FDA 510(k) clearances — page 1401
clearances on record, most recent first.
Clearances — page 1401
140,001–140,100 of 175,890- K864278 — DS-II DIGITAL SONOGRAPHY SYSTEM
- K870222 — AMEDA AMECARE(R) NEONATAL INCUBATOR
- K870223 — AMEDA AMELETTE(R) NEONATAL INCUBATOR
- K870945 — RABBIT PLASMA FIBRINOGEN SUPPLEMENT SR 122
- K871192 — SUBCUTANEOUSLY IMPLANTED DRUG DELIVERY DEPOT
- K871268 — RODENSTOCK SCANNING LASER OPHTHALMOSCOPE
- K871282 — SYNECTICS LIBERTY SYSTEM AMPLIFIER AND SOFTWARE
- K871318 — Q.I.C. BLEEDING TIME DEVICE
- K871610 — CONVEEN(R) NIGHT DRAINAGE BAG (2000 ML)
- K871643 — CONVEEN(R) LEG-BAG (600 ML)
- K871667 — URETERAL STENT
- K871668 — BIODAN TYPE COMET ELECTRODE
- K871748 — THE BUDDY SYSTEM W/OPTIONAL ECG ELECTRODE
- K871915 — MINIATURE TEMP. CARDIAC PACEMAKERS EC4542 & EC4543
- K872058 — ORICULT-N CULTURE-PADDLE
- K861730 — ACTRIL FOR KIDNEY MACHINE DISINFECTANT
- K870710 — MULTI-FLEX TABLE -- MODEL 101
- K870711 — MULTI-FLEX TABLE -- MODEL 102
- K870712 — MULTI-FLEX TABLE -- MODEL 103
- K870713 — MULTI-FLEX TABLE -- MODEL 104
- K870714 — MULTI-FLEX TABLE -- MODEL 105
- K870715 — MULTI-FLEX TABLE -- MODEL 106
- K870855 — UROSCAN
- K871019 — ENFUSE ENTERNAL ADMINISTRATION SET & PUMP SET
- K871656 — ORTHOMET AUSTIN-MOORE SYSTEM
- K871740 — LYOSHEET SURGICAL SHEET FOR BURNS
- K871801 — CYTOTECH ANTINUCLEAR ANTIBODY (ANA) IFA KIT
- K871906 — UNIMED SURGEON'S GOWNS
- K871926 — GRASPING FORCEP, 1.7MM
- K871927 — CUP BIOPSY FORCEP, 1.7MM
- K871982 — TOURNIQUET PRESSURE REGULATOR
- K870280 — ACCUDENT ACCUPROBE
- K870405 — DSL ESTRADIAL RADIOIMMUNOASSAY (DSL-4400)
- K870819 — BUBBLE TRAP CAT. NO. B-180
- K871072 — OMEGA NASAL SEPTAL BUTTON
- K871199 — MODIFIED PERTRACH DISP. PEDIATRIC PERCUT. TRACHEO.
- K871300 — VIP'S PROPHYLACTICS, NATURAL, ANATOMIC & FEMINA
- K871325 — BOWEN REUSEABLE/DISPOSABLE ELECTRODE
- K871350 — PREBYPASS FILTER
- K871353 — OXIMETER
- K871439 — COSMETIC SINGLE SPAN BRIDGE
- K871520 — TELSTAR MODEL FS HEARING AID
- K871569 — MODIFIED HEART*AID 97 AUTO. EXTERNAL DEFIBRILLATOR
- K871648 — TMJ CANNULA SET
- K871680 — MODIFIED COBAS FP REAGENTS FOR NAPA AND CALIBRATOR
- K871851 — RIBBED CUSHION MASK
- K871885 — ESKA-HERRMANN TRACHEOSTOMY VALVE
- K872017 — BTE HEARING AID OTICON MODEL E30P
- K864589 — TRI-SERVICE OMV VAPORIZER
- K870460 — DORROS(TM) SMALL VESSEL PTA CATHETER
- K870742 — AMERICAN LUBRICATING JELLY STERILE 2.7G & 5G
- K871040 — CONSULTANT BODY COMPOSITION ANALYZER
- K871149 — DRM 2300 PLETHYSMOGRAPHIC CARDIOTACHOMETER
- 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
Data sourced from openFDA. This site is unofficial and independent of the FDA.