FDA 510(k) clearances — page 410
clearances on record, most recent first.
Clearances — page 410
40,901–41,000 of 175,770- K130642 — SMR 3-PEGS GLENOIDS
- K130690 — Z-800 INFUSION SYSTEM
- K122521 — PREVENT SEAL
- K122748 — ENGLER 25K SERIES ULTRASONIC INSERTS
- K123292 — T3
- K123520 — MAMMOMAT INSPIRATION PRIME
- K130025 — SONENDO ENDOTHERAPY SYSTEM
- K130503 — PATHASSIST LED LIGHT FIBER
- K130567 — DR LONG LENGTH IMAGING SOFTWARE
- K131303 — DISPOSABLE CIRCULAR STAPLER
- K131528 — NON-PYROGENIC ULTRASOUND TRANSDUCER COVER
- K120892 — DISPOSABLE 330PSI EXTENSION LINES
- K124023 — STARBAND
- K130907 — HOFFMANN LRF (LIMB RECONSTRUCTION FRAME) SYSTEM
- K131380 — ACUMED TOTALW RIST FUSION PLATING SYSTEM
- K120945 — HITACHI CLINICAL ANALYZER S TEST REAGENT CARTRIDGE ALT, HITACHI CLINICAL ANALYZER S TEST REAGENT CARTRIDGE AST
- K123105 — XGEO GU60
- K123576 — IMR SOFTWARE APPLICATION
- K123785 — DIAZYME MYOGLOBIN; ASSAY, CALIBRATOR SET, CONTROL SET
- K130185 — 4WEB OSTEOTOMY BONE WEDGE
- K130259 — BEARING NSPVA EMBOLIZATION PARTICLES
- K130446 — FASTBRACES CERAMIC BRACKETS
- K130464 — CARESTREAM DRX-1 SYSTEM WITH DRX 2530C DETECTOR
- K130636 — TELERADPRO EDGE; TELERADPRO EDGE HD-CCD
- K130726 — DA VINCI SINGLE-SITE PERMANENT CAUTERY HOOK
- K130791 — PRELUDE SHEATH INTRODUCER
- K130944 — ISR'OBOT MONA LISA
- K131051 — HITACHI S TEST REAGENT CARTRIDGE TOTAL PROTEIN (TP) AND ALBUMIN (ALB)
- K131112 — LIMACORPORATE SMR CTA HUMERAL HEADS
- K131115 — ZEROWIRE DUO WIRELESS HD VIDEO TRANSFER SYSTEM, OR ZERO WIRE
- K131217 — S TEST REAGENT CARTRIDGE TOTAL BILIRUBIN
- K131300 — THE POWERWAND SAFETY INTRODUCER WITH AN EXTENDED DWELL CATHETER
- K120931 — CRITICAL CARE VENTILATOR
- K121436 — DAS MEDICAL EQUIPMENT DRAPES
- K121642 — WIZARD 230 NASAL PILOW MASK
- K121902 — NATRATONE
- K123394 — CORELEADER HYDRO-HEALER HYDROCOLLOID WOUND DRESSING
- K123481 — AQUACEL AG FOAM HYDROFIBER FOAM DRESSING WITH SILVER, ADHESIVE AND NON ADHESIVE
- K130149 — U2 HIP SYSTEM, EXPANDED INDICATIONS FOR USE
- K130645 — AQUILION PRIME, V5.00
- K130739 — ACUSON S2000 AND S3000 DIAGNOSTIC ULTRASOUND SYSTEMS
- K131103 — XRES BLOOD COLLECTION RESERVOIR XRES 120MICROMETER BLOOD COLLECTION RESERVOIR
- K131329 — VECTOR PTA BALLOON DILATATION CATHETER
- K131346 — MICROLIFE UPPER ARM AUTOMATIC DIGITAL BLOOD PRESSURE MONITOR
- K120954 — NOBELPROCERA PEEK ABUTMENTS
- K122020 — PHOTON PHOTON PLUS
- K123101 — TRC-50DX RETINAL CAMERA
- K123423 — ILLUMIGENE MYCOPLASAMA DNA AMPLIFICATION ASSAY, AND ILLUMIGENE MYCOPLASMA EXTERNAL CONTROLS KIT
- K123518 — ABBOTT CARBAMAZEPINE ASSAY
- K123843 — NEUROEPG SYSTEM
- K130328 — F&P SIMPLUS FULL FACE MASK
- K130382 — HEARTSTRING III PROXIMAL SEAL SYSTEM
- K130427 — PIONEER ASPECT ANTERIOR CERVICAL PLATE SYSTEM
- K130598 — INSPIRACHAMBER ANTI-STATIC VALVED HOLDING CHAMBER
- K130599 — WART FREEZE
- K130773 — TEMPUS PRO PATIENT MONITOR
- K131321 — CD HORIZON SPINAL SYSTEM
- K122365 — ULTRACHECK CURVE BLOOD PRESSURE CUFFS
- K122791 — LYOPLANT ONLAY
- K122979 — VIDAS LYME IGM
- K124012 — INFILL OBLIQUE TLIF DEVICE
- K130290 — MODIFICATION TO INTEL-GE CARE IINOVATIONS GUIDE
- K130640 — ATLANTIS ANTERIOR CERVICAL PLATE SYSTEM
- K122473 — TOTALCARE SPOT TOTALCARE BARIATRIC TOTALCARE DUO TOATALCARE BED SYSTEM TOTALCARE DUO2
- K122965 — HUMAN CAERULOPLASMIN KIT
- K123653 — SEAL BLOCK PRO (NOT FINALIZED), SEAL BLOCK OTC (NOT FINALIZED)
- K123885 — OSTEOMED SMARTFLEX CRANIAL SPRING DISTRACTOR
- K124046 — VALVED TEARAWAY INTRODUCER GENERATION II
- K130507 — FOOTPRINT MEDICAL POLYURETHANE PICC CATHETER
- K120900 — I-STAT PT CONTROL LEVIEL 1 I-STAT PT CONTROL LEVEL 2
- K122700 — PROSBEN CONTACT LENS CASES MODEL CA66-02, CA66-03WB, CA66-04T SERIES
- K123380 — STRIDE UNICONDYLAR KNEE
- K123823 — INTERLIG
- K130129 — UNIVERS REVERS SHOULDER PROSTHESIS SYSTEM
- K130267 — ROMEO POSTERIOR OSTEOSYNTHESIS SYSTEM
- K130277 — SINGLE ENERGY (SE) FEMUR EXAMS
- K130293 — ADVANCE 18LP LOW PROFILE PTA BALLOON DILATATION CATHETER
- K130319 — MEDLINE CANNULATED SCREW
- K130332 — VITROS CHEMISTRY PRODUCTS TRIG SLIDES
- K130338 — IMPEDIMED - BIS EXTRA CELLULAR FLUID ANALYSIS
- K130412 — OSTEOMED EXTREMIFUSE SYSTEM
- K130432 — PHT-6500, PHT-60CFO
- K130474 — SURGISEAL TOPICAL SKIN ADHESIVE
- K130498 — OSTEOSELECT DEMINERALIZED BONE MATRIX PUTTY
- K130547 — ENDOFORM RECONSTRUCTIVE TEMPLATE
- K130954 — ARS SCREW; SLANT SCREW
- K131132 — PELVIS II IMPLANT SYSTEM
- K131136 — GLUCOSE METER-CHECK SOLUTION FOR TAIDOC
- K131232 — WONDFO METHADONE URINE TEST (MTD 200), WONDOFO MORPHINE URINE TEST (MOP 100)
- K131324 — MAXTORQUE SCREW SYSTEM
- K120901 — HUMAN IGA CSF KIT FOR USE ON SPAPLUS
- K122663 — ORAMOIST
- K123202 — PROCLEAR (OMAFILCON A) SOFT HYDROPHILIC) CONTACT LENS
- K123491 — BIODENTA DENTAL IMPLANT SYSTEM - MULTI-USE ABUTMENT
- K123844 — CHEMTRUE HCG PREGNANCY URINE DIPSTICK, HCG PREGNANCY URINE CASSETTE TEST, AND HCG COMBO SERUM/URINE CASSETTE TEST
- K130287 — MR CONDITIONAL CUP ELECTRODE, MR CONDITIONAL WEBB ELECTRODE
- K130311 — TRANSTEK BODY FAT ANALYZER
- K130532 — IDRIVE ULTRA STERILIZATION TRAY
- K130699 — ALEUTIAN SPINAL SYSTEM
- K130869 — TAKE 1 ADVANCE
Data sourced from openFDA. This site is unofficial and independent of the FDA.