FDA 510(k) clearances — page 600
clearances on record, most recent first.
Clearances — page 600
59,901–60,000 of 175,825- K070162 — FORCETRIAD ELECTROSURGICAL GENERATOR; LIGASURE INSTRUMENTS
- K070359 — DEPUY ASR TAPER SLEEVE ADAPTER
- K061622 — PS SERIES
- K061706 — CADWELL EASYNET OXIMETER MODULE
- K062480 — JOYKEY SURGICAL DRAPES (STERILE)
- K063491 — T2 SCEPTOR SPINAL SYSTEM
- K063512 — LEKSELL GAMMA KNIFE PERFEXION
- K063673 — INNOVACON FLIPCARD FECAL OCCULT BLOOD TEST DEVICE
- K063676 — DBX DEMINERALIZED BONE MATRIX MIX
- K063722 — SEKURIT SHARPS COLLECTION CONTAINER
- K063786 — ENDOSCOPIC INSUFFLATION UNIT, MODEL XECR-2
- K063795 — GUARDIANCATHETER-URINARY DRAINAGE CATHETER
- K070077 — ULTRASOUND SCANNER PROFOCUS, MODEL 2202
- K060899 — FLEXILUX II CYSTOSCOPE AND HYSTEROSCOPE
- K062085 — S4 SPINAL SYSTEM
- K063298 — OSTEOMED HEADLESS CANNULATED SCREW SYSTEM
- K063466 — TOP FINE
- K063578 — PROMOS MODULAR SHOULDER SYSTEM
- K063588 — MATRYX INTERFERENCE SCREW, 239038T5,231025T5,231033T5,231038T5,231125T5,231133T5,231138T5
- K063633 — DEPUY KNEE PROSTHESIS SYSTEM UNIVERSAL STEM EXTENSIONS AND FEMORAL METAPHYSEAL SLEEVES
- K063698 — CO2 LASER SYSTEM, MODEL C-LAS
- K063731 — ADVANCE STATURE FEMORAL COMPONENT
- K063734 — ATLANTIS ABUTMENT IN ZIRCONIA FOR 3I CERTAIN INTERFACE
- K063776 — ABLE GLOVE LATEX POWDERED EXAMINATION GLOVES
- K063792 — OSTEOMED EXTERNAL MANDIBULAR DISTRACTION SYSTEM
- K070089 — SYNTERMED LIVE
- K070139 — WILLSON ONE-FIT HEALTHCARE PARTICLE RESPIRATOR AND SURGICAL MASK, HC-NB095
- K070170 — DALL-MILES SYSTEM
- K070269 — MODIFICATION TO COLLAWOUND DRESSING
- K070312 — EARCHECK ACOUSTIC REFLECTOMETER
- K070373 — APOZA LED CURING LIGHT, MODEL E-MORLIT, D-2000, TOP 3W, TOP 5W
- K062214 — BRACHYSCIENCES STRANDPORT
- K062762 — DERMA YAG
- K062792 — ERCHONIA IOTO_240
- K062840 — TRIAGE PROTEIN C CONTROLS AND CALIBRATION VERIFICATION CONTROLS
- K063348 — TOP FINE INSULIN SYRINGE
- K063390 — URINE CHEMISTRY ANALYZER UR-50
- K063449 — DELUXE NEBULIZER
- K063815 — VARIAN ESOPHAGUS BOUGIE APPLICATOR
- K063847 — FUJINON ULTRASONIC ENDOSCOPE AND PROCESSOR, MODELS EG-530UR, EG-530UT AND SU-700
- K070065 — AMS SINGLE INCISION SLING SYSTEM (SIS-0)
- K070090 — RADIESSE LARYNGEAL IMPLANT
- K070114 — CREATION CP-ZI PORCELAIN
- K070176 — MAXHEALTH MECHANICAL WHEELCHAIR, K1
- K070248 — VELOCITYAIS
- K070294 — SYNTHES TROCHANTERIC FIXATION NAIL (TFN) SYSTEM, ADDITIONAL HELICAL BLADES
- K062197 — ATLANTIS ABUTMENT FOR 3I CERTAIN MICRO MINI; GEMINI AND GEMINI+ ABUTMENT
- K062537 — ZOLL M SERIES WITH REAL CPR HELP
- K062977 — CRITIVIEW, MODEL CRV3
- K063408 — CTLOGICS NAVIGATIONS SYSTEMS
- K063465 — CHAMPION IONTOPHORETIC DRUG DELIVERY DEVICE
- K063471 — SHIJIAZHUANG JUNFEI PLASTICS PRODUCTS CO., LTD. POWDER FREE (WHITE) VINYL PATIENT EXAMINATION GLOVES
- K063871 — D-STAT HANDLE, MODEL 8500-053
- K070145 — POWDERED VINYL PATIENT EXAMINATION GLOVES
- K070238 — AMPLATZER RELIANT CATHETER DELIVERY SYSTEM
- K070400 — LC THERAPY, MODEL LCT-1000
- K061652 — PALOMAR LUX1540 HANDPIECE
- K062764 — POWDER-FREE NITRILE PATIENT EXAMINATION GLOVE, WHITE (NON-COLORED) AND BLUE COLORED
- K062789 — SYNTHES (USA) RAPID RESORBABLE FIXATION SYSTEM
- K063096 — PRECISION OXYGEN MONITOR
- K063307 — ELECTRIC POWERED WHEELCHAIR, MODEL - RUMBA SR (4R)
- K063320 — ELECTRIC POWERED LIFT WHEELCHAIR, MODEL VISION (P13)
- K063570 — BIOMET TIBIAL LOCKING NAIL SYSTEM
- K063592 — ADAPTER PS RP-NP, 34551, ADAPTER PS WP-RP,34552, ABUTMENT SCREW PS RP-NP, 34553, ABUTMENT SCREW PS WP-RP, 34554
- K063696 — COLLEAGUE VOLUMETRIC INFUSION PUMP MODEL# 2M8151,8153,8161,8163,9161,9163
- K063755 — PORTEX HYPODERMIC NEEDLE-PRO FIXED NEEDLE SYRINGE
- K070322 — SYNGO DYNAMICS, VERSION 6.0
- K061820 — DIASORIN LIAISON VZV IGG
- K062256 — HF54 COMBINATION ULTRASOUND INTERFERENTIAL AND PREMODULATED STIMULATION SYSTEM
- K062350 — SURGINETICS ADVANTAGEBLADE
- K062459 — ORIGEN DBM WITH BIOACTIVE GLASS
- K062869 — CONTOUR CURVED CUTTER STAPLER AND RELOADS, MODELS CS40B, CS40G, CR40B AND CR40G
- K063205 — ATLAS SPINE VERTEBRAL BODY REPLACEMENT
- K063336 — MEDELA DOMINANT 50 LIPO, MODEL 600-5706
- K063535 — CAPTION APPLICATOR
- K063562 — GYNECARE PROSIMA PELVIC FLOOR REPAIR SYSTEMS
- K063857 — SIMPLEX P SPEEDSET WITH TOBRAMYCIN BONE CEMENT
- K070085 — BALANCE REHABILITATION UNIT (BRU)
- K070319 — GC FUJI IX GP EXTRA
- K061497 — SYREX HEPARIN LOCK FLUSH SYRINGE, 1 UNIT/ML & 2 UNITS/ML
- K061629 — CERTAIN PREVAIL DENTAL IMPLANT
- K061775 — WAKO L-TYPE CREATININE-M TEST, AND WAKO CREATININE CALIBRATOR
- K061991 — PLATELETWORKS ARACHIDONIC ACID, MODEL PW-ACA
- K062263 — OMRON MICRO-AIR VIBRATING MESH NEBULIZER, MODEL NE-U22
- K062852 — BALLOON EXPANDABLE TRANSSEPTAL INDRODUCER, MODELS BETI-1840 AND BETI-1870
- K063023 — 3M HEALTH CARE PARTICULATE RESPIRATOR AND SURGICAL MASK, MODEL 1870
- K063100 — ATLANTIS ANTERIOR CERVICAL PLATE SYSTEM, TRANSLATIONAL PLATE
- K063268 — CPAP/VPAP MASKS, MODELS 1225, 1205 AND 1235
- K063399 — ALEUTIAN SPACER SYSTEM
- K063569 — EQUINOXE REVERSE SHOULDER SYSTEM
- K063608 — DIMENSION VISTA APOA1 AND APOB FLEX REAGENT CARTRIDGES AND PROTEIN 1 CALIBRATOR AND CONTROL MEDIUM AND HIGH
- K063754 — DIMENSION VISTA (TM) BHCG FLEX(R) REAGENT CARTRIDGE, AND BHCG CALIBRATOR, MODEL# K6430,KC632
- K063777 — ABLE GLOVE NITRILE BLUE POWDER FREE EXAMINATION GLOVE
- K070042 — POWDERED VINYL PATIENT EXAMINATION GLOVES, YELLOW
- K070107 — PARI HYDRATE G
- K070149 — POWDER-FREE VINYL PATIENT EXAMINATION GLOVES
- K070197 — ACUMEN LEAD DELIVERY SHEATH WITH STYLET, MODELS LDS-10-64-STY AND LDS-10-57-STY
- K070199 — RETIC-CHEX LINEARITY FOR BC
- K070260 — STAR ST AND ARRHYTHMIA SOFTWARE, RELEASE H.0
- K070268 — SIGNATURE EDITION INFUSION SYSTEM, MODELS 710X, 720X
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