 10 X 0.5 ML AMPULES, AVANTI POLAR LIPIDS BULK BDRL ANTIGEN, AVANTI
- K992370 — AMPLAID A724 AND A728
- K992559 — HOLLOW FIBER MEMBRANE OYGENATOR QUADROX HMO 1010
- K992990 — QUICKPAC II ONE STEP COCAINE TEST
- K983097 — TENS/FES/NMES ELECTRODES
- K983410 — @ TARGET
- K984358 — OLYMPUS DISTAL ATTACHMENT, MODELS MH-462,-463,-464,-465,-466,-483,-587,-588,-589,-590,-591,-592,-593,-594,-595,-596,-597
- K990194 — BIOBUTTON
- K990362 — INSTRUMENT, ULTRASONIC, SCALPEL
- K990641 — CALTAG FETAL HEMOGLOBIN TEST
- K990810 — ARGLAES-AB ANTIMICROBIAL BARRIER FILM DRESSING & ISLAND DRESSING
- K991480 — EXCEL GE BLOOD GLUCOSE TEST STRIPS & CODE STRIP
- K991532 — DRX QT. HCG
- K991927 — MEDI-TEST COMBI 11
- K991974 — FUTURA GLASS IONOMER SILVER REINFORCED
- K991998 — GAMMA-B 25-HYDROXY VITAMIN D RIA
- K992094 — GILTECH PLUS HYDROGEL SKIN DRESSING
- K992106 — MODUS SYSTEM SELF-DRILLING SCREWS
- K992129 — PHAZX VLD-100
- K992321 — SYSMEX AUTOMATED COAGULATION ANALYZER, MODEL CA-6000
- K992381 — CO2 GAS WARMER II, MODEL 6-800-00
- K992488 — TOTAL HAEMOLYTIC COMPLEMENT RID KIT
- K992670 — OXYGEN ENRICHMENT KIT, MODELS SG 066, SG 067
- K992772 — CARDIOPHONICS 1000 MEMORY MONITOR
- K992873 — LORENZ EXTERNAL MANDIBULAR DISTRACTOR
- K992903 — COLOR BUFFED CEMENTED FEMORAL
- K981047 — FRESH AIR
- K983717 — BP-TEL TRANS-TELEPHONIC BLOOD PRESSURE MEASUREMENT SYSTEM
- K984573 — OPTI-FREE EXPRESS MULTI-ACTION CLEANING AND REWETTING DROP
- K990642 — ECHOFLOW DOPPLER BLOOD VELOCITY METER
- K992143 — MODIFICATION TO PASCO MIC AND MIC/ID PANELS (CLINDAMYCIN)
- K992788 — BEAR CUB 750 PSV
- K992839 — SOCKET STAPES PISTON W/O LOOP, SCHOBEL, SCHOBEL-CAUSSE
- K992892 — STEPPING KINEMATIC IMAGING PLATFORM (SKIP)
- K983196 — PADTAK PACE/DEFIB/CARDIOVERT MONITORING ELECTRODE(S)
- K983232 — PADTAK PEDIATRIC DEFIB/CARDIOVERT/PACE/MONITOR-RADIOTRANSPARENT (2X2.25),MODEL 2602, PADTAK PEDIATRIC DEFIB/CARDIOVERT
- K983762 — NUCLISENS CMV PP67
- K991883 — REDI-TEST OPIATES
- K992072 — BOLUS ACCESSORY SET
- K992268 — NAC PRN NEEDLELESS ACCESS CONNECTOR
- K992399 — ADDITIONAL IMS ASSAYS FOR THE BAYER ADVIA IMS SYSTEM
- K992475 — CARESIDE CO2, TOTAL
- K992755 — CORDIS PALMAZ CORINTHIAN TRANSHEPATIC BILIARY STENT AND DELIVERY SYSTEM, CORDIS CRIMPING TOOLS, CORDIS INTRODUCER TUBE
- K992814 — CYNOSURE ACCOLADE LASER
- K992825 — CORDIS EXTREME PTA BALLOON CATHETER
- K992910 — AFFINITY NT HOLLOW FIBER OXYGENATOR WITH PLASMA RESISTANT FIBER WITH BALANCE BIOCOMPATIBLE SURFACE (MODEL 511B)
- K972267 — HELICA TC
- K982910 — HAMILTON MEDICAL GALILEOVENTILATOR
- K983276 — HYDROFERA BACTERISTATIC NASAL DRESSING
- K990212 — LOCKJAW 15 MINUTE INTERMAXILLARY FIXATION SYSTEM,MODEL LJ100-00
- K991036 — DANEK PLATE AND SCREW SYSTEM
- K991066 — MADTRONIC DLP ARTERIAL CANNULAE
- K991125 — SAUFLON AEROTAB DISINFECTING SYSTEM FOR THE DISINFECTION OF SOFT (HYDROPHILIC) CONTACT LENSES
- K991419 — MODIFIED HAM'S F-10 BASAL MEDIUM, MODIFIED HAMS'S F-10 BASAL MEDIUM HEPES, MODIFIED HAM'S F-10 SUPPLEMENT (50X) IYOPHILI
- K991529 — CSM STRETTA CONTROL MODULE ELECTROSURGICAL GENERATOR, MODEL S400
- K992050 — LUMENON XENON LIGHT SOURCE
- K992110 — PREMIER ANTERIOR CERVICAL PLATE SYSTEM
- K992128 — DASH SILICONIZED POLYMER COATED POWDER FREE LATEX EXAMINATION GLOVES WITH PROTEIN CONTENT LABELING CLAIM (50 MICROGRAMS
- K992171 — COATED STERILE LATEX POWDER-FREE SURGICAL GLOVES WITH PROTEIN CONTENT LABELING CLAIM (50 MICROGRAMS OR LESS)
- K992302 — DERMAPHYLYX SKIN PROTECTORS, PROTECT IT SKIN PROTECTORS
- K992437 — SCHOELLY RIGID ENDOSCOPES
- K992464 — SYNTHETIC POWDERED VINYL PATIENT EXAMINATION GLOVES
- K992540 — XENON LIGHT SOURCE PES 1
- K992557 — QUALATEX POWDERED LATEX EXAMINATION GLOVES
- K992661 — CONTROL III ELITE
- K992730 — HWA (AND) SILKTEX PRE-POWDERED LATEX EXAMINATION GLOVE
- K992807 — BIO-LOGIC EVOKED POTENTIAL FOR ABAER I
- K992917 — AEROCHAMBER PLUS VALVED HOLDING CHAMBER
- K972708 — ENDO-SPOR PLUS / HYPROCIDE
- K973971 — KION ANESTHESIA SYSTEM
- K991218 — ORATEC BIPOLAR ABLATION PROBES
- K991388 — ASSISTED HATCHING MICROPIPETTES, DENUDING PIPETTES, HOLDING MICROPIPETTES, ICSI MICROPIPETTES, PARTIAL ZONE DISSECTION M
- K991799 — DAVOL HYSTEROSCOPY POUCH DRAPE AND TUBING SET, MODEL OOXXXXO
- K992057 — IST RESPONSE MANUAL RESUSCITATOR, MODELS, 008000, 008003,008006
- K992119 — BIO-MODULAR SHOULDER SYSTEM
- K992131 — SAMSUNG RAYPAX LONG TERM ARCHIVE
- K992194 — CORTICAL MAPPING UNIT, MODEL CMU
- K992307 — EMBRYO GLIDE EMBRYO TRANSFER CATHETER, EMBRYO GLIDE STYLE FOR EMBRYO TRANSFER CATHETER
- K992308 — OOCYTE RETRIEVAL NEEDLE SET, MODEL 90138
- K992311 — K-ASSAY CRP(1), K-ASSAY CRP MULTI-CALIBRATOR A, K-ASSAY CRP MULTI-CALIBRATORC
- K992312 — K-ASSAY CRP (2), K-ASSAY CRP MULTI-CALIBRATOR A, K-ASSAY CRP MULTI-CALIBRATOR B
- K992417 — ROYAL SHIELD NON-STERILE POWDERED LATEX EXAMINATION GLOVES (PROTEIN LABELING CLAIM) 200 MCGM OR LESS OF TOTAL WATER EXTR
- K992418 — ROYAL SHIELD NON-STERILE PINK COLORED POWDERED LATEX EXAMINATION GLOVE WITH AND WITHOUT STRAWBERRY SCENT AND WITH PROTEI
- K992419 — ROYAL SHIELD NON-STERILE BLUE COLORED POWDERED LATEX EXAMINATION GLOVE WITH PROTEIN CONTENT LABELING CLAIM (200 MCGM OR
- K992743 — COLLINS CPL
- K992803 — SIGMA DIAGNOSTICS INFINITY CHOLESTEROL REAGENT, MODELS 401-25, 401-100P, 401-500P, 401-2000P, 402-20, 02-1OOP
- K991375 — BARD BALLOON INFLATION SYSTEM
- K991990 — TRI-POLAR SYSTEM
- K991991 — DUPEL IONTOPHORESIS SYSTEM
- K991994 — TWILIGHT
- K992011 — SYNEA-HS HIGH SPEED-HANDPIECE
- K992015 — FREEDOM INFUSION SYSTEM
- K992196 — BIOLOGIC-DT SYSTEM (BIOLOGIC-DT-1000 WITH DT-1000-TK)
- K992210 — SHIELDMASTER POWDERED PURPLE NITRILE EXAMINATION GLOVES
Data sourced from openFDA. This site is unofficial and independent of the FDA.