FDA 510(k) clearances — page 466
clearances on record, most recent first.
Clearances — page 466
46,501–46,600 of 176,542- 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
- K113112 — CLEARWAY RX NB CATHETER
- K113125 — INTELLIVUE MX40 PATIENT MONITOR
- K113191 — POWER FREE VINYL PATIENT EXAMINATION GLOVES, YELLOW COLOR
- K113234 — MOBCARDIO SYSTEM
- K103818 — CONFIRM ANTI-PROGESTORONE RECEPTOR (1E2) RABBIT MONOCLONAL PRIMARY ANTIBODY
- K110770 — HEALTHTRACKER
- K111026 — APOLLO
- K111323 — SYNTHES SYNPOR HD POROUS POLYETHYLENE THRER DIMENSIONAL IMPLANTS
- K111773 — RENU MEDICAL REPROCESSED OXIMAX SENSORS: ADULT, PEDIATRIC, INFANT AND NEONATE
- K111955 — MEDLINE PNEUMOPERITONEUM NEEDLE
- K112167 — SOYALA SILKGEL FULL FACE MASK
- K112205 — SNORERX 9.0
- K112276 — VIZION
- K112280 — STRAUMANN CARES SCREW-RETAINED BRIDGE TITANIUM, STRAUMANN CARES DOLDER BAR TITANIUM
- K112393 — TASMAN
- K112639 — THE BELMONT BUDDY LITE FLUID WARMER
- K112640 — HYPERELASTIC WIRE
- K113195 — POWDERED VINYL PATIENT EXAMINATION GLOVES, CLEAR (NON-COLORED)
- K113212 — DENTAL LASER THERAPY SYSTEM
- K111005 — ETHANOL REAGENT, ETHANOL CALIBRATOR, ETHANOL QC MATERIAL
- K111600 — REPROCESSED HAND ACTIVATE SEALER/DIVIDER
- K112069 — RSP GLENOID BASEPLATE POROUS COATED
- K112444 — ANATOMIC PEEK CERVICAL FUSION SYSTEM
- K112453 — STERISPINEPS PEDICLE SCREW
- K113156 — SONOSITE EDGE ULTRASOUND SYSTEM
- K102413 — FUZE: INTRAMEDULLARY INTERNAL FIXATION NAIL
- K111840 — EMERGE FRACTIONAL LASER
- K111843 — ACUFEX DIRECTOR APPLICATION ANATOMIC GUIDE SYSTEM
Data sourced from openFDA. This site is unofficial and independent of the FDA.