FDA 510(k) clearances — page 638
clearances on record, most recent first.
Clearances — page 638
63,701–63,800 of 175,825- K053279 — UROVANTAGE
- K053286 — MODIFICATION TO: NXSTAGE PUREFLOW-B SOLUTION
- K053369 — MEDILOG DARWIN HOLTER ANALYSIS
- K053408 — NEXA BONE PLATE AND SCREW SYSTEM
- K053458 — WEB1000
- K051294 — FEMTEST ENDOMETRIAL SUCTION CURETTE, MODEL FT-1
- K051694 — CLICKZIP NEEDLE RETRACTABLE SAFETY SYRINGE
- K051864 — MAGSTIM RAPID2, MAGSTIM SUPER RAPID2, MODELS 3004-000, 3005-00
- K052170 — SEASPINE VBR SYSTEM
- K052780 — DENTAPLAST HOT, MODEL 16-XXX
- K052811 — HSINER JET NEBULIZER, MODEL HS-31100
- K052923 — GREAT GLOVE POWDER FREE VINYL EXAMINATION GLOVES
- K052956 — NITRILE BLUE POWDER FREE EXAMINATION GLOVE
- K053269 — MASIMO SET RAD-8 PULSE OXIMETER
- K053404 — LIFESTENT FLEXSTART BILIARY STENT SYSTEM
- K053457 — VAPORMAX II
- K053470 — NOVOFINE 32G TIP
- K052135 — CYBERSONICS CYBERWAND DUAL PROBE LITHOTRIPTER
- K052288 — VITALOGIK
- K052467 — BRAIN VIEWRX VIEWER, VERSION 1.0
- K052700 — PANA-SPRAY
- K052772 — BARRIERPLUS GOLD ORTHO POWDER-FREE SYNTHETIC POLYISOPRENE ORTHOPEDIC SURGICAL GLOVES
- K052779 — BRECOMP
- K052810 — SCANDIUS TRITIS TIBIAL ACL RECONSTRUCTION SYSTEM
- K052889 — VITROS CA 19-9
- K052922 — GREAT GLOVE POWDERED VINYL EXAMINATION GLOVES
- K053089 — ASCENT PIT & FISSURE SEALANT
- K053142 — AMBU MARK IV BABY RESUSCITATOR
- K053203 — MYNEB NEBULIZER, MODEL RDD100
- K053214 — THERAKNIT GARMENT ELECTRODE
- K053245 — GP GENERAL PURPOSE DRAINAGE CATHETER; MINI-PIG DRAINAGE CATHETER; NEPHROSTOMY CATHETER; BILIARY CATHETER
- K052906 — ZIMMER TRABECULAR METAL REVERSE SHOULDER SYSTEM
- K053066 — SEPRAMESH IP BIORESORBABLE COATING/PERMANENT MESH
- K053100 — ESTECH COBRA BIPOLAR SYSTEM
- K053262 — KSEA UNIDRIVE ENT/NEURO/OMFS SYSTEM AND ACCESSORIES
- K043597 — FC 700 FETAL MONITOR
- K043598 — FC 1400 FETAL MONITOR
- K051195 — GRAFTON DBM
- K051386 — MASTERGRAFT PUTTY BONE VOID FILLER
- K051781 — GRAFTCAGE TLX
- K051896 — MODEL 750E SERIES MONITOR
- K052007 — ABX PENTRA 400 CLINICAL CHEMISTRY ANALYZER (OPTION: I.S.E. MODULE)
- K052081 — REMOTE ACCESS PERFUSION (RAP) FEMORAL VENOUS CANNULA
- K052120 — LUMIMED MONOCHROME LCD MONITOR, MODELS MM 20, MM 30 AND MM50
- K052160 — ACUITY CENTRAL STATION, MODEL 020XXXXX (NOTE: XXXXX = VARIOUS CONFIG.)
- K052263 — MULTIPLE (TOOTH DESENSITIZER)
- K052303 — READMYHEART, MODEL RMH2.0
- K052307 — BEAMER PAINLOW INFRARED LIGHT TREATMENT SYSTEM
- K052386 — MEDTRONIC M2 MAGNET ADJUSTMENT TOOL
- K052597 — BREATHEX OMEGA CPAP DEVICE, MODEL 322
- K052604 — STARLITE 2006
- K052646 — BIOSPACE BODY COMPOSITION ANALYZERS, MODELS INBODY 520, 720 AND S20
- K052694 — ONE STEP HCG PREGNANCY TEST - 2000 MIU/ML, MODEL 100 SERIES.
- K052727 — ROSSMAX NON-INVASIVE BLOOD PRESSURE MONITORS, MODELS S380, K350
- K052744 — C2000 AUTOMATED MANIFOLD KIT
- K052799 — MULTITAK 6.0 MM ABSORBABLE ANCHOR SYSTEM
- K052840 — IGI-SYSTEM
- K052845 — B-CARE POWDERED LATEX EXAMINATION GLOVES
- K052871 — STRYKER CUSTOM TI IMPLANT
- K052974 — WARMING LIQUID PERSONAL LUBRICANT
- K052990 — STAGEONE DISPOSABLE CEMENT SPACER MOLD FOR TEMPORARY HIP PROSTHESIS WITH REINFORCEMENT STEM
- K053090 — DRI-STAT ENZYMATIC BILIRUBIN REAGENT, SYNCHRON SYSTEMS BILIRUBIN CALIBRATOR
- K053116 — STERLING OTW PTA BALLOON DILATATION CATHETER, MODEL H74939032-XXXXXX
- K053118 — STERLING MONORAIL PTA BALLOON DILATATION CATHETER, MODEL H74939031-XXXXXX
- K053154 — MYLAB15/20 3D/4D ULTRASOUND IMAGING SYSTEM
- K053196 — ISCHEMIA ALBUMIN COBALT BINDING TEST (ACB TEST)
- K053252 — U-CLIP DEVICE, MODELS B140, B160 AND B180
- K053256 — 3M TEGADERM SILVER (AG) MESH
- K053330 — ARCHITECT B12 CALIBRATORS
- K053435 — GE VOLUSON I
- K051433 — I-STAT CREATINE KINASE MB (CK-MB)
- K051828 — NIPRO SUREFUSER AMBULATORY INFUSION PUMP
- K052338 — SOLAR GI
- K052606 — MARIETTA CONTACT LENS (POLYMACON), TINTED DAILY WEAR CONTACT LENS
- K052632 — VITREA2 VERSION 3.8 MEDICAL IMAGE PROCESSING SOFTWARE
- K052912 — YUSHENG DISPOSABLE VAGINAL SPECULUM
- K052943 — DDRFORMULA AND DDRFORMULA PLUS
- K053173 — DS CASSETTE
- K053197 — TRUFILL DCS ORBIT DETACHABLE COIL SYSTEM LINE EXTENSION
- K053250 — ANS 90 CM AND 110 CM (3100 AND 3200 SERIES) LEAD KIT
- K053296 — MENTOR ARIS SUPRAPUBIC SURGICAL KIT
- K053392 — FUTURABOND NR SINGLE DOSE
- K052087 — BREATHING FILTER BACTERIAL/VIRAL, MODEL AG7178
- K052259 — DR. SCHOLL'S DUAL ACTION FREEZE AWAY WART REMOVER, MODEL 40406
- K052503 — TROPONIN I ULTRA ASSAY AND CALIBRATOR FOR THE ADVIA IMS SYSTEM
- K052531 — FU HONG INDUSTRIES LIMITED SOOTHER TEETHER
- K052645 — VITROS CHEMISTRY PRODUCTS CALIBRATOR KIT 28, REF 680 2323; VITROS CHEMISTRY PRODUCTS FS CALIBRATOR 1, REF 6801873;
- K052724 — TECO ISE REAGENT SET FOR CX SYSTEM
- K053011 — PRO-NEO NEONATAL ECG ELECTRODE, MODELS SG15 AND SR20
- K053097 — VITEK 2 GRAM POSITIVE CEFOXITIN SCREEN
- K053141 — NEUROSIGN MOTOR NERVE MONITOR, MODELS NEUROSIGN 400 & 800
- K053146 — QUICKVUE INFLUENZA A + B TEST
- K053165 — ISE INDIRECT NA, K, CL FOR GEN.2
- K053199 — SYNTHES PATIENT SPECIFIC CRANIAL/CRANIOFACIAL IMPLANT
- K053394 — NEXA BONE SCREW SYSTEM
- K051242 — WINNER SELF SEAL STERILIZATION POUCH
- K051993 — LMA FASTRACH ETT SINGLE USE
- K052233 — TRACHEOSCOPIC VENTILATION TUBE (TVT) SYSTEM
- K052258 — VASCULAR SOLUTIONS SKYWAY SUPPORT CATHETER
- K052289 — DEEPWAVE NEUROMODULATION PAIN THERAPY DEVICE
Data sourced from openFDA. This site is unofficial and independent of the FDA.