FDA 510(k) clearances — page 697
clearances on record, most recent first.
Clearances — page 697
69,601–69,700 of 176,637- K033663 — SPINAL CONCEPTS INC. CODA
- K033704 — MODIFICATION TO LUMBO-PERITONEAL SHUNTS AND LUMBAR DRAINAGE CATHETERS
- K040090 — COMPPAC 200HD; CS12 POWER SUPPLY (AIRCRAFT/VECHILE); PS11 POWER SUPPLY (MAINS)
- K040411 — DRI OXYCODONE ASSAY
- K040512 — LIMITED FUNCTION WL/OTC-TENS DEVICE, MODEL WL-2103A, WL-2203A, WL-2203B AND WL-2401
- K040581 — MEDVIZERTM VITELCARE PATIENT MONITORING SYSTEM
- K040672 — PORTA REFLEX
- K040914 — POLYVIAL/POLYPAK, CONTACT LENS CASE AND STORAGE SYSTEM CONTAINER FOR OPHTHALMICS
- K041160 — AVON EXTRA-SMALL PATELLO-FEMORAL REPLACEMENT
- K041227 — MODIFICATION TO:ROCHE DIAGNOSTICS PRECINORM UNIVERSAL AND PRECIPATH UNIVERSAL CONTROL SERA
- K041267 — CARDIQ ANALYSIS III
- K041270 — CT COLONOGRAPHY II
- K041275 — PROCERA ABUTMENT OCTAGON
- K031517 — ZARGIS ACOUSTIC CARDIOSCAN
- K040246 — FUKUDA DENSHI DYNASCOPE MODEL DS-7141 PORTABLE PATIENT MONITOR
- K040555 — IMPAX CLIENT EMBRACE
- K040696 — MODIFICATION TO NXSTAGE SYSTEM ONE
- K041095 — PHOTOSILK PULSED LIGHT SYSTEM
- K041236 — PROCERA IMPLANT BRIDGE, MODELS 15-1001, 15-1002, 15-1051, 15-1052
- K031673 — REFOBACIN -PALACOS G
- K032914 — MODIFICATION TO:RAVEN BACTERIAL SPORE STRIPS
- K032945 — SIMPLEX X
- K032977 — JMS BYPASS TUBE
- K033457 — M2 COMPATIBLE MICROKERATOME BLADE
- K033540 — TRANSXCHANGE SUPPORT CATHETER
- K033642 — SMARTLANK WIRELESS, MODEL 001970
- K033849 — SIMPLANT SYSTEM
- K040412 — TRIDENT T ACETABULAR SHELLS
- K040461 — ECONOLITH E3000, MODEL 3000 (SW-6)
- K040480 — SONOTRAX ULTRASONIC POCKET DOPPLER
- K040500 — ARTHROTEK LACTONAIL
- K040656 — MODIFICATION TO SMITH & NEPHEW INTRAMEDULLARY HIP SCREW
- K040881 — METACRYL
- K040929 — TRIGEN ADOLESCENT TAN
- K040995 — SYNERAD MULTI DIGITAL X-RAY SYSTEM, MODEL AN6150
- K041053 — MEDLINE STRIDER MICRO 3
- K041054 — MEDLINE STRIDER MAXI 3
- K041055 — MEDLINE STRIDER MAXI 4
- K041067 — HEARTSINE SAMARITAN PAD
- K041187 — A&I SCOOTER, SC-301
- K041190 — A&I POWER WHEELCHAIR, PC-401
- K041193 — A&I SCOOTER, SC-402
- K040255 — POLYFLUX 14L, 17L, 21L HEMODIALYZER/FILTER LABELED FOR SINGLE USE
- K040296 — PHOSPHOPLASTIN RL
- K040337 — I-FLOW ELASTOMERIC PUMP (ON-Q, PAINBUSTER, C-BLOC, HOMEPUMP)
- K040378 — KODAK DIRECTVIEW CR CASSETTE/GP/15 X 30 CM, CATALOG# 8418253
- K041152 — THINSET 1.8 ML RESERVOIR, MODEL 326A; THINSET 3.0 ML RESERVOIR, MODEL 332A
- K041218 — GRIFFIN SPECT/CT IMAGING SYSTEM
- K041290 — RTA MODEL D RETINAL THICKNESS ANALYZER
- K041295 — RN SYNOCTA UCLA GOLD ABUTMENT FOR THE STRAUMANN DENTAL IMPLANT
- DEN040003 — GLUCATELL
- K032755 — MODEL 509M PULSE OXIMETER, MODEL 509M
- K033474 — ZOLL AED PLUS
- K033623 — CELSIUS CONTROL SYSTEM
- K033627 — Q.STEPS BIOMETER G BLOOD GLUCOSE MONITORING SYSTEM
- K033983 — VITALAB IRON REAGENT
- K040153 — I-TEC PORTABLE DENTAL OPERATORY
- K040475 — MICROMAX SUTURE ANCHOR
- K040639 — ISURG DISPOSABLE SUBDERMAL NEEDLE ELECTRODE
- K040676 — MEDTRONIC MINIMED PARADIGM INSULIN PUMP, MODELS MMT-515 AND MMT-715
- K040735 — ALM X'TEN (X10) SURGICAL LIGHT SYSTEM
- K040809 — CRYMED CRYO-ABLATOR
- K040895 — INTEGRITY TEMPORARY CEMENT
- K040957 — NOA III ENTERAL NUTRITION PUMP
- K041046 — MAXIM ACCEL (VANGUARD) PS+ BEARINGS
- K041073 — DOCUMENT SALICYLATE CAL VER
- K041182 — SYNTEGRA
- K041291 — RINSPIRATION SYSTEM
- K021845 — STARDUST II, MODEL 1011176
- K033899 — LIFESTREAM PLUS CHOLESTEROL MONITOR, MODIFICATION TO RESOLUTION CHOLESTEROL MONITOR
- K040324 — WILSON-COOK DOUBLE LUMEN BILIARY CYTOLOGY BRUSH
- K040442 — PROTEX STABILIZATION SYSTEM
- K040519 — SLIP UROLOGY CATHETER
- K040520 — SLIP UROLOGY INTRODUCER SHEATH
- K040524 — PORTA SOLDER 1090 W
- K040575 — PHARMATECH MENOPAUSE CHECK, MODELS 9111 AND 9112
- K040677 — COMBI SELF PROPELLED SHOWER COMMODE
- K040829 — GELWEAVE ANTE-FLO WITH COLLAR AND GELWEAVE 4 BRANCH PLEXUS WITH COLLAR
- K040859 — HERACERAM PRESS
- K041164 — L-TENS
- K041230 — CLINICAL LABORATORY ANALYZING SYSTEM
- K041273 — ONE-STEP PREGNANCY TEST
- K032575 — FIRST SIGN DRUG OF ABUSE SCREENING TEST
- K033142 — POWERED WHEELCHAIR
- K033688 — MICRO H2 BREATH MONITORING DEVICE WITH HYDRA SOFTWARE UTILITY
- K033885 — BMBP ENZYME IMMUNOASSAY, CAT #0610, 0611 (500, 5000 TEST KIT)
- K040152 — BONE CEMENT FOR CRANIOPLASTY
- K040371 — A & D MEDICAL UA-767BT DIGITAL BLOOD PRESSURE MONITOR
- K040433 — SINON
- K040445 — ACON PPX ONE STEP PROPOXYPHENE TEST STRIP AND ACON PPX STEP PROPOXYPHENE TEST DEVICE
- K040457 — NOMAD FROM DYNAMIS MOBILITY LTD.
- K040603 — PARADIGM LINK BLOOD GLUCOSE METER
- K040636 — CADD ADMINISTRATION SET WITH FLOW STOP, MEDICATION CASSETTE RESERVOIR WITH FLOW STOP AND EXTENSION SET
- K040822 — LIQUICHEK TORCH PLUS IGM CONTROL
- K040951 — SR ADORO
- K041006 — TANDEM-CATH HEMODIALYSIS CATHETER, MODEL 10 FR
- K031357 — GUARDDOG OCCLUSION SYSTEM, OCCLUSION GUIDEWIRE, 300 CM, GUARDDOG OCCLUSION SYSTEM OCCLUSION GUIDEWIRE, 200 CM
- K032517 — MEDSAFE CLICKSAFE SAFETY ANTISTICK SYRINGE WITH HYPODERMIC NEEDLE
- K040013 — ANGIOJET XPEEDIOR 120 CATHETER AND ANGIOJET POWER PULSE SPRAY ANCILLARY KIT
- K040477 — MONODERM
Data sourced from openFDA. This site is unofficial and independent of the FDA.