FDA 510(k) clearances — page 603
clearances on record, most recent first.
Clearances — page 603
60,201–60,300 of 175,825- K063574 — LUMINEX LL LASER SYSTEM
- K063823 — COAGUCHEK XS PT CONTROLS
- K070044 — POWDER FREE (YELLOW) VINYL PATIENT EXAMINATION
- K070165 — ENSEAL PTC TRIO
- K061297 — ANSPACH IMRI SAFE SURGICAL DRILL SYSTEM
- K061419 — TECO MICROALBUMIN 2-1 COMBO STRIPS
- K061499 — OSFERION
- K061898 — EZLASE
- K062354 — VECTRA GENISYS VMS FR
- K062528 — TISSUE SITE MARKING SYSTEM
- K062535 — K-Y BRAND TOUCH MASSAGE 2-IN-1 TINGLING
- K062712 — ERBE MONOPOLAR ATTACHMENT FOR HELIX HYDRO-JET, MODEL P/N 20139-094
- K062913 — ASTRAGUARD PULMONARY FUNCTION FILTER
- K063272 — DIMENSION VISTA B2MIC FLEX REAGENT CARTRIDGE, PROTEIN 1 CALIBRATOR, CONTROL MEDIUM, CONTROL HIGH
- K063378 — CIRRUS HD-OCT, MODEL 4000
- K063510 — LIFEPAK 12 DEFIBRILLATOR/MONITOR
- K063530 — ON-Q, PAINBUSTER, C-BLOC, SELECT-A-FLOW, ONDEMAND, HOMEPUMP, ECLIPSE, C-SERIES, ONE-STEP KVO, EASYPUMP
- K063567 — EZ-MIO STERNAL
- K063630 — ATRICURE ABLATION SYSTEM
- K063819 — ASAHI PTCA GUIDE WIRE, FIELDER FC
- K063846 — EIGEN DSA 2000
- K063851 — AUTO-FILL SYRINGE KIT, MODEL 7600
- K070019 — CARRARA VOLUMIA
- K070040 — POWDERED VINYL PATIENT EXAMINATION GLOVES, WHITE
- K070196 — FLIGHT DENTAL SYSTEMS A-SERIES DENTAL OPERATIVE UNIT
- K052973 — IPUMP PAIN MANAGEMENT SYSTEM, MODEL 2L3107, 2L3107K
- K061242 — DERMATHERAPY, MODEL 22216
- K061554 — MEPILEX AG ABSORBENT SILICONE-COATED DRESSING
- K061886 — ACTIM PROM AND CONTROLS
- K062082 — CONMED ABC DISSECTING BLADE ELECTRODE, MODEL 139330; BLUNT NEEDLE ELECTRODE, MODEL 139331
- K062099 — PHASE 3, MODEL DT-1
- K062397 — SENTINEL
- K062666 — VUSION TS, PS, AND CS PARTIAL VERTEBRAL BODY REPLACEMENTS
- K062899 — MICROTEK MEDICAL SURGICAL GOWN/TOGA
- K063377 — POWERPORT POLYMETRIC PORT WITH 8 FR S/L CHRONOFLEX CATHETER
- K063450 — PORTEX HYPODERMIC NEEDLE- PRO EDGE SAFETY DEVICE, 18GX1, 401810, 19GX1, 401910, 20GX1,402010, 21GX1402110
- K063577 — FEMORAL INTRAFIX SCREW AND SHEATH
- K063586 — MOORFLPI FULL-FIELD LASER PERFUSION IMAGER
- K063590 — V.A.C. FREEDOM CANISTER, MODEL M6275421; V.A.C. ATS CANISTER, MODELS K6275422, M6275423
- K063601 — PILOT SPINAL SYSTEM
- K063664 — GEN-PROBE APTIMA ASSAY FOR NEISSERIA GONORRHOEAE MODEL#1091
- K063666 — SHARPS CONTAINER, MODEL 039-413
- K063797 — GEODESIC EEG SYSTEM 300
- K063822 — MODIFICATION TO HIPSTAR FEMORAL STEM
- K063828 — DIOMED DELTA 25
- K063834 — REVLITE C6 Q-SWITCHED ND:YAG LASER SYSTEM
- K070010 — QUIKCLOT SPORT AND QUIKCLOT SPORT SILVER
- K070071 — OMNIGUIDE ZERO FLOW ZF-T WAVEGUIDE FIBER
- K070155 — INTEGRITY LOW SPEED DENTAL AIR HANDPIECE AND ATTACHMENT, MODELS: MOTOR INT-E, MOTOR INT-D AND ATTACHMENT INT-SNC
- K060708 — SOMNOSCREEN
- K062765 — MODIFICATION TO NUVASIVE NEUROVISION JJB SYSTEM
- K063235 — CYTORI LIPOPLASTY SYSTEM WITH CELASE REAGENT
- K063251 — ZIMMER M/L TAPER HIP PROSTHESIS WITH MODULAR NECK TECHNOLOGY
- K063294 — TOPACS
- K063322 — DIMENSION VISTA TRF FLEX REAGENT CARTRIDGE, PROTEIN 1 CALIBRATOR PROTEIN 1 CONTROL L,CONTROL M, CONTROL H
- K063774 — MODIFICATION TO MERCI RETRIEVER, MODELS X5 AND X6
- K063794 — MODIFICATION TO EASYSPINE SYSTEM
- K063821 — NOVA STATSTRIP GLUCOSE HOSPITAL METER SYSTEM
- K070080 — INTELEPACS
- K070093 — OSTENE, AOC, OSTEOTENE, CERETENE, CEREPOR, APTENE, APATENE, ACTIPASTE
- K060818 — ARCHITECT SHBG REAGENT KIT, ARCHITECT SHBG CALIBRATOR KIT, AND ARCHITECT SHBG CONTROL KIT WITH MODELS, 8K26-25, 8K26-01
- K061602 — DUET SYSTEM
- K063196 — LANDLEX, MODEL S403X
- K063410 — INION CPS/OTPS FREEDOMPLATE
- K063475 — IMC-HEARTWAY, LLC ELECTRIC WHEELCHAIR, MODEL TIARA (P4AS)
- K063483 — DEN TEK NIGHTGUARD
- K063508 — DIMENSION VISTA PROTEIN 1 CALIBRATOR AND CONTROL L, M, H; PROTEIN 2 CALIBRATOR AND CONTROL L, H; PROTEIN 3 CALIBRATOR AN
- K063524 — POWDER FREE NITRILE EXAMINATION GLOVES (WHITE AND BLUE COLOR)
- K063717 — CF-1
- K070035 — POWDERED VINYL PATIENT EXAMINATION GLOVE
- K061414 — EXPEDITIONARY DELPLOYABLE OXYGEN CONCENTRATION SYSTEM (EDOCS), MODELS 120B AND 30;MOBILE OXYGEN STORAGE TANK (MOST), MOD
- K061650 — SELECT TENS, MODEL 4600S
- K062892 — EUKARE
- K063018 — GLASS LOSS OF RESISTANCE SYRINGE
- K063351 — DIMENSION VISTA CYSC FLEX REAGENT CARTRIDGE, PROTEIN 3 CALIBRATOR AND CYSTATIN CONTROL LOW AND HIGH
- K063423 — TRIATHLON CS (CONDYLAR STABILIZING) LIPPED INSERT
- K063434 — TOSCA 500 TCPCO2, SPO2 AND PULSE RATE MONITORING SYSTEM
- K063439 — MEDICAL IMAGE MANAGEMENT DEVICES FOR VISION TOOLS
- K063451 — GEN-PROBE APTIMA ASSAY FOR CHLAMYDIA TRACHOMATIS, MODEL 1199
- K063476 — BREAS ISLEEP 20I
- K063487 — MERETE BLP SMALL FRAGMENT LOCKING BONE PLATE
- K063548 — COR ANALYZER 1, VERSION 1.4
- K063604 — TWINKY STAR NF
- K063829 — THERMOGARD THERMAL REGULATION SYSTEM
- K061042 — LINGLOCK
- K061670 — LUNDERQUIST WIRE GUIDE; DC WIRE GUIDE
- K062027 — A&D MEDICAL UA-789 DIGITAL BLOOD PRESSURE MONITOR
- K062046 — MODIFIED MERCI RETRIEVER, MODEL 90050
- K062503 — CATACHEM, INC., BILE ACIDS REAGENTS AND/OR BILE ACIDS TEST KIT
- K062849 — SMITH & NEPHEW DUONICS POWER II SHAVER SYSTEM
- K062868 — THE CROSSER CATHETER, MODEL CR1100 AND SYSTEM ELECTRONICS, MODEL FG1002-02
- K062998 — COMPRESS SEGMENTAL FEMORAL REPLACEMENT SYSTEM (SHORT SPINDLE AND ANCHOR PLUG)
- K063124 — INTEGRA MOZAIK BONE REGENERATION MATRIX - STRIPS
- K063208 — MAGNESIUM ASSAY (XB), MODELS 125-12, 125-50 AND 125-S7
- K063372 — RADIFOCUS GLIDEWIRE ADVANTAGE
- K063561 — MOORLDLS LASER DOPPLER LINE SCANNER
- K063597 — VITEK 2 GRAM POSITIVE AMOXICILLIN FOR STREPTOCOCCUS PNEUMONIAE
- K063780 — ACE BOND SE
- K063782 — ACCIN UNI-KNEE SYSTEM
- K063785 — SPIDERFX EMBOLIC PROTECTION DEVICE
Data sourced from openFDA. This site is unofficial and independent of the FDA.