FDA 510(k) clearances — page 458
clearances on record, most recent first.
Clearances — page 458
45,701–45,800 of 175,770- K111771 — NON-CONTACT TEAR FILM THERMOGRAGH
- K112354 — 5MP MONOCHROME LCD MONITOR, RADIFORCE GX530
- K112361 — ALAMO C
- K112570 — CENTRICITY CARDIO IMAGING
- K112697 — CHARGER PTA BALLON DILATATION CATHETER
- K102756 — SURECORE BIOPSY DEVICE
- K111087 — FOUNDATION
- K111272 — RHAUSLER PLAGE ANTERIOR CERVICAL FUSION SYSTEM
- K111908 — BIOMET MICROFIXATION STERNAL CLOSURE SYSTEM
- K110170 — RAPTOR FACET FIXATION SYSTEM
- K111891 — SYNTHES BRAINLAB TRAUMA COMPATIBLE INSTRUMENTS
- K113153 — DP-20 AND DP-30 DIGITAL ULTRASONIC DIAGNOSTIC IMAGING SYSTEM
- K113198 — NMI CONTROL SYRINGE, 7 ML NMI CONTROL SYRINGE, 8 ML
- K113241 — BD EMERALD SINGLE USE, HYPODERMIC SYRINGE
- K112636 — CYTOGUARD(TM) CLOSED LUER CONNECTOR
- K111342 — LIGHT GUIDE CABLE
- K102644 — ADVIA 2120 WITH AUTOSLIDE SYSTEM, AND ADVIA 2120I
- K103483 — INGENUITY TF PET/MR
- K103803 — HAMILTON-G5
- K110525 — VITALOGRAPH MODEL 7100 - VITALOJAK
- K110605 — ROM PLUS
- K110619 — ARCHITECT 25-OH VITAMIN D 100T, VITAMIN D 500T, VITAMIN D CALIBRATORS, VITAMIN D CONTROLS
- K111119 — TRABECULAR METAL (TM) FUSION DEVICE
- K111242 — MAGNETOM AERA AND MAGNETOM SKYRA
- K111748 — RECOVERY+ MODEL PS 511, DVTHERAPY MODEL PS 511A
- K112150 — PROFEMUR GLADIATOR HA HIP STEM
- K112488 — HOTDOG PATIENT WARMING SYSTEM
- K112564 — QUIXIE NEBULIZER
- K112751 — SDX-4343CS
- K113163 — PENUMBRA SYSTEM MAX
- K113280 — CAROTID COIL GE 1.5T
- K103424 — SAFIRE
- K110427 — FEMTEC LASER SYSTEM FOR CAPSULOTOMY
- K110893 — VTRUST FINGER TYPE PULSE OXIMETER
- K110955 — ANYRIDGE INTERNAL IMPLANT SYSTEM
- K111066 — MIGRA TAB, QUICKSPLINT MIGRAINE
- K111690 — DEVINE SPINAL SYSTEM
- K111944 — NB3D BONE VOID FILLER
- K112015 — PREMIER HB9210 HBA1C ANALYZER
- K112134 — TRUCLEAR OPERATIVE HYSTEROSCOPE
- K112210 — FRAXION
- K112220 — DEVILBISS INTELLIPAP / SLEEPCUBE AUTO BILEVEL
- K112270 — ACCUMED WRIST AUTOMATIC BLOOD PRESSURE MONITOR
- K112273 — ACCUMED UPPER ARM AUTOMATIC BLOOD PRESSURE MONITOR
- K112380 — CLEARVISION
- K112484 — ZAVATION SPINAL SYSTEM
- K112544 — UNIMED BLOOD PRESSURE CUFF
- K112647 — BESTSHAPE BLOOD PRESSURE MONITORING SYSTEM
- K112687 — CONNEX(R) VITAL SIGNS MONITOR 6000 SERIES
- K112760 — AMSCO V-PRO MAX LOW TEMPERATURE STERILIZATION SYSTEM
- K112784 — RENASYS AB ABOMINAL DRESSING KIT
- K112963 — TD-4257 BLOOD GLUCOSE MONITORING SYSTEMS,TD 4257 MULTI BLOOD GLUCOSE MONITORING SYSTEMS
- K112999 — DIMENSION CLINICAL CHEMISTRY SYSTEM
- K113027 — SYNGO AORTIC VALVEGUIDE SOFTWARE
- K113052 — INFINIX-CCI
- K113139 — LZI COCAINE METABOLITE HOMOGENEOUS ENZYME IMMUNOASSAY,CALIBRATORS,CONTROLS
- DEN100026 — APTUS STEERABLE ENDOGUIDE WITH OBTURATOR, APTUS ENDOSTAPLE APPLIER WITH ENDOSTAPLE CASSETTE, APTUS ENDOSTAPLE CASSETTE
- K103530 — SPIRODOC
- K110614 — PAD (PERSONAL ALCOHOL DETECTOR) BREATH ALCOHOL TEST SYSTEM
- K112097 — GIBRALT SPINE SYSTEMS FACET SCREW 04.0,04.5
- K112168 — COMPONEER
- K112405 — CLYDESDALES SPINAL SYSTEM
- K112425 — INFINITI VISION SYSTEM EVERGREEN II AUTOSERT IOL INJECTOR HANDPIECE
- K112493 — PASS LP SPINAL SYSTEM
- K112551 — S4 SPINAL SYSTEM
- K112724 — DEPUY PULSE ANTERIOR CERICAL PLATE SYSTEM
- K113174 — CD HORIZON SPINAL SYSTEM
- K113209 — CHIBA SONO
- K102833 — DISPOSABLE HEMODIALYSIS ACCESS CATHETER SETS
- K103376 — ELITECH CLINICAL SYSTEMS CREATINNE PAP SL MODEL CRSL-0250, CLITECH CLINICAL SYSTEMS ELICAL 2 MODEL CALI-0580, ELITECH CL
- K110294 — HIGH FLOW INSUFFLATION UNIT UHI-4
- K110560 — MEDTRONIC ARES ANTIBIOTIC-IMPREGNATED CATHETER
- K110596 — MW100 (MAMMOGRAPHY) LCD MONITOR SYSTEM
- K110762 — AVO BARRIER TOPICAL EMULSION
- K110962 — AMBU ASCOPE 2
- K111216 — OSSEOTITE 2 DENTAL IMPLANTS
- K111290 — PIEZO BONE SURGERY
- K111358 — SYNTHES USS
- K111593 — GUARDIAN INFLATABLE BONE EXPANDER SYSTEM
- K111642 — ONCO TRAC MODEL 1, 2, 4
- K111709 — FOUNDATION DENTAL RESIN
- K111960 — ELITECH CLINICAL SYSTEMS CARBON DIOXIDE ELECTRODE, ELITECH CLINICAL SYSTEMS ISE CALIBRATORS
- K111983 — VISTA-S DEVICE MODEL 08/06-401-XXXXX, 08/06-402-XXXXXX
- K112002 — CAROTID COIL
- K112050 — SOUNDSTAR ECO DIAGNOSTIC ULTRASOUND CATHETER
- K112053 — OBC BONE ANCHORED HEARING SYSTEM
- K112132 — KRYSTALRAD 660 DIGITAL RADIOGRAPHIC PORTABLE RETROFIT SYSTEM
- K112219 — TAPAS CATHETER
- K112420 — ONCENTRA PROSTATE 4.0
- K112531 — VITREA CT MYOCARDIAL ANALYSIS
- K112554 — TRANSRADIAL ARTERY ACCESS DEVICES
- K112768 — CALYPSO SYSTEMS WITH DYNAMIC EDGE GATING
- K113029 — SYNGO VIA MI WORKFLOWS
- K110661 — ACCELEDENT
- K111855 — HY-BOND RESIGLASS
- K111982 — CLEARFIL DC CORE PLUS
- K112085 — SYNTHES LCP PEDIATRIC PLATE SYSTEMS
- K112118 — DREAMBOND
- K112197 — MEMOMETAL INTRA-MEDULLARY BONE FASTENER
- K112214 — OCTRODEX(TM), QUATTRODEX(TM), INTRODEX(TM), EPIDURAL NEEDLE, STYLETS
Data sourced from openFDA. This site is unofficial and independent of the FDA.