FDA 510(k) clearances — page 633
clearances on record, most recent first.
Clearances — page 633
63,201–63,300 of 176,637- K060324 — BD PHOENIX AUTOMATED MICROBIOLOGY SYSTEM FOR USE WITH THE ANTIMICROBIAL AGENT GATIFLOXACIN 0.25-8 UG/ML - GRAM-NEGATIVE
- K060506 — STRYKER SPINE VLIFT VERTEBRAL BODY REPLACEMENT SYSTEM
- K060525 — VANGUARD REMOVABLE MOLDED POLY TIBIA
- K060647 — LTV 1200 VENTILATOR
- K060713 — PROCEED SURGICAL MESH
- K060723 — 40 L HIGH FLOW INSUFFLATOR F113
- K060726 — POWDER FREE NITRILE EXAMINATION GLOVE COATED WITH CUCUMBER WITH GLYCERINE (BLUE COLOR)
- K060746 — MEMORY STAPLE
- K060752 — ACMI DUR-HL LASER SYSTEMS
- K060776 — SURGICAL FACE MASK
- K060790 — BREAS, MODEL HA01
- K060811 — OMRON COMPRESSOR SYSTEMS, MODELS NE-C28,NE-C30
- K060893 — MODIFICATION TO REBILDA DC
- K060964 — ARCHITECT BNP ASSAY, MODEL 8K28
- K061059 — MODIFIED MERCI RETRIEVER, MODEL 90092
- K061067 — TRABECULAR METAL ACETABULAR AUGMENTS
- K061170 — 3.0T PEDIATRIC HEAD AND SPINE ARRAY, MODEL 808GE3000
- K061182 — CLINIQA LIQUID QC LIPID CONTROL LEVELS 1 & 2 +2 more
- K061238 — DIMENSION VISTA CARBON DIOXIDE, CREATININE AND LACTATE DEHYDROGENASE FLEX REAGENT CARTRIDGE
- K061274 — VENTURE ANTERIOR CERVICAL PLATE SYSTEM
- K061295 — VERSACLEAR SKIN THERAPY SYSTEM, MODEL 100
- K061303 — MEDICAL DISPLAY, MODELS MDM 1900-1NG AND MDM 1900-1NR
- K061305 — MEDICAL DISPLAY, MDC1900-1LG (1LR)
- K061326 — VOXAR 3D ENTERPRISE WITH CARDIAMETRIX
- K061330 — PSL PORTABLE SLIT LAMP
- K050367 — BIOPHEN HEPARIN 3, BIOPHEN HEPARIN 6
- K051442 — PHOTOSILK PLUS PULSED LIGHT SYSTEM AND LASER ATTACHMENT
- K052511 — CARDIOFAX CE, MODEL ECG-1500 A
- K052674 — CONTACT LENS OPHTHALMODYNAMOMETER
- K053539 — MERIDIAN HEMODIALYSIS MACHINE, MODEL 5M5576
- K060381 — ALLIENT SORBET HEMODIALYSIS SYSTEM, MODEL 1100
- K060535 — SPACER-S TEMPORARY SHOULDER SPACER
- K060552 — BC100 BODY COMPOSITION ANALYSIS SYSTEM
- K060805 — MODIFICATION TO GIVEN DIAGNOSTIC SYSTEM
- K060909 — POWDERED VINYL PATIENT EXAMINATION GLOVES, CLEAR (NON-COLORED)
- K060977 — MEDLITE C SERIES COMPRESSION TOOL AND HANDPIECE ATTACHMENT ACCESSORY, MODEL 659-0523
- K061022 — BIO 1-KIT BIOSORB FILLED CARTRIDGE
- K061074 — ABLE GLOVE, NITRILE BLUE POWDERED EXAMINATION GLOVES
- K061098 — EBI OPTILOCK PERIARTICULAR PLATING SYSTEM
- K061132 — MODIFICATION TO SUPEROPEN 0.35T, MODEL NSM-P035
- K052299 — REPROCESSED ENDOSCOPIC TROCAR
- K052404 — DENALI DEFORMITY SYSTEM
- K060822 — VANTAGE INDIRECT OPHTHALMOSCOPE
- K061010 — FUTURE MOBILITY HEALTHCARE INC. ORION II WHEELCHAIR AND STELLATO MECHANICAL WHEELCHAIR
- K061072 — ROTAFLOW CENTRIFUGAL PUMP WITH SAFELINE COATING, MODEL BSQ-RF-32
- K061113 — ORTHOMON
- K061125 — DVTCARE CA5
- K061127 — CG FUTURE ANNULOPLASTY SYSTEM, MODEL 638R
- K061175 — CLARIS I310D INTRAORAL CAMERA SYSTEM & ACCESSORIES
- K061192 — BLUE COLOUR POWDER FREE BARRIERPRO POLYMER BP2000 POLYBUTADIENE COPOLYMER EXAMINATION GLOVES
- K061264 — TEMPFX ESTHETIC PROVISIONAL SYSTEM
- K061273 — 7000 SERIES LIGHTWEIGHT WHEELCHAIR, MODELS 7160L, 7180L AND 7200L
- K060530 — SD CERAMIC COPING FOR QUICK ABUTMENT, LOCKING. MODEL 45301. RD CERAMIC COPING FOR QUICK ABUTMENT, LOCKING, MODEL 45302.
- K060649 — GENIUS 2 INFRARED TYMPANIC ELECTRONIC THERMOMETER, MODEL 303000
- K060928 — CRYOSHAPE
- K060994 — MONDIAL
- K060995 — DUCKWORTH & KENT LTD LENS DELIVERY SYSTEM, MODEL DK7788
- K061112 — CONMED PRO2 PULSE REFLECTANCE OXIMETER, MODEL PRO-M
- K061128 — MODIFICATION TO MEDRAD CONTINUUM MR INFUSION SYSTEM
- K061191 — FINGER AND EAR SENSORS AND NEONATAL-ADULT AND ADULT/PEDIATRIC ADHESIVE SENSORS FOR USE WITH NELLCOR R-CAL SPO2
- K053207 — ARGUS, MODEL LCM
- K053337 — DIMENSION URINE ECSTASY SCREEN FLEX REAGENT CARTRIDGE, MODEL DF 109
- K053552 — GLOBAL FERTILIZATION, EMBRYO CULTURE AND TRANSFER MEDIA
- K053637 — MANI NEEDLE & SUTURE PACK (NYLON)
- K053638 — MANI NEEDLE & SUTURE PACK (SILK)
- K060063 — LEGACY ABUTMENT SYSTEM
- K060122 — SLEEP SPLINT
- K060240 — K-JUMP DIGITAL THERMOMETER WITH BATTERY-LESS PATCH, MODEL KD-2100
- K060478 — ARTHREX BIO-COMPRESSION SCREW
- K060581 — DEPUY SOLUTION SYSTEM HIP PROSTHESIS
- K060704 — ZIMMER TRABECULAR METAL REVERSE SHOULDER SYSTEM, SIZES 8MM AND 10MM
- K060827 — MYLAB30, 50, 70 AND 90 SYSTEMS ADDITION OF 3D/4D, MODELS 7300, 7350, 6150, 6100
- K060860 — TURKOM-CERA
- K060926 — TRIPOD
- K060979 — XIA TITANIUM AND 4.5 SPINAL SYSTEMS
- K061012 — AXSOS PLUS LOCKING PLATE SYSTEM
- K061078 — BRIGHT ELEMENT SND BHD LATEX POWDER FREE EXAMINATION GLOVES
- K061118 — ONETOUCH ULTRAMINI BLOOD GLUCOSE MONITORING SYSTEM
- K053193 — PM-8000 EXPRESS PATIENT MONITOR, MODEL PM-8000 EXPRESS
- K060502 — DIMENSION TACR FLEX REAGENT CARTRIDGE, MODEL DF107
- K060503 — DIMENSION TACR CALIBRATOR, MODEL DC107
- K060821 — SPECIALEYES 50 AND SPECIALEYES 49 SHPERE AND TORIC SOFT CONTACT LENSES
- K060950 — 3MATIC
- K061063 — MODIFICATION TO: SILVERHAWK PERIPHERAL PLAQUE EXCISION SYSTEM, MODELS P4028/FG08300
- K061119 — ENPATH MEDICAL STEERABLE SHEATH
- K061258 — TRABECTOME HIGH FREQUENCY GENERATOR/LP
- K061259 — MODIFICATION TO ARTHROCARE PERC-D SPINEWAND
- K061260 — INTUITIVE SURGICAL ENDOWRIST PK DISSECTING FORCEPS, MODELS 400214 & 420214
- K050032 — EUROMED SURESKIN III WITH SILVER WOUND DRESSINGS
- K051073 — MIDIVIEW SERIES OF MICROENDOSCOPES
- K052691 — SURETEK MEDICAL REPROCESSED COMPRESSION SLEEVES
- K053166 — SINCLAIR ORAL RINSE
- K053579 — COLUMBUS ULTRA CONGRUENT (UC) TIBIAL INSERT/GLIDING SURFACE
- K060036 — PORT-A-CATH, PORT-A-CATH II, PROPORT AND P.A.S. PORT IMPLANTABLE VENOUS ACCESS SYSTEMS WITH DUAL LAYER CATHETER
- K060388 — TAP II ANTI-SNORING AND OBSTRUCTIVE SLEEP APNEA ORAL APPLIANCE WITH ATTACHMENT
- K060409 — HEMOHALT HEMOSTASIS PAD
- K060412 — ACTIVE UNICOMPARTMENTAL KNEE SYSTEM
- K060473 — TTC PLATE
- K060476 — LAPIDUS PLATE
- K060724 — POWDER FREE NITRILE EXAMINATION GLOVE (BLACK AND GRAY)
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