FDA 510(k) clearances — page 513
clearances on record, most recent first.
Clearances — page 513
51,201–51,300 of 176,542- K100930 — PRIMEWIRE PRESTIAGE PRESSURE GUIDE WIRE, MODELS 8185, 8185J, 8300, 8300J
- K100939 — INTELLIVUE PATIENT MONITOR MODEL: MP2, MP5, MP5T, MP20, MP30, MP40, MP50, MP60, MP70, MP75, MP80 AND MP90
- K100994 — PRELOADED TISSUE MARKER DEVICE
- K101041 — DC-7 DIAGNOSTIC ULTRASOUND SYSTEM
- K090510 — DOPPLER FETAL HEARTBEAT RATE DETECTOR
- K091486 — K-ASSAY MICROALBUMIN AND K-ASSAY MICROALBUMIN CALIBRATOR
- K093017 — STELLAR 300
- K093422 — VITAL SYNC MODEL 5000 SERIES
- K093728 — BE MICRO, TREA
- K093899 — MAMMOTOME BIOPSY SYSTEM FOR MOLECULAR IMAGING
- K100266 — ACTIWAVE 1E, ACTIWAVE2E, ACTIWAVE2M, ACTIWAVE4E, ACTIWAVE CARDIO MODEL 08-514, 08-521, 08-536, 08-557, 08-603
- K100301 — OPAL BOND FLOW
- K100517 — INSTRUMED FORCEPS OBSTERICAL, MODEL# 46-5XXX, OB-XXXX
- K092611 — SONARMED AIRWAY MONITORING SYSTEM, MODEL 0901
- K092901 — EPICAGE INTERBODY FUSION DEVICE
- K093128 — ILLUMINA BEADXPRESS SYSTEM
- K093129 — ILLUMINA VERNCODE GENOTYPING TEST FOR FACOR V AND FACTOR II
- K093561 — ZIMMER TRABECULAR METAL MODULAR ACETABULAR SYSTEM
- K093770 — EXTREMITY MEDICAL SCREW SYSTEM
- K100258 — ELECTROSURGICAL PENCIL WITH ELECTRODE, WP200
- K100319 — MERIT MANIFOLD WITH INTEGRATED TRANSDUCER, MODEL 203LTCHN-R; 503LTCHN-R; 203LTPHN-R,203LTCHWN-R; 503LTCHWN-R
- K100378 — 1 SERIES MODEL 1 SERIES T2, 1 SERIES X2, 1 SERIES T4, 1 SERIES X4
- K100410 — PIEZOELECTRIC SYSTEM
- K100710 — ROLL-X GUIDEWIRE
- K100866 — PROFEMUR HIP SYSTEM MODULAR NECKS
- K091472 — URITEST 50 AND URITEST 500 URINE ANALYZER
- K093241 — V7 PORTABLE SUCTION UNITS
- K093377 — POLARIS CONTACT LENS CASE
- K094031 — ELECSYS FOLATE III CALCHECK 5
- K094040 — F&P ICON SERIES CPAP
- K092171 — VOLUX, DIGITAL EXTRAORAL SOURCE X-RAY SYSTEM
- K092382 — NEXUS PRESSURE RATED EXTENSION SETS
- K092748 — SURESHOT TAN NAILS AND ACCESSORIES
- K092911 — SMART HBA1C ASSAY KIT, MODEL DZ168B-POC, SMART HBA1C ASSAY CONTROL KIT, MODEL DZ168B-CON, SMART HBAC1C ANALYZER
- K093207 — ENDURAMESH, MODEL 762.XXX
- K093478 — KODAK RVG 6500 SYSTEM AND KODAK RVG 6500 IPS SYSTEM
- K094025 — CRESCENT SPINAL SYSTEM
- K100268 — SECHRIST MONOPLACE HYPERBARIC OXYGEN CHAMBER
- K100548 — VERSAPORT BLADELESS LOW PROFILE TROCAR MODEL NB3SHFLP, NB5SHFLP, NB5STFLP
- K100810 — ELECSYS C-PEPTIDE CALCHECK 5
- K090882 — FLUSH SYRINGE FILLED WITH 0.9% SODIUM CHLORIDE
- K091987 — ANASTOCLIP MODELS 4001-01, 4000-02, 4000-03, 4000-04, 4004-01, 4004-02, ANASTOCLIP
- K092542 — M
- K093421 — ELECSYS TESTOSTERONE II IMMUNOASSAY
- K093618 — BILI-MIRROR MODEL BLM-1
- K093705 — FUORECAM
- K093940 — ADVOCATE REDI-CODE DASH BLOOD GLUCOSE MONITORING SYSTEM MODEL TD-4276
- K094052 — LENSX 550 LASER SYSTEM. MODEL 550
- K100237 — DIALYSATE METER, MODEL D-6
- K100283 — VERSATUBE TAPERED TRACHEOSTOMY TUBE WITH DISPOSABLE INNER CANNULA, MULTIPLE, PREFIXES C-VT, C-VTIC
- K100315 — 12 LEAD GLOVE
- K100343 — PAP-CAP
- K100449 — MINXRAY MODEL CMDR-2S
- K100528 — BREATHE TECHNOLOGIES VENTILATOR AND ACCESSORIES BT-V2S
- K100838 — ERGO IMAGING SYSTEM
- K100941 — INFINITY MCABLE - MAINSTREAM CO2
- K091404 — IVUE, MODEL 100
- K093343 — GRAFTY QUICKSET
- K093799 — TORNIER SURGICAL MESH
- K093871 — PERIOPHIL B-TCP
- K093889 — MODIFICATION TO: HG III ULTRA WIDE SYSTEM
- K093971 — DENTAL HANDPIECE
- K093974 — ESENOR FII-FV-MTHFR GENOTYPING TEST, ESENOR FII-FV GENOTYPING TEST, ESENOR FII GENOTYPING
- K093977 — ALLIGATOR-HD RETRIEVAL DEVICE (ARD-HD), MODEL FA-88840-XX
- K094038 — COMPACT TOUCH
- K094045 — MODIFICAITON TO: CARDO MEDICAL HIP SYSTEM
- K100096 — LINAC COLLIMATOR ASSEMBLY HOUSING (LCAH) MODEL LCAHART
- K100113 — VANGUARD BREAST MRI AUXILIARY TABLE WITH 16 CHANNEL COIL ARRAY FOR GE 3T MRI SYSTEM, MODEL 4000451-51
- K100273 — INSTAFLO BOWEL CATHETER SYSTEM KIT
- K100334 — DIACAP POLYSULFONE HIFLO 23 HEMODILAYZER , MODEL 72036811
- K100361 — NANOSS BONE VOID FILLER
- K100377 — DIAMONDBACK SPINAL SYSTEM
- K100400 — PRESTODR PORTABLE
- K100454 — HYDROCOIL EMBOLIC SYSTEM-HYDROFRAME MODEL 100931HFM-V, 101243HFM-V, 180827HFM-V, 181139HFM-V, 181445HFM-V, 181850HFM-V
- K100526 — AMERITUS ENTRAL (TM) ENTERAL FEEDING TUBE
- K100803 — OLYMPUS FLUSHING PUMP OFP MODEL: OFP-1
- K100855 — POWDER FREE VINYL PATIENT EXAMINATION GLOVES, CLEAR (NON-COLORED)
- K100959 — SPECIMEN RETRIEVAL SYSTEM
- K090982 — SMITH & NEPHEW HIP SYSTEMS WITH HA
- K092240 — ACUPUNCTURE NEEDLES
- K100195 — NDS SURGICAL IMAGING, LLC FOR THE ZEROWIRE DUO WIRELESS HD VIDEO TRANSFER SYSTEM, MODEL WU-WX-WY (WHERE U=R OR T, W=P, X
- K100229 — VENTRIO HERNIA PATCH
- K100415 — ACUPULSE 30/40 ST CO2 LASER SYSTEM AND ACUPULSE 40WG CO2 LASER SYSTEM
- K100470 — GTX 12 GIDEWIRE
- K100789 — MODIFICATON TO: STEERABLE GUIDE CATHETER, MODEL SGC01ST
- K093431 — CLEARWAY OTW MODEL 85912
- K100155 — TRUVUE WIRELESS AMBULATORY ECG MONITORING SYSTEM
- K100208 — IMC SURGICAL DRAPE
- K100312 — DISTALOCK FEMORAL INTRAMEDULLARY NAIL SYSTEM
- K100383 — VITAPHONE. MODEL 100 BT
- K100618 — MAXLOCK EXTREME EXTREMITY PLATING SYSTEM WITH VARIABLE ANGLE TECHNOLOGY
- K092048 — ONE STEP EDDP (METHADONE METABOLITE) TEST STRIP
- K100159 — SMITH AND NEPHEW TWINFIX ULTRA TI SUTURE ANCHOR
- K090436 — AIRWAYEASE MAS
- K092031 — VAPOR-CLEAR, MODEL 100
- K093014 — AMERICAN DENTAL PRODUCTS SE BONDEASY
- K093186 — AMBU ASCOPE AND MONITOR
- K093511 — SORING MBC200/BCC140
- K093780 — ATLANTIS ABUTMENT FOR DENTSPLY IMPLANT, ATLANTIS GEMINI ABUTMENT, ATLANTIS GEMINI + ABUTMENT
- K093880 — PEANUT GROWTH CONTROL PLATING SYSTEM
Data sourced from openFDA. This site is unofficial and independent of the FDA.