FDA 510(k) clearances — page 858
clearances on record, most recent first.
Clearances — page 858
85,701–85,800 of 175,890- K992349 — VITROS IMMUNODIAGNOSTIC PRODUCTS TROPONIN I RANGE VERIFIERS
- K992477 — ROTOSNARE
- K992608 — ATC OPTION FOR EVITA 2 DURA AND EVITA 4
- K992663 — ALOKA SSD-5500 DIAGNOSTIC ULTRASOUND SYSTEM
- K992672 — BELMONT FLUID MANAGEMENT SYSTEM (FMS2000)
- K980244 — AEQUALIS SHOULDER PROSTHESIS
- K991007 — K-DEFIB/PACE RADIOLUCENT ADULT ELECTRODE, MODEL KRT-60
- K991254 — QS DELIVERY SYSTEM
- K991559 — MEDLINE PROHIBIT SERIES SURGICAL MASK WITH FLUID SHIELD
- K991896 — MG ATC: ATTENUATION CORRECTION SYSTEM FOR DUAL-HEAD VARIABLE-ANGLE GAMMA CAMERA
- K991943 — MRGP OPTICAL TRACKING UNIT
- K992104 — PARSET, MODEL A10001E
- K992107 — BALDUR BRAND VINYL POWDERED EXAMINATION GLOVES
- K992123 — SCIMED IMPULSE ANGIOGRAPHIC CATHETERS
- K992299 — HEALTH-PLUS, SANITEX, RELIANCE PRE-POWDERED NITRILE EXAMINATION GLOVE
- K992470 — ULTRAMARK 400C/SONOACE 6000 ULTRASOUND SYSTEM
- K992644 — SIDEXIS DIGITAL RADIOGRAPHY IMAGING SYSTEM
- DEN990005 — THE 3PM EGG MACHINE
- K990236 — MODIFICATION OF JELCO*,JELCO*-W AND JELCO* PLUS I.V. CATHETERS, CATHLON* I.V. CATHETERS, OPTIVA* I.V. CATHETERS, PROTECT
- K991083 — RLP CHOLESTEROL IMMUNOSEPARATION ASSAY
- K991312 — SOOTHE & SMOOTH SCAR CARE - SILICONE SHEETING
- K991570 — JOBST READY-TO-WEAR ARM SLEEVES
- K991830 — CAPSULAR SHRINKAGE ELECTRODE
- K991909 — DELTON FS WITH FLUORIDE PIT & FISSURE SEALANT
- K991932 — INTRAVASCULAR ADMINISTRATION SET
- K991985 — COOK HIGH VOLUME INFUSION ADAPTER INTRAVASCULAR ADMINISTRATION SET
- K992132 — CHOLESITE TEST SYSTEM
- K992158 — LACTOSORB SHEETS
- K992361 — PALL SURGICLEAR LAPAROSCOPIC SMOKE FILTRATION SYSTEM, MODEL CLSF1
- K992441 — ADVANTA GRAFT
- K992443 — ADVANTA GRAFT
- K992620 — BLULAZE
- K983886 — POCKIT HSV 2 RAPID TEST
- K984338 — JOSTRA HL-20 TWIN PUMP
- K990230 — ELECTRO-NERVE STIMULATOR TENS, MODEL LX
- K990630 — SAS ADENO TEST
- K991119 — TILT/RECLINER FOR POWER WHEELCHAIRS, MODEL 2G
- K991664 — LDL CHOLESTEROL, PRODUCT NO'S, 124-01, CH102-01
- K991735 — MAC SERIES ELECTROCARDIOGRAPHS INCLUDING MAC 5000, MAC PC, MAC 6, MAC VU, MAC 8 ELECTROCARDIOGRAPHS
- K991739 — COROMETRICS 120 SERIES MATERNAL/FETAL MONITOR
- K991819 — MAGNATEK 30
- K991828 — STREP B OIA
- K991892 — TRUSTEX MINT FLAVORED CONDOM IN GREEN COLOR, IMPULSE MINT FLAVORED CONDOM IN GREEN COLOR
- K991941 — EBI XFIX DFS RAIL SYSTEM
- K992032 — ACRY ISLAND BORDER DRESSING, MODELS 2031, 2032, 2033
- K992081 — VARIOUS ANSELL TRADENAMES OR PRIVATE LABEL
- K992086 — OLYMPUS SERUM PROTEIN MULTICALIBRATOR 2
- K992149 — GEIGER ELECTROSURGICAL HANDPIECE SHEATH, MODEL 405
- K992313 — XL TEK EVOKED POTENTIAL HEADBOX, MODEL EP-16
- K992324 — FUNNEL TROCAR
- K992413 — ESCORT 100/300 SERIES B (ESCORT II) PATIENT MONITOR
- K992490 — B2C HIP SYSTEM
- K992506 — MINI 6800 DIGITAL MOBILE C-ARM
- K992508 — TSX PROBE, OCULAR CONTACT PROBE;TSX PROBE,OCULAR CONTACT PROBE,SMA
- K992541 — LAPAROCAM
- K990565 — SUZANNE
- K991273 — SWEMED FOLLICLE ASPIRATION SET, DOUBLE LUMEN, SINGLE LUMEN, AND LUER NEEDLE
- K991283 — DYNA TORQ TORQUE WRENCH, TORQUE WRENCH
- K991585 — BIPOLAR SHOULDER PROSTHESIS
- K991719 — EPISTAR/EPISTAR CSE SPINAL/EPIDURAL ANESTHESIA ADMINISTRATION SETS
- K991769 — CUTANEOUS (BAR) ELECTRODE
- K991770 — CUTANEOUS (GROUND) ELECTRODE
- K991771 — DIGITAL RING ELECTRDE
- K991772 — CUTANEOUS (DISC) ELECTRODE
- K991875 — K-L-W INTRAORAL DISTRACTOR
- K992114 — KSEA CALCUSPLIT
- K992118 — PRODIGY 4 TRANSLUCENT SHADES
- K992160 — NEXUS 2
- K992327 — DUTECK DIGITAL CLINICAL THERMOMETER
- K992391 — UROSURGE SPIRALFLO URETERAL STENT
- K992411 — ESCORT II+ 400 SERIES (ESCORT PRISM) MONITOR
- K992446 — DAILIES (NELFILCON A) ONE-DAY
- K992500 — CANTOR & SILVER 5X PROSTHETIC TINTED (HIOXIFILCON A) SOFT DAILY WEAR CONTACT LENS
- K990359 — KONICA DIRECT DIGITIZER, MODEL DD-341
- K991693 — TWO RIVERS POWER LIFT/RECLINE CHAIR
- K991753 — MAXIM REMOVABLE MOLDED POLY TIBIA
- K991764 — SOMATOM PROJECT 10-CT SCANNERS
- K991785 — MANUAL JET VENTILATOR (WITH REGULATOR AND GAUGE), MANUAL JET VENTILATOR (WITHOUT REGULATOR AND GAUGE), MODELS BE 183-SUR
- K991873 — KMI WRIST FUSION SYSTEM
- K991980 — MAMMOTOME HH HAND-HELD PROBE, VACUUM SET, CONTROL MODULE, HH HAND-HELD HOLSTER AND CABLES, SOFTWARE PACKAGE, FOOTSWITCH,
- K992006 — NEUROVIEW INSTRUMENT HOLDER, MODEL 300-33
- K992152 — GENERAL PURPOSE TRANSDUCER STANDOFF, BIOPSY TRANSDUCER STANDOFF, BI-PLANE ENDOCAVITY TRANSDUCER STANDOFF
- K992200 — TEXTURED POWDER-FREE LATEX EXAMINATION GLOVES WITH ALOE VERA GREEN, CONTAINS 50 MCGM OR LESS OF TOTAL WATER EXTRACTABLE
- K992337 — BLOSSOM POWDER FREE LATEX EXAMINATION GLOVES WITH PROTEIN CONTENT LABELING CLAIM 50 MCGM OR LESS OF TOTAL WATER EXTRACTA
- K992412 — IPASS BOLUS TRACKING
- K992515 — EBI XFIX DFS OPTIROM ELBOW FIXATOR
- K983298 — BUFFALO FILTER VIROSAFE ERBIUM:YAG FILTER - #VSEYAG1-4 BUFFALO FILTER VIROSAFE ERBIUM:YAG PREFILTER - #BFEYAG04PF
- K992048 — MODIFICATION OF PROMPT L-POP
- K992339 — COLORSOFT PROSTHETIC TINTED SOFT CONTACT LENS
- K982860 — UM-L20/ UM-L30
- K983577 — ARTHREX MENISCAL DART SYSTEM
- K984546 — BIOLOGIC-DT MACHINE, MODEL DT-1000 AND BIOLOGIC-DT TREATMENT KIT, MODEL DT-1000-TK
- K990178 — BURNFREE PAIN RELIEVING GEL, MODEL 4B
- K990179 — BURNFREE 1/8 OZ. STERILE PAIN RELIEVING GEL, MODEL SD
- K990180 — BURNFREE (4X4, 8X8, 16X24) STERILE BURN & WOUND DRESSING
- K990651 — SKIN 2 FORTE SILICONE SHEETING
- K990724 — CONWAY STUART MODEL 100 IRRIGATION PUMP & ACCESSORIES
- K991427 — PARAMED PARAFFIN WARMER
- K991685 — HALOLITE AAD SYSTEM WITH DEDICATED COMPRESSOR
- K991721 — EBI OMEGA 21 SYSTEM
Data sourced from openFDA. This site is unofficial and independent of the FDA.