FDA 510(k) clearances — page 959
clearances on record, most recent first.
Clearances — page 959
95,801–95,900 of 175,890- K963304 — STRYKER TEMPEST ORTHOPEDIC PUMP
- K963319 — OLYMPUS,JASMINE,JIMMY-O RAINCOAT,DRINK,ARES,APHRODIT,ZEUS,APOLLO,SELFCARE,CAREPLUS,TITAN
- K963321 — OLYMPUS,JASMINE,JIMMY-O RAINCOAT,DRINK,ARES,APHRODITE,ZEUS,APOLLO,SELFCARE,CAREPLUS,TITAN
- K963322 — OLYMPUS,JASMINE,JIMMY-O RAINCOAT,DRINK,ARES,APHRODITE,ZEUS,APOLLO,SELFCARE,CAREPLUS,TITAN
- K963339 — COHERENT ULTRAPULSE CO2 SURGICAL LASERS
- K963380 — CO 2 SMO PLUS
- K963468 — RESTRICTIVE LIMB HOLDER
- K963474 — TUXEDO VEST RESTRAINT
- K963475 — PONCHO VEST RESTRAINT
- K963476 — DISPOSABLE LIMB HOLDER
- K963480 — MULTI-PURPOSE UTILITY RESTRAINT/BODY HOLDER
- K963548 — DENTAPURE DENTAL UNIT WATER LINE FILTER-IODINATED
- K963702 — ACS HI-TORQUE IRON MAN GUIDE WIRE
- K963739 — LEIBINGER - LUHR SMALL ORTHOPEDIC BONE SCREWS
- K963937 — NORTHWEST PRECISION TECHNOLOGIES 6.5 MM CANNULATED CANNULATED CANCELLOUS SCREW
- K964191 — CALCIUM HYDROXIDE MEDICAMENT
- K964240 — BIAFINE WOUND DRESSING EMULSION
- K964246 — NOVABED PATIENT TRANSFER SYSTEM
- K964248 — HEARTPORT ENDOCORONARY SINUS CATHETR
- K964279 — SOFTRANS INTRAUTERINE PRESSURE CATHETER SYSTEM (IUP 4000 SOFTRANS IUPC)
- K964283 — AUTOPRIME
- K964285 — TETRIC CERAM
- K964380 — LC-250 INFRARED LIGHT COAGULATOR
- K964381 — AVANTA ORTHOPAEDICS TRAPEZIAL IMPLANT
- K964409 — HCL - 200 BIOCHEMISTRY ANALYZER
- K964470 — APPLIED MEDICAL CLIP APPLIER
- K964525 — PRIME & BOND 2.1 M.P. DENTIN/ENAMEL BONDING AGENT W/ACTIVATOR
- K964619 — DELIVERY SYSTEM(SDS 1400 XL)/DELIVERY SYSTEM CUSPIDOR(SDS1450,SDS1650 XL)
- K964754 — ORTHO-MUNE OKB (CD19)- MONOCLONAL ANTIBODY (MURINE) PHYCOERYTHRINE CONJUGATE
- K964921 — BASIC BIOPSY TRAY. DISPOSABLE, STERILE
- K964925 — SEALITE SCIENCES, INC. AQUALITE LH
- K965149 — A.C.T. I
- K965150 — A.C.T. IV
- K965151 — A.C.T. III
- K965152 — A.C.T. II
- K954214 — CEP X SPECTRUMORANGE\Y SPECTRUMGREEN DNA PROBE KIT
- K961508 — IMMUNOCARD H. PYLORI
- K962796 — NEUROGUARD TRANSCRANIAL DOPPLER ULTRASOUND SYSTEM
- K963500 — GLUCOMETER DEX DIABETES CARE SYSTEM
- K964574 — AFFIRM ONE-STEP PROFESSIONAL PREGNANCY TEST
- K964639 — TELEX IN-THE-EAR CUSTOM HEARING AID WITH THRESHOLD COMPRESSION-II
- K964748 — ELECSYS PROLACTIN ASSAY
- K964995 — SAS ONE-STEP PREGNANCY
- K960685 — ORTHODOC PREOPERATIVE PLANNER MODEL 500
- K961275 — SIRIUS 10, 10L, 40, 40L
- K961636 — MEDILOG VISION
- K961638 — MEDILOG MPA-S
- K961642 — MEDILOG MR95
- K962075 — HSW GMBH ARTHROSCOPE
- K962153 — DIGITAL IMAGE ANALYSIS SYSTEM
- K962175 — PORTEX ADJUSTABLE FLANGE TRACHEOSTOMY TUBE
- K962404 — SIEMENS SC 6000 & SC 6000 P PORTABLE BEDSIDE MONITORING SYSTEM
- K962648 — OHMEDA MODEL 5330 ANESTHETIC AGENT MONITOR
- K963535 — SIGMA DIAGNOSTICS GLUCOSE REAGENT
- K963695 — IMMULITE ANTI-TPO-AB(LKTOI,LKT05,LKTOZ
- K963872 — FEMRX MORCELLATOR SYSTEM
- K964304 — OSTEONICS SPINAL SYSTEM-TOPLOADING TRANSVERSE CONNECTOR ASSEMBLY
- K964306 — MAGNETIC RESONANCE DIAGNOSTIC ACCESSORY
- K964327 — IPU RX-2
- K964330 — BIOHORIZONS DENTAL IMPLANT SYSTEM (NAME SUBJECT TO CHANGE)
- K964430 — PULPDENT SNOOP
- K964548 — APEX UNIVERSAL DRIVE SYSTEM
- K964583 — XRT-7.0
- K964586 — PRESCOTT'S LIGHT SOURCE MODEL NO. II-150
- K964772 — AQUARIUS HPF (WILL BE SOLD AS WILLIAMS CLASSIC VISIONS)
- K964816 — AUDINA 153 BEHIND THE EAR AND AUDINA 158 BEHIND THE EAR
- K964856 — CD3 FITC/CD19 R-PE/CD45 TRI-COLOR MONOCLONAL ANTIBODY COMBINATION
- K965013 — DIGISCOPE RX-2 (9 OPTION)
- K965126 — AST/SGOT
- K965157 — CEDIA DAU MULTI-DRUG CONTROL CEDIA DAU SPECIALTY CONTROL SET 1
- K950099 — SYNERGY(TM) TI POSTERIOR SPINAL SYSTEM
- K960508 — PATHWAY ELECTROMYOGRAPH MODEL PATHWAY II/MR-10/MR-15/MR-20/MR-25
- K962632 — OMNIPULSE/OMNIPULSE-MAX
- K963930 — CTS MIDCAB/SVH BIPOLAR SCISSORS
- K964258 — INSTRUMENTS FOR ENDOSCOPIC SUBFASCIAL DISCISION OF PERFORATING VINS ESDP, MODEL 8781
- K964350 — MODULA OPTIONS FOR SEVERE BONE LOSS AND TRAUMA
- K964362 — KINAMED PROFIX SYSTEM
- K964581 — SOFSILK
- K964601 — CUSA SYSTEM 200C ULTRASONIC ASPIRATOR/CUSA SYSTEM 200T ULTRASONIC ASPIRATOR/CUSA LAP ACCESSORY
- K964848 — WALLACE ARTIFICIAL INSEMINATION CATHETER - 8CM/18CM
- K964527 — N RHEUMATOLOGY STANDARD SL
- K964560 — BHI W/VANCOMYCIN AGAR
- K964991 — 700-FR SERIES RADIOLUCENT STIMULATION ELECTRODES
- K943230 — MAYO HIP PROSTHESIS
- K962144 — PHOENIX ETE TISSUE EXTENSION SYSTEM
- K962220 — HEATED WIRE CIRCUITS FOR SCT 3000 HEATED HUMIDIFIER
- K962223 — WATER CHAMBERS FOR ST 3000 HEATED HUMIDIFIER
- K963424 — OLYMPUS LIPASE REAGENT
- K964154 — SEGUE INFUSION CATHETER
- K964227 — METAL ACETABULAR COMPONENT
- K964249 — BRIDGE LONG STEM FEMORAL COMPONENT
- K964275 — ALPHA POSTERIOR SPINAL SYSTEM
- K960511 — GIBECK WARMBAG REUSABLE CONVECTIVE WARMING BLANKET
- K961883 — VERSA-CATH ARTERIAL CATHETER
- K962179 — STAT IM 5000 CASSETTE AUTOCLAVE
- K962438 — MISTY OX TURBOHEATER
- K962455 — FOUR-CHANNEL PREAMPLIFIER
- K962457 — TWO-CHANNEL PREAMPLIFIER
- K962458 — CADWELL FOUR-/EIGHT-CHANNEL PREAMPLIFIER
- K962873 — CEP 12 SPECTRUMORANGE DIRECT LABELED CHROMOSOME ENUMERATION DNA PROBE
Data sourced from openFDA. This site is unofficial and independent of the FDA.