FDA 510(k) clearances — page 533
clearances on record, most recent first.
Clearances — page 533
53,201–53,300 of 175,825- K090530 — SPIN-LOC SUTURE ANCHOR SYSTEM FG-0302-01,FG-0305-01
- K090725 — OCULUS MICROCYN WOUND GEL
- K090736 — POWER INFUSER, MODEL M100B-3A
- K091133 — APLION TOPICAL CARE SYSTEM
- K091373 — SYNGO TRUED
- K090005 — BRANEMARK INTEGRATION BIOHELIX IMPLANTS
- K090196 — EG-3670URK
- K090197 — EG-3870UTK
- K090425 — GUIDED LATERAL INTERBODY FUSION (GLIF) SYSTEM
- K090793 — BONGROS HA
- K090899 — DEPUY SPINE LATERAL SYSTEM
- K091070 — MANOSCAN MOTILITY WITH IMPEDANCE VISUALIZATION SYSTEM
- K081823 — MASTERSCREEN PAED - BABY BODY
- K083327 — SYNGOCIRCULATION DYNAMICPET, VERSION 1.0
- K083455 — LIPOKIT WITH DISPOSABLE 50CC AFT SYRINGE, MODEL ZLK-100
- K083507 — BATTERY PACK FOR MCV100 AND MCV200 EMERGENCY VENTILATORS
- K090062 — WV1417A DIGITAL X-RAY DIRECT IMAGING FLAT PANEL DETECTOR SYSTEM
- K090520 — STRETCH VINYL EXAMINATION GLOVE, POWDER FREE (YELLOW/WHITE)
- K090672 — AGFA COMPUTED RADIOGRAPHY SYSTEMS WITH NX WORKSTATIONS
- K090749 — ROOGRAPH EVO, MODEL 9307XY11Z1, ROTOGRAPH EVO D, MODEL 9307XY1191
- K090800 — VS-100 ILLUMINATION AND IMAGING SYSTEM
- K091009 — MY LABS25 GOLD/MYLAB30 GOLD CARDIOVASCULAR MODEL 7340, MY LAB70/MY LAB70XVISION/MYLAB60, MODEL 6150
- K091154 — UTRECHT INTERSTITIAL FLETCHER CT/MR APPLICATOR SET, MODEL 110.270, INTERSTITIAL RING CT/MR APPLICATOR SET,MODEL 110.330,
- K091194 — ALGISEAL PAD
- K091206 — SLEUTH AT IMPLANTABLE CARDIAC MONITORING SYSTEM-6 AND 8CM ANTENNA, PERSONAL DIAGNOSTIC MANAGER(PDM) ACCESSORY KIT, MODEL
- K091215 — INTELLIGENT POWER UNIT, INTELLIGENT CONSOLE, INTELLIGENT DELIVERY SYSTEM, INTELLIGENT SURGICAL INSTRUMENT
- K081591 — NEUCODIA
- K082403 — MEDOS HILITE OXYGENATOR, MODEL 7000 & 7000 LT
- K083253 — LOTUS II PULSED ER: YAG LASER SYSTEM
- K083545 — ZIEHM VISION RFD
- K083851 — INVIROBLUNT CANNULA WITH AND WITHOUT EZ WINGS, MODELS 120522 AND 120022
- K090066 — POWDER FREE POLYMER COATED LATEX SURGICAL GLOVES, STERILE, WITH PROTEIN LABELING CLAIM OF 50 MICROGRAMS PER DM2 OF GLOVE
- K090234 — SPECTRA SYSTEM DENTAL IMPLANTS 2008
- K090265 — BRAVO AUTOCLAVE, MODELS 17, 17V AND 21V
- K090270 — BACKSTOP CATHETER, MODEL 60-0000-3100
- K090390 — CD HORIZON SPINAL SYSTEM
- K090834 — EPICARDIA 5000
- K090966 — AMIGO CATEGORY III FULL-SIZED REGULAR DUTY 3 WHEEL (310000) AND AMIGO CATEGORY V HEAVY DUTY 3 WHEEL (650000)
- K091112 — RESPIRONICS SLEEPEASY CPAP SYSTEM
- K091119 — MODIFICATION TO THE CROSSER SYSTEM
- K091286 — SYNGO US WORKPLACE
- K091295 — APLIO XG DIAGNOSTIC ULTRASOUND SYSTEM MODEL SSA-790A VERSION 4.0
- K080868 — AONGEN COLLAGEN MATRIX
- K081130 — BRIDGEPOINT MEDICAL CROSSBOSS PERCUTANEOUS CORONARY CATHETER
- K083184 — TEARLAB OSMOLARITY SYSTEM
- K083385 — MASS CASUALTY VENTILATORS, MODELS: MCV200 AND MCV200-B
- K083648 — GOTFRIED PHYSIOLOGICAL HIP (PH) NAIL
- K083821 — VITAL SIGNS MONITOR
- K090113 — BREAS VIVO 40 SYSTEM
- K090413 — A1CNOW+ (10 TEST KIT, PROFESSIONAL USE) MODEL 3024, A1CNOW+(20 TEST KIT, PROFESSIONAL USE) MODEL 3021, A1CNOW SELF CHEC
- K090424 — DVX SPINE SYSTEM
- K090470 — AUTOSUTURE PROTACK; TACKER SYSTEM; ABSORBATACK FIXATION DEVICES
- K090489 — ABTHERA OPEN ABDOMEN DRESSING, MODEL: M8275026
- K091073 — WBR XPRESS.CARDIAC AND XPRESS3.CARDIAC INCLUDING ATTENUATION AND SCATTERING CORRECTIONS
- K081803 — ST. JUDE MEDICAL EPICARDIAL CATHETER SYSTEM
- K091040 — MICROLIFE DIGITAL INFRARED EAR THERMOMETER, MODEL IRIDVI-1
- K091169 — ELITE MPX LASER SYSTEM WITH CRYO C
- K083214 — AMPLATZER TORQVUE 45DEGREEX45DEGREE DELIVERY SHEATH, MODELS 9-TV45X45-09F-100, 9-TV45X45-10F-100
- K083838 — SCALEMAN BODY FAT SCALES, MODEL: FS-148BW1 SERIES
- K090187 — FORA G30 BLOOD GLUCOSE MONITORING SYSTEM, MODEL TD-4241
- K090354 — LAMINOPLASTY PLATING SYSTEM
- K090833 — SEGMENT
- K091042 — CRONO S-PID 50
- K091261 — NMI PICC
- K082686 — MULTI-CHANNEL LASER THERAPY SYSTEM
- K083102 — REFINE LIFT SYSTEM
- K090092 — SOCKIT! AND MCMERLIN DERMAL WOUND GEL
- K090391 — PULPDENT MICRO-HYBRID COMPOSITE
- K090601 — FSC 2
- K090826 — MONOBOND PLUS
- K091043 — POWER DRIVE CHAIR, MODEL: TMM6
- K091113 — MAXIMA V, THREE WHEEL SCOOTER, MODEL SC900V MAXIMA V, FOUR WHEEL SCOOTER, MODEL SC940V
- K081286 — MONOCLONAL RABBIT ANTI HUMAN ESTROGEN RECEPTOR ALPHA ANTIBODY CLONE SP1, MODEL M3634
- K082060 — CRANIAL IMAGE GUIDED SURGERY SYSTEM
- K082474 — PMT SUBDURAL CORTICAL ELECTRODES
- K083156 — NON STERILE POWDER FREE NITRILE EXAMINATION GLOVES, BLUE
- K083499 — EXAIR ANTERIOR AND POSTERIOR PROLAPSE REPAIR SYSTEMS
- K083729 — HEMOCLOT QUANTI- V-L, FACTOR V-L CALIBRATOR, BIOPHEN V-L CAL (UNDILUTED), BIOPHEN ACT. PC-R CONTROL PLASMA AND BIOPHEN
- K083844 — ADVIA CENTAUR TSH3-ULTRA METHOD
- K090078 — KERASYS BIOENGINEERED LAMELLAR PATCH GRAFT
- K090243 — REMSTAR M-SERIES AUTO WITH AFLEX CPAP SYSTEM
- K090338 — ULTRA LOW TOTAL CHLORINE, E-Z CHEK SENSITIVE TOTAL CHLORINE
- K090363 — ZIO PATCH, MODEL Z100
- K090409 — BIOPLEX 2200 HSV-1 AND HSV-2 IGG ON THE BIOPLEX 2200 MULTI-ANALYTE DETECTION SYSTEM
- K090513 — VINYL EXAMINATION GLOVE, POWDER FREE CLEAR (NON-COLORED)
- K090683 — SYNGO RT THERAPIST CONNECT
- K090692 — ORTHOLOC 2.0/2.4 PLATE SYSTEM
- K090717 — FLEX-TENS
- K090864 — CUSA SHEAR TIP, AN ACCESSORY OF THE CUSA EXCEL ULTRASONIC SURGICAL ASPIRATOR SYSTEM
- K091068 — ACCUTORR V MONITOR, MODEL 0998-00-2000
- K091071 — NUVASIVE LATERAL PLATE SYSTEM
- K091131 — PELVIC FLOOR REPAIR SYSTEM
- K091175 — GRIND NO MORE VERSION 2 AND 3
- K091257 — MEDI-GLOBE SONOTIP II EBUS-TBNA NEEDLE SYSTEM
- K091269 — NEUROPET
- K081138 — SAFEFLO VENA CAVA FILTER
- K082134 — CIRCULATOR BOOT
- K082497 — INTUITIVE SURGICAL ENDOWRIST ONE HOT SHEARS INSTRUMENT
- K082834 — ELLMAN INTERNATIONAL NON-ABLATIVE TECHNIQUE FOR SURGITRON IEC
- K090069 — PROCERA IMPLANT BRIDGE OVERDENTURE
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