FDA 510(k) clearances — page 568
clearances on record, most recent first.
Clearances — page 568
56,701–56,800 of 176,542- K072326 — OSTAPEK VBR SYSTEM
- K072356 — S-TEST CA
- K072861 — CEEMAX SLIT LAMP (HALOGEN LAMP SERIES/SOLID STATE ILLUMINATION SERIES)
- K073556 — MEDXPERT P.E.S. (PECTUS EXACVATUM SYSTEM), MEDXPERT STRATOS
- K080181 — MODIFICATION TO GALILEO GOLD
- K080197 — PLASMAJET NEUTRAL PLASMA SURGERY SYSTEM
- K080223 — ZURA TEE SYSTEM
- K080639 — SYMPHONY GLUCOSE MANAGEMENT SYSTEM
- K080816 — VISUAL FOOTCARE TECHNOLOGIES TEMPSTAT
- K080879 — ACTIVATM PRODUCT GROUP INCLUDING BIOABSORBABLE DEVICES ACTIVAPIN FUSION, ACTIVANAILTM CONICALTM
- K080886 — IPLAN RT IMAGE
- K081160 — AVITA RADAR THERMO IR THERMOMETER, NT1 SERIES
- K081471 — ECARD AND CCARD
- K081648 — DIGITAL RADIOGRAPHY CXDI-60G
- K081661 — HD15 DIAGNOSTIC ULTRASOUND SYSTEM
- K063261 — NUCLISENS EASYQ ENTEROVIRUS SYSTEM
- K073280 — BENEVIEW T SERIES PATIENT MONITORS, MODELS T8, T6 AND T5
- K073577 — SHARPS TRANSPORT TUBE, MODEL 50035
- K080516 — LAMIN AIR
- K081144 — CLEVER CHEK AUTO-CODE VOICE BLOOD GLUCOSE MONITORING SYSTEM, MODEL TD-4243
- K081453 — BIOGRAPH HD FAMILY
- K081621 — INFX-8000C (INFINIX CC-I AND VC-I)
- K081624 — INFX-8000F (INFINIX CSI AND INFINIX DPI)
- K081664 — NOMAD PRO X-RAY SYSTEM
- K071973 — EPLEY OMNIAX
- K072985 — DUCKWORTH & KENT LTD INJECTOR, MODEL: DK7797-2
- K073316 — CERAMENT BONE VOID FILLER, MODEL A0210
- K073330 — FREEDOM SCIENCES MOTION CONTROL MODULE (MCM)
- K080112 — PATIENT CABLE
- K080244 — PALOMAR LUX 1540 HANDPIECE
- K080251 — APEXPRO TELEMETRY SYSTEMS
- K080304 — PRO TENS, MODEL WL-240 RX
- K080368 — MAKO SURGICAL CORP. UNICONDYLAR KNEE IMPLANT SYSTEM II
- K080614 — DR VISION NEO, DR VISION DOU
- K080652 — MERCURY VCO2 MODULE WITH CAPNOSTAT 5
- K080675 — PAJUNK INFILTRALONG WOUND INFILTRATION CATHETER KIT
- K080687 — SMARTBURS
- K080692 — MACS CPAP SYSTEM
- K080765 — CROSSER LP SYSTEM
- K080811 — TINA-QUANT CYSTATIN C, CALIBRATOR F.A.S. CYSTATIN C AND CYSTATIN C ANDCYSTATIN C CONTROL SET
- K081076 — VELOCITYAIS, VELOCITY AI, VELOCITYVX, VELOCITYRT, V-RESPONSE
- K081094 — OLYMPIC PASTEURMATIC, MODELS 3000 AND 3500
- K081428 — MODIFICATION TO DOUBLEPLAY SUTURE ANCHOR
- K081484 — HORIZON XVU
- K081578 — ACCELA SYSTEM
- K081585 — ENDOSCOPY VIDEO CAMERA SYSTEM
- K081628 — MODIFICATION TO COOLTOUCH, MODELS LC225 AND COOLLIPO
- K072169 — DUREX SYNTHETIC POLYISOPRENE MALE CONDOM
- K072876 — PRONTOSAN WOUND IRRIGATION SOLUTION
- K073634 — MULTIGENT CREATININE (ENZYMATIC) ASSAY
- K080536 — MICRO-TOUCH NITRAFREE
- K080940 — ESTELITE SIGMA QUICK
- K081183 — WOUNDSTAT
- K081221 — LEVITRONIX CENTRIMAG PRIMARY CONSOLE, THORATEC CENTRIMAG PRIMARY CONSOLE
- K081327 — RELIMESH
- K081491 — SMITH & NEPHEW CDS SYSTEM
- K081538 — TUTOPATCH, TUTOMESH
- K081580 — BEAMER ARGON SNARE PROBE
- K081584 — DERMA SCIENCES OTC MEDIHONEY DRESSINGS WITH ACTIVE MANUKA HONEY
- K081590 — YA HORNG ARM TYPE DIGITAL BLOOD PRESSURE MONITOR, MODELS BP-600, BP-600R, BP-600U, BP-600B, BP-600RB, BP-600UB, BP-600J
- K072602 — VACUETTE PREMIUM SAFETY NEEDLE SYSTEM
- K080580 — COMFORT IONTOPHORESIS ELECTRODES/ BUFFERED IONTOPHORESIS ELECTRODE TREATMENT, MODEL SMALL DDS275, MEDIUM DDM325, LARGE D
- K081052 — OCCLUSION BALLOON CATHETER, MODEL VENOS
- K081106 — PERI-LOC PERIARTICULAR LOCKED PLATING SYSTEM VOLAR DISTAL RADIUS LOCKING PLATE FOR THE UPPER EXTREMITY-ASTM F139
- K081198 — ECHELON RAPID HEAD COIL, MODEL MR-RHC-150N, ECHELON RAPID TORSO COIL, MODEL MR-RBC-150N
- K081322 — MAGNETIC RESONANCE DIAGNOSTIC DEVICE, MODEL 0100140201, PEDIATRIC HEAD-SPINE COIL
- K081340 — PEDIATRIC BODY AND CARDIAC COIL, MODEL 01000140201
- K081392 — BIORETEC ACTIVASCREW, ACTIVASCREW CANNULATED AND ACTIVASCREW CANNULATED WITH ACTIVAPIN
- K081477 — LUXTEC MLX LIGHT SOURCE
- K072560 — ENVELA (HYDROHESIVE OCCLUSIVE DRESSING)
- K080034 — THREE STAGE VENOUS RETURN CANNULA, MODEL 816460
- K080297 — MEDRAD INTEGO PET INFUSION SYSTEM
- K080523 — KRONUS BLOCKING ACETYLCHOLINE RECEPTOR AUTOANTIBODY (ACHRAB) RIA ASSAY KIT
- K080528 — E-POLY TIBIAL BEARINGS
- K080615 — ENDOSKELETON TA INTERBODY FUSION DEVICE (IBD)
- K080997 — ASCENSION PYROCARBON LUNATE
- K081057 — INTACT BREAST LESION EXCISION SYSTEM WITH INTACT EXCISION XL
- K081262 — DC NEURO
- K081324 — CANDELA FAMILY OF Q-SWITCHED ALEXANDRITE LASERS
- K081414 — MODIFICATION TO CORAL SPINAL SYSTEM
- K081439 — VITOSS BIOACTIVE FOAM PACK BONE GRAFT SUBSTITUTE
- K081582 — INFX-8000V, INFINIX-CFI AND INFINIX VFI
- K062254 — AXIS FIXATION SYSTEM
- K080023 — MODIFICATION TO: SPIRIT
- K073416 — ARKRAY GLUCOCARD 01 BLOOD MONITORING SYSTEM
- K073598 — BARD DIGNICARE STOOL MANAGEMENT SYSTEM
- K080447 — SURGICRAFT SCREW FIXATION SYSTEM
- K080519 — PRISMAFLEX M150 SET
- K080609 — SWC/DWC WARMING CABINETS
- K080902 — FREMS SSC DISPOSABLE FOAM ELECTRODES, MODEL 800-000-057; FREMS SSC DISPOSABLE NON-WOVEN ELECTRODES, MODEL 800-000-058
- K081164 — D3 DFA CYTOMEGALOVIRUS IMMEDIATE EARLY ANTIGEN IDENTIFICATION KIT
- K081212 — MRSASELECT - EXTENDED INCUBATION
- K081381 — RANGE SPINAL SYSTEM, LARGE DENALI SCREWS
- K081454 — GUARDDOG OCCLUSION GUIDEWIRE, INFLATION DEVICE
- K081589 — WATERLASE, VERSION 3.0
- K072731 — ENDSNOR
- K073288 — ETHICON ENDO SURGERY ARTICULATING SNARE
- K081469 — SECTRA WORKSTATION, IDS7 VERSION 11.3, IDS5 VERSION 11.1 P2
- K081496 — OPTIMA PET/CT 560
- K072427 — SIGMA SERIES HYPERBARIC CHAMBER
Data sourced from openFDA. This site is unofficial and independent of the FDA.