FDA 510(k) clearances — page 1600
clearances on record, most recent first.
Clearances — page 1600
159,901–160,000 of 175,890- K822313 — PROCEDURE #430 & REAGENTS FOR ACETAMIN
- K822350 — SWAN-GANZ FLOW-DIRECTED THERMODIL. CATH
- K822378 — TENS ELECTRODE
- K822388 — LIFE TRACE 14
- K827796 — INNOSCAN EXAMINATION LIGHT
- K827815 — SONOLINE 6000
- K827816 — PODIATRY X-RAY UNIT
- K827858 — MODEL 835 SPOT FILM DEVICE
- K827890 — FOLDALITE UNIT
- K820811 — PROXIMATE DISPOSABLE SKIN STAPLERS
- K821713 — POROCOAT LOW PROFILE METAL BACKED CUP
- K821714 — POROCOAT STANDARD METAL BACKED CUP
- K821819 — PIGTAIL STENTS
- K822098 — BT 794-BLOOD/FLUID WARMER
- K822105 — LENS EASY ON
- K822166 — MICROSURGICAL EAR HOOK
- K822167 — STILL ENDOSCOPIC CAMERAS
- K822169 — SURGICAL HEAD SUPPORT
- K822175 — ADAPTOR FOR FIBEROPTIC LIGHT SOURCE
- K822180 — RIGID FIBEROPTIC ENDOSCOPES
- K822191 — HEAD MIRROR WITH HEADBAND
- K822192 — FIBEROPTIC LIGHT CARRIERS
- K822203 — KNIFE HANDLE
- K822254 — ELECTRIC CORD FOR ENDOSCOPE
- K822295 — SURGI TEK'S DISPOS. INNER CANNULA FOR
- K822305 — ORTHO-LEVEL
- K822311 — DISPOSABLE COLLECTION BOTTLE W/TUBING
- K822321 — IOI 32 TM FEMORAL COMPONENT
- K822356 — MODULAIDE EMERG. CARDIAC LIFE SUPP. KT
- K822379 — DISPOSABLE ANESTHESIA BREATHING CIRCUIT
- K827818 — DOPPLER FLOW METER, LASER
- K821065 — DATASCOPE 10.5 FRENCH INTRA-AORTIC BAL
- K821258 — SELOPOR
- K821532 — PERIGUARD PERICARDIAL PATCH
- K821987 — EARETTE HEARING AID OPTICON MODEL E28P
- K822001 — FRI ALIT DENTAL IMPLANT -TUBING
- K822040 — POWERED EMERGENCY VENTILATOR
- K822062 — BALL TIP COAGULATING ELECTRODES
- K822069 — ELIMINATOR #BPS 201 BIPOLAR ELECTRO
- K822070 — ELITE #MPS 101 ELECTROSURGICAL SWITCH
- K822072 — MPI ELECTROSURGICAL CAPACTIVE DISPER
- K822084 — PRO-SPEC
- K822151 — SURGICAL INSTRUMENTS REPRESENT. 4 CLASS
- K822247 — CATH-SEAL
- K822301 — ROYAL 1 OXYGEN CONCENTRATOR
- K822320 — KAMPNER FEMORAL COMPONENT
- K822387 — BEHIND-THE-EAR MODEL SERIES 123
- K821511 — POWERED MUSCLE STIMULATOR
- K821555 — EXACON THERMOMETER SYSTEM 8000
- K821556 — EXACON TEMP. PROBES SYSTEM 8000-#TH-103
- K821765 — PHOTOTHERAPY EYE PROTECTION FOR INFANTS
- K821823 — I.V. SENTINEL
- K821930 — SECHRIST MODEL 990 JET VENTILATOR
- K821936 — CRITIKON OXYGEN MONITOR, MODEL 8030
- K821982 — TITAN GEL SERUM CONTROL
- K821997 — MEDI + BIO SAFE STEAM STERILIZ. INDICAT
- K822032 — LARGE VOLUME CLOSED WOUND SUCTION DRAIN
- K822049 — LUNDIA 10-5 N PARALLEL FLOW DIALYZER
- K822065 — KAM SUCKER
- K822083 — U-100 INSULIN SYRINGE
- K822094 — DENTAL MATRIX BAND
- K822116 — ANESTHESIA BREATHING BAG, VARIOUS SIZES
- K822136 — LASER BRONCHOSCOPE
- K822162 — MYRINGOTOMY KNIFE (VARIOUS TYPES)
- K822165 — ENT CHISELS
- K822168 — ANTRUM TROCARS
- K822176 — MICROSURGICAL EAR PICKS
- K822183 — MOUTH GAGS
- K822184 — ENT METAL TONGUE DEPRESSORS
- K822189 — BECKMAN ADENOID CURRETTE
- K822190 — ENT ELEVATORS
- K822197 — NEEDLE HOLDERS
- K822206 — TOTAL IGE DISCS
- K822211 — STERILE HD PAN SET
- K822216 — VOLUMETRIC CONTROLLER
- K822224 — EMPI SINGLE USE
- K822225 — ERIKA NEGAT. PRESSURE ARTER. BLOOD LINE
- K822226 — ERIKA NEGATIVE PRESSURE VENOUS BLOOD LIN
- K822227 — IMMO PHASE FSH RADIOIMMUNOASSAY
- K822232 — ACA URINARY PROTEIN CALIBRATOR
- K822237 — UREA NITROGEN REAGENT SET (MOD. BERTHEL
- K822263 — VARIOUS TYPES OF TONSILS HEMOSTATS
- K822266 — NAGASHIMA KN-52 SACCADE & PURSUIT STIM
- K822270 — VARIOUS TYPES OF ENT ELEVATORS
- K822308 — VANCOMYCIN FLUORESCENT IMMUNOASSAY
- K822332 — C-REACTIVE PROTEIN TEST KIT
- K822352 — HEMATOXYLIN STAIN SOLUTION
- K822361 — DIANEAL SOLUTION EXCHANGE DEVICE #5C4193
- K827503 — SONOLINE 1000, 8008 AND 8080
- K827573 — DIASONICS CARDIO/IMAGING ECHOSCOPE
- K827662 — AUTO-TECH GENERATOR
- K827663 — SINUSON 810 ULTRASOUND SCANNER
- K827712 — LIGHT PEN ACCESSORY FOR USE WITH FETASCAN 800 SERIES
- K827718 — UNKNOWN
- K827748 — THYRO-COUNT THYROID UPTAKE SYSTEM 90IZD PROBE
- K827792 — SIREMOBILE 3
- K821685 — TOM'S NATURALLY WAXED FLOSSING TAPE
- K821752 — SYNTHOGRAFT LG-AUGMENTATION & BONE FILL
- K821849 — EBV-VCA ANTIBODY ASSAY KIT
- K821991 — DANAVOS CUSTOM EAR
Data sourced from openFDA. This site is unofficial and independent of the FDA.