FDA 510(k) clearances — page 1355
clearances on record, most recent first.
Clearances — page 1355
135,401–135,500 of 175,890- K881706 — PROXIMA 1 PH MONITOR
- K881713 — SPECIAL PROCEDURES BASE UNIT MODEL 500
- K881782 — MSI 4000 SERIES BED
- K881908 — TRACER(TM) II BLOOD GLUCOSE SYSTEM
- K881942 — EMIT HVA COCAINE METABOLITE ASSAY
- K881986 — ESCORT - PORTABLE PATIENT MONITOR
- K882005 — HARMONY HEARING AID MODELS LP, M, HO, HF, & C
- K882045 — HIGH TORQUE TEMPORARY PERVENOUS LEAD W/DEPTH MARK
- K882161 — ACUCAIR CUSHION CONTINUOUS AIRFLOW SYSTEM
- K882179 — EMIT HVA PHENCYCLIDINE ASSAY
- K882267 — SYSMEX QUICKLYSER-II (QLS-200A)
- K882300 — SCEPTOR ENTERIC MIC PANEL (REVISED 4/88)
- K882301 — SCEPTOR ENTERIC MIC/ID PANEL (REVISED 4/88)
- K882302 — IVAC(R) UNVENTED VOL. INFUSION SET MODEL 52080
- K882304 — DIGITAL THERMOMETER SHEATHS (ORAL AND RECTAL)
- K882369 — ACCRAASSAY RID KITS
- K882513 — MODIFIED HEART*AID 97 AUTO. EXTERNAL DEFIBRILLATOR
- K882534 — ABBOTT TESTPACK(TM) GONORRHEA POSITIVE CONTROL
- K882641 — TECNOL CATHETER LEG STRAP
- K882677 — STAT-20 FLUOROMETER
- K882105 — CODE #D2020-FINE NEEDLE ASPIRATION BIOPSY SYSTEM
- K871143 — IMMUNOCCULT EIA TEST KIT
- K871512 — SL-100 ND:YAG LASER FOR GYNECOLOGY USE
- K872466 — ADULT STAR
- K875204 — DU PONT VCA-IGM ANTIBODY ELISA KIT
- K880702 — MODEL MR430 SPECIAL PURPOSE HUMID. HEATER BASES
- K880703 — QUANTAI BG(TM) REAGENT STRIP
- K881100 — CONDOM
- K881135 — COOL EYE(TM) EYE PROTECTOR
- K881188 — BLOOD PH CAPILLARY TUBES, HEPARIN
- K881386 — X-RAY GENERATING SYSTEM TF 1000
- K881387 — X-RAY GENERATING SYSTEM, TF 800
- K881430 — LIQUI-SERA SERUM ALCOHOL CONTROLS
- K881503 — MODIFIED DADE COMPRE. ELECTROPHORESIS CONTROL
- K881609 — SITZMARKS
- K881619 — 4000/4900/6000/8000/8900 YAG, & 1700 YAG/CO2 LASER
- K881639 — KODAK EKTACHEM CLINICAL CHEMISTRY SLIDES (PROT)
- K881654 — ACCI-GUARD MULTI-SAMPLE BLOOD COLLECTION NEEDLE
- K881679 — CIBA CORNING MAGIC LITE DIGOXIN IMMUNOASSAY
- K881689 — LINDLEY II RESUSCITATOR
- K881692 — DIDECO-SHILEY FLUID COLLECTION BAG
- K881709 — IMMUNOCARD(TM) HCG II TEST KIT
- K881742 — BIOTROL ALKALINE PHOSPHATASE
- K881761 — UNSATURATED IRON BINDING CAPACITY
- K881794 — IVORY FINDER SET
- K881802 — ALPINE PORTABLE OXYGEN GENERATOR
- K881846 — SCEPTOR- NEW ANTIMICROBIAL AGENT: NORFLOXACIN
- K881852 — REP SP ELECTROPHORESIS SYSTEM CAT NO. 3170
- K881894 — ADENOCLONE(R)-TYPE 40/41 EIA DIAGNOSTIC TEST (48)
- K881907 — HEMAGEL(TM) TEST FOR FECAL OCCULT BLOOD
- K881913 — PROTECTO-SHIELD
- K881928 — MONOCLONAL RADIAL IMMUNODIFFUSION KIT
- K881943 — EMIT HVA CALIBRATOR KIT
- K881944 — EMIT HVA CONTROL KIT
- K882064 — LO-CORE NEEDLE
- K882082 — QM300 ALBUMIN ANTIBODY PACK
- K882083 — QM300 IGG ANTIBODY PACK
- K882204 — RESUSCITATOR VALVE ASSEMBLY W/FILTER
- K882374 — WAKO(TM) CRP
- K882404 — KEVOR-CURETTE
- K882446 — ALPHA1ANTITRYPSIN FOR TECHNICON DPA-1(TM) SYSTEM
- K882489 — REVISED PNEUMATIC DIAGRAMS FOR MODULUS II PLUS
- K882494 — ELAN-E DISPOSALBE DRAPE
- K882524 — UNIVERSALLY ADJUSTABLE ARMBOARD
- K882563 — RADKOR, CST-18
- K882580 — MECHANICAL CHANGE IN IN-VITRO MICRO DEVICE
- K882620 — APOLIPOPROTEIN FOR THE TECHNICON DPA-1(TM) SYSTEM
- K882621 — COMPLEMENT C4 FOR THE TECHNICON DPA-1(TM) SYSTEM
- K882622 — CERULOPLASMIN FOR THE TECHNICON DPA-1(TM) SYSTEM
- K882623 — PROPERDIN FACTOR B FOR TECHNICON DPA-1(TM) SYSTEM
- K882669 — APPOLLO BATH
- K864893 — ANTI-CYTOKERATIN MONOCLONAL ANTIBODY
- K881792 — CANNULA MODEL AR-6551
- K881923 — ULTRAVIOLET RESOURCES INT'L MODEL 2-FS72
- K882381 — PTI HEART-LIFT(TM) CARDIAC RETRACTION GLOVES-STERI
- K872867 — BIOSIGN
- K881437 — CHLORIDE/TOTAL CO2 SERUM RANGE LINEARITY STANDARDS
- K881438 — UREA/GLUCOSE/CREATININE SERUM RANGE LINEARITY STAN
- K881733 — SHILEY FEMORAL CORONARY PERFUSION CATHETER
- K882029 — LABELING FOR REVISED PASCO MIC AND MIC/ID PANELS
- K882233 — TDX (R) DIGOXIN NXT
- K882637 — ACCU-CULSHURE TM
- K875182 — MODIFIED LABELING FOR TOXI-LAB THC SCREEN
- K881691 — PREASSEMBLED SURGICAL WASH SET 122,175,225,375AA
- K881717 — PTI HEART-LIFT(TM) CARDIAC SUPPORT SLING (STERILE)
- K881734 — SHILEY FEMORAL LEFT VENTRICULAR VENT CATHETER
- K881735 — CONDOM
- K882104 — ION SELECTIVE ELECTRODE SUBSYSTEM OF PARA. ANALYT.
- K882150 — HEARING AID (ALL-IN-THE-EAR)
- K882243 — SPTL-1 PULSED DYE LASER
- K882409 — PE100R FM RECEIVER USED W/PE100T FM TRANSMITTER
- K874236 — APOLLO CONDOM
- K874910 — SHIMADZU DIGITAL SUBTRACTION SYSTEM DAR-200
- K875198 — DIGITAL NUCLEAR IMAGING SYSTEM
- K875229 — DSL SOMATOMEDIN-C (DSL #5600)
- K875357 — BIOPSY FIXATION UNIT-TYPE UA 0997
- K880076 — G-MARK
- K880543 — UNI-PORT
- K880741 — ESPE VARNISH
- K880750 — NOVA STAT PROFILE 6 ANALYZER + QUALITY CONTROL MAT
Data sourced from openFDA. This site is unofficial and independent of the FDA.