FDA 510(k) clearances — page 1214
clearances on record, most recent first.
Clearances — page 1214
121,301–121,400 of 175,890- K912076 — POLY BRAIDED PIGTAIL/PERC CARD CATH W/VAR TIP CONF
- K912084 — MEDTRONIC CARDIOCARE MEMORYTRACE ER MODEL 4221
- K912136 — CHOLESTECH LIPID MONITORING SYS.
- K912191 — SOFTOUCH(R) GUIDING CATHETER W/BUMPER TIP
- K912194 — PA-393 GOLD BASED/PRECIOUS METAL ALLOYS CLIN USE
- K912195 — PA-396 GOLD BASED/PRECIOUS METAL ALLOYS CLIN USE
- K912199 — SOFTTOUCH(R) GUIDING CATHETER
- K912237 — STRYKER ECLIPSE WARMING STRETCHER
- K912291 — DISTAT ANTI-SCL-70 KIT
- K912292 — DIASTAT ANTI-JO-1 KIT
- K912346 — MEDIKEEPER
- K912423 — VITAL-PORT M.R.I. VASCULAR ACCESS SYSTEM 7012,7112
- K912424 — VITAL-PORT VASCULAR ACCESS SYSTEM 7010 AND 7110
- K912434 — SALTER LABS INFANT NASAL CPAP CANNULA
- K912465 — VITAL-PORT DUAL LUMEN VASCULAR ACCESS SYSTEM 1121
- K912495 — IONOSEAL
- K912497 — IONOBOND
- K912587 — K-FREE
- K912596 — MECONIUM ASPIRATION
- K912603 — REP ALP-15, 8, & 4 KITS
- K912725 — TOTAL IRON & UNSAT IRON BIND CAP/IRON BIND CONTROL
- K912808 — ABBOTT QUICK START GLUCOSE (GLUE) ITEM# 5A15
- K912810 — ABBOTT QUICKSTART TOTAL PROTEIN TEST ITEM# 5A13
- K912831 — BACTI-SWAB(TM) II
- K912858 — LONDON DIAGNOSTICS LUMATAG(R) HGH CHEM IMMUN ASSAY
- K912912 — SYNERMED SERUM IRON-600 REAGENT KIT
- K912917 — MILENIA ESTRADIOL
- K912938 — RHYTHM
- K913066 — EMIT(R) 2000 CARBAMAZEPINE ASSAY/CALIBRATORS
- K903962 — INSTRUMENTS FOR ONE TIME USE/ DISPOSABLE
- K903963 — KITS AND TRAYS FOR ONE TIME USE ONLY
- K911922 — BRONCHOSCOPE ACCESSORY, NSN 6515-00-315-2200
- K903175 — ADVANCE SUTURE NONABSORBABLE DACRON SUTURE
- K904723 — FORCEPS
- K904737 — GROSS HIP FEMORAL COMPONENT
- K904834 — INTAVENT LARYNGEAL MASK
- K910304 — RAPID CORYNE SYST/IDENTIF OF CORYNEFORM BACTERIA
- K910839 — ULTIMATE 3000
- K910849 — SYSMEX F-810
- K910877 — FINN KNEE PROSTHESIS
- K910957 — MASTERPIECES MICRO SYSTEM
- K911154 — SUN MEDICAL SMOKE/FLUID EVAC SYST, MODEL SFE-200
- K911172 — SYSMEX F-610
- K911173 — SYSMEX F-310
- K911190 — PERRYMETER(TM)
- K911374 — PLASTIC OVERLAYS
- K911443 — INSUL-LINE
- K911597 — THE NEEDLE NABBER
- K911744 — PRECISION OPTICS CORPORATION LAPAROSCOPE
- K911788 — ECONOVAGE R
- K911887 — MAJOLI UTERINE MANIPULATOR/INJECTOR
- K911890 — OSTEONICS(R) PRT HIP STEM SERIES
- K911901 — MAXI CABINET OPTIONAL BUILT IN S6000 LIGHT SOURCE
- K911904 — MODELS UES-10 & PSD-10
- K911919 — MINIVAGE(R)
- K911982 — BONE NAIL, KUNTSCHER
- K911998 — MULTITOME MODEL 1000, VITRECTOMY DRIVING SYSTEM
- K912036 — ROBOTIC SAMPLE PROCESSOR
- K912048 — ABUSCREEN(R) ONLINE(TM) THC CALIBRATORS
- K912143 — CEDIA(R) TOBRAMYCIN ASSAY
- K912146 — URETERAL CATHETER HOLDER
- K912254 — COX DIAPOSABLE POLYPECTOMY SNARE
- K912333 — ARTEMA AQUA+
- K912334 — ARTEMA AQUA+ T & TS
- K912335 — ARTEMA AQUA+ N
- K912336 — ARTEMA AQUA+ FLEX
- K912427 — MULTICHANNEL RECORDING SYSTEM
- K912520 — 3M WATER DISPERSIBLE ADHESIVE TAPE, 98XX
- K912545 — MODEL 4205 PULSE GENERATOR SURGICAL EXTEN CABLE
- K912579 — THE VOSS DISPOSABLE SUCTION/IRRIGATION CANNULA
- K912756 — ABUSCREEN RADIOIMMUNOASSAY FOR COCAINE METABOLITE
- K912757 — ABUSCREEN RADIOIMMUNOASSAY FOR CANNABINIODS
- K912758 — ABUSCREEN ONLINE FOR AMPHETAMINES
- K912817 — SOMNIMIC (R)
- K912825 — MAGNESIUM ASSAY KIT, CAT.# 100-12
- K912826 — WHOLE BLOOD ALCOHOL CONTROL, LEVEL 1 & 2
- K912834 — SHUR-GRIP
- K912959 — MICROTRAK MANAGER
- K912980 — MONOSCOPY BRAND 5MM LOCK TROCAR SLEEVE, MODIFIED
- K913024 — ABBOTT QUICKSTART GAMMA-GLUTAMYTRANSFERASE TEST
- K905418 — GATES GLIDDEN DRILLS
- K910090 — DIMAC WIRES
- K910186 — WYMAN SUTURE WASHER
- K911252 — PRECISE BARND PI DISPOSABLE SURGICAL STAPLES
- K911961 — BRANEMARK SYSTEM-5.0MM FIXTURE
- K912004 — SHEPARD CRYOPRESS/CAMP MULTI-TEMP SPORT PUMPS
- K912110 — DISPOSABLE O.R. TOWEL
- K912134 — TBD, LENS MEASURING DEVICE
- K912151 — LANDERS THREE STRUT VITRECTOMY LENS RING
- K912318 — ESTRADIOL SEROZYME ENZYME IMMUNO (MAG SOLID-PHASE)
- K912485 — COLTENE PRESIDENT JET LIGHT/REG BODY HYDROPHILIC
- K912502 — LAPAROSCOPIC LASER FIBER DIVERTER
- K912522 — OMNIVIEW(TM) OPHTHALMIC FIBERENDO W/NEEDLEHOLDER
- K912533 — NARKOMED AV-E VENTILATOR
- K912638 — BLOOD PRESSURE CUFFS
- K912714 — RT40 RADIO TRANSLUCENT
- K912800 — KALLESTEAD TOTAL IGE MICROPLATE KIT
- K903565 — E560 ELECTROCARDIOGRAPH
- K904032 — ELITE II ELECTROCARDIOGRAPH
- K904496 — CROMATEST SYPHILIS DIAGNOSTIC
Data sourced from openFDA. This site is unofficial and independent of the FDA.