FDA 510(k) clearances — page 1222
clearances on record, most recent first.
Clearances — page 1222
122,101–122,200 of 176,637- 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
- K904883 — OPTYX
- K904899 — VITAL SIGNS CODE BLUE ADULT MANUAL RESUSCITATOR
- K910229 — SOFT TISSUE SUTURE WASHER/3 HOLE WASHER
- K910492 — BARD REPLACEMENT GASTROSTOMY TUBE
- K910634 — DC200 DEFIBRILLATOR
- K910652 — SPINAL TAP NEEDLE
- K910905 — SFA-II MICROPROCESSOR-CONTROLLED MODULE
- K911417 — ICON STREP B IMMUNOENZYMETRIC ASSAY
- K911640 — OLYMPUS PK TP(TM) SYSTEM, MODIFICATION
- K911740 — SALTER LABS NEONATAL NASAL OXYGEN CANNULA
- K911897 — GASPARAITIS ESOPHAGRAM CATHETER SET
- K912061 — HEPARIN ADSORBENT
- K912174 — SALTER LABS DISPOSABLE NIPPLE AND NUT
- K912208 — FRESENIUS SAFE-CONNECT CAPD MANUAL ASSIST DEVICE
- K912256 — PRECISE(R) BETA QUARTZ GLASS-CERAMIC INSERT
- K912316 — QUIKPAC-II ONE STEP PREGNANCY HOME TEST
- K912395 — HOWMEDICA PRECIS OSTEOLOCK FEM COMP W/HYDRO COAT
- K912408 — MERIFLUOR-CRYPTOSPORIDIUM/GIARDIA
- K912473 — ACCU-PLACER TM KIT
- K912488 — FLUORECENT EBV-EARLY ANTIGEN IGG ANTIBODY TEST SYS
- K912489 — COLORZYME EBV EARLY ANTIGEN IGG ANTIBODY TEST SYS
- K912665 — SYSTEM BT W/REMOTE CONTROL OPTION HEARING AID
- K912940 — COAT-A-COUNT BETA-2 MICROGLOBULIN IRMA
- K911825 — TRIP(TM) NASOGASTRIC SUMP CATHETER
- K911827 — MODEL 5866-9M & MODEL 6981M
- K912542 — PURITAS 100% COTTON ABSORB OPER ROOM SURG TOWELS
- K903734 — ADVANTAGE EP
- K904918 — BELSCOPE LARYNGOSCOPE
- K905168 — HYPERLITE
- K905435 — UNIQUANT
- K905633 — HUMAN C-REACTIVE PROTEIN RID KIT
- K905752 — ARGON BEAM COMBO LAPAROSCOPIC ELECTRODE
- K910002 — GENESYS AND THE ROI
- K910169 — FETALGARD 2000
- K910648 — THERAPY CHAIR SYSTEM
- K910895 — SURGICAL GLOVES
- K911216 — INFUSABLE
- K911358 — CMD/DLCO DIAGNOSTIC SPIROMETER
- K911853 — PULSATILE ANTI-EMBOLISM SYS.PUMP
- K911935 — CARDIAC ELECTROPHYSICAL LEAD SELECTOR, MODIFIED
- K912007 — BAXTER SINGLE PATIENT USE BLOOD PRESSURE CUFF
- K912225 — 3M DIGITAL RECORDING AUTOMATIC FILM HANDLING UNIT
- K912234 — SOMNIPROBE(R) MODEL NUMBER 10093, MODIFICATION
- K912680 — ANTIGENZ CHLAMYDIA
- K912729 — EMIT CALIBRATOR B LEVEL 1(CUTOFF) & LEVEL 2(HIGH)
- K912733 — AMERLEX-M SPECIFIC ESTROL(UNCONJUGATED) RIA KIT
- K912723 — POSEY CUFFLATOR
- K905802 — CENTAURI/PEGASUS
- K911787 — MONOPOLAR SPHINCTERTOME
- K911794 — CATH SHEATH INTRODUCER SYST PLUS W/UNISTASIS VALVE
- K911813 — ENTREE CANNULA
- K911826 — IMMUNOCARD HCG ONE STEP (I-S) TEST KIT
- K911838 — ROCHE REAGENT FOR C02
Data sourced from openFDA. This site is unofficial and independent of the FDA.