FDA 510(k) clearances — page 498
clearances on record, most recent first.
Clearances — page 498
49,701–49,800 of 176,542- K083746 — BIOSIGN FLU A+B
- K100100 — DIO STEADY EXTERNAL IMPLANT SYSTEM
- K100590 — EDGE CO2 LASER SYSTEM
- K100797 — FETAL MATERNAL MONITOR MODEL F9 EXPRESS AND EXPRESS
- K101105 — POWDER-FREE, NATURAL COLOR, LATEX EXAMINATION GLOVE MODEL: MEPF1
- K101106 — POWDERED, NATURAL COLOR, LATEX EXAMINATION GLOVE MODEL: MEP1
- K101654 — IMPROVIS IMAGING SYSTEM
- K101912 — THE INFRARED FOREHEAD THERMOMETER, MODEL FS-300&301
- K102162 — PARCUS PEEK CF PUSH-IN SUTURE ANCHOR
- K102240 — NIVO NEBULIZER SYSTEM
- K102445 — ROSTAM SCENTED AND UNSCENTED BIODEGRADABLE PLASTIC APPLICATOR TAMPONS
- K103012 — EXACTECH BIOLOXDELTA / BIOLOX FEMORAL HEADS, 28MM OD, 32MM OD, 36MM OD, EXACTECH BIOLOX OPTION ADAPTERS/FEMORAL HEADS
- K103052 — V-LOC(TM) NONABSORBABLE WOUND CLOSURE DEVICE
- K103164 — VONFLEX HEAVY, VINFLEX LIGHT
- K103165 — BLOOD SAMPLING SET
- K103184 — SILK'N FLASH N GO
- K092258 — RANDOX METABOLITE (EDDP) ASSAY
- K092541 — INTERFACE
- K101183 — MODIFICATION TO: OASYS SYSTEM
- K101321 — EMATRIX CO2
- K101382 — DPL NUVE
- K101400 — LOCKING COMPRESSION PLATE
- K102048 — ATRAUMATIC VASCULAR CLAMPS
- K102215 — KIRSCHNER WIRES, STEINMAN PINS
- K102245 — CARE ZY5BA OXYGEN CONCENTRATOR
- K102344 — MDIXON SOFTWARE OPTION FOR INTERA 1.5T, ACHIEVA 1.5T & ACHIEVA 3.0T MR SYSTEMS
- K102484 — SEQURE SNARE SYSTEM
- K102666 — KIMBERLY-CLARK SURGICAL DRAPES WITH AAMI LIQUID BARRIER LEVEL 4 CLAIM
- K102988 — ELECTRONIC BLOOD PRESURE MONITOR
- K103003 — AESCULAP- MEITHKE PROGAV PROGRAMMABLE SHUNT SYSTEM
- K103007 — AFFINITI TOTAL AND HEMI-SHOULDER SYSTEM
- K103041 — VACUETTE BLOOD COLLECTION TUBE WITH LITHIUM HEPARIN AND GEL SEPARATOR
- K101582 — CAM STRUCTSURE BARS
- K101808 — SHAPELOC-CL (CRUCIATE LIGAMENT) SOFT TISSIE FASTNER, SHAPELOC-ST (TENODESIS) SOFT TISSUE FASTNER
- K101943 — SYNTHETIC, POWDER-FREE NITRILE EXAMINATION GLOVES
- K102073 — MED-RX TRANSFER SET, MODELS 10-1227TS, 10-1300TS, 10-1305TS AND 10-1306TS
- K102337 — SYNTHETIC VINYL EXAMINATION GLOVES, POWDER FREE
- K102354 — GRANDIO SO HEAVY FLOW
- K102487 — NOVATION FEMORAL STEM, TAPERED 12/14 , STANDARD/EXTENDED OFFSET, PLASMA COATED, PRESS-FIT, SIZE 19/20
- K102581 — DEFENDO DISPOSABLE SUCTION VALVE MODEL 100305
- K100407 — LIFE SPINE INTERSPINOUS FIXATION SYSTEM
- K101220 — EXPLORER 4D TREATMENT PLANNING SYSTEM
- K101519 — PARIETEX PLUG AND PATCH
- K101538 — HANDHELD MANUAL BREAST PUMP (AVENT MANUAL BREAST PUMP)
- K102067 — ENDOSKELETON TO
- K102198 — COMPACT TOUCH STS
- K102393 — VIVID S5 DIAGNOSTIC ULTRASOUND SYSTEM; VIVID S6 DIAGNOSTICULTRASOUND SYSTEM
- K102527 — IMAGER II UROLOGY TORQUE CATHETER (C1 TIP); IMAGER II UROLOGY TORQUE CATHETER (C2 TIP
- K102757 — LIFENET SYSTEM
- K102820 — APPLIANCE, FIXATION, SPINAL INTERVERTEBRAL BODY
- K102975 — NOVATION CROWN CUP WITH INTEGRIP ACETABULAR SHELL, CLUSTER-HOLE
- K101112 — RELIANCE SPINAL SCREW SYSTEM
- K102200 — INTEGRITY MODEL 1014284
- K102388 — VIVID I DIAGNOSTIC ULTRASOUND SYSTEM
- K102409 — DEFENDO DISPOSABLE AIR/WATER VALVE MODEL 100304
- K102500 — STERILE NEOPRENE POWDER-FREE SURGICAL GLOVES WITH NITRILE COATING
- K102631 — KD-931D FULLY AUTOMATIC ELECTRONIC BLOOD PRESSURE MONITOR
- K102951 — EXACTECH EQUINOX FIXED ANGLE REPLICATOR PLATE (0MM,1.5MM,4.5MM), HUMERAL HEAD-SHORT (44MM,47MM), GLENOSPHERE (38MM,42MM)
- K102953 — HEPARIN DOSE RESPONSE CARTRIDGE
- K102967 — SMITH & NEPHEW, INC. SURESHOT DISTAL TARGETING SYSTEM V2.0.2
- K091360 — CLEARFLUX DIALYZER REPROCESSING SYSTEM
- K100364 — GAMBRO CARTRIDGE BLOOD SET LOW WEIGHT- LOW VOLUME, MODEL 003422-520
- K100917 — FIDIS VASCULITIS ASSAY KIT AND ANALYZER AND CARIS SYSTEM
- K101182 — IOLMASTER 500
- K101882 — PRONTOSAN ANTIMICROBIAL WOUND GEL
- K102072 — MEMOMETAL IMPLANTS (K-SNAP & TI-FUSE)
- K102093 — POWDER FREE VINYL PATIENT EXAMINATION GLOVES
- K102231 — DISCOVERY NM 750B
- K102372 — OBS DISPOSABLE ELECTROSURGICAL PADS, MONOPOLAR, BIOPOLAR, MODELS GBS-DM, GBS-DB
- K102478 — OTC ELASTO-GEL MANUKA HONEY WOUND DRESSING
- K102646 — SPIDER FLEX MONOPOLAR HOOK
- K102865 — DC-7 DIAGNOSTIC ULTRASOUND SYSTEM, DC-3/DC-3T DIAGNOSTIC ULTRASOUND SYSTEM
- K102930 — FULLY AUTOMATIC ELECTRONIC BLOOD PRESSURE MONITOR
- K102994 — K-SHIELD ARTERIAL VENOUS FISTULA SET WITH ANTINEEDLE STICK PROTECTOR
- K102074 — POWDER FREE NITRILE EXAMINATION GLOVES, TESTED FOR USE WITH CHEMOTHERAPY DRUGS, BLUE (SG)
- K102351 — GRANDIO SO
- K102583 — MUCHECK, VERSION 9.0
- K092273 — RANDOX ETHANOL ASSAY
- K102086 — ELECSYS CA 125 II CALCHECK 5
- K102983 — VASCUCLEAR PRECISION BIPOLAR
- K092451 — INTERSURGICAL INTER-THERM BREATHING FILTER AND HEAT AND MOISTURE EXCHANGER, INTERSURGICAL INTER-GUARD BREATHING FILTER
- K092477 — NeuroWave NeuroFAST MONITORING SYSTEM, MODEL NF-701
- K092896 — REMPRESS AND ANGIOGRAPHY CONTRAST DELIVERY SYSTEM REMPRESS
- K100589 — MRSA SELECT - SKIN AND SOFT TISSUE WOUND SPECIMENS
- K100926 — ARROWHEAD FIXATION DEVICE
- K101035 — WMI REPROCESSED DVT WRAP, WMI REPROCESSED THERMAL WRAP MODEL: RD-1000F, RD-1000C, RT 2000A, RT 2000B, RT 2000KF, RT 2000
- K101042 — BLADEVIEW
- K101305 — ARK LAMOTRIGINE ASSAY, CALIBRATOR & CONTROL
- K101437 — SPEEDFIX SUTURE SYSTEM
- K101504 — TI-CORE FLOW
- K101540 — GRANITEC DUAL-CURE CORE BUILD-UP, N'DURANCE DIMER CORE
- K101686 — FDR IMAGE STITCHING OPTION
- K101707 — FULACCESS MODEL 1.0
- K101917 — COMFORT RUBBER GLOVES IND.SDN.BHD.
- K101961 — TIGERPAW SYSTEM
- K102013 — DIGITAL RETINAL CAMERA
- K102314 — 3M INTEGRATED CYCLER (110V) & (220V)
- K102347 — GRANDTEC
- K102423 — DEPUY PINNACLE ALTRX ACETABULAR LINERS
- K102575 — ORTHO MTA (MINERAL TRIOXIDE AGGREGATE)
Data sourced from openFDA. This site is unofficial and independent of the FDA.