FDA 510(k) clearances — page 474
clearances on record, most recent first.
Clearances — page 474
47,301–47,400 of 175,770- K103509 — UNIMAX SUCTION IRRIGATION SET
- K103822 — SYNTHES HEMOSTATIC BONE PUTTY (HBP)
- K110230 — ROG KNOTLESS SUTURE ANCHOR
- K110283 — ZENIUS SPINAL SYSTEM
- K110302 — ADHESIVE EXL-759
- K110335 — CERAMIC BRACKETS
- K110533 — STRYKER PATIENT SPECIFIC CUTTING GUIDE
- K110709 — ARK CARE DIABETES MANAGMENT SYSTEM
- K111039 — ZIMMER PERIARTICULAR LOCKING PLATE SYSTEM
- K101946 — VIDAS TOXO IGG AVIDITY
- K102733 — VISION-SCIENCES ENT-5000 VIDEO ENT SCOPE WITH ENDOSHEATH TECHNOLOGY, VISION-SCIENCES DPU-5000/DPU-5050 VIDEO PROCESSOR
- K103377 — CHARTER GUIDEWIRE MODEL 45-281, 45-282, 45-283
- K103560 — SHASER IPL HAIR REMOVAL SYSTEM
- K103812 — MITRA-LIFT
- K110006 — OIS SYMPHONY IMAGE MANAGMENT SYSTEM
- K110229 — ROG SUTURE ANCHOR 5.5MM, 2.9MM
- K110574 — BIOMET MICROFIXATION STERNALOCK BLU STERNAL CLOSURE SYSTEM
- K111064 — TIGERPAW SYSTEM II
- K083423 — COLONCAD API 3.1
- K102251 — DASH KNEE
- K102317 — IQ VENTILATION NASAL MASK
- K103094 — VIGILEO ARTERIAL PRESSURE CARDIAC OUTPUT / OXIMETRY MONITOR; VIGILEO APCO / OXIMETRY MONITOR
- K103765 — MAC 600 RESTING ECG ANALYSIS SYSTEM
- K110188 — DIAZYME GLYCATED SERUM PROTEIN ASSAY / CALIBRATOR KIT / CONTROL KIT
- K110484 — SELF CURE TEMPORARY CROWN AND BRIDGE MATERIAL
- K110706 — EXACTECH EQUINOXE CUFF TEAR ARTHROPLASTY (CTA) HEAD
- K110722 — RPS ADENO DETECTOR PLUS
- K111001 — STERILE STORM (R) OPERATING KIT
- K111163 — CHITOGAUZE FUSION
- K111321 — REMOTE VIEW SOFTWARE
- K100130 — PATHFAST CTNI-II TEST, PATHFAST CTNI CALIBRATORS, PATHFAST SAMPLE DILUENT 2
- K101779 — CLEARVISION DR 2000 DIGITAL RADIOGRAPHY X-RAY SYSTEM
- K102535 — ETEST TELAVANCIN IN 0.002-32 UG/ML AND 0.016-256 UG/ML
- K102887 — ACCORDION STONE MANAGEMENT DEVICE MODEL AC281205 AND AC3814510
- K110303 — STRATUS CS ACUTE CARE D-DIMER
- K110415 — SIGNATURE PLANNER / SIGNATURE GUIDES
- K110510 — S20 DIGITAL COLOR DOPPLER ULTRASOUND SYSTEM
- K110986 — OPTOMED SMARTSCOPE M5 EY3 AND M5 ES1
- K111243 — FUJINON ULTRASONIC PROCESSOR
- K100987 — INVADER MTHFR 677
- K102328 — BLUNT FILL NEEDLE AND BLUNT PLASTIC CANNULA
- K102510 — DIMENSIONS HB1C KIT, MODEL DF105A
- K102598 — HI-DOW-XP
- K102619 — COMPUTED RADDIOGRAPHY SCANNER
- K102748 — 31P/1H HEAD COIL 3T; 23NA/1H HEAD COIL 3T; 13C/1H HEAD COIL 3T
- K102845 — MAHE FIXATION PLATE AND SCREW SYSTEM
- K103025 — GIVEN PILLCAM PLATFORM WITH RAPID 6.5 / GIVEN PILLCAM PLATFORM WITH PILLCAM ESO 3 CAPSULES
- K103407 — COTRONIC DIGITAL THERMOMETER
- K103473 — ZOLL RESCUENET EPCR MODEL RESCUENET EPCR
- K103545 — BT-350
- K103589 — NEOBLUE BLANKET LED PHOTOTHERAPY SYSTEM
- K103635 — CONTINUOUS NEBULIZATION TUBE SET (CNTS) TUBING: AG-AS3075 + SYRINGE: AG-AS3085; CONTINOUS NEBULIZATION TUBE SET (CNTS) S
- K110102 — POWDERFREE NITRILE EXAMINATION GLOVES COATED WITH ALLOGEL,COLORS BLUE,MAGNETA,COPPER AND WITHOUT ALLOGEL,COLORS BLUE,MAG
- K110146 — NITRILE POWDER FREE PATIENT EXAMINATION GLOVES
- K110225 — ANGIODYNAMICS, INC. VENACURE 1470 LASER
- K110235 — BEAUTIBOND MULTI
- K110252 — BEAUTIBOND MULTI PR PLUS
- K110449 — ENDOBON XENOGRAFT GRANULES
- K110454 — COUGAR LS LATERAL CAGE SYSTEM
- K110540 — TERUMO SUPPORT CATHETER
- K110771 — BD SINGLE USE, HYPODERMIC SYRINGE
- K110774 — ELECTRONIC SPHYGMOMANOMETER
- K110775 — ELECTRONIC SPHYGMOMANOMETER
- K110853 — VR MEDICAL ENTERAL ORAL SYRINGE
- K110948 — HEALTH CARE SYSTEM SOFTWARE
- K110978 — ONESTEP PEDIATRIC MFE'S
- K111079 — SYNGO.VIA WEB VIEWER
- K111121 — VITAMESH (TM) BLUE LIGHTWEIGHT MACROPOROUS PP SURGICAL MESH
- K111227 — ALOKA SSD-3500 DIAGNOSTIC ULTRASOUND SYSTEM
- K111234 — CLICK-IT
- K111257 — HEISENBERG DYEING LIQUIDS
- K101155 — AURADORM (NEUROMUSCULAR SLEEP)
- K102026 — SEASPINE SPACER SYSTEM
- K103211 — AVEA VENTILATOR
- K103312 — UPD-Y0003
- K103716 — ROCHE ELECSYS FOLATE RBC; ROCHE ELECSYS FOLATE RBC CALSET
- K103744 — DROPPER A1C DIABETES CONTROL
- K110122 — MUSTANG BALLOON DILATAION CATHETERS
- K110159 — ACTIVECARE SFT
- K110433 — CLEARBLUE EASY PREGNANCY TEST
- K110613 — ELECSYS PROLACTIN II CALCHECK 5
- K110628 — SIMPLEABI
- K110692 — STREAMLINE TL SPINAL SYSTEM
- K100910 — IMMULITE 2000 3GALLERGY SPECIFIC IGE ASSAY KIT, MODEL L2KUN6
- K103523 — 185A+ TRANSPORT INCUBATOR WITH MASIMO PULSEOX, 185A+ TRANSPORT INCUBATOR WITH NELLCOR PULSEOX
- K103525 — A750I TRANSPORT INCUBATOR WITH MASIMO PLUSEOX, A750I TRANSPORT INCUBATOR WITH NELLOR PULSEOX
- K103633 — ACHILLES
- K110409 — ASPIRA PLEURAL DRAINAGE SYSTEM
- K110413 — POWER PROCESSOR SAMPLE PROCESSING SYSTEM WITH GENERIC CONNECTIONS
- K110430 — DOLPHIN IMAGING
- K110528 — INTEGRA LED SURGICAL HEADLIGHT SYSTEM
- K110965 — RENOVIS T 710 LARGE EXTERNAL FIXATION SYSTEM
- K100567 — PEARL DIABETES MANAGEMENT SYSTEM
- K101585 — K-Y BRAND LONG LASTING VAGINAL MOISTURIZER
- K102725 — CROSSBOSS CATHETER MODEL M-2000, STINGRAY ORIENTING BALLOON CATHETER MODEL M-1000, STINGRAY GUIDEWIRE MODEL M-3004 AND M
- K102788 — TORNIER BIOFIBER SCAFFOLD
- K102860 — ALCON MULTI-PIRPOSE DISINFECTING SOLUTION
- K103718 — DYNACOR LUBRICATION GEL
- K110121 — WEXLER ENDOSCOPE ACCESSORIES
- K110314 — STRETCH VINYL EXAMINATION GLOVE, POWDER FREE (YELLOW/WHITE/CLEAR(NON-COLORED)
Data sourced from openFDA. This site is unofficial and independent of the FDA.