FDA 510(k) clearances — page 655
clearances on record, most recent first.
Clearances — page 655
65,401–65,500 of 176,637- K041820 — SOLO-CARE AQUA ANTIMICROBIAL LENS CASE
- K051130 — VCS S3Y
- K051269 — RII INFRARED EAR THERMOMETER, MODELS TH00XY SERIES
- K051320 — SATELLITE SPINAL SYSTEM
- K051614 — PRIMACONNEX INTERNAL CONNECTION IMPLANT SYSTEM, PRIMACONNEX INTERNAL CONNECTION PROSTHETICS
- K051665 — SYNTHES VECTRA-T SYSTEM
- K051810 — WHOLE PTH (1-84) SPECIFIC IMMUNORADIOMETRIC ASSAY (IRMA) COATED TUBE KIT, MODEL 3KG014
- K051876 — MULTIWAVE XR
- K051904 — ALL PURPOSE CUFF, MODEL 222APC
- K052117 — I-FLOW ELASTOMERIC PUMP (ON-Q, PAINBUSTER, C-BLOCK, HOMEPUMP, EASYPUMP)
- K052330 — TRU-SWAB STOCOCK
- K052353 — Z-CHAIR
- K052362 — BIS EEG MONITOR, MODEL A-3000
- K052375 — ALILIFE STAND UP POWERED WHEELCHAIR, HC-300
- K052389 — I-PORT
- K041952 — ZIVF-AIRE
- K051134 — HEARTSTART MRX WITH Q-CPR OPTION, MODELS M3535A OR M3536A
- K051209 — LEVITRONIX CENTRIMAG BACK-UP CONSOLE
- K051281 — THE NEEDLE CATCHER
- K051297 — ELECSYS N-MID OSTEOCALCIN, ELECSYS OSTEOCALCIN CALSET, ELECSYS OSTEOCALCIN CALCHECK
- K051407 — LEGEND ALL-POLY CUP
- K051650 — STRATUS CS ACUTE CARE MB ISOENZYME OF CREATINE KINASE (CKMB) TEST PAK; STRATUS CS ACUTE CARE CKMB TESTPAK.
- K051676 — SPINEASSIST DEVICE WITH ADDITIONAL ACCESSORIES
- K051956 — DR. OPPEL ST-501
- K051986 — SYNTHES 4.5 MM LCP STRAIGHT RECONSTRUCTION PLATES
- K052150 — VOLAR PLATE SYSTEM
- K052153 — OMRON AUTOMATIC BLOOD PRESSURE MONITOR, MODEL HEM-741CREL
- K052154 — OMRON AUTOMATIC BLOOD PRESSURE MONITOR, MODEL HEM-711AC
- K052158 — WELCH ALLYN CARDIOPERFECT WORKSTATION VERSION 1.5.0 SOFTWARE
- K052167 — DATEX-OHMEDA S/5 TONOMETRY MODULE, E TONO AND ACCESSORIES
- K052181 — MODIFICATION TO XIA SPINAL SYSTEM
- K052216 — SOMATOM DEFINITION
- K052260 — SUPERDIMENSION/BRONCHUS 4.1
- K052305 — MRI SOFT TISSUE MOTION CORRECTION SOFTWARE VA10A
- K052337 — MONOCHROME LCD MONITOR, MODEL RADIFORCE G33
- K042287 — UNIPLAIN & UNICHROM
- K050174 — BIO-STIM KIT
- K050388 — REFIX INTERNAL FRACTURE FIXATION SCREWS
- K051112 — WHITTLESTONE EXPRESSER
- K051251 — INFRARED EAR THEMOMETER, MODELS DX6603, DX66390
- K051279 — CALDYNE, INC. EXHALOMETER EX100, MODEL EX100
- K051716 — VERTEBRON PSS PEDICLE SCREW SYSTEM
- K051831 — GEMINI SURGICAL CONTROL & DISPLAY SYSTEM
- K051952 — EUGENONE
- K051966 — FIRST CHECK MULTI DRUG CUP 7 FOR MARIJUANA (THC), COCAINE (COC), AMPHETAMINE (AMP), METHAMPHETAMINE (MET), ECSTASY
- K052024 — NSTRAND IMPLANTATION KIT
- K052078 — ACHIEVA, INTERA AND PANORAMA 1.0 RELEASE 2-SERIES
- K052098 — CONNEXUS, .5CC, MODEL 023000-005
- K052159 — AIDA COMPACT II SYSTEM
- K050435 — E-STIM II
- K051192 — PRAXAIR MEDICAL AIR MIXER
- K051556 — ACUMATCH A-SERIES CONNEXION GXL ENHANCED CROSSLINKED POLYTHYLENE
- K051585 — F-400 SYSTEM
- K051611 — MBARESORB IMPLANT
- K051616 — VANGUARD REPROCESSED EXTERNAL FIXATION DEVICES
- K051661 — IMPLANT HANDPIECES
- K051740 — TAPERED COMPRESSION PIN
- K051747 — SBI WRISTFIT
- K051775 — OSTEOMIMETIC SYNTHETIC BONE MATRIX
- K051820 — PARALLAX EZFLOW CEMENT DELIVERY SYSTEM
- K051866 — PREMIER TEMPORARY CEMENT
- K051915 — FREELITE HUMAN KAPPA AND LAMBDA FREE KITS FOR USE ON THE BAYER ADVIA 1650 ANALYZER
- K051945 — MIOT PLATING SYSTEM
- K051975 — POROUS COATED DISCOVERY ELBOW
- K052005 — R&R EXTERNAL FIXATION SYSTEM
- K052185 — DESTINATION CAROTID GUIDING SHEATH
- K052209 — VCS DOPPLER TRANSCEIVER, MODEL 09-0023-01
- K052237 — SC CERAMIC BALL HEADS
- K042782 — SEER MC
- K043373 — DOLOTENS DENTAL TM 1
- K050411 — ZIMMER A.T.S. 3000 AUTOMATIC TOURNIQUET SYSTEM
- K050443 — ACCU-LEAD
- K050629 — ANGIOSCULPT SCORING BALLOON CATHETER
- K050863 — IMAGER II ANGIOGRAPHIC CATHETER
- K050999 — YI XIN STERILE SYRINGE FOR SINGLE USE
- K051018 — INTERMEZZO IMPLANT SYSTEMS
- K051035 — SYNERGEYES (PAFLUCON D HEM-IBERFILCON A) HYBRID CONTACT LENS
- K051160 — MANIPUSEAL
- K051507 — MODIFICATION TO BLUE SKY BIO DENTAL IMPLANT SYSTEM
- K051592 — MODIFICATION TO ACCU-CHEK GO SYSTEM
- K051593 — UROPASS URETERAL ACCESS SHEATH, MODEL 61224
- K051594 — MCCARTNEY ACCESS TUBE
- K051671 — RADIANCY SKINSTATION WITH MODIFIED LIGHT UNIT ADDEMBLY
- K051874 — SEDLINE SEDATION MONITOR WITH FRONTAL PSI AND SEDTRACE EEG ELECTROSE SET
- K051910 — MAXISONIC FAMILY AND SWIFT ULTRASONIC SCALER
- K051924 — POWDERED VINYL PATIENT EXAMINATION GLOVES, COLORED (WHITE, YELLOW)
- K052076 — DAR-8000I
- K052149 — EDWARDS PERIPHERAL DILATION CATHETER
- K052296 — CLIRPATH TURBO EXCIMER LASER CATHETERS
- K052334 — CAVITRON RF ULTRASONIC SCALER SYSTEM WITH STERIMATE HANDPIECE, MODEL G-131
- K050352 — IN-VITRO DIAGNOSTIC VAGINITIS TEST KIT
- K051091 — SYNTHOGRAFT
- K051157 — INSTRU-SAFE INSTRUMENT PROTECTION SYSTEMS
- K051264 — COMFORT AND INSET SUBCUTANEOUS INFUSION SETS FOR USE WITH ABBOTT INFUSION PUMPS
- K051422 — DUAL MODE UP-GRADE FOREHEAD/UNDERARM THERMOMETER DEVICE
- K051515 — MODIFIED ACUMEN SHEATH, MODEL TTW 10-65
- K051576 — AVANA DENTAL IMPLANT SYSTEM
- K051669 — TEVADAPTOR CLOSED DRUG RECONSTITUTION AND TRANSFER SYSTEM
- K051712 — MODEL 2800 PFT FILTER
- K051838 — MODIFIED CONCENTRIC RETRIEVER, MODEL 90039
Data sourced from openFDA. This site is unofficial and independent of the FDA.