FDA 510(k) clearances — page 626
clearances on record, most recent first.
Clearances — page 626
62,501–62,600 of 176,637- K061994 — WEB VIEWER, POCKET VIEWER AND CELLULAR VIEWER WITH L- WEB05 SOFTWARE
- K062201 — SPIDERX EMBOLIC PROTECTION DEVICE
- K062220 — MODIFICATION TO GUARDDOG OCCLUSION SYSTEM
- K050590 — ENZY-WELL SYPHILIS IGG, MODEL 91106
- K053287 — COBAS AMPLICOR CT/NG TEST FOR CHLAMYDIA TRACHOMATIS
- K053289 — COBAS AMPLICOR CT/NG TEST FOR NEISSERIA GONORRHOEAE
- K061017 — EASYSPINE SYSTEM
- K061086 — DM-3000 DIGITAL BLOOD PRESSURE MONITOR
- K061215 — VOLCANO S51 FAMILY OF IMAGING SYSTEMS
- K061367 — BLUESKY VISTA WOUND VACUUM SYSTEM, MODEL 100.0500
- K061425 — PUREWRIST SCISSORS, MODEL PW1101-01; PUREWRIST DISSECTOR, MODEL PW1201-01; PUREWRIST HOOK, MODEL PW1301-01
- K061783 — KNEE FUSION NAIL
- K061789 — LATERAL PLATE SYSTEM
- K061855 — NEUROQUANT
- K061867 — BD PHOENIX AUTOMATED MICROBIOLOGY SYSTEM-CEFAZOLIN (GN) 0.5-32 UG/ML
- K061975 — PLASMASEAL OPEN FORCEPS, MODELS 2103PK AND 91701PK
- K062154 — VITAL CONNECT 4.0
- K042850 — CARDIODRIVE, MODEL 001-004115 (NON-STERILE); 001-1169-1 (STERILE)
- K060367 — TENOLIG
- K061179 — POWERHICKMAN LONG-TERM INTRAVASCULAR CATHETER
- K061335 — ENHANCE DENTAL IMPLANT SYSTEM
- K061491 — LAC-MAC INNERBLOC O.R. GOWN
- K061936 — KENDALL ARGYLE NEONATAL/PEDIATRIC PICC, MODEL 43311
- K061938 — VERTE-STACK SPINAL SYSTEM
- K062008 — ENDO CAR COMPRESSION ANASTOMOSIS RING (CAR)
- K062126 — EMBOCATH PLUS INFUSION MICROCATHETER, MODEL ECP-100 AND ECP-135
- K060151 — ORBITAL TISSUE EXPANDER (OTE)
- K060318 — HEPATIC ENZYMES ON ABX PENTRA 400 CLINICAL CHEMISTRY ANALYZER
- K060690 — ONLINE VALPROIC ACID
- K061107 — DPC T60I KUSTI, MODEL 984248; DPC T60I, MODEL 984247
- K061500 — SICACE DENTAL IMPLANT SYSTEM AND SIC ANGLED ABUTMENTS
- K061904 — COMPUDENT STA
- K062091 — POROUS MEDIA HUMIDIFLOW HUMIDIFIER FOR UNIVERSAL HUMIDIFICATION
- K062108 — COMCASET SAFETY IV CATHETER
- K053570 — TREP-SURE TREPONEMAL ANTIBODY EIA
- K060355 — ACRO BIOTECH LLC RAPID MDMA URINE TEST, CATALOG MDMA0010000
- K060760 — RAPIDONE-BUPRENORPHINE TEST
- K060810 — ONE STEP DRUG TEST - AMP/MET/MOR/THC/COC
- K060936 — PARAGOLFER
- K061306 — CO-1000 COLPOSCOPE, MULTIPLE
- K061404 — MONO-CRAWFORD NASO-LACRIMAL INTUBATION DEVICE
- K061727 — GORE PRECLUDE VESSEL GUARD
- K061755 — MYLAB15/20 NEW INDICATIONS ULTRASOUND SYSTEM
- K061793 — DIMENSION VISTA IRON FLEX REAGENT CARTRIDGE AND CALIBRATOR
- K061801 — 2.8 & 3.5MM LACTOSCREW SUTURE ANCHORS
- K061810 — COUGAR WHEELCHAIR
- K061831 — MEDCHANNEL HTS SYSTEM
- K061834 — XCAT; XCAT FOR NEURO
- K062053 — MONOCHROME LCD MONITOR, RADIFORCE, GS320
- K062055 — DIMENSION VISTA PROTEIN 1 CALIBRATOR, CONTROL LOW, CONTROL MEDIUM, CONTROL HIGH
- K053348 — STRYKER ORTHOPAEDICS RFID INSTRUMENTATION
- K053399 — VERSALET 7700 CARE CENTER
- K060010 — NAUTIFLUX
- K060235 — ENDO-EASE ENDOSCOPIC OVERTUBE
- K060307 — 12 RL ALGORITHM
- K060624 — MARATHON STENT WITH FUSION TECHNOLOGY
- K060972 — KEDALL 14.5 FR CHRONIC HEMODIALYSIS CATHETER W/SILVER IMPREGNATED SLEEVE (PALINDROME RUBY)
- K061450 — HOSPIRA LATEX-FREE ADVANCED SENSOR CATHETERS; HOSPIRA LATEX-FREE CRITICAL CARE CATHETERS
- K061589 — SOLARC / SOLRX HANDHELD ULTRAVIOLET PHOTOTHERAPY LAMP UNIT FAMILY
- K061638 — BEST STRAND AND BEST SPACER
- K061730 — OSMETECH OPTI R CRITICAL CARE ANALYZER, MODEL GD7044
- K061753 — SYNTHES (USA) CLAVICLE HOOK PLATES
- K061779 — COMPETITOR UNICONDYLAR ALL-POLY TIBIAL BASEPLATE
- K061827 — SONIX ULTRASOUND SCANNER
- K061955 — RAYHACK LOW PROFILE LOCKING PLATE AND INSTRUMENTS
- K061963 — MICRUS MICROCATHETER COURIER PRE-SHAPED, MODELS MPS170045-00, MPS170090-00, MPS190045-00, MPS190090-00
- K062219 — PRODRIVE SYSTEMS REPLACEMENT TURBINE
- K060474 — LISFRANC PLATE
- K061015 — FAST-CATH HEMOSTASIS INTRODUCER AND TRANSSEPTAL INTRODUCER
- K061165 — ELIA CCP, MODEL 14-5515-01; ELIA CCP CONTROL, MODEL 83-1009-01
- K061230 — VECTORS TEMPORARY ANCHORAGE SYSTEM
- K061383 — BTI STERILE DENTAL DRILLS KIT, BTI ABUTMENTS AND CAPS
- K061492 — MONOJECT MAGELLAN INSULIN AND TUBERCULIN SAFETY SYRINGE
- K061836 — AVS ASL PEEK SPACER SYSTEM
- K061986 — 1.9F X 20 CM VASCU-PICC, MODELS VP1.9S20 AND VP1.9S50
- K062037 — TRIATHLON LOW PROFILE TIBIAL TRAY
- K050842 — AGCEL WOUND DRESSING,AGCEL BURN DRESSING
- K053041 — MED SCULPT
- K060297 — PEPER
- K061226 — TRABECULAR METAL ACETABULAR REVISION SYSTEM CAGE
- K061256 — SMARTMONITOR 2PS
- K061344 — EXCIA TOTAL HIP SYSTEM LATERAL OFFSET
- K061565 — LANGSTON DUAL LUMEN CATHETER
- K061675 — VISION VXC CENTRAL STATION, MODEL 4300
- K061703 — DIMENSION VISTA CHEMISTRY 2 CALIBRATOR (CHEM 2 CAL, KC120)
- K061722 — BLOXX RAPID CLOTTING AGENT
- K061822 — OMRON AUTOMATIC BLOOD PRESSURE MONITOR WITH COMFIT CUFF, MODEL HEM 780 N3
- K062057 — U-CLIP DEVICE, MODEL NC65
- K053092 — MEDCOMP VASCU-SHEATH II
- K060833 — 12SL ECG ANALYSIS PROGRAM
- K061373 — VNUS CLOSUREFAST CATHETER, MODELS CF7-7-60 AND CF7-7-100
- K061392 — IKONISCOPE FASTFISH AUTO/AMNIOCYTE TEST SYSTEM
- K061455 — DORNIER MEDILAS H 20 LASER
- K061486 — TAMPAX TAMPONS - (LIGHT,REGULAR,SUPER AND SUPER PLUS ABSORBENCIES)
- K061513 — LEVEL 1 SNUGGLE WARM PEDIATRIC AND LARGE PEDIATRIC UNDERBODY BLANKET
- K061522 — TRIVARION BUFFERED IONTOPHORESIS ELECTRODE SYSTEM
- K061762 — TIBURON DRAPE, MODEL 9349N/ OPTIMA DRAPE, MODEL 9446N
- K061843 — VENTURE WIRE CONTROL CATHETER, MODEL WCC
- K061857 — MODEL MULTI-FLO IC-1545-KT/-F INTERMITTENT CIRCULATOR
- K061882 — OXYGENLESS PACKAGING CONVERSION OF LEGACY CENTERPULSE STANDARD POLYETHYLENE DEVICES
Data sourced from openFDA. This site is unofficial and independent of the FDA.