FDA 510(k) clearances — page 690
clearances on record, most recent first.
Clearances — page 690
68,901–69,000 of 175,825- K040733 — ELECSYS TROPONIN T STAT TEST
- K040779 — RESTORE WOUND CLEANSER
- K040795 — MULTICORE HB; MULTICORE FLOW
- K040825 — LAKE REGION HYDROPHILIC GUIDEWIRE
- K040870 — SHIMADZU IMAGE AMPLIFIER, MODEL IA-16L/HS
- K040918 — WAKO LIPID CONTROL, LEVEL 1 AND LEVEL 2
- K040927 — LINICAL PROTEIN 1 CALIBRATION VERIFIERS LEVELS A - E FOR OLYMPUS AU ANALYZERS
- K041058 — MISONIX INC. LYSONIX 2000/3000 ULTRASONIC SURGICAL ASPIRATOR SYSTEMS
- K041166 — SIEMENS ENHANCED IMAGING SYSTEM
- K041176 — URETEX TO TRANS-OBTURATOR URETHRAL SUPPORT SYSTEM
- K041228 — MYTECH/HAPPY LIFE BLOOD PRESSURE MONITOR, MODEL HPL-200
- K024215 — ENERTRON CPR JACK
- K030425 — LORENZ RESORBABLE DISTRACTION SYSTEM OR EXPANDER
- K030869 — BITESTRIP
- K030941 — AEQUALIS REVERSED SHOULDER PROSTHESIS
- K032761 — KMC-950 C-ARM MOBILE SYSTEM
- K033316 — TABLE TILT DEVICE
- K033957 — INFINITY MODULAR MONITORS VF4 MODIFICATIONS WITH SCIO, MODELS DELTA, DELTA XL, KAPPA, SC 8000, SC 7000, SC 9000XL
- K040017 — ABC CAUDAL AND CRANIAL EXTENSION PLATE (E-PLATE)
- K040174 — BILIRUBIN ASSAY ON THE OMNI S ANALYZER
- K040384 — MYDON C
- K040406 — POLYMER COATED, CHLORINATED, POWDER-FREE LATEX EXAMINATION GLOVES WITH PROTEIN LABELING (LESS THAN 50 UG/G PER GLOVE)
- K040504 — BARDEX, LUBRI-SIL AND LUBRI-SIL IC ALL-SILICONE FOLEY CATHETERS
- K040587 — MINI GAMMA CAMERA, MODEL MGC-500
- K040666 — STEP-TIP CHRONIC HEMODIALYSIS CATHETER
- K040716 — BD PHOENIX AUTOMATED MICROBIOLOGY SYSTEM-PENICILLIN (GP) 0.0625-32 UG/ML
- K040810 — VARELISA HISTONE ANTIBODIES, MODEL 16496
- K040962 — MODIFICATION TO CD HORIZON SPINAL SYSTEM
- K041027 — DIGITAL RADIOGRAPHY SYSTEM WITH FLAT PANEL DETECTOR, MODEL DFP8000D
- K041028 — CROWN DELTA HYDROPHILIC IMPRESSION MATERIAL
- K041071 — BD VACUTAINER TRACE ELEMENT SERUM PLUS TUBE AND BD VACUTAINER TRACE ELEMENT K2EDTA PLUS TUBE, MODELS 368380/368381
- K041137 — NEWTOM 3G QR-DVT 9000
- K041145 — MODIFICATION TO E-SCAN XQ MRI SYSTEM
- K041185 — TORSO ARRAY COIL, MODEL 558GE-64
- K032322 — CLEAR-THERM MICRO HME, MODEL 1441
- K032818 — INOGEN ONE OXYGEN CONCENTRATOR
- K032965 — LAPAROSCOPIC INSTRUMENT, ELECTRODE AND CABLE
- K033003 — SUCTION COAGULATOR
- K033008 — AIR SAFETY HEPA AND NON-HEPA FILTERS
- K033197 — INOGEN SATELLITE CONSERVER
- K040011 — POLARIS 2004 CAPNOGRAPH
- K040598 — KLS MARTIN HAND PLATING SYSTEM
- K040811 — VARELISA SSDNA ANTIBODIES, MODEL 14896
- K040982 — COLOR LCD MONITOR, MODEL RADIFORCE R12
- K040990 — MODIFICATION TO SELF-DRILLING RADIOGRAPHIC MARKERS
- K041064 — BIOKNOTLESS RC ANCHOR
- K041098 — COOL TEMP NATURAL
- K041131 — APPLE MEDICAL OB MOBIUS ELASTIC RETRACTOR
- K031327 — VERICOR
- K033990 — ALVEOLUS INC. TB-STS TRACHEOBRONCHIAL STENT SYSTEM
- K040165 — REFLEXION CANNULATOR STEERABLE ELECTROPHYSIOLOGY CATHETER WITH LUMEN, MODEL 402805
- K040344 — IMPAX OT3000 ORTHOPEDIC WORKSTATION
- K040350 — RANDOX AMPHETAMINE CLASS ASSAY
- K040381 — HATRIC, 6&7MM, 9&10MM, 11&12MM, 14&15MM, MODELS AR-13000B-07, -10, -12, -15
- K040383 — TRIFLANGE II ACETABULAR CUP SYSTEM
- K040463 — AESKULISA CARDIOLIPIN AGM
- K040939 — SKY BONE EXPANDER SYSTEM (SKY SYSTEM)
- K040945 — MODIFICATION TO INFINITY EXPLORER
- K040955 — M3290A INTELLIVUE INFORMATION CENTER SOFTWARE RELEASE E.01 AND INTELLIVUE CLINICAL NETWORK ON VLAN
- K041056 — 10-SECOND DIGITAL THERMOMETER, MODELS ST87, ST89, ST80, ST88
- K041072 — KUSCHALL CHAMPION, KUSCHALL COMPACT, KUSCHALL ULTRA-LIGHT
- K041087 — INFINITY GAMMA
- K030413 — Y2K2 ENTERNAL FEEDING MANAGER
- K032016 — DERMAGRIP-X POWDER FREE LATEX EXAMINATION GLOVES COATED WITH ALPHA LIPOIC ACID AND VITAMIN E, AND WITH PROTEIN CONTENT
- K032747 — BIOTOP DJT-A SAFETY SYRINGE
- K033364 — CHAD THERAPEUTICS SAGE
- K033912 — CRADLE PACS
- K040208 — NEPTUNE PAD, NEPTUNE DISC, NEPTUNE COMFORT-BAND, COMFORT-BAND
- K040424 — LASER ENDOSCOPIC DECOMPRESSION KIT, MODEL 1100, AND PERCUTANEOUS DISCECTOMY KIT, MODEL 1120
- K040449 — VARELISA B2 GLYCOPROTEIN I IGG ANTIBODIES, MODELS 18748 AND 18796
- K040450 — VARELISA B2 GLYCOPROTEIN I IGA ANTIBODIES, MODELS 18948 AND 18996
- K040451 — VARELISA B2 GLYCOPROTEIN I IGM ANTIBODIES, MODELS 18848 AND 18896
- K040452 — VARELISA B2 GLYCOPROTEIN I ANTIBODIES SCREEN, MODELS 19048 AND 19096
- K040585 — EXACTRAC 4.0 AND EXACTRAC X-RAY 6D
- K040688 — STANDARD IMAGING E.IMRT CALCULATOR
- K040954 — FOX PLUS PTA CATHETER
- K024245 — ENVOY PATIENT MONITOR
- K033324 — COMPRESSION ANASTOMOSIS CLIP (CAC)
- K033596 — CEMEX GENTA BONE CEMENT; CEMEX GENTA SYSTEM BONE CEMENT
- K040403 — COLLAGEN WOUND DRESSING - ORAL
- K040570 — RANDOX METHADONE ASSAY
- K040602 — SURELINE LAPAROSCOPIC CLIP APPLIER WITH IMPLANTABLE TITANIUM CLIPS
- K040740 — ENDOTINE TRANSBLEPH DEVICE
- K040857 — MODIFICATION TO ADPER PROMPT
- K040879 — QUANTEX FERRITIN
- K040920 — AMYLASE LIQUID REAGENT, MODEL A532-200
- K041032 — MODIFICATION TO LIFESTENT SDS AND XL SDS BILIARY ENDOPROSTHESIS
- K041135 — VAPR 3 ELECTROSURGICAL SYSTEM AND VAPR LD AND LP SUCTION ELECTRODES
- K030396 — OMNI~NEB; OMNI~MAX
- K032154 — G-FREEZEKIT BLAST
- K032155 — G-THAWKIT BLAST
- K032400 — LAFACI
- K032877 — G-OOCYTE
- K032894 — OSTEO ACL SCREW MODEL;237020T, 237025T, 237030T, 238020T, 238025T, 238030T, 239020T, 239025T, 239030T, 231020T, 231025T,
- K032927 — FULL AUTO ARM DIGITAL BLOOD PRESSURE MONITOR
- K033101 — G-PGD
- K033722 — APAPORE BONE GRAFT SUBSTITUTE
- K033789 — LATEX POWDER-FREE EXAMINATION GLOVES WITH COATING
- K040317 — IVC SYSTEM
- K040454 — BIOFILL BONE VOID FILLER
Data sourced from openFDA. This site is unofficial and independent of the FDA.