FDA 510(k) clearances — page 1409
clearances on record, most recent first.
Clearances — page 1409
140,801–140,900 of 176,637- K871208 — UNIPOLAR ENDOCARDIAL SCREW-IN LEAD, MODEL 1007M
- K871221 — CDI(TM) EXTRACORPOREAL BLOOD GAS SYSTEM 300
- K871239 — ACUSON PHYSIOLOGICAL CONTROL MODULE
- K871305 — COCAINE METABOLITE ENZYME IMMUNOASSAY KIT
- K871336 — M-1 PRESSURE MONITOR
- K871337 — M-2 OXYGEN/TEMPERATURE MONITOR
- K871363 — MODEL 420 SYSTEM MEASUREMENT, BLOOD PRESSURE
- K871390 — BARD BIOPTY BIOPSY SYSTEM
- K871399 — OHIO(R) CARE PLUS INCUBATOR
- K871459 — SURVIVAL KIT, INDIV TROP TACT AIR CREW/PLASTIC BAG
- K871482 — HYPERTENSION RISK DETECTOR(TM)
- K871518 — TELSTAR MODEL F3TS HEARING AID
- K871521 — FULL SHELL ITE HEARING AID
- K871522 — TELSTAR MODEL C HEARING AID
- K871551 — MODEL NUMBER 8200 RESPIRATION/HEART RATE MONITOR
- K871594 — BIRTHING ROOM WARMER
- K871621 — THE KARL STORZ MODEL 28805 ARTHRO PUMP
- K871626 — ELECTROTRACE DISP REST EKG ELECTRODE, CAT. ET1200
- K871695 — DOUBLE ANTIBODY CANNABINOIDS KTHD1 AND KTHD5
- K871696 — DOUBLE ANTIBODY AMPHETAMINE KAPD1 AND KAPD5
- K871717 — MODEL 28200C MICRO-ARTHROPLASTY SYSTEM
- K871719 — MODIFIED MODEL UA-751 DIGITAL SPHYGMONOMETER
- K871753 — MASTER MEDICAL DEVICE IS I.V. STAT 2
- K871793 — LIDO ACTIVE
- K871808 — DUCERAM-METAL-CERAMIC DENTAL PORCELAIN SYSTEM
- K871861 — IMPLANTABLE PROGRAMMABLE CARDIAC PULSE GENERATORS
- K871891 — KARL STORZ MODEL 28184 PNEUMATIC SHUTTLE SHAVER
- K871937 — IMPRESSION SYRINGE
- K871975 — MULTICHEM TOTAL PROTEIN REAGENT #S0928
- K871976 — MULTICHEM GLUCOSE HEXOKINASE REAGENT #S0919
- K871980 — D-23 DENTURE ADHESIVE
- K864645 — ADENOLEX (R) LATEX AGGLUTINATION TEST
- K870814 — HERPES SIMPLEX ANTIBODY TEST FOR DECT. OF HSV 1&2
- K870897 — KODNER ANAL PERIONEAL RETRACTOR
- K870991 — IMED(R) MODEL 960A VOLUMETRIC INFUSION PUMP
- K870992 — IMED(R) MODEL 965A VOLUMETRIC INFUSION PUMP
- K871003 — ENTROSET-SW
- K871219 — TITANODONT SUBCORTICAL IMPLANT WITH POROCOAT
- K871376 — FIRST AID KIT, VARIOUS SIZES
- K871462 — PROSTHETIC - FEMORAL HIP COMPONENT
- K871780 — ULTRAVIOLET ASPARTATE AMINO-TRANS (UV-AST/UV-GOT)
- K870095 — BILIRUBIN TESTER
- K870626 — FREEDOM SET II WITH TRIFLEX VALVE
- K870979 — HEMODIALYSIS CONCENTRATES & RELATED PRODUCTS
- K871235 — TANDEM(R) ICON(R) QSR(TM) HCG IMMUNO. ASSAY KIT
- K871248 — KRONNER COLLES-FOREARM EXTERNAL FIXATION
- K871397 — ANALYZER: NOVA STAT PROFILE 3 ANALYZER
- K871450 — 25MM PEYMAN WIDE FIELD YAG LASER LENS
- K871485 — SITE PHACOEMULSIFICATION SYSTEM/OPHTHALMIC USE
- K871735 — VOROSCOPE(TM)
- K871772 — KINEMATIC III POST CRUCIATE TOTAL CONDYLAR KNEE SY
- K871781 — ULTRAVIOLET LACTATE DEHYDROGENASE REAGENT SET
- K871902 — THE URIC ACID REAGENT SET
- K871935 — T P C (TONOMETER PROBE COVER)
- K871943 — D.A.T. (TM) AMYLASE REAGENT
- K871961 — MULTIPLE SPECTACLE LENS
- K863439 — INTRAUTERINE HEMOSTASIS BALLOON STENT
- K863815 — ELECTROCONVULSIVE THERAPY DEVICE, MODEL MF-1000
- K864745 — POET OXIMETER
- K870411 — CENTRAL VEIN CATHERIZATION KIT W/WITHOUT MEDICA.
- K871125 — ELECTRO-NERVE STIMULATOR TENS MODEL B5/SKN
- K871126 — ELECTRO-NERVE STIMULATOR TENS MODEL C & B11, B11C
- K871292 — HEALTH CONCEPTS CONDUCTIVE MEMBRANE
- K871501 — KIT, FIRST AID, GENERAL PURPOSE, RIGID CASE
- K871769 — OMNIFIT(R) TOTAL KNEE SYSTEM (MODIFICATION)
- K872020 — MUCATE AGAR, SLANTS AND MUCATE BROTH
- K870197 — KDI QUIK TEST(TM) MARIJUANA SCREEN
- K870413 — PERCUTANEOUS SHEATH W/WO MEDI. (5,6,7,8,8.5FR)
- K870746 — STANBIO ALPHA-AMYLASE TEST SET, CATALOG 0180-715
- K870786 — AXIAL COMPRESSION SCREW
- K870831 — PDA699/PDA700 PROTAMINE DOSE ASSAY FOR HEP. NEUTRA
- K870890 — ALKALINE PHOSPHATASE INDOLYL BLUE REAGENT
- K871334 — LASE SYSTEM II
- K871383 — FETALERT ADR FETAL MONITOR
- K871394 — THEOPHYLLINE FPIA CALIBRATORS
- K871672 — STERILIZATION INDICATOR FOR FLASH STERILIZATION
- K871692 — TRACHEOSTOMY & NASAL SUCTIONING KIT, 3C-TNS-1
- K871901 — ULTRAFLOW
- K871910 — SURGITEK DISPOSABLE BIPOLAR CORD
- K871923 — MICRO SCISSOR, 1.7MM
- K871924 — STERILIZATION TRAY, TMJ INSTRUMENT SET
- K871925 — STRAIGHT CUP CURRETTE, 1.7MM
- K870235 — OMNIFIT II HIP PROSTHESES: CEMENT FIXATION
- K870807 — BKS-1000 REFRACTIVE SET USE IN KERATOREFRACTIVE
- K870911 — INDWELLING BLOOD CARBONDIOXIDE PARTIAL PRES. ANALY
- K870997 — SOLA UV GARD(TM) SUNGLASSES
- K871107 — VASOTRAIN 447
- K871158 — SIBIS REMOTE ACTUATOR
- K871202 — FLASHPAK CONTAINER SYSTEM
- K871222 — TANTONE MULTI-DAY #633 TENS ELECTRODE
- K871236 — HOLLOW FIBER DIALYZER FOCUS 70,90,120,90H,120H
- K871255 — MODIFIED HERCON ANTISEPTIC TRANSPARENT DRESSING
- K871270 — PERFORM DENTURE BASE RESIN
- K871295 — ADAPTALITE* PORCELAIN VENEER CEMENTATION SYSTEM
- K871359 — CHECK-MATE AND CHECK-MATE [+]
- K871386 — BREATHING CIRCUIT
- K871387 — SECOND NATURE(TM)
- K871433 — PPG BIOMEDICAL VENTILATOR MODEL AV 400
- K871457 — FIRST AID KIT, EYE DRESSING
- K871649 — CLASSIC 70 LENS
Data sourced from openFDA. This site is unofficial and independent of the FDA.