FDA 510(k) clearances — page 835
clearances on record, most recent first.
Clearances — page 835
83,401–83,500 of 175,890- K000595 — DIMENSION PENTA L
- K000629 — FLEXTIME
- K000725 — HWA (AND) SILKTEX POWDER-FREE LATEX EXAMINATION GLOVE WITH PROTEIN LABELING CLAIM (50 MICROGRAM OR LESS)
- K000872 — DISPOSABLE POWDER FREE VINYL SYNTHETIC EXAM GLOVES, WHITE COLOR
- K000908 — SKYLIGHT IMAGING SYSTEM
- K000951 — LUXAFORM
- K992781 — ARCHITECH AFP MASTERCHECK, MODEL 6C01-05
- K000028 — RENAFLO II HF 2000 HEMOFILTER
- K000029 — STELA UT46 AND BT45/46 STRAIGHT TINED PACING LEADS, STELA UJ45 AND BJ44/45 J-SHAPED TINED PACING LEADS
- K000049 — SUNI MAX
- K000113 — PROVEN KNEE SYSTEM
- K000414 — MEDISUL DISPOSABLE VAGINAL SPECULUM
- K994065 — MS-ONE, MODEL MS-1
- K000027 — INSUFFLATION NEEDLE, MODEL R65-933
- K000080 — ASNIS III CANNULATED SCREW SYSTEM
- K000262 — BOHN FEMORAL COMPONENT
- K000459 — URINE BARBITURATES (BARB) SCREEN FLEX REAGENT CARTRIDGE, CATALOG NO. DF 96A
- K000662 — RANDOX FERRITIN
- K000797 — OBL 2.0 MM MINI TAC ANCHOR, MODEL 10-1629-01
- K000858 — WEHRS INCUS-STAPES
- K992451 — RAPIDONE- BARBITURATE TEST
- K992720 — RAPIDONE- BENZODIAZEPINE TEST
- K992918 — STC AMPHETAMINE-SPECIFIC INTERCEPT MICRO-PLATE EIA, MODEL 1103I
- K993208 — STC METHAMPHETAMINE INTERCEPT MICRO-PLATE EIA, MODEL 1104I
- K993925 — WAKO L-TYPE UN TEST
- K000026 — APPLE MEDICAL ONE-TOUCH UTERINE SAMPLER
- K000202 — CORTEK LAPAROSCOPES
- K000305 — HARDYDISK, CEFOXITIN, 30MCG
- K000422 — S57D DIGITAL OPERATING ROOM CAMERA
- K000423 — S52D DIGITAL VIDEO LAPAROSCOPE
- K000424 — S51D DIGITAL ENDOSCOPY CAMERA
- K000454 — DIMEX 2
- K000483 — RANDOX ALBUMIN
- K000715 — ENVOY AND VISTA BRITE TIP
- K000722 — UNIPOLAR NEEDLES
- K000731 — MODIFICATION TO RTA RETINAL THICKNESS ANALYZER
- K991383 — HYDROCISION DEBDRIDEMENT SYSTEM
- K992392 — RTLX
- K993412 — BITX PROBES
- K993512 — DATEX-OHMEDA TUFFSAT 3000 PULSE OXIMETER
- K993552 — ISOSEED PD-103
- K000018 — BRANEMARK NOVUM
- K000032 — LEVEEN NEEDLE ELECTRODE
- K000037 — MONOFILAMENT BIOSYN SUTURE
- K000046 — KNIGHT ENDOSCOPIC SPINE SYSTEM (KESS)
- K000369 — VACUFLOW+ BLOOD COLLECTION SET, MODEL 52221/3/5; VACUFLOW+ WITH HOLDER BLOOD COLLECTION SET, MODEL 82021/3/5 WITH HOLDER
- K000588 — DIMENSION GARANT L, DIMENSION GARANT L QUICK
- K000591 — DIMENSION PENTA H, DIMENSION PENTA H QUICK
- K000697 — MODIFICATION TO AIRLIFE HEATED VENTILATOR AND ANESTHESIA BREATHING CIRCUITS
- K000717 — SMITH & NEPHEW SUTURELOK, MODEL 7207321
- K984360 — COLORADO II SPINAL SYSTEM
- K993019 — PACIFIC SURGICAL PATTIES
- K993041 — OLYMPUS XCYF-1T3 OES CYSTOFIBERSCOPE/NEPHROFIBERSCOPE ACCESSORIES AND ANCILLARY EQUIPMENT
- K993970 — MICRINS MICROSURGICAL SUTURE
- K000019 — SINGLE SIZE TENDON SPACER
- K000154 — ELIACHAR LARYNGEAL FOAM STENT, MODEL ELL-1
- K000292 — BARCO MWD 321 PLUS MEDICAL WORKSTATION DISPLAY
- K000293 — BARCO MGD 221 2 MEGAPIXEL DIAGNOSTIC DISPLAY
- K000304 — HARDYDISK, TETRACYCLINE 30MCG
- K000648 — SPIRO PRO
- K000659 — MODIFICATION TO SOFTOUCH DIAGNOSTIC INTRAVASCULAR CAT
- K000671 — POWDERED LATEX EXAM GLOVES, PINK, WITH/WITHOUT STRAWBERRY SCENT, PROTEIN LABELING
- K000677 — ZUMA GUIDE CATHETERS
- K000742 — SYNTHES ANTERIOR CSLP SYSTEM
- K992215 — MULTICOMPATIBLE ENVITEC FINGER CLIP SENSOR, MULTICOMPATIBLE ENVITEC ADULT DISPOSABLE SENSOR, MULTICOMPATIBLE ENVITEC PED
- K992554 — SYNTHETIC POWDERED VINYL PATIENT EXAMINATION GLOVES
- K993201 — HEALTH-PLUS, SANITEX, RELIANCE POWEDER-FREE STERILE LATEX SURGICAL GLOVES
- K994026 — EUB-6000 ULTRASOUND DIAGNOSTIC SCANNER
- K000013 — ACIST ANGIOGRAPHIC INJECTION SYSTEM, MODEL R-2000
- K000495 — BALLARD MEDICAL PRODUCTS EPIDURAL AND SPINAL NEEDLES
- K000660 — ESCORT II+ 400 SERIES (ESCORT PRISM), MODEL 20400, 20401, 20403, MONITOR, MODELS 20411, 20412, 20413
- K981093 — WESCO BLANKET
- K993060 — GAS FILTER
- K993129 — UCLA/UNIVERSAL ABUTMENT
- K993199 — POCKET CHAMBER VALVED AEROSOL HOLDING CHAMBER
- K994194 — (TAS) LOW RANGE HEPARIN MANAGEMENT CARD RAPIDPOINT
- K994278 — ACCESS OSTASE IMMUNOENZYMETRIC ASSAY
- K994423 — AUTOMATED NON-INVASIVE BLOOD PRESSURE MONITOR, MODEL BPM-100
- K994430 — IMPACT.WF MOBILE WAVEFORM RECEIVING SYSTEM
- K000060 — GEL MARK BIOPSY SITE MARKER, MODELS MKOOO1, MK0004, MK0007
- K000115 — RETIC CHEX LINEARITY
- K000291 — MFCD 118
- K000294 — MFCD 120
- K000315 — VENTRICULAR ANALYSIS TOOLKIT OPTION
- K000393 — NOVA CORDLESS CURING LIGHT
- K000468 — RANDOX COMPLEMENT C4
- K000469 — RANDOX COMPLEMENT C3
- K000600 — SYVA EMIT 2000 THYROXINE ASSAY, CALIBRATORS
- K983214 — RITA RF GENERATOR AND ACCESSORIES, MODEL 500 SERIES
- K991133 — MLC FIT
- K992303 — SONOGRAPHIC PLANNING OF ONCOLOGY TREATMENTS (SPOT), MODEL V.. 1.0
- K993896 — MCA-601, C-ARM MOBILE
- K994389 — COBE HVR 2200 HARDSHELL VENOUS RESERVOIR, FILTERED
- K000021 — AESCULAP BONE WAX
- K000169 — NUPRO PROPHYLAXIS PASTE WITH FLUORIDE AND TRICLOSAN
- K000302 — HARDY DISK, PENICILLIN, 10 UNITS
- K000436 — BELLEGLASS HP TRANSLUCENT DENTIN
- K000598 — 5F GUIDING CATHETER
- K000679 — THROMBOSTRATE CONTROL PLASMAS
- K000821 — ABBOTT GEMSTAR I.V. INFUSION PUMP - 7 THERAPY CONFIGURATION, 6 THERAPY CONFIGURATION, 1 THERAPY CONFIGURATION
Data sourced from openFDA. This site is unofficial and independent of the FDA.