FDA 510(k) clearances — page 444
clearances on record, most recent first.
Clearances — page 444
44,301–44,400 of 175,770- K112790 — AXIS-SHIELD 3-REAGENT HOMOCYSTEINE ASSAY FOR SYNCHRON
- K113713 — GEN_2 MECHANICAL WHEELCHAIR
- K113732 — IPLAN (IPLAN CRANIAL, IPLAN STEREOTAXY, IPLAN ENT, IPLAN CMF, IPLAN VIEW, IPLAN SPINE)
- K120106 — APIXIA DIGIREX DIGITAL DENTAL REDIOGRAPHY SYSTEM
- K120550 — CARTO(R) EP NAVIGATION SYSTEM, VERSION 3.0 (WITH STANDARD LOCATION PAD)
- K120724 — PIONEER LATERAL PLATE SYSTEM
- K112279 — QUANTUM DENTAL IMPLANT SYSTEM
- K112549 — IV CLEAR ANTIMICROBIAL CLEAR SILICONE ADHESIVE DRESSING WITH CHLORHEXIDINE AND SILVER
- K112665 — TRI AUTO MINI - ENDODEONTIC TREATMENT MOTORIZED HANDPIECE
- K112671 — STERILCONTAINER SYSTEM
- K112797 — POWERFLEX PRO PERCUTANEOUS TRANSLUMINAL ANGIOPLASTY CATHETER
- K113340 — KIMBERLY-CLARK CHILD'S FACEMASK
- K113689 — DUKAL LUBRICATING JELLY
- K120020 — VIVIX-S
- K120141 — KENSEY NASH BONE VOID FILLER XC
- K120171 — ACCUSONIC ADVANTAGE
- K120362 — METAFIX FEMORAL STEM FOR HEMI-ARTHROPLASTY
- K120364 — UNIMED DISPOSABLE BLOOD PRESSURE CUFF
- K120507 — UNITED U2 FEMORAL COMPONENT, PS, #7
- K120518 — END TIDAL CO2 NASAL CANNULA
- K120548 — HLIC NEEDLE-LESS VALVE
- K121015 — EMBOSHIELD NAV6 EMBOLIC PROTECTION SYSTEM
- K121057 — COOK CELECT AND GUNTHER TULIP VENA CAVA FILTER SETS
- K102577 — FORCE MEDICAL IM NAIL SYSTEM
- K111409 — APTIMA COMBO 2 ASSAY
- K112083 — LIFEGLOBAL TOTAL, TOTAL FOR FERTILIZATION, TOTAL W/HEPES, HTF TOTAL, HTF TOTAL W/HEPES
- K112995 — GEM PREMIER 4000
- K113216 — RAPIDPOINT 500 BLOOD GAS ANALYER
- K113341 — GUIDESHOT OPTION, SCENARIA WHOLE-BODY X-RAY CT SYSTEM
- K113660 — COLD PACK, PLASTIC APPLICATOR (MEDICAL GRADE)-NON-CHEMICAL
- K113812 — ATAL-8
- K120335 — EMBRACE THERMOPLASTIC
- K120344 — RADIAPAK BRACHYTHERAPY APPLICATOR BALLOON DEVICE
- K120351 — CARESENS N POP BLOOD GLUCOSE MONITORING SYSTEM CARESENS N POP BLOOD GLUCOSE METER CARESENS N BLOOD GLUCOSE TEST STRIP CA
- K120359 — ORTHOLOC 3DI HALLUX SYSTEM
- K120431 — HALO90 ULTRA ABLATION CATHETER
- K120704 — 3M LITTMANN TELESTETH ONLINE AUSCULATION SYSTEM
- K120768 — ES FLOW
- K121006 — ENSITE ARRAY MULTI-ELECTRODE DIAGNOSTIC CATHETER
- K121020 — VIPER SYSTEM
- K121037 — LOSPA TIBIAL BASE PLATE
- K121182 — VIALOK NON-VENTED
- K121194 — ENDO CLIP III 5MM CLIP APPLIER
- K111008 — MICROWARE BONE PLATES AND BONE SCREW
- K112288 — JIAJIAN TENS
- K112924 — RS SAFE BLACK NITRILE MEDICAL EXAMINATION GLOVES POWDER OR OTHER PROPRIETARY NAME
- K113088 — HUMMINGBIRD SUBDURAL H900DS (DRAINAGE AND ICP), HUMMINGBIRD SUBDURAL- H800S (ICP ONLY)
- K113355 — POSEY BED
- K113511 — ECHOSTAR SPICA 1.5T MR SYSTEM
- K120023 — ZELTIQ COOLSCULPTING
- K120168 — LULLABY LED PHOTTHERAPY SYSTEM
- K120184 — POWDER FREE NITRILE EXAMINATION GLOVE, BLUE COLORED, BLACK COLORED AND WHITE COLORED
- K120261 — PPS PI PRESSURE INJECTABLE SAFETY HUBER NEEDLE WITHOUT LATERAL INJECTION SITE, PPS PI PRESSURE INJECTABLE SAFETY HUBER
- K120438 — FLASH (DIFFERENT MATERIALS)
- K120978 — OSTEOBRIDGE IKA KNEE ARTHODESIS NAIL WITH COLLAR
- K120980 — 1.9F X 20CM VASCU-PICC 1.9F X 50CM VASCU-PICC
- K120981 — 2.6F X 20CM VASCU-PICC 2.6F X 50CM VASCU-PICC
- K120983 — ULTRAFLEX ESOPHAGEAL NG STENT SYSTEM
- K121139 — ACCUMESH DEPLOYMENT SYSTEM
- K121167 — CAIRE COMPANION 5 OXYGEN CONCENTRATOR
- K110212 — INRATIO2 PI/NR MONITORING SYSTEM; INRATIO PT/INR TEST STRIP
- K111925 — PSYCHEMEDICS COCAINE EIA
- K111926 — PSYCHEMEDICS OPIATES EIA
- K111927 — PSYCHEMEDICS METHAMPHETAMINE EIA
- K111928 — PSYCHEMEDICS PHENCYCLIDINE EIA
- K111929 — PSYCHEMEDICS CANNABINOIDS EIA
- K112593 — STYKER CONSOLIDATED OPERATING ROOM EQUIPMENT (CORE) SYSTEM
- K112684 — MONT BLANC PEDICLE SCREW SYSTEMS
- K112801 — AYERS ROCK CERVICAL CAGE
- K112986 — LATERAL FUSION DEVICE
- K113145 — ECHELON OVAL MRI SYSTEM
- K113384 — EXTERNAL FIXATOR ST.A R 90 F4
- K113833 — VITAL SIGNS MONITOR
- K120748 — SPEEDUP SOFTWARE OPTION
- K121044 — ILLUMIGENE GROUP B STREPTOCOCCUS CARROT BROTH CLAIM
- DEN110016 — PERCUTANEOUS SURGICAL SET WITH 5MM OR 10MM ATTACHMENTS
- DEN120013 — PORTRAIT ANALYZER
- K110530 — ABX PENTRA CREATININE 120 CP; ABX PENTRA MULTICAL; ABX PENTRA N CONTROL; ABX PENTRA P CONTROL; ABX PENTRA URINE CONTROL
- K112148 — POWERED MUSCLE STIMULATOR
- K112909 — OCD04 3% HYDROGEN PEROXIDE CLEANING AND DISINFECTING SOULTION
- K113687 — EQUINOX RELIEVE
- K120215 — SINGLE-SITE MEDIUM-LARGE CLIP APPLIER, SINGLE-SITE CADIERE GRASPER, SINGLE-SITE FUNDUS GRASPER, SINGLE-SITE CROCODILE
- K120492 — K2 MEDICAL VASCULAR CLAMPS
- DEN100016 — PROSTATE MECHANICAL IMAGER
- K110629 — RESMART CPAP, RESMART AUTO-CPAP AND RESMART HUMIDIFIER
- K111250 — DRY MOUTH MOUTHWASH
- K111895 — ECHOTIP(R) ULTRA FIDUCIAL NEEDLE
- K112314 — NEPHROS OLPUR H2H HEMODIAFILTRATION (HDF) MODULE AND OLPUR MD 220 HEMODIAFILTER
- K112535 — GENESIS REUSABLE RIGID CONTAINER SYSTEM
- K113119 — ENDOGATOR ADVANTAGE IRRIGATION PUMP
- K113221 — NAMSA BIOLOGICAL INDICATOR SPORE STRIPS
- K113286 — ENCORE 14 SOFTWARE RELEASE FOR THE GE LUNAR DXA BONE DENSITOMETERS
- K113599 — SURGICASE CONNECT
- K113616 — ACCUDXA2
- K113707 — STERILE NEOPRENE POWDER-FREE SURGICAL GLOVES WITH NITRILE COATING
- K113837 — POWDER FREE VINYL PATIENT EXAMINATION GLOVES
- K113848 — R3 XLPE LINERS
- K120043 — CSM INTERNAL-R IMPLANT SYSTEM
- K120108 — APTUS PROXIMAL HUMERUS SYSTEM
- K120341 — PLASTIC NEEDLE WITH MANDRIN 2.0 DIAMETER LENGTH 113MM
Data sourced from openFDA. This site is unofficial and independent of the FDA.