FDA 510(k) clearances — page 506
clearances on record, most recent first.
Clearances — page 506
50,501–50,600 of 176,542- K101261 — CATHETER REPAIR KIT WITH REPLACEMENT CONNECTOR, MODEL 5587000
- K101521 — ST/AR ST AND ARRHYTHMIA SOFTWARE MODEL: RELEASE K.O
- K102050 — Q-SWITCHED ND:YAG LASER SYSTEM, MODEL GLOBALCURE-SC6
- K090346 — ADVIA 2120/2120I BODY FLUIDS
- K093664 — AMPHETAMINES II ASSAY
- K093926 — FIREBIRD SPINAL FIXATION SYSTEM
- K100411 — VARIOUS DENTAL IMPLANTS
- K101276 — DERMA+FLEX QS HIGH VISCOSITY TISSUE ADHESIVE MODEL: QS70404
- K101295 — MROPEN
- K101322 — JOINSOON ELECTRONICS MFG CO., LTD INFRARED EAR THERMOMETER, MODEL TT-001
- K101615 — POWERWIRE RADIOFREQUENCY GUIDEWIRE
- K101678 — ROMEO POSTERIOR OSTEOSYNTHESIS SYSTEM
- K101826 — HYDROFIX VASO SHIELD, MODEL HVS-001-0610
- K101879 — XPERT MRSA/SA BC (BLOOD CULTURE) ASSAY MODEL GXMRSA/SA-BC-10
- K101949 — PEDIATRIC BODY-CARDIAC COIL, MODEL: 5000012601
- K102002 — TALYMED
- K093266 — MAM COOLER
- K093493 — AESCULAP STERILCONTAINER S
- K100536 — TRANSBOND IDB PRE-MIX CHEMICAL CARE ADHESIVE
- K101026 — POWERED PD-IO INFUSION SYSTEM, EZ-IO HUMERAL HEAD, POWERED PH-IO
- K101076 — PROWESS PANTHER PROARC, MODEL VERSION 5.0
- K101172 — RDT3 HANDPIECE HEAD MODEL RDT3
- K101191 — NAVIAID ICVI DEVICE
- K101663 — POWDER-FREE VINYL PATIENT EXAMINATION GLOVES
- K101664 — POWDERED VINYL PATIENT EXAMINATION GLOVES
- K092328 — MED-SEG, MODEL BTMS 1000
- K092982 — THE PANPAC SUCTION CURETTE
- K100420 — PHILIPS OBTRACEVUE MODEL SW REV. G.00
- K101662 — SYNAPSE 3D BASIC TOOLS
- K091939 — THERMEDX PRODIGY FLUID MANAGEMENT SYSTEM, MODELS P1000, P2000
- K092261 — DEFCON TSA/TSH DENTAL IMPLANT SYSTEM
- K100133 — AIRSTRIP REMOTE PATIENT MONITORING (RPM) REMOTE DATA VIEWING SOFTWARE, VERSION 3.1
- K100147 — S4 CERVICAL OCCIPITAL PLATE SPINAL SYSTEM
- K100247 — DETAX IMPLANTLINK SEMI
- K100543 — MEDISSISS REPROCESSEDENT ABLATION WANDS (COBLATORS), MODEL#EIC8872-01
- K100682 — GSP NEONATAL 17A-OH-PROGESTERONE KIT MODEL: 3305-001U
- K100813 — QRS CARD S-T SEGMENT ANALYSIS PATIENT MONITORING SYSTEM MODEL: QRS CARD USB
- K100909 — REPROCESSED COMPRESSION SLEEVES
- K100958 — MODIFICATION TO: MICROBLADE SHAVER AND ACCESSORIES
- K101101 — MINI-TONG
- K101165 — PRO-TOE VO HAMMERTOW IMPLANT SYSTEM
- K101206 — TGS UNICOMPARTMENTAL KNEE ARTHROPLASTY (TGS UKA) MODULAR TIBIA SYSTEM
- K101214 — GUARDIAN CONNECTION
- K101240 — CLOSED FUSION PLATE, MTP PLATE, TALUS PLATE, MODEL 824077021, 22; 824677021, 22, 824071001, 824071101, 824671001, 82467
- K101314 — ADVANIX BILIARY STENT WITH NAVIFLEX RX DELIVERY SYSTEM
- K101776 — SCOUTPRO ACS
- K101777 — PIONEER PLUS CATHETER, MODEL PLUS 120
- K101786 — ADVANIX DOUBLE PIGTAIL BILIARY STENT
- K101833 — INFISTITCH FOR I5 DIGITAL X-RAY IMAGING SYSTEM, MODEL I5
- K101855 — PROFAST+ ASSAY
- K101866 — CRYOPATCH SG PULMONARY HUMAN CARDIAC PATCH
- K083418 — CPR MASK
- K092981 — PANPAC VAGINAL PESSARY
- K093981 — YRNSORTIP OXIMANOMETER
- K100488 — IR EAR/FOREHEAD THERMOMETER MODE DX6635, DX6637, DTH1081
- K100544 — IMPIX LUMBAR INTERBODY DEVICE
- K100558 — QUANTA DIODE LASER SYSTEM
- K100640 — 20 MMVIAL FLUID TRANSFER ADAPTER, MODEL 7E2500
- K100706 — VENUS BASIC SPINAL FIXATION SYSTEM
- K101302 — ALEUTIAN IBF SYSTEM
- K101434 — AUDIT MICROCV PROCALCITONIN LINEARITY
- K101576 — CENTERRIDGE DIAGNOSTIC ECG ELECTRODE, CENTERRIDGE MONITORING ECG ELECTRODES
- K101857 — RTC-24 VP METERED DOSE INHALER ADAPTER, MODEL RTC 24-V
- K101972 — SOLARIS REUSABLE AND DISPOSABLE BLOOD PRESSURE CUFFS
- K082573 — SARGON NON-EXPANDABLE DENTAL IMPLANT
- K090661 — NES REPROCESSED VARICOSE VEIN RF CATHETER
- K092830 — DIGITAL X-RAY IMAGING SYSTEM, MODEL DRC-1000
- K100531 — VISCOPE, MODEL 100P,100S
- K100678 — SUPRA SCAN DELIVERY SYSTEM
- K100766 — IBA PROTON THERAPY SYSTEM, MODEL PROTEUS 235
- K101043 — ECT DIGITAL THERMOMETER
- K101232 — JOINSOON ELECTRONICS MFG CO. LTD HIGH SPEED DIGITAL THERMOMETER, MODEL TC-001
- K101255 — ALPHATEC SPINE ANTERIOR LUMBAR PLATING SYSTEM
- K101282 — SCOUTPRO HEMOSTATIC VALVE
- K101596 — KIMBERLY-CLARK PURPLE NITRILE POWDER-FREE EXAM GLOVE (CHEMOTHERAPY GLOVE) AND KIMBERLY-CLARK PURPLE NITRILE XTRA POWDER-
- K101674 — WVSM (WIRELESS VITAL SIGNS MONITOR), MODEL 5.0
- K101778 — GIRAFFE INCUBATOR
- K101788 — GIRAFFE OMNIBED
- K101804 — GIRAFFE AND PANDA WARMERS
- K102008 — GLIDESHEATH
- K092329 — SOPIX 2
- K100702 — STARTROL LED LIGHTING SYSTEMS (X=# OF PODS, Y=# OF LEDS, N=TO MOUNTING STYLE) MODEL X X Y -N-S-W. X=NUMBER OF LIGHT PODS
- K100802 — AESCULAP IMPLANT SYSTEMS SIBD SPINAL SYSTEM
- K100805 — GALLERY LAMINOPLASTY FIXATION SYSTEM
- K100986 — CALLOS BONE VOID FILLER, SKAFFOLD NEXT GENERATION BONE VOID FILLER, OSTEO VATION
- K100031 — IND ONE STEP FECAL OCCULT BLOOD TEST MODEL 440-10
- K100765 — FIXPINE II SYSTEM
- K101095 — DIRECT PERORAL CHOLANGIOSCOPY BALLOON
- K101455 — EKO 7 DIAGNOSTIC ULTRASOUND SYSTEM
- K101625 — COHEN CROSSOVER CATHETER
- K092713 — SPECTRE WIRELESS ENCRYPTED FOOTSWITCH AND HAND SWITCH SYSTEM
- K092813 — ASTRASONIC SPIROMETER, MODEL 29-8000
- K092860 — LASEMAR 800, 1000, 1500
- K093784 — ATHENA MULTI-LYTE TORCH IGG PLUS TEST SYSTEM
- K100439 — MEDIWORKS SLIT LAMP
- K100603 — RS SAFE BLUE NITRILE MEDICAL EXAMINATION GLOVES (POWDER FREE)
- K100611 — RS CARE LATEX MEDICAL EXAMINATION GLOVE (POWDER FREE)
- K100752 — PEAK UNIVERSAL BOND (LIGHT CURE RESIN ADHESIVE AND CHLORHEXIDINE)
- K100964 — POWDERED VINYL PATIENT EXAMINATION GLOVES, CLEAR (NON-COLORED)
- K101087 — REPROCESSED RESTEP COMPRESSION SLEEVES
Data sourced from openFDA. This site is unofficial and independent of the FDA.