FDA 510(k) clearances — page 792
clearances on record, most recent first.
Clearances — page 792
79,101–79,200 of 176,637- K011405 — EXEL INJECTION PLUG WITH CAP
- K011800 — VANGUARD REPROCESSED ELECTRIC BIOPSY FORCEPS
- K012062 — PF2
- K012078 — RADIOFIX
- K012160 — COMPCORE AF COMPOSITE CORE BUILD-UP MATERIAL, MODEL 3001408
- K012202 — NUMARIS 4VA15A
- K012901 — COLOR-MONOGEN
- K013084 — AFFINITY 38 MICON ARTERIAL FILTER WITH TRILLIUM BIOPASSIVE SURFACE, MODEL 351T
- K011877 — FF450 PLUS FUNDUS CAMERA AND VISUPAC DIGITAL IMAGE ARCHIVING SYSTEM, OR FF450 PLUS VISUPAC SYSTEM
- K011961 — POWDER-FREE BUTADIENE COPOLYMER EXAM GLOVES WITH ALOE, VITAMINS E PH5.5
- K011970 — BIOSAFE CHOLESTEROL PROFILE BLOOD COLLECTION AND TRANSPORT SYSTEM
- K012084 — SONOREAL 3D
- K012298 — THE INTUITIVE COLORIMETER
- K012397 — URISYS 2400 URINE TEST STRIP
- K012479 — STERILE NITRILE SURGICAL GLOVES (POWDERED)
- K012540 — BLY-501 ADAPTOR
- K012866 — THE NEXGEN TMT TIBIA, MODELS 00-5886-XXYY, 05-120-XXYY-0
- K010891 — MODIFICATION TO HYBRID CAPTURE II CT/GC TEST, MODEL 03M90-01
- K012004 — EASY GUIDE ELECTROSURGICAL ACCESS DEVICE
- K012074 — XBO1-824-18/19/20 BIOPSY FORCEPS
- K012106 — ACCUIMAGE SMARTGATE UPGRADE
- K012411 — HP-ONE
- K012865 — SUPERSTITCH VASCULAR SUTURING DEVICE
- K012922 — ULTRAFLEX EV HEMOSTASIS INTRODUCER
- K013099 — MODIFICATION TO: QWH-420 WRIST ARRAY COIL
- K010892 — MODIFICATION HYBRID CAPTURE II CT-ID DNA TEST, MODEL 03M91-01
- K010893 — MODIFICATION TO HYBRID CAPTURE 2 GC-ID DNA TEST, MODEL 03M92-01
- K011017 — PROMAX-XP, TENS AND MICROCURRENT DEVICE; PROMAX-TENS, TENS DEVICE; PROMAX-LIBRA, TENS DEVICE; PROMAX-MC, MICROCURRENT
- K012030 — PORTABLE INTENSIVE CARE UNIT
- K012043 — VACUETTE EDTA K2 GEL TUBES
- K012149 — POWDER-FREE LATEX EXAMINATION GLOVES WITH PROTEIN, CHEMOTHERAPY LABELING CLAIM
- K012190 — AOS MODULAR FEMORAL NAIL
- K012250 — RAICHEM MULTI-ANALYTE CALIBRATOR
- K012870 — XIA STAINLESS STEEL SYSTEM
- K012970 — GE SIGNA ASSET IMAGING OPTION
- K012984 — BREATHABLE IMPERVIOUS GOWNS
- K004023 — INTRA OPERATIVE RADIATION THERAPY
- K010232 — PRE-POWDERED NITRILE EXAMINATION GLOVES
- K010844 — ASTORIA-PACIFIC SPOTCHECK BIOTINIDASE KIT, 50 HOUR, PART NO. 80-8000-13K
- K011340 — LH 450 ENTERAL FEEDING BAG PUMP SET W/INTEGRATED Y-PORT
- K011341 — LH400 YES-SET Y-PORT ENTERAL SPIKE PUMP SET
- K011343 — LH 500 ENTERAL FEEDING GRAVITY BAG SET
- K012008 — STS RANGE , MODELS STS20,STS30,STS40
- K012093 — AETMED IMAGE PROCESSING SOFTWARE
- K012306 — AUDIOSCAN VERIFIT, MODEL VF-1
- K012329 — WIENER LAB.ALBUMINA AA, MODELS 6X60 ML CAT N 1690008, 6X120 ML CAT 1009300
- K012352 — SQA, SPERM QUALITY ANALYZER
- K012456 — SODEM HIGH SPEED SYSTEM (ELECTRIC) (EAR, NOSE, AND THROAT)
- K012653 — MALE LATEX CONDOM
- K012814 — COLLAGEN NERVE CUFF
- K012857 — NON-STERILE POWDER FREE PURPLE LATEX EXAMINATION GLOVE WITH BLUEBERRY SCENTED AND PROTEIN CONTENT CLAIM (50 MICROGRAMS O
- K012860 — POWDER-FREE LATEX EXAM GLOVES WITH CHOCOLATE SCENTING AND PROTEIN LABELING CLAIM (<50UG/G)
- K012863 — NON-STERILE POWDER FREE LATEX EXAMINATION GLOVES WITH VANILLA AND PROTEIN CONTENT LABELING CLAIM (50 MICROGRAMS OR LESS)
- K012904 — ADVIA 120 HEMATOLOGY SYSTEM, CYANIDE-FREE HIGH DETERMINATION
- K000122 — COLLAGRAFT STRIP BONE GRAFT MATRIX (FOR USE AS A BONE FILLER), MODEL 1X,3X,6X (1,3 OR 6 STRIPS PER BOX)
- K002241 — QUANTUM VERSATILITY (QVS) DENTAL IMPLANT SYSTEM
- K010981 — GSA GENITO SENSORY ANALYZER
- K011223 — QUANTUM VERSATILITY (QVS) DENTAL IMPLANT SYSTEM
- K011964 — INSIGHT MILLENNIUM PLUS
- K011988 — SURGICAL LIGHTSTIC 180, MODEL 180 L, MODEL 180 C
- K012010 — MODIFICATION TO LR 5200 FILM RECORDER
- K012033 — MULTIFUNCTION ENDOSCOPIC INSTRUMENT
- K012042 — KINETIC CANNULA
- K012082 — OPTIBOND SOLO PLUS ACTIVATOR
- K012098 — PRECLUDE PERICARDIAL MEMBRANE
- K012150 — PATTON ENDO-BAG
- K013018 — REAADS ANTI-PHOSPHATIDYLSERINE IGA SEMI-QUANTITIVE TEST KIT
- K991250 — QUANTUM VERSATILITY IMPLANT SYSTEM
- K003620 — NSI HEXED AND NON-HEXED IMPLANT SYSTEM
- K011087 — ORTHOVITA PISTON SYRINGE OR IMBIBE BONE MARROW ASPIRATION SYRINGE
- K011241 — NEUROSOFT'S SOURCE
- K011943 — IMPRO VISE ABSORBABLE CEMENT FLOW RESTRICTOR
- K011944 — DYONICS VISION 635 DIGITAL CAPTURE SYSTEM, MODEL 7209088
- K011954 — SULZER ORTHOPEDICS ALLEGRETTO UNICOMPARTMENTAL KNEE
- K011975 — HORIZON OUTLOOK WITH DOSECOM
- K011996 — TAMPAX PEARL SCENTED AND UNSCENTED TAMPONS - JUNIOR, REGULAR, SUPER & SUPER PLUS
- K012007 — RHS HELMET
- K012047 — 3I CALCIUM SULFATE BONE CEMENT
- K012079 — GEODESIC EEG SYSTEM, MODEL 200
- K012124 — MERSILK BLACK SILK BRAIDED NON-ABSORBABLE SUTURE, USP
- K012153 — LOWSLEY SUPRAPUBIC TRACTOR
- K012154 — AURORA MAGNETIC RESONANCE DIAGNOSTIC DEVICE
- K012165 — OLDELFT THORASCAN MODEL NUMBER 180T
- K012201 — PREMICRON NONABSORBABLE PET SURGICAL SUTURE
- K012260 — WIENER LAB. UREA UV CINETICA AA
- K012301 — IMMULITE 2000 DIGOXIN, MODELS L2KDI2 (200 TESTS) AND L2KDI6 (600 TESTS)
- K012334 — CONTOUR MENISCUS ARROW, MODELS 541110, 541113, AND 541116
- K012371 — TINA-QUANT TRANSFERRIN VER.2
- K012393 — TINA-QUANT TRANSFERRIN VER.2
- K012515 — BIFURCATED VACCINATING NEEDLE
- K012927 — M71 POWER WHEELCHAIR
- K010851 — HARRISON HAND HELD ADJUSTING INSTRUMENT
- K011434 — G7 AUTOMATED HPLC ANALYZER
- K011929 — HANDPIECE SHEATH-MODEL #A910
- K012152 — DS30 HCY BLOOD COLLECTION TUBES
- K012168 — ADVANCE MEDICAL DESIGNS FLUID POUCH
- K012351 — BDPROBETEC ET CT/GC AMPLIFIED DNA ASSAY
- K012413 — MACROPORE FX, PS, NS, LP
- K012711 — DISPOSABLE POWDER FREE VINYL PATIENT EXAMINATION GLOVES
- K012722 — LYPHOCHEK COAGULATION CONTROL LEVEL 1, LYPHOCHEK COAGULATION LEVEL 2, LYPHOCHEK COAGULATION LEVEL 3, MODELS 781,782,783
Data sourced from openFDA. This site is unofficial and independent of the FDA.