FDA 510(k) clearances — page 1370
clearances on record, most recent first.
Clearances — page 1370
136,901–137,000 of 176,637- K874738 — 10 AND 12 FRENCH VESSEL DILATORS
- K880485 — XENEX DENTAL ROULETTE
- K880531 — MAMMOGRAPHIC X-RAY SYSTEM ATHENA
- K880542 — DENTALVISION TV SYSTEM
- K880616 — MINOS AUTOMATIC CELL COUNTER
- K880661 — FIBEROPTIC CATHETER
- K880699 — ENDOMED CV405
- K880776 — 7 FR. TRIPLE LUMEN CENTRAL VEIN CATHETERI. SYSTEM
- K880865 — RESUBMITTED ERGOMETER EXERCISE BIKE MODEL FT1300
- K881161 — TECH-CAL(TM)/MULTIPLE
- K881348 — VERIFY(R) REFERENCE PLASMA
- K873398 — EXL-22DP X-RAY RADIATION THERAPY SYSTEM
- K874154 — ELECATH(R) TRANSESOPHAGEAL PACING CATHETER
- K875266 — SSH-160A ULTRASONIC PULSED ECHO IMAGING SYSTEM
- K875347 — MODEL 210A INFUSION PUMP
- K875348 — MODEL 400A INFUSION PUMP
- K875365 — MODEL 200A INFUSION PUMP
- K880681 — MINI-FILTER, VIROBAC II
- K880838 — BASSINET STAND WITH DRESSING TRAY
- K880928 — MARQUETTE MEDICAL, INC. IV EXTENSION SETS
- K880960 — NDYAG LASER TRACHEAL TUBE
- K880961 — ALCON SURGICAL PROCEDURE PACKS
- K881117 — RESUBMITTING OF HJD TOTAL HIP SYSTEM
- K881390 — NEEDLE SHIELD NEEDLE DISPOSAL UNIT
- K881396 — OPERATING ROOM TOWELS -STERILE & NON-STERILE
- K881398 — TOURNIQUET
- K881487 — OPHTHALMIC CANNULA
- K881499 — SURGILASE YAG 100 FOR GYNECOLOGY USE
- K881516 — COMPRESAID
- K881614 — MODIFIED OHMEDA PEEP VALVE (FOR GMS ABSORBER)
- K873577 — GEM-STAT, GEM-PAK 2, GEM-CHECK, GEM-CRIT CHECK
- K874202 — ACS HI-TORQUE GUIDE WIRES
- K874909 — MICRO-BUMINTEST REAGENT TABLETS
- K880237 — CHOLESTEROL
- K880421 — DESCENDING ARCH CANNULA
- K880451 — SCIMED MODELS P-7-14 AND A-19-38 HEAT EXCHANGERS
- K880478 — PREGNANCY BETA-HCG CARD & LIQUID TEST
- K880493 — MEDRAD MICROPROCESSOR CT INJECTION SYSTEM
- K880594 — VACUGUARD(TM)
- K880866 — CARBON DIOXIDE ASSAY KIT(ENZY. SINGLE) 203-10
- K880967 — MICRO CO2 APPARATUS
- K881104 — PARAMAX IRON REAGENT
- K881123 — ALLEGRO(TM) FOLLICLE STIMULATING HORMONE IMMUNO.
- K881166 — DIRECT BILIRUBIN PROCEDURE
- K881167 — IRON PROCEDURE
- K881169 — CARBON DIOXIDE REAGENT
- K881171 — PHOSPHORUS (INORGANIC)
- K881200 — CHLORIDE LIQUID STABLE REAGENT SET
- K881202 — IRON TEST
- K881204 — ACP KINETIC TEST (ACID PHOSPHATASE TEST)
- K881237 — CREATINE KINASE (CK) REAGENT SET
- K881240 — CHLORIDE REAGENT SET
- K881302 — DUODERM(R) HYDROACTIVE(R) PASTE
- K881311 — BIOTROL -GT GAMMA-GLUTAMYL TRANSFERASE (GGT) TEST
- K881395 — GAUZE AND LAP SPONGES -STERILE & NON-STERILE
- K881400 — CREATININE FOR CONTINUOUS FLOW INSTRUMENTS
- K881439 — MODIFIED UTISCREEN(TM) BACTERIAL ATP TEST SYSTEM
- K873947 — BIO-EMG MODEL 800
- K874084 — MULTIPLE ARTIFICIAL KIDNEY SYSTEMS (MAKS) #IDM
- K880209 — PERIODONTAL PROBE - AUTOPROBE
- K880391 — DACOMED CYSTOMETER
- K880700 — ENZYGNOST(R) TAT REAGENTS
- K880745 — LX-100 SLIDE STAINER
- K880753 — UMBILICAL CORD CLAMP
- K880958 — LIFEGUARD BACTERIAL AND VIRAL FILTER
- K881028 — 7.5 MHZ ENDORECTAL PROBE
- K881137 — VAPOR-PHASE HEATED WIRE CONTROLLER
- K881290 — MODIFIED SHILEY DUAL LUMEN SUBCLAVIAN CANNULA
- K881332 — DIAFLEX GRASP FORCEPS/RETRIEVAL LOOP & CYTO BRUSH
- K881500 — ORTHO* CHLAMYDIA DIRECT DETECTION (FA) TEST
- K881502 — BREWER GEL FOR CAMPYLOBACTER
- K881591 — A2J MZ 45 LASER LIGHT FOR POSITIONING
- K881699 — ACROMED WASHERS
- K870910 — PRECISION SPINAL ADJUSTER MODEL 115
- K880305 — LIFEPORT LOW PROFILE VASCULAR ACCESS PORT W/CATH.
- K880476 — LYME DISEASE ELISA
- K874573 — FRESENIUS PURISTERIL 340 (TM)
- K874684 — TC2-64B TRANSCRANIAL DOPPLER
- K874685 — TRANS-SCAN 3-D TRANSCRANIAL DOPPLER
- K874750 — VIDEO ANALYZER 4000
- K880204 — CADD-TPA(TM) MODEL 5600 AMBULATORY INFUSION PUMP
- K880217 — SSD-870 CARDIO VASCULAR PHASED ARRAY SECTOR SCANN.
- K880479 — IMED(R) GEMINI(TM) PC-1 VOLUMETRIC INFUSION PUMP
- K880592 — LASEGUIDE 600A, 600B, 400A, 400B FOR PULMONARY USE
- K880734 — SCENTED OR SCENTED DEODORIZED MENSTRUAL PADS
- K880735 — UNSCENTED MENSTRUAL PADS
- K880766 — RELIANCE METAL PRIMER
- K881105 — CULTURE COLLECTION DEVICE
- K881141 — PHARMASEAL ISOFLEX ANESTHESIA BREATHING CIRCUIT
- K881277 — PACE SYSTEM FOR NEISSERIA GONORRHOEAE ADDI. CLAIMS
- K881393 — RONDEX RESCUE MASK
- K881429 — YANKAUER SUCTION INSTRU./LAYTEX GLOVES/SUCT. CATH.
- K870088 — S-ROM SUPERCUP ACETABULAR CUP
- K870878 — EUB-305 DIAGNOSTIC ULTRASOUND DEVICE
- K873702 — REI-38 RADIOGRAPHIC TABLE
- K874739 — ELECTRIC MOBILITY'S SPARKY
- K880298 — PERIPHERAL DILATATION CATHETER
- K880310 — ANGIO DRAPE PACK ACP-010FM
- K880768 — MIC (SPECIFIC LINE) REPLACEMENT KIT
- K880981 — A2J MZ 44 B TYPE
Data sourced from openFDA. This site is unofficial and independent of the FDA.