FDA 510(k) clearances — page 793
clearances on record, most recent first.
Clearances — page 793
79,201–79,300 of 176,637- K012768 — HEMOSIL RECOMBI PLASTIN
- K012775 — GE POSITRACE/DISCOVERY VI PET/CT DUAL MODE ONCOLOGY SCANNER
- K012802 — MP3CF ELECTRIC WHEELCHAIR
- K012842 — V*CARE MANUAL RESUSCITATOR
- K012899 — GREEN NITRILE POWDER-FREE MEDICAL EXMAINATION GLOVE
- K012978 — RANDOX GENTAMICIN
- K011059 — INFARED EAR THERMOMETER, MODEL TH8 SERIES
- K011613 — POWDER-FREE GREEN BARRIER-PRO SYNTHETIC BUTADIENE COPOLYMER EXAMINATION GLOVE
- K011911 — SUCTION PUMP FOR INTRACORPOREAL ULTRASOUND LITHOTRIPTER AND ACCESSORIES, MODEL 2207.XXX
- K012032 — FIRST SPEP
- K012067 — CLINCARE LATEX SURGEON'S GLOVE
- K012125 — OPUS MAGNUM ANCHOR & INSERTER
- K012300 — ACON BZO ONE STEP BENZODIAZEPINES TEST STRIP; ACON BZO ONE STEP BENZODIAZEPINES TEST DEVICE
- K012558 — POWDER FREE LATEX PATIENT EXAMINATION GLOVES WITH ALOE VERA AND PROTEIN CONTENT LABELING CLAIM OF 50 MICROGRAMS OR LESS
- K012898 — MODIFICATION TO: CSC14 BLOOD CARDIOPLEGIA SYSTEM
- K010657 — COPELAND MB RESURFACING HUMERAL HEADS
- K010827 — COPELAND MB/HA RESURFACING HUMERAL HEADS
- K010849 — VERTEX ETCHANT
- K011898 — E-STETH ELECTRONIC STETHOSCOPE
- K011979 — ALLERSHARP ALLERGY SKIN TESTER
- K012103 — BANDVIEW SYSTEM
- K012386 — ACTICLOT PROTEIN S, MODEL 843L
- K012526 — BIOTEQUE SCALP VEIN SET
- K012733 — CARIES DETECTOR
- K012734 — CLEARFIL NEW BOND
- K012735 — CLEARFIL DC CEMENT
- K012737 — CHROMA ZONE COLOR STAIN
- K012740 — CLEARFIL AP-X
- K012742 — TEETHMATE F-1
- K012743 — TRILLIUM TRI-OPTIC MEASUREMENT CELL, MODEL TMC 25T, TMC38 T, TMC 50T
- K012747 — TRILLIUM BIO DISPOSABLE BLOOD FLOW PROBE (MODELS DP38T & FP38P)
- K012837 — MODIFICATION TO: DATEX-OHMEDA CARDIOCAP 5 (REV B) AND ACCESSORIES
- K012845 — SIMPLICITY SOFT QD MICRO INFUSION SET
- K001687 — COLORMATE TLC BILITEST SYSTEM
- K011240 — EVENCARE BLOOD GLUCOSE MONITORING SYSTEM
- K011338 — OTO-CEM
- K012009 — MX8000 IDT CT SYSTEM
- K012086 — AQUARIUSNET SERVER
- K012707 — ESTENIA
- K012729 — CLEARFIL REPAIR
- K012730 — CLEARFIL PORCELAIN BOND ACTIVATOR
- K012871 — SYNERGY TI INTEGRAL OPEN SCREWS MODELS # 6193, 6194, 6195,6196, 6173, 6174, 6175, 6176, 6177
- K010602 — VECTORVISION HIP
- K011857 — SYNTHES (USA) TROCHANTERIC FIXATION NAIL (TFN) SYSTEM
- K011918 — NIHON KOHDEN BSM-2300A SERIES BEDSIDE MONITOR AND ACCESSORIES, MODEL BSM-2300A SERIES
- K011945 — RIGID GAS PERMEABLE CONTACT LENS SOLUTION
- K011980 — ADAPTER, PACING ANALYZER/UNIVERSAL PACING ADAPTER, MODELS 4820 AND 4825
- K012023 — ANCHOR GUIDE LESION LOCALIZATION DEVICE; ANCOR GUIDE HOLDER; RF GENERATOR CABLE
- K012116 — ACRYDERM SILVER ANTIMICROBIAL PERFORATED WOUND DRESSING
- K012205 — GLUCOMETER DEX TEST SENSOR
- K012259 — MEDFUSION 2001 & 2010, MODEL N7215IWC
- K012262 — BAXTER AS40A, AS41 SYRINGE PUMP, MODEL N61WC
- K012266 — SHERWOOD 224, 324 FEEDING PUMP & K524 INTRI-FLUSH, MODEL N7213IWC2
- K012318 — RANDOX THERAPEUTIC DRUG CALIBRATOR
- K012565 — SENSITITRE HAEMOPHILUS/STREPTOCOCCUS PNEUMONIAE (HP) MIC PLATE
- K012741 — LIQUICHEK TDM CONTROL
- K012867 — SONOACE 9900 DIAGNOSTIC ULTRASOUND SYSTEM
- K012887 — SA6000II DIAGNOSTIC ULTRASOUND SYSTEM
- K010303 — ARTSCAN CARTILAGE STIFFNESS TESTING DEVICE
- K010973 — DIASCREEN 50 URINE CHEMISTRY ANALYZER, MODEL # 1242-00; DIASCREEN REAGENT STRIP FOR URINALYSIS, CAT. # D11000
- K011045 — TEXTURED POWDER-FREE LATEX EXAMINATION GLOVES CONTAINS 50 MICROGRAMS OR LESS OF TOTAL WATER EXTRACTABLE PROTEIN PER GRAM
- K011066 — STERILE LATEX SURGICAL GLOVES (POWDERED) WITH PROTEIN CONTENT LABELING CLAIM (100 MICROGRAMS OR LESS)
- K011242 — HUANQIU AND SUPER (TWO BRANDS) STERILE ACUPUNCTURE NEEDLE FOR SINGLE USE
- K011403 — SURGIPLASTER CALCIUM SULFATE HEMIHYDRATE
- K011407 — LATEX POWDER-FREE EXAMINATION GLOVES BLUE, POLYMER COATED, CONTAINS 50 MICROGRAMS OR LESS OF TOTAL WATER EXTRACTABLE PRO
- K011848 — CIRCON AEH-4 ELECTROHYDRAULIC LITHOTRIPSY PROBE
- K011926 — ELEC-MATE E
- K012157 — CHURCHILL MEDICAL SYSTEMS STOPCOCK
- K012233 — STRATUS CS TROPONIN I CALIBRATOR
- K012705 — CLEARFIL PHOTO CORE
- K000031 — AQUANET, MODEL EC 2000
- K010618 — PALOMAR DERMALUX PULSED LIGHT SYSTEM
- K011044 — TEXTURED POWDER-FREE LATEX EXAMINATION GLOVES WITH CONTAINS 50 MICROGRAMS OR LESS OF TOTAL WATER EXTRACTABLE PROTEIN PER
- K011841 — KSEA SAWAHLE ELECTROMECHANICAL MORCELLATOR
- K011888 — PRESSURE ACTIVATED CHECK VALVE
- K012136 — AVITA AGIL IT 101 INSTANT DIGITAL THERMOMETER
- K012223 — CG-2211 SELFCHECK ECG TRANSMITTER
- K012229 — SCALE-TRONIX 48, 2001, 2009,2700,3003,4004, 4800, 5005,5700,6005,6500,6700,6006C & 20009, MODEL N661WC
- K012442 — MODIFICATION TO CLEARFIL SE BOND
- K012703 — CLEARFIL CORE NEW BOND
- K012704 — CLEARFIL ST OPAQUER
- K012902 — POLY PER-Q-CATH SINGLE LUMEN PICC CATHETER, MODEL 3143100; POLY PER-Q-CATH DUAL LUMEN PICC CATHETER, MODEL 3246100
- K010750 — PACIFIC HEMOSTASIS INR CONTROL PLASMAS, MODEL CATALOG 100560
- K011664 — IMAGER II ANGIOGRAPHIC CATHETER
- K011806 — PROTEGE SELF-EXPANDING NITINOL STENT WITH STARPORT DELIVERY TECHNOLOGY
- K011810 — ORTHOGENESIS LPS PROXIMAL TIBIAL REPLACEMENT AND ORTHOGENESIS LPS TIBIAL BEARING
- K011816 — MINI MULTILEAF COLLIMATOR, MODEL KMI
- K011828 — CYNOSURE ACCLAIM DERMATOLOGY LASER
- K011836 — MPF ACETABULAR CUP
- K012208 — ACCESS THYROGLOBULIN ANTIBODY AND CALIBRATORS ON THE ACCESS IMMUNOASSAY SYSTEMS, MODELS 33890, 33895
- K012590 — CORDIS PALMAZ GENESIS TRANSHEPATIC BILIARY STENT ON OPTA PRO .035 DELIVERY SYSTEM
- K012836 — MODIFICATION TO: LIGHTSPEED PLUS MOBILE CT SYSTEM
- K002352 — JMS A.V. FISTULA NEEDLE SET ACCORDION TYPE
- K003988 — UROSCOPE, ARTES MEDICAL, USA
- K010431 — LEAD-LOK REUSABLE TENS/ NMES ELECTRODES
- K010450 — LIVER TAMPONADE BALLOON
- K010612 — VECTORVISION KNEE
- K011128 — NICHOLS ADVANTAGE DIRECT RENIN (CALIBRATORS, CALIBRATION VERIFIERS, CONTROLS, AND SAMPLE DILUENT)
- K011361 — DESAI VECTORCATH MAPPING CATHETER, DESAI VECTORCATH CONNECTOR CABLE
- K011387 — NEUROTHERM, MODEL JK4
Data sourced from openFDA. This site is unofficial and independent of the FDA.