FDA 510(k) clearances — page 947
clearances on record, most recent first.
Clearances — page 947
94,601–94,700 of 175,890- K971141 — FT4 METHOD FOR THE DIMENSION RXL CLINICAL CHEMISTRY SYSTEM
- K971142 — ADVENTURER
- K941514 — VENTANA ANTI-S100 PRIMARY ANTIBODY
- K953982 — SIMPLEX TENS
- K954204 — DRAGER INCUBATOR 8000 IC
- K962930 — SPACELABS MEDICAL ECG ANALYSIS SYSTEM
- K964715 — PARAMAX SALICYLATE REAGENT
- K964762 — IMMAGE IMMUNOCHEMISTRY SYSTEM CERULOPLASMIN (CER) REAGENT
- K964766 — IMMAGE IMMUNOCHEMISTRY SYSTEM ALPHA-1-ANTITRYPSIN (AAT)
- K970180 — VSA 3000 VIBRATORYN SENSORY ANALYZER
- K970303 — SATURNE MULTILEAF COLLIMATOR
- K970317 — MODIFIED E-PACK PROCEDURE KIT
- K970334 — NATURE'S CRADLE
- K970380 — F.A.S.T. 1 INTRAOSSEOUS INFUSION SYSTEM
- K970593 — UNIVERSAL REAGENT FACTOR VIII DEFICIENT PLASMA
- K970607 — UNIVERSAL REAGENT FACTOR VII DEFICIENT PLASMA
- K970820 — ETEST SPARFLOXACIN
- K971122 — ACCULINE PREGNANCY TEST
- K960764 — SAFE-CATH
- K962882 — SONOLINE VERSA PRO DIAGNOSTIC ULTRASOUND SYSTEM
- K962936 — IMMULITE TOXOPLASMA QUANTITATIVE IGG
- K963886 — EVS
- K963989 — P.D. ACCESS (PERCUTANEOUS DOPPLER) VASCULAR ACCESS DEVICE
- K963991 — FSI LAPAROSCOPIC PROBE FOR ALL FSI ULE-OVERCLAD FF201 FIBERS
- K963996 — (FSI) LAPAROSCOPIC PROBE FOR ALL FSI ULE FF101 FIBERS. MODEL FSI FF101-LP-XXX, WHERE XXX = FIBER DIAMETERS 100, 200, 400
- K965183 — VANTAGE PERIPHERAL DILATATION CATHETER
- K970288 — CLINICAL DIAGNOSTIC SOFTWARE
- K970291 — ACCESSORIES TO THE STEREOTACTIC BODY FRAM
- K970299 — JUPITER PTA CATHETERS (VARIOUS)
- K970392 — CORDIS AVANTI+CATHETER SHEATH INTRODUCER SYSTEM
- K970519 — UNITRON MODEL SOUND F/X PROGRAMMABLE ITE (SF/X PROGRAMMABLE)
- K970574 — ACUPUNCTURE NEEDLES
- K970697 — OSTEONICS NORMALIZED AD ACETABULAR COMPONENT SYSTEM
- K970832 — PYR SWAB
- K970931 — COPALIS TORC TOTAL ANTIBODY ASSAY
- K962087 — SERVOTRONIC EC100 SYSTEM
- K963223 — EZ-CIRC
- K964152 — UNICAP TOTAL IGE ASSAY/PHARMACIA TOTAL IGE CONTROLS LMH
- K964288 — CALL-RAD PC TELERADIOLOGY
- K964377 — THERMAL REGULATION SYSTEM BLANKET
- K964393 — CHASE RETROGRADE CARDIOPLEGIA CANNULA
- K964756 — PROSTATIC ACID PHOSPHATASE REAGENT TEST/PROSTATIC ACID PHOSPHATASE REAGENT KIT
- K964956 — E-Z SPACER MASK (SMALL)
- K965139 — SURGICAL MICROSCOPE NAVIGATOR (SMN) SYSTEM/SURGICAL TOOL NAVIGATOR (STN) SYSTEM
- K970033 — MONARCH IOL DELIVERY SYSTEM
- K970266 — KENDALL HYDROPHILIC POWDER WOUND DRESSING
- K970292 — IN-FAST BONE SCREW SYSTEM/IN-FAST BONE SCREW INSERTER/IN-FAST BONE SCREW
- K970341 — MEDTRONIC PS MEDICAL RIVAS VASCULAR CATHETER REPAIR KIT
- K970631 — PUNCTUAL OCCLUDER
- K970930 — BILATERAL INFANT CLEFT PALATE ORTHODONTIC APPLIANCE
- K970949 — SMITH & NEPHEW MIS INSTRUMENTS
- K970969 — KENDALL CURITY SUPRAPUBIC CATHETER TRAY, KIT, & REPLACEMENT SET
- K971014 — LIFESCAN SURESTEP PRO GLUCOSE CONTROL/LINEARITY SOLUTIONS
- K971071 — LIQUID LIGAND 1,2,3
- K971092 — QA-ES
- K941170 — VENTANA ANTI-MELANOMA PRIMARY ANTIBODY
- K960553 — CARD GUARD MODEL CG-900
- K962571 — COAGUCHEK PST SYSTEM
- K963593 — IMT LOUPE-COLPOSCOPE
- K963731 — TRU-5000 THERMAL RECOVERY RADIANT HEATING UNIT
- K963844 — HYDRAGEL 15 HB A1C KIT
- K963850 — PLEUR-EVAC SAHARA PLUS MODEL S-1150 CONTINUOUS REINFUSION AUTOTRANSFUSION SYSTEM
- K964309 — SONOS 2000, SONOS 2500 (M2406 A)
- K964365 — RESECTOSCOPE CUTTING LOOP ELECTRODE
- K964440 — EUDERMIC HYPOALLERGENIC SURGICAL GLOVES/EUDERMIC SURGICAL GLOVES (VARIOUS)
- K964596 — PROSELECT 3 PERIDONTAL THERAPY SYSTEM
- K964742 — RONIX II ROTARY ULTRASONIC SURGICAL SYSTEM
- K965095 — NITRA-TOUCH POWDER-FREE NITRILE MEDICAL EXAMINATION GLOVE
- K970144 — VINYL EXAM GLOVE POWERED
- K970307 — MINNOVA PELVIC FLOOR STIMULATION SYSTEM
- K970350 — EQUI-PISE 1000 MRS
- K970394 — OSTEONICS NORMALIZED AD-HA ACETABULAR COMPONENT SYSTEM
- K970524 — SAFE-CONNECT I.V. EXTENSION SET
- K970764 — COMEG ENDOSCOPY RESECTOSCOPE ACCESSORIES
- K970966 — COMFORT CATH CHOICE MALE EXTERNAL CATHETER
- K941707 — ANTI-MUSCLE ACTIN PRIMARY ANTIBODY
- K951640 — HUMAN PROTEIN S RID TEST KIT
- K963589 — VAIL 3000 BED ENCLOSURE
- K963863 — JANUS I
- K964254 — TITANIUM LIBERTY POSTERIOR SPINAL SYSTEM
- K964281 — AESCULAP ANGLED NEUROENDOSCOPES
- K964898 — IN THE EAR HEARING AID
- K965033 — IMMAGE IMMUNOCHEMISTRY SYSTEM ALPHA-1-MICROGLOBULIN (AI) REAGENT
- K970090 — SOLO-SLED
- K970201 — GSI CANNULA WITH INTRODUCER
- K970205 — VITALLIUM 2000 ALLOY; VITALLIUM 2000 PLUS ALLOY; COBALT CHROME CASTING ALLOY
- K970284 — ARTOS, DIPLOS SYSTEM
- K970314 — SYNCHRON LX SYSTEMS APOLIPOPROTEIN (APOA AND APOB) REAGENTS
- K970328 — ULTRACELL NEURO SPONGES
- K970416 — ACUFEX DOUBLE ARMED SUTURE NEEDLE
- K970422 — RIGHT ANGLE LASER FIBERS;OPTILASE ND:YAG LASER;OPTILASE PL100 ND LASER SYSTEMS
- K970485 — SMARTSITE ACCESS PIN
- K970608 — EVT MARKER BOARD
- K970616 — MINI SAMPLER PROCESSOR
- K970617 — CT-MODELLER SYSTEM
- K970734 — SIREGRAGH T.O.P. 33 AND SIREGRAPH T.O.P. 40 UNIVERSAL FLUOROSCOPIC X-RAY SYSTEMS
- K970754 — INNERDYNE STEP TROCAR EXPANABLE PORT, OPEN STEP
- K970781 — LIQUID GLUCOSE (OXIDASE) REAGENT SET
- K970867 — URIC ACID REAGENT
- K970897 — BTI DISTAL FEMORAL INTRAMEDULLARY ROD SYSTEM
Data sourced from openFDA. This site is unofficial and independent of the FDA.