FDA 510(k) clearances — page 553
clearances on record, most recent first.
Clearances — page 553
55,201–55,300 of 176,542- K081788 — INFRARED EAR THERMOMETER, MODELS INNOTHERM ICT-100 AND ICT-200
- K081814 — REPROCESSED ENT SHAVERS
- K081960 — INVISALIGN SYSTEM
- K082094 — BARD PTFE (TEFLON) COATED GUIDE WIRES
- K082116 — HEMOSTASYL PASTE
- K082180 — PERMA FIBER,MODEL 441; PERMA MESH, MODEL 440
- K082344 — STOCKERT S5 SYSTEM, STOCKERT ELECTRICAL VENOUS OCCLUDER (EVO)
- K082421 — HEARTSUITE HEMODYNAMICS 7.10
- K082481 — FLOWPICC CATHETER
- K082590 — SYMPHONY METER REMOTE
- K082625 — SYNTHES (USA) 3.5MM LCP PERIARTICULAR PROXIMAL HUMERUS PLATES
- K082631 — THROMBO TEK PSE, MODEL 90-480
- K082725 — GRAFTGUARD PRESSURE CONTROLLING SYRINGE
- K082731 — ML24000 UVA-1 PHOTOTHERAPY CABINET
- K082766 — MODIFICATION TO MINISPIR, SPIROLAB III
- K082783 — CADD -SOLIS MEDICATION SAFETY SOFTWARE: ADMINISTRATOR AND POINT-OF-CARE
- K082904 — STASYS MOTION CORRECTION SOFTWARE
- K082985 — A-DEC 334/335 DELIVERY SYSTEM
- K083392 — NOVATION 12/14 CEMENTED FEMORAL STEMS
- K083498 — PHILIPS MODEL MX 16 SLICE CT SYSTEM
- K083610 — FILTEK SUPREME ULTRA UNIVERSAL RESTORATIVE
- K080741 — MEGA SOFT REUSABLE PATIENT RETURN ELECTRODE
- K081929 — VACUETTE BLOOD COLLECTION TUBE WITH CLOT ACTIVATOR AND GEL SEPARATOR
- K082210 — TOTAL BILIRUBIN L3K, MODEL 295-10 AND 295-30
- K082278 — MAMMOMARK, MAMMOMARK MR AND CORMARK BIOPSY SITE IDENTIFIERS
- K082424 — UNITED U2 TOTAL KNEE SYSTEM
- K082451 — STRYKER VIDEOSCOPE
- K082724 — NEWPORT HTS50 VENTILATOR WITH DUAL PAC BATTERY SYSTEM
- K083063 — BIS INTERFACE FOR VITALOGIK PATIENT MONITORS
- K083070 — TOGGLELOC SYSTEM
- K083137 — NEURO III-SV
- K083164 — SYSTEM-ARMS, MODELS 390, X60
- K083171 — INTROL CF PANEL I CONTROL, MODEL: G106
- K083272 — SKINCLEAR Q-SWITCHED ND:YAG LASER
- K083538 — NEUROSTAR TMS THERAPY SYSTEM, MODEL 1.1
- K083555 — PICTURE ARCHIVING AND COMMUNICATION SYSTEM (PACS), PETAVISION
- K073417 — EMBOZENE MICROSPHERES
- K080542 — DISTRAX
- K082224 — DIAGNOSTIC ULTRASOUND SYSTEM SARANO, ECHO VIEW, SHIMASONIC
- K082355 — VISIONSENSE STEREOSCOPIC VISION SYSTEM
- K082460 — CENEFOM PVA SURGICAL SPEAR
- K082509 — EOS SPINAL SYSTEM
- K082705 — BIOPRO BIPOLAR HEAD, MODELS 18130-18152
- K082755 — SEDAT FLAMINGO
- K083093 — CHEETAH RELIANT
- K083129 — SHARPS COMPLIANCE CONTAINER
- K083202 — COMBOCARE 2000
- K083211 — AIRSEAL OPTICAL TROCAR & CANNULA SYSTEM
- K083335 — MODIFIED OMNIWAVE ENDOVASCULAR SYSTEM
- K083402 — AGILIS NXT STEERABLE INTRODUCER, MODEL G408322 AND G408323
- K083535 — HEARTRAK SMART ECAT
- K072831 — FROG
- K081095 — PROLITE III TOWER AND PR AND HR HANDPIECE
- K081852 — TRULY AUTOMATIC BLOOD PRESSURE MONITOR, MODEL DB11
- K082090 — 9131 DEFIBRILLATION ELECTRODES
- K082248 — STA SATELLITE AUTOMATED MULTI-PARAMETER ANALYZER
- K082269 — VISAGE PACS, VERSION 6.0/CS 3.1
- K082382 — ANGIOJET ULTRA AVX THROMBECTOMY SET, MODEL 105039
- K082416 — IBA PROTON THERAPY SYSTEM- PROTEUS 235
- K082603 — TRIMIRA OCS 3000
- K082673 — CONSERVE PRESSFIT FEMORAL COMPONENT
- K082795 — SINGLE USE PERPOS PLS SYSTEM, 4.5 BONE-LOK PLS IMPLANT
- K082932 — CPS AIM SL SLITTABLE INNER CATHETER
- K082970 — MARVEL WHEELCHAIR, MODEL EDCAL01
- K083044 — HUBANG, MODEL HBL13/HBG12-S
- K083282 — MODEL TSX-301B AQUILION CT SYSTEM
- K083370 — D-CLOT THROMBECTOMY CATHETER SYSTEM, MODEL: DC 4006
- K083379 — CYNOSURE SMARTLIPO MPX LASER WITH SMARTSENSE C MODULE
- K083440 — PRIMATRIX DERMAL REPAIR SCAFFOLD
- K083504 — GE DISCOVERY NM/CT 570C
- K083505 — DC-3/DC-3T DIAGNOSTIC ULTRASOUND SYSTEM
- K070541 — IVIVI SOFPULSE, MODELS 912-M10, ROMA3 AND TORINO II
- K081824 — BD PROBETEC CHLAMYDIA TRACHOMATIS (CT) Q AMPLIFIED DNA ASSAY
- K081825 — BD PROBETEC NEISSERIA GONORRHOEAE (GC) Q AMPLIFIED DNA ASSAY
- K081972 — BIOCLEAN CHEMO EMERALD POWDER FREE NITRILE EXAMINATION GLOVES
- K082008 — BIONET BM3PLUS PATIENT MONITOR
- K082385 — CHAPERON GUIDING CATHETER
- K082559 — SPECTRANETICS CROSS-PILOT TURBO ELITE SUPPORT CATHETER
- K082671 — HERCULITE ULTRA
- K082744 — BEAUTIBOND
- K082769 — MESA AND RANGE SPINAL SYSTEMS
- K082770 — ZIMMER NATURAL NAIL SYSTEM TIBIAL NAIL
- K082914 — CLAMPFIX
- K083353 — CAPSURE(R) PS SYSTEM
- K083364 — 2.5 MM MULTIDIRECTIONAL THREADED PEGS, MODELS 131211110-131211130, 1.5 MM LOCKING SCREWS, MODELS 131220408-131220424
- K083400 — CUSTOM COMFORT NIGHTGUARD
- K083560 — EXPANDED SPECTRUM PHOTO THERAPY DEVICE, MODEL ESPT-3X
- K071474 — DIMENSION CLINICAL CHEMISTRY SYSTEM MPO FLEX REAGENT CARTRIDGE, CALIBRATOR,CONTROL, MODEL RF425, RC425,RC426
- K071526 — UNI-VENT 731 SERIES VENTILATORS, MODEL 731, 731EMV
- K080810 — EASYRA BILIRUBIN DIRECT AND TOTAL REAGENT, PHOSPHORUS INORGANIC REAGENT AND IRON AND MAGNESIUM REAGENT
- K082448 — DISPOSABLE VINYL SYNTHETIC EXAMINATION GLOVES, POWDERED
- K082561 — SPECTRANETICS QUICK-CROSS EXTREME SUPPORT CATHETERS
- K082902 — RZ ENDOSCOPIC (MINIMALLY INVASIVE) INSTRUMENTS AND ACCESSORIES
- K083299 — TAIDOC TD-11 SERIES AND CLEVER TD-1112 EAR/SKIN/ SURFACE IR THERMOMETERS & FORA IR16/17 EAR THERMOMETER
- K083306 — MODIFICATION TO ARTHROCARE ARTHROWANDS
- K083308 — PASS LP SPINAL SYSTEM
- K071573 — RUGALIFT, MODEL# V.2.1
- K073681 — NANOBEAM 940, MODEL 940-900-02
- K080022 — GEL-SPONGE ENT, ABSORBABLE GELATIN SPONGE, USP
- K080428 — ATTAIN COMMAND 6250 LEFT HEART DELIVERY SYSTEMS AND ATTAIN COMMAND 6250 GUIDE CATHETERS FOR LEFT HEART DELIVERY
Data sourced from openFDA. This site is unofficial and independent of the FDA.