FDA 510(k) clearances — page 386
clearances on record, most recent first.
Clearances — page 386
38,501–38,600 of 175,770- K132144 — KERATOR
- K132607 — NS 2500 HOLMIUM LASER SYSTEM
- K133657 — DISCOVERY PET/CT 710
- K133735 — EYE SECRET 55 UV ASPHERIC (METHAFILCON A) SOFT (HYDROPHILIC) CONTACT LENS
- K133782 — NOVA FA DR SYSTEM
- K133786 — DORNOCH DUO SUCTION CART WITH: DL2800 LID, CL500 LID, DORNOCH QUAD SUCTION CART WITH: DL2800 LID, CL500 LID
- K133944 — RANGE, SPINAL SYSTEM, EVEREST SPINAL SYSTEM
- K140524 — TERASON USMART3200 AND BENQ UP200ULTRASOUND SYSTEM
- K131971 — IM60/IM70 PATIENT MONITOR
- K132123 — TRC-PEX, RADIC-SEALER
- K132436 — VARIOGUIDE DRILL KIT
- K133073 — CAIR DRIVE, NEUTRACLEAR
- K133211 — ZIRTOUGH
- K133231 — DIGORA OPTIME
- K133319 — ET LIGHTSHEER 1060, HIGH SPEED LIGHTSHEER 1060
- K133398 — STRYKER PEDIATRIC MANDIBLE DISTRACTOR
- K133529 — CAMBER SPINE COVERIS CERVICAL CAGE
- K133613 — INTRA-LOCK DENTAL IMPLANTS
- K133842 — TYBER MEDICAL TRAUMA SCREW
- K133958 — FLOW-I ANESTHESIA SYSTEM C20, C30 & C40
- K134038 — CAMBER SPINE DIAGON OBLIQUE CAGE
- K140253 — MAGNETOM ARTIS COMBI SUITE FOR THE MAGNETOM AERA/SKYRA/SKYRA WITH TIMTX TRUESHAPE
- K140465 — VIRTUOSO SYSTEM FOR IHC ER (SP1) WITH BENCHMARK ULTRA STAINER
- K132078 — METALLIC INTRAMEDULLARY NAIL SYSTEM
- K132151 — SRS ENDOSCOPIC STAPLING SYSTEM
- K132206 — MELYS ATRIAL FIBRILLATION SCREENING MONITOR
- K133144 — SONOSURE SONOHYSTEROGRAPHY & ENDOMETRIAL SAMPLING DEVICE
- K133217 — CIRRUS PHOTO
- K133374 — STREAMLINE OCT OCCIPITO-CERVICO-THORACIC SYSTEM
- K133734 — SEAL SINGLE-USE BIOPSY VALVE
- K133780 — SPEED XL
- K133892 — IVUE 500
- K140398 — EMBOL-X INTRODUCER SHEATH
- K131210 — ELECTRONIC THERMOMETER
- K132975 — SPHINX JR
- K133308 — TINNITUS SOUNDSUPPORT
- K133865 — ASAHI GAIA FIRST, SECOND, THIRD
- K133894 — SURFLO WINGED INFUSION SET WITH FILTER & NEEDLE PROTECTION (SURSHIELD)
- K140105 — HEVYLITE HUMAN IGA KAPPA KIT FOR USE ON SIEMENS BNII, HEVYLITE HUMAN IGA LAMBDA KIT FOR USE ON SIEMENS BNII
- K131258 — SATURN DENTAL IMPLANT
- K133209 — FORESEE (4C) IMAGING SYSTEM
- K134054 — BOVIE IDS-310 HIGH FREQUENCY ELECTROSURGICAL GENERATOR, AARON A3350 HIGH FREQUENCY ELECTROSURGICAL GENERATOR
- K131386 — EZ-OX PLUS GENERATION II
- K131796 — MANUKA FILL WOUND DRESSING
- K131899 — SW-THERM
- K131928 — FREND TSH (REAGENT CARTRIDGE)
- K132393 — CERCOM II CEMENT
- K132698 — FASTOUCH FIXATION SYSTEM
- K132805 — BG MORSELS
- K132944 — ADVANTAGESIM MD MR PELVIC ORGAN AT RISK SEGMENTATION
- K133227 — SMART SEGMENTATION - KNOWLEDGE BASED CONTOURING
- K133252 — HEALTHINTERLINK BEACON
- K133323 — VOLCANO IFR MODALITY
- K133406 — CS 8100 3D
- K133410 — DIAZYME 25-OH VITAMIN D ASSAY; DIAZYME 25-OH VITAMIN D CONTROL SET
- K133608 — TRINIA
- K133824 — CERASMART
- K133893 — STERISPINE LC CAGE
- K134052 — RADIANCE 330 PROTON THERAPY SYSTEM
- K140345 — THE SHERLOCK 3CG TIP CONFIRMATION SYSTEM (TCS)
- K140388 — LUMENIS PULSE 120H
- K130501 — INTENSIF
- K132752 — ULTRACONGRUENT INSERT
- K133005 — HEMOSIL VON WILLEBRAND ACTIVITY ASSAY
- K133015 — INSTRU-SAFE INSTRUMENT PROTECTION SYSTEM
- K133097 — E-Z LINK
- K133205 — CAPSTONE PTC SPINAL SYSTEM, CLYDESDALE PTC SPINAL SYSTEM
- K133221 — ARSENAL SPINAL FIXATION SYSTEM
- K133381 — OMNI ARC MONOBLOCK HIP STEM
- K133665 — MALLEABLE SUCTION INSTRUMENTS
- K133764 — CHLORASHIELD IV DRESSING WITH CHG ANTIMICROBIAL
- K133832 — KLASSIC HD HIP SYSTEM, OFFSET FEMORAL STEM, NON-POROUS / POROUS
- K140107 — EMERGE MEDICAL DISTAL RADIUS SET
- K140276 — CD HORIZON SPINAL SYSTEM
- K130981 — FLEXSTENT BILIARY SELF EXPANDING STENT SYSTEM; S.M.A.R.T. RE-FLEX BILIARY ELF-EXPANDING STENT SYSTEM
- K131675 — BODIHEALTH SYSTEM
- K132080 — SNAP WOUND CARE SYSTEM
- K133486 — STELLARIS PC VISION ENHANCEMENT SYSTEM
- K133746 — POLARIS SPINAL SYSTEM
- K140064 — SURGISLEEVE WOUND PROTECTOR
- K140098 — EMERGE MEDICAL SMALL FRAGMENT LOCKED PLATING SYSTEM
- K140119 — EMERGE MEDICAL PERIARTICULAR AND LOCKING LARGE FRAGMENT SYSTEM
- K140318 — SOUNDSTAR ECO 8F GULTRASOUND CATHETER, SOUNDSTAR ECO 8F ULTRASOUND CATHETER
- K140405 — TORRENT IRRIGATION SYSTEM
- DEN120019 — CEFALY
- K122358 — NOVEON
- K131433 — ISYS 1 (U.S),ACCESSORY, NON-STERILE
- K131916 — BPROSOFT CASP PC SOFTWARE
- K132094 — CIOS ALPHA
- K132322 — NEWTRON P5 XS B.LED
- K132736 — ACCURO 3000 ULTRASOUND SCANNER
- K133350 — REVERE STABILIZATION SYSTEM
- K133386 — OVATION TRIBUTE HIP STEM; OVATION NARROW HIP STEM
- K133401 — SYNO MR NEUROLOGY, SYNGO MR ONCOLOGY, SYNGO. MR BREVIS, SYNGO MMR GENERAL
- K133442 — BONE SUPPRESSION SOFTWARE
- K133483 — PORTABLE THERAPEUTIX SQUID ACTIVE COLD COMPRESSION DEVICE AND COLD PACK FOR OTC USE
- K133755 — KOWA SL-17
- K140248 — S TEST REAGENT CARTRIDGE CARBON DIOXIDE (CO2)
- K140327 — ULTIMUM EV HEMOSTASIS INTRODUCER
- K121123 — BIOFUSIONARY BEBE
Data sourced from openFDA. This site is unofficial and independent of the FDA.