FDA 510(k) clearances — page 1417
clearances on record, most recent first.
Clearances — page 1417
141,601–141,700 of 175,890- K864445 — STAT PROFILE 4 ANALYZER + QUALITY CONTROL MATERIAL
- K864499 — PODOSCOPE
- K864510 — PSORALITE 12800 SERIES
- K864511 — PSORALITE 18400 SERIES
- K864522 — ASTRA SYSTEMS MULTIPLE CHEMISTRY MODULE
- K864566 — ADX(TM) ANALYZER
- K864569 — PODODIGITAL
- K864591 — HCG SOLID PHASE COMPONENT SYSTEM
- K864611 — IMMUNO-SURE
- K864627 — WHITESIDE ORTHOLOC II METAL BACKED PATELLA
- K864659 — BIO-MEGA DIAGNOSTIC COATED TUBE IRMA TSH
- K864660 — MODEL M402 EMG MONITOR
- K864661 — UNIFAST CALCIUM TEST
- K864721 — CRYOTHERM
- K864771 — CHUCK HANDLE
- K864789 — BETAFLO 2000 PIGGYBACK SYSTEM
- K864791 — POIRIER POWERED WHEELCHAIR
- K864839 — TSH MAB IRMA
- K864853 — OMNI THERM TEMPERATURE MONITOR
- K865089 — FERRIS DYNADERM PLUS
- K870018 — E-Z JECT INSULIN SYRINGE
- K870020 — IV SECUREMENT DEVICE
- K870045 — SKYTRON MODEL 610-2
- K870057 — T1365 (BIRD SEED AGAR SLANT)
- K870090 — IV SECUREMENT DEVICE USING HYTREL THERMO. FILM
- K870091 — IV SECUREMENT DEVICE USING PCCE THERMO. FILM
- K870122 — SURGICAL DRAPES AND ACCESSORIES USING HYTREL FILM
- K870123 — SURGICAL DRAPES AND ACCESSORIES USING PCCE FILM
- K870124 — SURGICAL DRAPES AND ACCESSORIES USING PEBAX FILM
- K870125 — EXTREMITY ELEVATOR
- K870134 — MCBRIDE LISTERIA AGAR W/CYCLOHEXIMIDE, DRI & PRE
- K870231 — KULTSURE
- K861582 — INJET-100, FLUID INJECTOR
- K861987 — 2120 NON-INVASIVE BLOOD PRESSURE MONITOR W/CUFF
- K862226 — DIALOG MODELS 748, 748K AND 748T PULSE GENERATORS
- K862383 — MODIFIED MODEL BIA-103 BODY COMPOSITION ANALYZER
- K862402 — OTT DISINFECTOR FOR FLEXIBLE ENDOSCOPES
- K862462 — LIFESCOPE 6, OEC-6120 PORTABLE PATIENT MONITOR REC
- K863100 — CEN STA MON AC/DC ALARM CENTRAL ACCES ALARM RECOR
- K863156 — TECA/MEDELEC AUDIOSTAR
- K863227 — COOK-VPI CONTINENCE CUFF
- K864170 — LEECO VIS-CUBE STREP A (EIA)
- K864588 — PENLON CIRCLE SYSTEM
- K864605 — VAPLOK
- K864619 — CAPS LOW LEVEL DETECTOR & DETECTOR/BUBBLE MONITOR
- K864803 — GC-LECT(TM)
- K870102 — TUPPER TROLLEY
- K870126 — FEMUR WRENCH
- K870141 — URESIL T-SYSTEM BONE SCREWS
- K861120 — THE GOLDEN QUAD TEST (HSV)
- K861121 — THE GOLDEN QUAD TEST (EBV)
- K861122 — THE GOLDEN QUAD TEST (TOXO)
- K861123 — THE GOLDEN QUAD TEST (CMV)
- K861515 — OSTEOPAK BMD (BONE MINERAL DENSITOMETER)
- K862859 — EUB 151 ULTRASOUND SYSTEM/EUB 150 ULTRASOUND
- K863776 — MICRODILUTION MIC PANELS
- K864315 — CYTOTECH RUBELLA IGG ENZYME IMMUNOASSAY
- K864347 — INDIRECT IMMUNOFLUORESCENT ANTIBODY ASSAY/ EBV-VCA
- K864396 — LYMPHOCYTE MAINTENANCE MEDIUM
- K864400 — EXTRA STRONG CONDOM
- K864420 — CMV MICROASSAY
- K864443 — EGG-TOP TORP AND EGG-TOP PORP
- K864449 — DIGOXIN/RIA KIT COATED TUBE RADIOIMMUNOASSAY KIT
- K864452 — DELFIA(TM) TRIIODOTHYRONINE (T3) KIT
- K864493 — REVISED RESISTANT 5 MIC PANEL
- K864524 — SPERM SELECT(TM)
- K864548 — ALFERR TIBC TUBE
- K864604 — EBV VCA IGM ANTIBODY ASSAY KIT
- K864657 — ATL'S ULTRAMARK 6 ULTRASOUND SYSTEM
- K864663 — PATHFINDER CHLAMYDIA CULTURE CONFIRMATION SYSTEM
- K865020 — SERA-TEK THYROGLOBULIN ANTIBODY TEST
- K870032 — REVISED T-SCAN SYSTEM
- K864173 — HPD HUMIDIFYING CHAMBER
- K864225 — ANGIOMED URETERAL D&M SETS/URETEROSCOPY GUID STENT
- K864408 — EMG-1, MOTOR NERVE MONITOR
- K864837 — MODIFIED MAINFRAME OF MODEL 902 MOBILE C-ARM
- K864903 — MOD. 4006 ADU., OXY. DELIVE.-ORAL CO2 SAM. CANNULA
- K864958 — ALPHA II DIAGNOSTIC X-RAY
- K850100 — BLOOD LANCET
- K863985 — EVOPORT 100
- K864345 — NTE-2 THERMAL SENSITIVITY TESTER
- K870047 — COLTENE RAPID
- K863866 — RESPIRADYNE II(TM)
- K864005 — ALPINE
- K864085 — BROOKER BIO-GROOVE FEMORAL COMPONENT
- K864103 — CURITY ANESTHESIA FILTER
- K864280 — ECONOL (PORTABLE) ECONO 30 & 40 LITER BASE UNIT
- K864487 — LIFEWATCH SENSOR BELT
- K864641 — VENTEX-IA
- K864750 — KOTEX SECURITY TAMPONS, REGULAR AND SUPER
- K864883 — NEONATAL CANNULA CAP
- K864902 — MOD. 4003 ADU., OXY. DELIVE.-ORAL/NASAL CO2 CANNU.
- K864929 — HALL (R) MICRO E POWERED SURGICAL INSTRUMENT SYST
- K864934 — 'EXMOOR' SHAH SILICONE DISCS
- K864935 — 'EXMOOR' SHAH PACKING STRIPS
- K870043 — GUO GUANG WHEEL CHAIR
- K870084 — RD 140 SURGICAL BENDER
- K870100 — PLASTER STAND
- K861069 — TECA NEUROPTO WITH OS-5 STIMULATOR
- K863711 — REGULATOR OXYGEN MECHANICAL
Data sourced from openFDA. This site is unofficial and independent of the FDA.