FDA 510(k) clearances — page 490
clearances on record, most recent first.
Clearances — page 490
48,901–49,000 of 175,770- K102097 — POWDER FREE VINYL PATIENT EXAMINATION GLOVES
- K102159 — POWERPICC SV CATHETERS
- K102531 — MUCOGRAFT
- K102546 — CHITOGAUZE
- K102555 — CD HORIZON SPINAL SYSTEM
- K102603 — SA FLOWABLE ADHESIVE
- K102650 — CYBERKNIFE ROBOTIC RADIOSURGERY SYSTEM
- K102657 — CONCENTRIC BALLOON GUIDE CATHETER
- K102668 — ETEST TOBRAMYCIN 0.016-256 UG/ML AND 0.064-1024 UG/ML
- K102669 — DIODE LASER THERAPY SYSTEM
- K102807 — CD HORIZON SPINAL SYSTEM
- K103100 — MOUNTAINEER OCT SPINAL SYSTEM
- K100565 — DURA PADZ (REUSABLE ELECTRODE), DURA PADZ GEL (DISPOSABLE HYDROGEL) MODEL 8900-0300, 8900-0325
- K102068 — MINIATURIZE CHEST COMPRESSOR (MCC)
- K102171 — POWDER FREE VINYL PATIENT EXAMINATION GLOVES
- K102540 — PTFE PORTABLE INTRODUCER
- K103282 — LAPAROSCOPIC DISSECTOR
- K093054 — SCALP DURA RETRACTOR, MODEL KS00474
- K100888 — MODIFICATION TO LANX POSTERIOR CERVICOTHORACIC SPINAL FIXATION SYSTEM
- K101762 — VIPER F2 FACET FIXATION SYSTEM
- K102204 — CHOICE SPINE STARFIRE PEDICLE SCREW SYSTEM
- K102326 — PARCUS 3.5MM PEEK CF PUSH-IN SUTURE ANCHOR
- K103215 — CIANNA S1, SINGLE LUMEN BALLOON APPLICATOR KIT
- K101174 — ATRICURE BIPOLAR SYSTEM INCLUDING ISOLATOR SYNERGY DUAL ELECTRODE CLAMPS MODEL OLL2, OSL2, EMR2, EML2
- K101285 — CONSTELLATION VISION SYSTEM
- K101619 — WELCH ALLYN 1500 PATIENT MONITOR
- K102558 — POWDER FREE VINYL PATIENT EXAMINATION GLOVES, COLORED (WHITE)
- K102626 — VEGA MEDICAL SUCTION EQUIPMENT, MODEL SU-01/SU-DC01
- 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; IMAGER II UROLOGY TORQUE CATHETER
- 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
Data sourced from openFDA. This site is unofficial and independent of the FDA.