FDA 510(k) clearances — page 544
clearances on record, most recent first.
Clearances — page 544
54,301–54,400 of 176,542- K083693 — PB 840 VENTILATOR SYSTEM WITH LEAK COMPENSATION OPTION, MODEL 840
- K090003 — ZETAJET
- K090130 — ATMOS S041 WOUND
- K090585 — NEOSALUS CREAM
- K090624 — COOK MREYE EMBOLIZATION COILS
- K090713 — ELEVATE PROLAPSE REPAIR SYSTEM WITH PC COATED INTEPRO LITE- APICAL AND POSTERIOR PROLAPSE REPAIR SYSTEM, ANTERIOR AND AP
- K081527 — LIGHT DIAGNOSTICS HSV 1/2 TYPING DFA KIT
- K082080 — ALCO TUBE PLUS
- K082796 — SOPRO 184 CAMERA
- K083098 — NAVIGATOR APPLICATIONS SUITE
- K083310 — SPINE & TRAUMA ICT
- K083393 — XIA 3 SPINAL SYSTEM
- K083524 — SYNGO DUAL ENERGY WITH EXTENDED FUNATIONALLY
- K083569 — SURGYBONE
- K083674 — PK-141 PATIENT CABLE
- K083820 — VASOMEDICAL BIOX CB-1305-C, 3 CHANNEL ECG HOLTER MONITOR, MODEL CB-1305-C
- K090047 — SYNTHES (USA) 1.5MM MINI FRAGMENT LCP SYSTEM
- K090163 — STYLET, MODELS 4060, 4062, 4064, 4090, 4091 AND 4078
- K090323 — REPROCESSED ELECTROPHYSIOLOGY CATHETERS
- K090376 — SPINESMITH CYNCH SPINAL SYSTEM
- K090759 — BIODRAIN STREAMWAY FLUID MANAGEMENT SYSTEM
- K083114 — ACUSON P50 ULTRASOUND SYSTEM
- K083432 — DRILL FREE MMF SCREW
- K083446 — CARDIAC FUNCTION ANALYSIS, CALCIUM SCORING
- K083722 — ASCEND
- K090026 — CHITOGAUZE, MODELS 130, 131, 263, 264, 265, 266
- K090106 — PRELUDE ONE
- K090223 — ICAD BREAST INTERVENTIONAL PLANNING SOFTWARE, MODEL D70024
- K090259 — OKAMOTO ULTRA THIN
- K090403 — AUTOSPECT
- K090492 — 1.5MM SMALL LOCKING PLATE, 1.5MM NON-LOCKING AND LOCKING SCREWS
- K090499 — LIFEDOP MODEL, L350R
- K090553 — NAVISCAN PEMFLEX SOLO II HIGH RESOLUTION PET SCANNER
- K090644 — VITABLOCS, MODEL VX55-****
- K090722 — SHAPE-HF CARDIOPULMONARY EXERCISE TESTING SYSTEM
- K080852 — KSEA ELECTRONIC CO2 ENDOFLATOR LC, MODEL 26430320-1
- K082582 — SENTINEL, MODEL SP-001
- K082719 — NIKKLINE BLOOD TUBING LINES WITH TRANSDUCER PROTECTORS, MODELS AV06A-P, AVO6B-P, AV06C-P
- K083169 — EPTFE SLFTM SPIRAL VASCULAR GRAFT
- K083487 — EMIT 2000 SIROLIMUS ASSAY, EMIT 2000 SIRO/TACRO SAMPLE PRETREATMENT REAGENT, AND EMIT 200 SIROLIMUS CALIBRATOR
- K083784 — PRONTO V3 EXTRACTION CENTER, MODEL 5003, PRONTO LP EXTRACTION CATHETER, MODEL 5010, SKYWAY RX SUPPORT CATHETER,
- K090372 — THE WAND MICROACCESS SAFETY INTRODUCER
- K081748 — ONEPLANT DENTAL IMPLANT SYSTEM
- K082177 — KIMGUARD ONE-STEP STERILIZATION WRAP
- K083024 — HYLATOPIC EMOLLIENT FOAM
- K083161 — ZEN WIRELESS FOOTSWITCH (W1000), ZEN WIRELESS FOOTSWITCH ADAPTER (W1100)
- K083266 — GORE BIO-A FISTULA PLUG
- K083307 — SYNTHASOME X-REPAIR
- K083863 — THEKEN ATOLL OCT SPINAL SYSTEM
- K083869 — BT-TITE CV3, MINI IMPLANT, MINI SINGLE, SLOT IMPLANT, MODEL(S) DDDIII BTICV3, 1, AND DDDIIIBTISI
- K090153 — SPI VARIOMULTI ANGLED ABUTMENT
- K090201 — UA-CELLULAR FOR IQ
- K090410 — COOLTOUCH THERMAL SENSING HANDPIECE ACCESSORY
- K090495 — TRUEBALANCE BLOOD GLUCOSE SYSTEM
- K090512 — POWERPORT DUO M.R.I. IMPLANTED PORT WITH 9.5 FR. DUAL LUMEN CHRONOFLEX POLYURETHANE CATHETER
- K090649 — VRAD PICTURE ARCHIVING AND COMMUNICATIONS SYSTEM SOFTWARE
- K081433 — EK/P. AERUGINOSA PNA FISH
- K081978 — RELIANCE SPINAL SCREW SYSTEM
- K082227 — MINICAP HEMOGLOBIN(E) KIT, MODEL 2207, 2227
- K082499 — C. DIFF QUIK CHEK COMPLETE
- K082662 — V-LOC 180 ABSORBABLE WOUND CLOSURE DEVICE
- K082967 — MORTARA STRESS ECHO BED
- K083020 — STRYKER SPINE REFLEX TRANSLATIONAL ANTERIOR CERVICAL PLATING SYSTEM
- K083389 — COALITION SPACER
- K083662 — CRITICOOL
- K083739 — HYDRORISE AND HYDROSYSTEM
- K090112 — MIDAS REX MR7 PNEUMATIC HIGH SPEED SYSTEM, MODELS PM700, PM710, PC700, PC710, PC720, PA700
- K090478 — AOS PROXIMAL HUMERAL NAIL
- K090508 — THE BELMONT BUDDY LITE FLUID WARMER
- K090536 — FORA V12 NO-CODING BLOOD GLUCOSE MONITORING SYSTEM, MODEL TD-4247
- K090659 — ATTAIN COMMAND 6250 LEFT HEART DELIVERY SYSTEMS AND GUIDE CATHETERS FOR LEFT HEART DELIVERY
- K081775 — THE MEDCOMP .010 VASCULAR GUIDEWIRES
- K081946 — SUPRA TWIN OPHTHALMIC LASER PHOTOCOAGULATOR
- K082465 — EVERON
- K082558 — COMFORTLITE NASAL MASK
- K083234 — KIMBERLY-CLARK KC100 SURGICAL DRAPES, MODEL KC 100, KIMBERLY-CLARK KC100 SURGICAL EQUIPMENT COVERS, MODEL KC 100
- K083562 — STRYKER SPINE NULOCK ANTERIOR CERVICAL PLATING SYSTEM
- K083792 — WEDGELOC SUTURE ANCHOR WITH OPTI-FIBER SUTURES, MODEL 1000-01-055
- K090433 — I_OPEN 0.4T
- K090439 — FORUM
- K090473 — DISCOVERY ELBOW - X-SMALL
- K062187 — BETACHEK GLUCOSE TEST
- K083224 — CPI RAD VISION, MODEL VZW2944XX-YY
- K083445 — N ANTISERA TO HUMAN IMMUNOGLOBULINS (IGG, IGA AND IGM) AND N/T PROTEIN CONTROL LC
- K083606 — SENSITITRE 18-24 HOUR SUSECEPTIBILITY PLATES
- K083853 — IMMULITE 2000 3GALLERGY SPECIFIC IGE ASSAY KIT
- K090067 — BACTRACK SELECT BREATHALYZER, MODEL S80
- K090120 — REFSTAR PLUS WITH QWIKPATCH EXTERNAL REFERENCE PATCH, MODEL D-1210-03, REFSTAR PLUS CABLE, MODEL M-4700-106
- K090310 — EQUIVABONE
- K090623 — DIGITAL RADIOGRAPHY CXDI-40G COMPACT
- K090625 — WIRELESS PORTABLE DETECTOR FD-W17
- K081168 — BRIT PACS SYSTEMS
- K081346 — HOYA IS INJECTOR SYSTEM
- K082439 — DISPOSABLE ANGIOGRAPHIC SYRINGE, MODEL(S) CT-200-NE, CT-200-MA, CT-200+200-MA, CT-200-LF, CT -100-NE, CT-200NE, CT-50+CT
- K082853 — CLINICAL OXYGEN DOSE RECORDER (CODR), MODEL 300-CR
- K083750 — CAPNOSTAT / CAPNOFLEX CO2 SYSTEM
- K083780 — SUPERELELASTIC NITINOL PISTON, SUPERELASTIC NITINOL TRIMMABLE PISTON, MODEL SPL03.39/40/41/42 (DETAILS IN 510(K) ANNEX 2
- K083789 — ACE FISCHER EXTERNAL FIXATION SYSTEM
- K083852 — BIOGRAPH 16 TRUE POINT SYSTEMS
- K083886 — SIMPLER MINI IMPLANT, MODELS SM 5002, SM 5003, SM 5004
Data sourced from openFDA. This site is unofficial and independent of the FDA.