FDA 510(k) clearances — page 617
clearances on record, most recent first.
Clearances — page 617
61,601–61,700 of 175,825- K062328 — VITREAACCESS, VERSION 1.0
- K062389 — Z-BLOCK, MODELS 20/19, 40/19, 55/19
- K060657 — ISLEEP BY BREAS, MODELS ISLEEP 10, ISLEEP 20.
- K061223 — ADVANCE TOTAL KNEE SYSTEM
- K061279 — LD-578 FULLY AUTOMATIC DIGITAL BLOOD PRESSURE MONITOR
- K061401 — INTERPLATE VBR SYSTEM
- K061560 — SONOMARK
- K061699 — EXCIA
- K061736 — COMFORT FLO HUMIDIFICATION SYSTEM AND NASAL CANNULA
- K061853 — GRACE MEDICAL ADJUSTABLE AND FIXED LENGTH PARTIAL & TOTAL OSSICULAR REPLACEMENT PROSTHESES
- K061869 — BD PHOENIX AUTOMATED MICROBIOLOGY SYSTEM-PIPERACILLIN-TAZOBACTAM (GP) 1/4-128/4 UG/ML
- K061873 — VERT-X
- K061891 — SYNEX II
- K061903 — RELIEVA SINUS BALLOON CATHETER
- K061918 — FOLEY CATHETERS WITH TEMPERATURE PROBE
- K061926 — CORONIS 2MP AND MDCG 2121 - CB
- K061950 — HHF1 ECHELON MULTI-PURPOSE COIL
- K062084 — 7F ACUMEN CORONARY SINUS VISUALIZATION SYSTEM, MODEL CSVS-7-67
- K062107 — SECURVIEW DX DIAGNOSTIC WORKSTATION, MODELS SV-0001, SV-0002 AND SV-0003
- K062116 — DELTA CTA REVERSE SHOULDER SYSTEM HUMERAL HEADS
- K062168 — CONTRAST DELIVERY SYSTEM - DUAL SHOT ALPHA
- K062247 — HD11 DIAGNOSTIC ULTRASOUND SYSTEM
- K062310 — REFLEX HYBRID ACP SYSTEM
- K060559 — ZOLL R SERIES DEFIBRILLATOR
- K060652 — TIGRIS DTS GEN-PROBE APTIMA COMBO 2 ASSAY
- K061354 — MICROSELECTRON V3, MODEL 106.990
- K061371 — SYDNEY IVF SPERM CRYOPRESERVATION BUFFER
- K061448 — BONART ART-P3II & P4 PIEZO ELECTRIC ULTRASONIC SCALER UNITS WITH ACCESSORIES
- K061595 — XAMINER
- K061721 — PEDI-SPIDER STRAP
- K061808 — DARCO LOCKING BONE PLATE SYSTEM
- K061980 — SIEMENS ACUSON X500 ULTRASOUND SYSTEM
- K062019 — RESPCARE HYBRID NE FACE MASK, MODEL TBD,; DISPOSABLE, MODEL TBD
- K062221 — CXDI-40EC
- K062224 — RESPCARE HYBRID AV MASK
- K062248 — AZURYT MODEL CTL 1401, CO2 SURGICAL LASER SYSTEM
- K053509 — ACUBAND ACUPRESSURE WRIST BAND DEVICE
- K060325 — ABX PENTRA BILIRUBIN, DIRECT CP, ABX PENTRA BILIRUBIN, TOTAL CP, ABX PENTRA MULTICAL, ABX PENTRA N CONTROL, ABX PENTRA P
- K060372 — INTRALASE FS LASER, INTRALASE FS30 LASER, MODELS 1, 2, 3
- K060738 — TDM N-ACETYLPROCAINAMIDE
- K061397 — ACE SURGICAL ORTHODONTIC BONE SCREW SYSTEMS, 1.2/1.5 MM X 6MM,8MM, MODEL 454-91001,454-91002 AND 1.2/1.5MM X 6,8,10MM, M
- K061581 — EXCEL HIGH SPEED DENTAL HANDPIECE
- K062007 — DMS 300-7
- K062041 — MODEL 3875 1 X 8 SC TEST STIMULATION LEAD
- K062110 — VERTEBRON SCP CERVICAL PLATE SYSTEM
- K062132 — AVS PL PEEK SPACER SYSTEM
- K062152 — CREATININE KINASE MB ISOENZYME VERIFIER, MODEL DC27
- K062195 — MODIFICATION TO ONE TOUCH ULTRA BLOOD GLUCOSE MONITORING SYSTEM
- K062218 — JAN MAO WHEELCHAIR, MODELS JMC612-FL318EPP AND JMC612-FL418EPP
- K060423 — CYAN DXD, MULTITEST CD8/CD4/CD3, CD3-FITC, CD3-RPE, CD3-APC AND FLUOROSPHERES
- K060557 — SURESAVE TM SELF-EXPANDABLE NITINOL STENT AND PRECISION TM DELIVERY CATHETER-SS06120060
- K060923 — NAVIAID BGE DEVICE, MODEL 21-001
- K061013 — PLAYTEX EMBRACE PETITE BREAST PUMP
- K061166 — DEEPWAVE PERCUTANEOUS NEUROMODULATION PAIN THERAPY SYSTEM
- K061361 — FAXITRON DIGITAL RADIOGRAPHY SYSTEM, MODEL DX-50
- K061752 — SPINAL USA VBR SYSTEM
- K061953 — 9900 PLUS MOBILE FLUOROSCOPY SYSTEM WITH 3D AND NAVIGATION OPTIONS
- K061999 — DRY LASER IMAGER, DRYPRO MODEL 832
- K062004 — MODIFICATION TO QUANTUM VERTEBRAL BODY REPLACEMENT
- K062066 — OMEGA 3 SYSTEM
- K062259 — ISCIENCE SURGICAL FIBEROPTIC ILLUMINATOR, MODEL FI - 100
- K053505 — REGENEREX ULTRA POROUS CONSTRUCT-FEMORAL AND TIBIAL KNEE AUGMENTS
- K060576 — NELLCOR OXIMAX N-600X PULSE OXIMETER
- K061269 — XLTEK CLEAN SIGNAL ADHESIVE ELECTRODES
- K061463 — ESOPHAGEAL MAPPING CATHETER, MODEL D-1272-01-S
- K061468 — REFSTAR EXTERNAL REFERENCE PATCH
- K061483 — VACUETTE VISIO PLUS BLOOD COLLECTION NEEDLES
- K061610 — PHILIPS MODEL MP20, MP30, MP40, MP50, MP60, MP70, MP80 AND MP90 INTELLIVUE PATIENT MONITORS
- K061716 — PRESTIGE AMERITECH FACE MASK
- K061760 — ARM BLOOD PRESSURE MONITOR, MODEL KP-7600
- K061885 — DIMENSION VISTA SYSTEM TOTAL TRIIODOTHYRONINE CALIBRATOR, MODEL KC250
- K062073 — VERTE-STACK SPINAL SYSTEM
- K053519 — SAFETY SYRINGE
- K060620 — ACCU-CHEK AVIVA TEST STRIPS
- K060978 — COAGUCHEK XS SYSTEM
- K061099 — BREATHX NASAL PILLOW AND MASK SYSTEM, MODEL 011-0003
- K061176 — STRAUMANN DENTAL IMPLANTS
- K061332 — FILTERWIRE EZ EMBOLIC PROTECTION SYSTEM (2.25 MM-3.5 MM)
- K061451 — ASCENSION, MODELS CMC-400,13,CMC-400-20,CMC-400-30,CMC-400-40
- K061477 — MULTI-UNIT ABUTMENTS FOR ASTRATECH, CAMLOG AND ANKYLOS IMPLANT SYSTEMS
- K061521 — TRIATHLON METAL BACKED PATELLA
- K061559 — ACON URINALYSIS REAGENT STRIPS
- K061579 — MODIFICATION TO CD HORIZON SPINAL SYSTEM
- K061707 — HEARTSTART MRX, INVASIVE PRESSURE & TEMPERATURE OPTIONS
- K061750 — DIMENSION VISTA SYSTEM LIPID CALIBRATOR, MODEL KC220
- K061832 — JOSTRA HLM TUBING SETS WITH SAFELINE COATING
- K061916 — NEURO II-SE, MODELS OR-MB-DR AND OR-DR
- K061978 — EBI, L.P.'S LINE EXTENSION TO THE ARRAY SPINAL SYSTEM
- K061994 — WEB VIEWER, POCKET VIEWER AND CELLULAR VIEWER WITH L- WEB05 SOFTWARE
- K062201 — SPIDERX EMBOLIC PROTECTION DEVICE
- K062220 — MODIFICATION TO GUARDDOG OCCLUSION SYSTEM
- K050590 — ENZY-WELL SYPHILIS IGG, MODEL 91106
- K053287 — COBAS AMPLICOR CT/NG TEST FOR CHLAMYDIA TRACHOMATIS
- K053289 — COBAS AMPLICOR CT/NG TEST FOR NEISSERIA GONORRHOEAE
- K061017 — EASYSPINE SYSTEM
- K061086 — DM-3000 DIGITAL BLOOD PRESSURE MONITOR
- K061215 — VOLCANO S51 FAMILY OF IMAGING SYSTEMS
- K061367 — BLUESKY VISTA WOUND VACUUM SYSTEM, MODEL 100.0500
- K061425 — PUREWRIST SCISSORS, MODEL PW1101-01;PUREWRIST DISSECTOR, MODEL PW1201-01;PUREWRIST HOOK, MODEL PW1301-01
- K061783 — KNEE FUSION NAIL
Data sourced from openFDA. This site is unofficial and independent of the FDA.