FDA 510(k) clearances — page 636
clearances on record, most recent first.
Clearances — page 636
63,501–63,600 of 176,637- K052929 — PREFTEST PROFESSIONAL SUITE
- K053572 — C. DIFF QUIK CHEK
- K053612 — DRI-STAT ACID PHOSPHATASE REAGENT
- K060308 — COOLGARD 3000
- K060377 — DR DISPOSABLE PROPHY ANGLE MODEL H310
- K060392 — ASP TITANIUM
- K060447 — BD PHOENIX AUTOMATED MICROBIOLOGY SYSTEM -NITROFURANTOIN (GN) 8-512 UG/ML, TRIMETHOPRIM-SULFAMETHOXAZOLE (GN)
- K060710 — UNIVERSAL LOCKING SYSTEM, 3.5MM PLATES AND SCREWS-4936 PLATES,4835 SCREWS
- K060990 — ENDIUS TITLE 2 POLY AXIAL SPINAL SYSTEM
- K050674 — PHYSIOGLOVE ES
- K053263 — CARDIONET AMBULATORY ECG MONITOR WITH ARRHYTHMIA DETECTION, MODEL CN1003
- K053415 — LESIONPOINT RF CANNULA
- K060016 — THROMCAT THROMBECTOMY CATHETER SYSTEM
- K060376 — SIMPLER HA THREADED, ST 5002-8, SIT 5002-8, ST 5011-ST5014, ST 5021-24
- K060660 — EW200 SYSTEM (OXYGEN SATURATION MONITORING SYSTEM) AND PRESEP OXIMETRY CATHETER
- K060717 — NURSE ASSISTANT 1.7 O.R. CONTROL SYSTEM
- K060845 — MONOCHROME LCD MONITOR, RADIFORCE MODEL GS310
- K052520 — RAPID FORSURE ONE STEP MULTIPLE DRUG (UP TO 6) SCREEN TEST DEVICE FOR AMPHETAMINE, METHAMPHETAMINE, BENZOYLECGONINE, THC
- K060111 — IVA (MXA II SOFTWARE OPTION)
- K060140 — CRP-ADVANCE MULTI CALIBRATOR SET, MODEL SE-250
- K060168 — VITRIFICATION FREEZE KIT, VITRIFICATION THAW KIT
- K060195 — GAMBRO POLYFLUX HD-C4 CAPILLARY DIALYZER/FILTER FOR SINGLE USE
- K060462 — NEOMARKERS RABBIT MONOCLONAL ANTI-HUMAN PROGESTERONE RECEPTOR ANTIBODY (CLONE SP2)
- K060640 — DIGIREX DIGITAL DENTAL RADIOGRAPHY SYSTEM
- K060684 — ADPER PROMPT, ADPER PROMPT L-POP
- K060733 — SYNTHALON PI POWDER-FREE SYNTHETIC POLYISOPRENE/POLYCHLOROPRENE EXAMINATION GLOVES MDL 1362-10 TO 1362-44
- K060807 — SCOUTPRO 7F CORONARY SINUS LEAD DELIVERY SYSTEM
- K060865 — BAIR PAWS TEMPERATURE MANAGEMENT SYSTEM MODEL 850
- K060940 — VITROS CHEMISTRY PRODUCTS CALIBRATOR KIT 99, VITROS CHEMISTRY PRODUCTS AAT/HPT PERFORMANCE VERIFIER I, II, AND III
- K053386 — XLTEK EMU40 EEG HEADBOX, MODEL PK1072
- K060166 — OHMEGA
- K060169 — BARRX HALO COAGULATION SYSTEM, BARRX HALO COAGULATION GENERATOR, BARRX COAGULATION CATHETER, MODELS 2200-115A, 1520F
- K060466 — ACON BUP ONE STEP BUPRENORPHINE TEST STRIP AND ACRON BUP ONE STEP BUPRENORPHINE TEST DEVICE
- K060545 — UNITY HUMERAL PLATE
- K060555 — SPRAYGENIX CRYO ABLATION SYSTEM
- K060573 — BURBANK TENACULUM
- K060613 — VARIAX LOCKING PLATE SYSTEM
- K060621 — SUSCEPTIBILITY TEST PLATE FOR ERTAPENEM 0.002-16UG/ML FOR GRAM NEGATIVE. SUSCEPTIBILITY TEST PLATE FOR ERTAPENEM 0.015-
- K060646 — BLUE LUXCER CURING LIGHT, MODELS M-830, M-835 AND M-855
- K060679 — SURTRAK IMPLANTATION KIT
- K060768 — PRECISION XTRA BLOOD B KETONE TEST STRIPS, OPTIUM BLOOD B KETONE TEST STRIPS
- K060774 — FOLATE ON THE ACCESS IMMUNOASSAY SYSTEMS, MODEL A14208
- K060806 — HOSPIRA GEMSTAR INFUSION PUMP SYSTEM, 7 THERAPY, MODEL 13087; 6 THERAPY, MODEL 13086; PAIN MANAGEMENT, MODEL 13088
- K060835 — HL888SF
- K060954 — MODIFICATION TO ENSITE SYSTEM, MODEL EE3000
- K050094 — LADY COMP USA
- K060579 — COMFORT/IO IONTOPHORESIS ELECTRODES
- K060625 — NEXUS DETACHABLE COIL SYSTEM, MORPHEUS 3D CSR
- K060843 — MODIFICATION TO HEALTH BUDDY APPLIANCE
- K052947 — SOURCE PRODUCTION & EQUIPMENT CO, INC., MODEL M-19 IR-192 BRACHYTHERAPY SOURCE
- K053306 — IVIEW
- K053353 — RESCUE IMPLANT SYSTEM
- K053356 — MODIFICATION TO: CIC PRO CLINICAL INFORMATION CENTER CENTRAL STATION
- K053599 — SPACELABS MEDICAL MULTIGAS ANALYZER MODULE 91518 AND ACCESSORIES
- K053610 — ABARIS
- K060052 — GE LIGHTSPEED XTRA CT SCANNER SYSTEM
- K060167 — ATRIA 3100, ATRIA 6100
- K060382 — FLO-RITE, MODEL 478-1; FLO-RITE II, MODEL 478-1; SIMPULSE II, MODEL 478-2S; NUMATIX, MODEL NCD401; SIMPULSE, MODEL 478-1
- K060636 — PALLADIUM-103 SEED IMPLANT KITS -MULTIPLE
- K060712 — VITELCARE C-TURTLE PATIENT MONITORING SYSTEM
- K060731 — EVOLVE MODULAR RADIAL HEAD
- K060750 — STRYKER INJECTABLE CEMENT
- K060757 — INQUIRY OPTIMA PLUS STEERABLE ELECTROPHYSIOLOGY CATHETER
- K060828 — MODIFICATION TO ENDOTINE RIBBON
- K060834 — PROBEAT WITH MGCS
- K060879 — MODEL EC9-4 TRANSDUCER
- K060912 — MODIFICATION TO: HI-ART SYSTEM
- K060941 — CAAS MRV VERSION 3.0
- K060947 — SONICATH ULTRA IMAGING CATHETER, 3.2F,20MHZ MODELS 37410/456221/C1020
- K060962 — ENDOGATOR ENDOSCOPY IRRIGATION PUMP, MODEL EGP-100
- K060025 — SLIMPLICITY ANTERIOR CERVICAL PLATE SYSTEM
- K060177 — KLS MARTIN RIGID FIXATION - STERILE
- K060356 — CONSERVE PLUS QUADRAFIX ACETABULAR SHELL
- K060438 — RHS
- K060683 — ENDIUS MINIT POSTERIOR CERVICAL AND UPPER THORACIC FIXATION SYSTEM
- K060736 — SMITH & NEPHEW 6.5MM AND 8.0MM CANNULATED SCREWS
- K060754 — ELECSYS TSH CALSET W/MODELS 04738551
- K060804 — COLLAGRAN-COLLAGEN WOUND DRESSING, COLLAGRANAG-COLLAGEN W/SILVER ANTIMICROBIAL WOUND DRESSING
- K060815 — JULIESSE INJECTABLE LARYNGEAL AUGMENTATION IMPLANT
- K052817 — EUREKA INFUSION PUMP, MODELS EUREKA-IP, EUREKA-LF
- K052843 — BUSSE HOSPITAL DISPOSABLES NEEDLE STICK BLOCK/CUBE
- K053568 — BILISOFT PHOTOTHERAPY SYSTEM
- K060365 — APEXCAL
- K051651 — G4, MODEL IGM-0004
- K051842 — GREEN LOVE MALE CONTRACEPTIVE (CONDOM)
- K053481 — KELO-COTE SPRAY
- K053497 — GUAVA EZCD4 SYSTEM
- K053577 — DIMENSION VISTA CTNI FLEX FLEX REAGENT CARTRIDGE, CALIBRATOR AND SDIL SAMPLE DILUENT
- K060145 — FDS INTIMATE AND INTIMATE WARMING LUBRICANT
- K060257 — BD PHOENIX AUTOMATED MICROBIOLOGY SYSTEM - CEFOXITIN - 0.5-64 UG/ML
- K060341 — SHERLOCK TIP LOCATION SYSTEM (TLS)
- K060359 — ARCHIECT INSULIN AND CONTROLS, MODEL 8K41-01, 8K41-10
- K060533 — LENSTEC INTRAOCULAR LENS (IOL) INJECTION SYSTEM
- K060696 — ACCLAIM TOTAL ELBOW SYSTEM
- K060719 — MODIFICATION TO VERTE-STACK SPINAL SYSTEM
- K060873 — VANGUARD MRI AUXILIARY PATIENT TABLE WITH 4 AND 8 CHANNEL COIL ARRAY FOR GE SIGNA SYSTEMS
- K060892 — GALILEOS
- K052457 — PICSI SPERM SELECTION DEVICE
- K053354 — INTERMEZZO PLUS FIXTURE
- K053589 — LONG-TERM HEMODIALYSIS CATHETERS WITH BIOBLOC COATING
Data sourced from openFDA. This site is unofficial and independent of the FDA.