FDA 510(k) clearances — page 1377
clearances on record, most recent first.
Clearances — page 1377
137,601–137,700 of 176,637- K875168 — QUIDEL TOTAL IGE TEST
- K875255 — DREAM DAM
- K875344 — HERAEUS' HERAGAM 48, NON GAMMA 2 DEN. AMAL. ALLOY
- K875351 — DEN-MAT PORETCH (PORCELAIN ETCHANT)
- K880333 — CUSTOM I.T.E. HEARING AIDS CE-5, CE-6, CE-7
- K880334 — CUSTOM CANAL HEARING AIDS INTRA II CC-5, 6 & 7
- K880335 — INTRA II SECRET EAR HEARING AIDS ISE
- K880482 — SECONDARY SOLUTION ADMINISTRATION SET W/SHEATH
- K880711 — CLP 0.02 M CALCIUM CHLORIDE SOLUTION.
- K880713 — CLP 0.1 M SODIUM CITRATE SOLUTION
- K875237 — OPTEC 1000 DMV VISION TESTER MODIFY
- K880007 — TOXO IGM TEST
- K880020 — 3 IN 1 AUTOMATIC TOURNIQUET
- K880031 — PATHFINDER(TM) DIRECT DETECTION SYS C. TRACHOMATIS
- K880293 — THE STORZ BIPOLAR PENCIL AND CORD
- K880373 — IONOMETER E-HK AND ACCESSORIES
- K880398 — POWER TOILET ELEVATOR
- K880669 — L-5 PLASTIC SURGERY CANNULAS
- K880851 — FLAT STICK SPONGE
- K880852 — ROSEBUD DISSECTORS
- K880853 — CHERRY SPONGE
- K880854 — STRUNG ABSORBENT BALLS
- K880861 — MECHANICAL ADJUSTABLE CHAIR (AC POWERED)
- K880874 — IMMUNOADSORBED FACTOR VII DEFICIENT PLASMA HUMAN
- K880901 — SONICATOR 710 (MODEL ME710)
- K880907 — TRIANGLE SPONGE
- K880909 — TRACHEOTOMY SPONGES
- K880910 — ROUND STICK SPONGES
- K880911 — BLUNT SPONGE
- K880964 — POLYDERM PEC(TM), POROUS ELASTIC COVER
- K881012 — WOUND-EVAC RS
- K871242 — REVERSE OSMOSIS WATER PURIFICATION SYSTEM
- K872059 — DRIPRIDE PROVIDE ULTRA
- K874361 — BIODYNAMICS MODEL BI-300 BODY COMPOSITION ANALYZER
- K880230 — SIXALYZER
- K880315 — DADE ANTITHROMBIN III CHROMOGENIC ASSAY
- K880496 — LYPHOCHEK QUANTITATIVE URINE CONTROL NORMAL (1)
- K880609 — ANALYTE CARBON DIOXIDE ASSAYED ON TECHNICON RA(TM)
- K880617 — ADDITION OF AMPICILLIN/SULBACTAM & CIPROFLOXACIN
- K880630 — LACTATE DEHYDROGENASE (LDH-L)
- K880662 — VISION(R) THYROXINE (T4)
- K880726 — JMS APHERESIS NEEDLE
- K873939 — ADI/B/*/HA-2 STAGE OSSEO. HYDRO. DENTAL IMPLANT
- K880065 — NIDEK UP-2000
- K880081 — VISION CARE/PHAKOSYSTEMS ECHOPACH
- K880090 — ION TRAP DETECTOR
- K880100 — COOK UROLOGICAL WIRE GUIDE W/HYDROMER COATING
- K880236 — GLUCOSE HEXOKINASE
- K880238 — TRIGLYCERIDE
- K880242 — KONE CALCIUM TEST
- K880263 — OSI RIZZOLI ORTHOPEDIC TABLE/MANUAL VERSION
- K880268 — CO2 REAGENT
- K880307 — ALKALINE PHOSPHATASE REAGENT SET
- K880328 — HCG-NOSTICK
- K880381 — TELOS DISTAL TARGETING DEVICE
- K880395 — TOTAL BILIRUBIN PROCEDURE RUN ON A DEMAND INSTRU.
- K880396 — TOTAL BILIRUBIN PROCEDURE RUN ON A AU5000 INSTRU.
- K880397 — DIRECT BILIRUBIN PROCEDURE RUN ON A AU5000 INSTRU.
- K880461 — PERFECTA TOTAL HIP SYSTEM
- K880495 — LYPHOCHEK QUANTITATIVE URINE CONTROL ABNORMAL (2)
- K880577 — CONCEP-7-BHCG
- K880628 — TRIGLYCERIDES (GPO-TRINDER)
- K880787 — EASY-TEST LACTIC ACID (LA)
- K880912 — DYNATRON 2000
- K873255 — THE MICRO-VENT/HA
- K874837 — KTP/532 LASER FOR OB-GYN USE
- K875004 — PRISMA DISPOS. BRITE LITE FIBEROPTIC ENDO. W/PICK
- K875005 — PRISMA DISPOS. BRITE LITE FIBEROPTIC ENDOILLUMINA.
- K875006 — PRISMA DISPOSA. BRITE LITE FIBEROPTIC ENDO. W/PICK
- K875007 — PRISMA DISPOS. BRITE LITE FIBEROPTIC ENDOILLUMINA.
- K875277 — ADDITIONAL INDICATIONS FOR XOMED AUDIANT BONE CON.
- K875309 — SANITARY MENSTRUAL NAPKIN
- K880195 — GYNESCOPE
- K880223 — MAGIC EAR MODEL MB BEHIND-THE-EAR HEARING AID
- K880273 — WIDEX HEARING AID MODEL C1
- K880737 — SELF GUIDING (SG) INTERLOCKING NAIL
- K880786 — BUSHLINE CARE CHAIR
- K880800 — GOLDEN POWER LIFT CHAIR
- K880826 — MICROLOC(TM) POROUS COATED UNICONDYLAR KNEE SYSTEM
- K880895 — URESIL WOUND DRAIN TROCAR
- K880986 — MECHANICAL WALKER
- K873150 — PDS, MODEL NST 40 FETAL MONITOR, RECORDER & TRANS.
- K874152 — RNP ANTIBODY TEST KIT
- K874195 — LA ANTIBODY TEST KIT
- K874554 — ENVICLUSIVE (TM)
- K874631 — HEALTHPHONE TOCO MODEL
- K874693 — OBT STEREOTACTIC SYSTEM
- K875008 — GUARDALL SHIELD
- K880003 — ADDITIONAL ALLERGENS FOR IGE FAST-PLUS TEST
- K880009 — REVISED LABELING FOR ADX COCAINE METABOLITE
- K880064 — YESNG MODEL 200S11 ELECTROSURGICAL UNIT
- K880073 — YESNG MODEL 500SII ELECTROSURGICAL UNIT
- K880172 — MODEL 4900 ND:YAG LASER FOR NEUROSURGERY APPLICA.
- K880206 — POLYDERM WBC (TM), WATERPROOF BREATHABLE COVER
- K880253 — BLAKEMORE RETAINER
- K880513 — DISP. NON-MAGNETIC SURGICAL INSTRU. DRAPE
- K880603 — COHERENT XA-40 CO2 SURGICAL LASER
- K880757 — TECNOL FLUID SHIELD SURGICAL MASK W/EYEGUARD
- K880785 — SKILCRAFT
- K880812 — SPINAL NEEDLE
Data sourced from openFDA. This site is unofficial and independent of the FDA.