FDA 510(k) clearances — page 557
clearances on record, most recent first.
Clearances — page 557
55,601–55,700 of 175,825- K081299 — DIMENSION VISTA SYSTEM TRF FLEX REAGENT CARTRIDGE, DIMENSION VISTA SYSTEM PROTEIN 1 CALIBRATOR, AND DIMENSION VISTA
- K081337 — APPROACH CTO WIRE GUIDE
- K081457 — ATRILAZE LASER ABLATION SYSTEM
- K081476 — SURGICAL CONCEPT DESIGNS POSITIONOR SURGICAL DRAPE
- K081651 — INSTRUMED RONGEUR
- K081766 — PKS OMNI INSTRUMENT
- K081915 — FDTX GLUCOSE CONTROL SOLUTION
- K082028 — LASERPEEL SOFT-MET MODIFIED ERBIUM LASER
- K071649 — NEONATAL TOTAL GALACTOSE KIT; NEONTAL TOTAL GALACTOSE KIT, MODELS 3029-0010 AND 3029-110B
- K071687 — FAMILI OF IRIDEX IQ LASER SYSTEMS
- K073047 — APROXI 1100 AND 4000 SERIES DENTAL INLAYS
- K073396 — ANTIMICROBIAL ULTRASITE VALUE, ULTRASITE AG
- K073499 — VERSYS EPOCH FULLCOAT HIP PROSTHESIS, MODEL 4088 SERIES
- K080606 — ALATECH POWDERED LATEX PATIENT EXAMINATION GLOVE
- K080799 — ATLAS-BASED AUTOSEGMENTATION
- K080833 — LOVE GUARD MALE LATEX CONDOM
- K080899 — ARCTIC BLAST INTRAVENOUS FLUID CHILLER
- K080930 — MODIFICATION TO AUTOMATED BREAST ULTRASOUND SYSTEM, MODEL ABUS
- K080983 — PROVENT NASAL CANNULA
- K081051 — SPINEVU ENDOSCOPIC SPINE SYSTEM (SESS), SPINEVU MINISCOPE
- K081191 — TCM ENDO 20
- K081636 — PEEK-OPTIMA ALIF SPACER
- K081729 — MODIFICATION TO GFX NERVE ABLATION SYSTEM
- K081756 — OCULAR RESPONSE ANALYZER
- K081941 — NAVIGATOR APPLICATIONS SUITE
- K081973 — METHA SHORT STEM HIP SYSTEM; MODULAR HIP SYSTEM; EXCIA HIP SYSTEM
- K072293 — FOSSA URETERAL OPEN STENTS
- K072486 — MODIFICATION TO HEMCON BANDAGE AND HEMCON BANDAGE OTC
- K072629 — DIGIMATCH ROBODOC SURGICAL SYSTEM
- K080484 — INOMAX DS (DELIVERY SYSTEM), MODEL 10003
- K080847 — RFVISION, MODEL 9.9D
- K080935 — SONIX MDP ULTRASOUND SCANNER
- K080966 — HYPER-BOX TOPICAL WOUND OXYGEN SYSTEM
- K081232 — TOTAL KNEE SURGETICS NAVIGATION SYSTEM WITH PRAXITELES
- K081721 — TRICOS A RESORBABLE SUBSTITUTE
- K081752 — EDGE PACS
- K081921 — GE VIVID E9 ULTRASOUND
- K082054 — GYRUS ACMI PLASMAKINETIC (PK) SUPERPULSE SYSTEM, MODEL 744000 AND DUAL FOOTSWITCH CONNECTOR CABLE, MODEL 710003
- K082100 — ALLTECH ECHOSTAR 1.5 T MR SYSTEM
- K082157 — KETTOSIL AND SILGINAT
- K080298 — DERMABIOSAFE
- K080303 — EZ REGULAR
- K080603 — HYBRID NERVE LOCATION NEEDLE COATED AND UNCOATED
- K081149 — BIOPRO GO-EZ SCREW
- K081804 — PIONEER PLUS CATHETER
- K081957 — U-RIGHT TD-4247 BLOOD GLUCOSE MONITORING SYSTEM
- K081968 — MODIFICATION TO LUCENT
- K081992 — DIMENSION VISTA CSAE FLEX REGENT CARTRIDGE, MODEL K4108
- K073381 — PLEXUS EBV IGM MULTI-ANALYTE DIAGNOSTICS, MODEL: MP0600M
- K080276 — SELF-ADHESIVE ELECTRODES
- K080749 — RADIANCE
- K081017 — TEMPLATE AND COUNTER-FIT
- K081289 — V-LINK ANTIMICROBIAL LUER ACTIVATED DEVICE AND EXTENSION SETS WITH V-LINK ANTIMICROBIAL LUER ACTIVATED DEVICE
- K081319 — DIMENSION CLINICAL CHEMISTRY SYSTEM LIPASE CALIBRATOR, MODEL DC56
- K081510 — TIGER CANNULATED SCREW SYSTEM
- K081859 — MODIFICATION TO ONEDOSE PATIENT DOSIMETRY SYSTEM
- K081980 — KYMCO FORU, MODEL EQ35
- K073112 — DA VINCI SONICPRO CLEANING SYSTEM, MODEL 400253
- K073523 — INTERCEPTOR PLUS CORONARY FILTER SYSTEMS
- K073677 — SCANSCOPE XT SYSTEM
- K080037 — MODIFICATION TO ZILVER 635 BILIARY STENT
- K081085 — STARCHMARK BIOPSY SITE MARKER, MODEL STMKEC-10GSS, STMKEC-10GTR, STMKMT-11GS
- K081876 — OSTEOMED RESURFACING METATARSAL IMPLANT WITH HYDROXYLAPATITE COATING
- K082041 — FIATLUX VISUALIZE
- K082043 — CARRIAZO-PENDULAR MICROKERATOME
- K082045 — MODIFICATION TO MCARE 300 VITAL SIGNS MONITOR, MODEL 91220
- K072109 — STATMAP, MODEL 7200
- K073042 — HEMOSIL D-DIMER
- K080326 — KD-391 SEMI AUTOMATIC ELECTRONIC BLOOD PRESSURE MONITOR
- K080370 — ABL 80 CO-OX SYSTEM
- K080552 — CYTO-CHEX BCT
- K081124 — MDF REVISION HIP SYSTEM
- K081272 — PORCINE SURGICAL MESH; DERMAL MATRIX
- K081444 — BRAEMAR FUSION WIRELESS - AMBULATORY ECG ARRHYTHMIA MONITORING SYSTEM
- K081552 — SKYLINE 55
- K081870 — MASIMO COMPATIBLE SATURATION MODULE, E-MASIMO
- K081954 — GYRUS ACMI GENERAL SURGERY WORKSTATION, MODEL G400, AND DUAL FOOTSWITCH CONNECTOR CABLE
- K082031 — APPASAMY SLIT LAMP, A1A-11 AND A1A-12 SERIES
- K082033 — NANNOLIGHT INTENSE PULSED LIGHT SYSTEM
- K071759 — LTC VAD SYSTEM, MODELS #VAD.400 (ELECTROSURGICAL GENERATOR); PCS-900 AND PCC-900 (HAND PIECE INSTRUMENTS)
- K072884 — FABIUS MRI
- K073386 — JOINT STIM, MODEL 1000
- K080668 — G2 EXPRESS FILTER SYSTEM-FEMORAL (RF400F) AND JUGULAR/SUBCLAVIAN (RF400J) DELIVERY KITS
- K080745 — GENADYNE A4 POWERED SUCTION PUMP
- K080780 — ANCHORAGE SCOPE, MODEL 000003
- K080832 — STOCKERT S5 SYSTEM, STOCKERT GAS BLENDER
- K080896 — PATHWORK DIAGNOSTICS TISSUE OF ORIGIN TEST
- K080995 — MODIFICATION TO AFFYMETRIX GENECHIP MICROARRAY INSTRUMENTATION SYSTEM
- K081113 — COOK AND COOK SPECTRUM CENTRAL VENOUS CATHETERS
- K081244 — LOWER EXTREMITY EXTERNAL FIXATION - EXPANDED INDICATIONS
- K081429 — THD SLIDE
- K081466 — STERILE, POWDER FREE NITRILE EXAMINATION GLOVES, BLUE
- K081698 — MAINSTREAM OR SURGICAL LIGHT CONTROL (MSLC)
- K081836 — CARESTREAM DR LONG LENGTH IMAGING SYSTEM FOR DR 7500 SYSTEM
- K081879 — SPSMEDICAL SPORVIEW PA CULTURE SET
- K073089 — LIFEPAK 20E
- K080426 — MAESTRO WRIST FRACTURE IMPLANT
- K080939 — SURGICAL HANDPIECES, MIKRO SAW HANDPIECES
- K081112 — FLEXIPLAN BRACHYTHERAPY TREATMENT PLANNING SYSTEM
- K081238 — REPROCESSED MASIMO PULSE OXIMETER SENSORS
Data sourced from openFDA. This site is unofficial and independent of the FDA.