FDA 510(k) clearances — page 539
clearances on record, most recent first.
Clearances — page 539
53,801–53,900 of 176,542- K091368 — R2 DIGITALNOW HD(DIGITALNOW HD)
- K083336 — LEVEL 1 SNUGGLE WARM ADULT UNDERBODY CONVECTIVE WARMING BLANKET, MODEL SW-2013, LEVEL 1 SNUGGLE WARM LEFT LATERAL
- K090367 — SE-601 SERIES ELECTROCARDIOGRAPH
- K090615 — OPUS SPEEDLOCK KNOTLESS FIXATION DEVICE
- K090656 — INTERTAN CHS LIMITED COLLAPSE SET SCREW
- K090737 — HEMOGLOBIN CAPILLARY COLLECTION SYSTEM (HCCS), 1 TEST, HEMOGLOBIN CAPILLARY COLLECTION SYSTEM (HCCS), 5 TESTS, HEMOGLOBI
- K082166 — MASTERGRAFT STRIP
- K083057 — I-MAX TOUCH
- K083917 — X-RAY, TOMOGRAPHY, COMPUTED, DENTAL
- K090034 — EASY ON-PC SPIROMETER
- K090060 — NEXLINK OCT SYSTEM, MODEL 7000 SERIES
- K090206 — OCULUS PURACYN ANTIMICROBIAL SKIN AND WOUND CLEANSER
- K090209 — HEMOSIL LIQUID HEPARIN, HEPARIN CALIBRATORS AND LMW AND UF HEPARIN CONTROLS
- K090430 — BACKSTOP AND BACKSTOP INJECTOR
- K090630 — NOBEL BIOCARE ENDOSSEOUS IMPLANTS (MAXILLOFACIAL INDICATION)
- K090776 — MEGAPULSE LASER SYSTEM AND FIBERS
- K090824 — BD PROBETEC CHLAMYDIA TRACHOMATIS (CT) QX AMPLIFIED DNA ASSAY
- K090907 — PENTA LEAD KITS, MODELS: 3227-3234
- K090934 — PFR SLING SYSTEM, PART OF THE AMS PELVIC FLOOR REPAIR SYSTEM
- K091346 — CODMAN HAKIM MICRO II VALVE
- K083899 — REVLITE Q-SWITCHED ND:YAG LASER SYSTEM
- K090412 — POWDER FREE NITRILE EXAMINATION GLOVES (PINK, GREEN, ORANGE,WHITE).
- K090415 — EMINENT SPINE BUTTRESS (FANG) PLATE SYSTEM
- K090525 — LOI SYSTEM
- K090566 — PATHWAY AVID
- K090632 — COMPEX REHAB
- K090900 — ADVIA CHEMISTRY DRUG CALIBRATOR II, MODEL 10376771
- K091069 — MEDACTA BONE SCREWS - EVOLIS AND VERSAFIT
- K091151 — POWDER FREE NITRILE EXAMINATION GLOVE, GREEN TEA SCENTED, GREEN
- K091322 — CONTOUR CURVED CUTTER STAPLER AND RELOADS, MODELS: CS40B, CS40G, CR40B, CR40G
- K081147 — ISOFLOW INFUSION CATHETER
- K082436 — EXTT-101
- K082957 — NON-STERILE, POWDER FREE NITRILE EXAMINATION GLOVE, BLUE COLOR, POLYMER COATED, TESTED WITH CHEMOTHERAPY DRUGS
- K083598 — KARL STORZ VOICE1 SCB R-UI SPEECH CONTROL APPLICATION
- K090052 — CRANIAL ELECTRICAL NERVE STIMULATOR, MODEL FM 10/C
- K090282 — QMS LIDOCAINE
- K090383 — SRI LEVEL II SURGICAL GOWN
- K090421 — MODEL 350G GAS CONSERVER
- K090432 — HEMORPEX SYSTEM
- K090831 — TANTHERA-T35
- K091254 — THE CROSSER 14 OTW CATHETER, MODEL CRU014
- K091271 — RESPIRONICS PERFORMAX TOTAL FACE MASK
- K091329 — PINNACLE DESTINATION PERIPHERAL GUIDING SHEATH
- K091435 — DIGITAL RADIOGRAPHY MODEL CXDI-55G
- K091436 — DIGITAL RADIOGRAPHY, MODEL CXDI-55C
- K081769 — INNOVANCE ANTITHROMBIN WITH MODELS OPFH03, OPFHO5
- K083117 — ELIA RNP70 IMMUNOASSAY, ELIA SCI-70 IMMUNOASSAY AND ELIA JO-1 IMMUNOASSAY, MODELS 14-5511-01, 14-5506-01 AND 14-5507-01
- K090071 — ROSTAM LTD. FRAGRANCED OR UNFRAGRANCED NEW PLASTIC APPLICATOR TAMPONS
- K090262 — PERCUCATH URINARY CATHETER
- K090458 — DEXIS SENSOR
- K090528 — DUET LONG-TERM HEMODIALYSIS CATHETER SYSTEM, DUET LONG-TERM HEMODIALYSIS CATHETER SYSTEM CATHETER REPAIR KIT
- K090602 — CARDIODYNAMICS BIOZ RX, MODEL 7101-SYS
- K090700 — IMMUNOCARD STAT CAMPY, MODEL 751530
- K090957 — BLACKROCK NEUROPORT BIOPOTENTIAL SIGNAL PROCESSING SYSTEM
- K090979 — DISPOSABLE HANDLE ASSEMBLES, MODELS DH0100 AND DH0500 SERIES
- K091358 — ECSCOPE 100
- K082419 — REOSS POWDER, REOSS PUTTY, REOSS GEL, MODELS R-1,RP-1, RG-1
- K082824 — FLUID FILLED TEETHER
- K082858 — EXSEPT WC ANTIMICROBIAL SKIN AND WOUND CLEANSER
- K083118 — SPINAL USA ANTERIOR CERVICAL INTERBODY FUSION DEVICE
- K083322 — NEUROMETRIX BIOAMPLIFIER
- K090321 — RIC CONFORMAL SOURCE, MODEL 100
- K090420 — SMITH & NEPHEW PIGALILEO SCREW TARGETING SYSTEM V 1.0
- K090531 — RADCALC SOFTWARE, VERSION 6.0
- K090567 — ORTHODONTIC CERAMIC BRACKET
- K090588 — POWER PROCESSOR SAMPLE PROCESSING SYSTEM WITH GENERIC CONNECTION MODULE, MODEL: 4210
- K090827 — BD PROBETEC NEISSERIA GONORRHOEAE (GC) QX AMPLIFIED DNA ASSAY
- K090856 — JOURNEY (OR RPSP), JOURNEY CUBIC (OR SUPRA OR TP02)
- K090880 — XYLOS POROUS SURGICAL MESH
- K090943 — ABT GLUCOSE CONTROL SOLUTION, MODEL: 2120089
- K091050 — 506CN PATIENT MONITOR
- K091097 — PROMEDICAL SURGICAL GOWN, MODELS 18-301, 18-401 AND 18-501
- K091145 — FLEXIPLAN 3D AND 3D+
- K091195 — PHILIPS MX 16 SLICE CT SYSTEM PHASE11, MODEL 9896 056 56511
- K091212 — WU'S 3 WHEELED ELECTRICAL SCOOTER, WT-T3H
- K091326 — ACTIVAPATCH
- K081122 — FUSION MEDICAL CANNULATED SCREW SYSTEM
- K090257 — IMMULITE 2000 3GALLERGY SPECIFIC IGE ASSAY KIT
- K091374 — GE LOGIQ I/E & VIVID E COMPACT ULTRASOUND
- K081917 — DEPUY SPINE BENGAL, CONCORDE, COUGAR, DEVEX AND LEOPARD SYSTEMS
- K082111 — STRAUMANN MEMBRAGEL
- K082455 — RECTANGULAR MULTIPLACE HYPERBARIC CHAMBER
- K082589 — BAROSENSE ENDOGASTRIC TUBE (EGT), MODEL F0034
- K083328 — ENSITE SYSTEM, MODEL EE3000, AND ENSITE NAVX SURFACE ELECTRODE, MODEL EN0010
- K083441 — FREEDOM STIM 100 AND 200 ELECTRODE AND LEADWIRE EXTENSION
- K083514 — TERUMO SYRINGE WITH/WITHOUT NEEDLE
- K083805 — ANKYLOS C/X DENTAL IMPLANT SYSTEM
- K083833 — ENABLER-P CATHETER, 1000 PART NUMBER:1160
- K090037 — MEDICALGORITHMICS REAL-TIME ECG MONITOR AND ARRHYTHMIA DETECTOR, MODEL POCKETECG
- K090155 — CAAS MR FLOW 1.0
- K090208 — BIOPRO FEMORAL HEADS
- K090330 — DIMENSION VISTA ENZYMATIC CREATININE FLEX REAGENT CARTRIDGE, AND ENZYMATIC CREATININE CALIBRATOR, MODELS K1270, KC270
- K090340 — FREEHAND
- K090452 — NEOSS IMPLANT SYSTEM 03.25
- K090461 — IMAGE-ARENA 4.0 AND IA APPLICATIONS 2D CARDIAC PERFORMANCE ANALYSIS 1.0
- K090469 — CARESTREAM DRYVIEW 5850 LASER IMAGER
- K090665 — EMBOSHIELD NAV6 EMBOLIC PROTECTION SYSTEM-SMALL/LARGE, MODEL 22437-19/22438-19
- K090676 — MONTBLANC IMPLANTOLOGY AND OMNIPRATIQUE CONTRA-ANGLES
- K091099 — C-PORT - HP POWER INJECTABLE PORT
- K091250 — DIAGNOSTIC CATHETER SYSTEM
Data sourced from openFDA. This site is unofficial and independent of the FDA.