FDA 510(k) clearances — page 949
clearances on record, most recent first.
Clearances — page 949
94,801–94,900 of 176,637- K970590 — N/A
- K970592 — N/A
- K970785 — SIMS HYPERINFLATION BAG SYSTEM
- K970959 — INSTANT FLOW VAVLE (FLOWMETER, POLE, RAIL, WALL MOUNT)
- K970964 — MAESTRO DIGITAL IMAGE AND PATIENT RECORD STORAGE SYSTEM
- K970970 — CARDIOMATCH
- K970983 — PERITONEAL/CARDIAC CATHETER
- K971001 — AUTIMO
- K971054 — OSTEO CT FOR THE SOMATOM AR FAMILY AND PLUS 4 CT SYSTEMS
- K971074 — THERAPAX SXT 150
- K971087 — SUNGLASSES (FRAME,CELLULOSE PROPINATE, LENS, ACRYLIC)
- K971115 — GE MEDICAL-NEEDLE GUIDE FOR SV, TR ANDATF, ACUSON-NEEDLE GUIDE
- K971158 — DUALINE 400 CIC
- K971186 — AMO DIPLOMAX/OPSYS CONSOLE
- K971230 — SHERWOOD MEDICAL COMPANY , KANGAROO, ENTRISTAR, PERCUTANEOUS GASTROSTOMY KIT
- K971253 — VARIOUS ARTHROSCOPES, ENDOSCOPIC BLADES, MANUAL INSTRUMENTS
- K971274 — C.A.T.S CONTINUOUS AUTOTRANSFUSION SYSTEM, AT1 AUTOTRANSFUSION SET, PSQ SET
- K971399 — AURIS AE, AURIS TL, AURIS HS, AURIS AC, AURIS MM, AURIS COE, AURIS CIC
- K971707 — SUNGLASSES (NON-PRESCRIPTION)
- K971805 — ELECTROSURGICAL TIP CLEANER, TIP CLEANING PAD, LECTROBRASIVE TIP CLEANER, ELECTROSURGICAL TIP CLEANER, ELECTRODE TIP CLE
- K971875 — OPTIM-EYES 450
- K960724 — BIO-GIDE RESORBABLE BILAYER MEMBRANE
- K961711 — ASPISAFE GASTRIC TUBE
- K963612 — DURATION STABILIZED UHMWPE
- K963653 — WALLACH QUANTUM 2000 ELECTROSURGICAL SYSTEM
- K964842 — IMMAGE IMMUNOCHEMISTRY SYSTEM COMPLEMENTC3 (C3) AND COMPLEMENTC4 (C4) REAGENT
- K965173 — DURATION STABILIZED UHMWPE KNEE COMPONENTS
- K970177 — ANTI-CARDIOLIPIN ANTIBODY (ACA) SCREEN ELISA
- K970934 — CB ERBIUM/2.94(TM) ER:YAG LASER
- K970955 — ACROMED ANTERIOR CERVICAL STABILIZATION SYSTEM
- K971061 — OPPORTUNITY INC. BONE MARROW BIOPSY AND ASPIRATION TRAY
- K971248 — KANEDA SR ANTERIOR SPINAL SYSTEM
- K971334 — PILLING WECK SECONDARY FLEXIBLE SLEEVE WITH TROCAR
- K971444 — 3M RED DOT 2234 & 2266 RADIOLUCENT MONITORING ELECTRODES
- K971505 — SYNCHRON SYSTEMS CHOLESTEROL (CHOL) REAGENT
- K971674 — VALLEYLAB SINGLE USE SOLID LAPAROSCOPIC ELEC. SPATULA (STRAIGHT & CURVED) J&L HOOK, BALL CONMED SOLID SHAFT ELECTRODE ST
- K971713 — N-ACETYLPROCAINAMIDE ASSAY FOR THE BAYER IMMUNO 1 SYSTEM
- K971817 — OLYMPUS CK-MB REAGENT
- K971886 — ACCUTEST HCG-URINE
- K971954 — LIQUICHEK URINE CHEMISTRY CONTROL (CAT.NO. 397,398)
- K952172 — HOTMAN
- K963717 — MILLEX - MP FILTER UNIT (SLMPO25SS/SLMPL25SS)
- K964679 — WHITE RIVER AUTOMATIC BREAST PUMP
- K970528 — CLYDE CORONARY GUIDEWIRE
- K970917 — SOLOS 10MM OPERATING LAPAROSCOPE
- K970946 — MEDLINE Y-TYPE TUR/BLADDER IRRIGATION SET
- K970954 — O.B. APPLICATOR TAMPONS
- K971468 — SCAR HEAL
- K971887 — BREATH TAKER
- K964005 — SYNERGETICS SYNERLIGHT FIBER OPTIC LIGHTSOURCE
- K964805 — BIO-ANCHOR
- K970896 — MITEK 3.5 MM PANALOK WEDGE ABSORBABLE SUTURE ANCHOR SYSTEM
- K970929 — DEPUY LOW PROFILE BONE SCREW
- K971062 — OPPORTUNITY INC. GENERAL PURPOSE TRAY
- K971064 — BAYERS BIMANUAL I/A HANDPIECES
- K954142 — STERRADD STERILIZATION SYSTEM
- K963748 — BIO-PLEXUS DROP-IT NEEDLE HOLDER
- K964042 — EXTRESAFE PHLEBOTOMY
- K964396 — DOUBLE UP BREAST PUMP
- K964634 — ANOKRYO
- K970324 — GSI SA60 DPOAE SYSTEM
- K970376 — PTCA GUIDEWIRE
- K970735 — BOEHRINGER MANNHEIM DIRECT HDL-CHOLESTEROL
- K970868 — MODEL HNC NEUROVASCULAR ARRAY COIL
- K970880 — POWER D, TRU 5, PERSONA, PERSONA CHOICE, MERIDIAN
- K970939 — VISTA V-38 CIC
- K971016 — MRP-7000/AIRIS QD C-SPINE COIL (P/N MR-QCSC-42,MR-QCSC-52)
- K971080 — MAICO MA52
- K971143 — NEURO PULSE II,III
- K971240 — ALEXANDER MANUFACTURING CO. RECHARGEABLE BATTERY PART NUMBER M006
- K971244 — PROVOX 2 VOICE PROSTHESIS SYSTEM
- K971299 — SCIENTIFIC PLASTICS MODEL SP
- K971303 — INSTEAD, SOFTCUP
- K971361 — AQ OPIATES (MORPHINE) TEST
- K971382 — PRONE BREAST POSITIONING BOARD, MODEL #37-018
- K971535 — WIDEX SENSO DIGITAL (MINI CANAL)
- K971693 — RIONET HB-79P
- K971701 — CONTINU-FLO SOLUTION SET
- K971804 — PHILIPS S1694, S1695
- K963064 — ANO-RECTAL MANOMETRY OPTION, MODEL NUMBER UDS-ARM
- K964067 — GORE IRRIGATION SET
- K965180 — STRAIGHTFIRE REUSABLE OPTICAL FIBERS (400,600,800,1000)
- K970153 — LAMIN-2 HYDRATING GEL
- K970816 — GLARE WARE
- K970843 — INTERGARD WOVEN COLLAGEN COATED VASCULAR PROSTHESES
- K970846 — 22.2/+4MM CO CR & ZIRCONIA FEMORAL HEAD
- K970852 — MAGNETOM PROJECT 024 SYSTEM (NUMARIS 3.5 SOFTWARE)
- K971099 — ALEXANDER MANUFACTURING CO. RECHARGEABLE BATTERY PART NUMBER MS5169
- K971107 — ALEXANDER MANUFACTURING CO. RECHARGEABLE BATTERY PART NUMBER STR5
- K971135 — MAGELLAN INTRAMEDULLARY FEMORAL NAIL SYSTEM
- K971235 — ALEXANDER MANUFACTURING CO. RECHARGEABLE BATTERY PART NUMBER GL625-W
- K971272 — TRAUMA-FIX EXTERNAL FIXATOR
- K963018 — BIO-RAD SERUM PROTEINS BY CAPILLARY ELECTROPHORESIS
- K964660 — PARAMAX CHOLESTEROL REAGENT
- K965062 — SIEMENS SC9000/SC9015 MULTIGAS AND MULTIGAS+ MODULES
- K965137 — FOGARTY VALVULOTOME MODEL 700091
- K970339 — TRI AUTO ZX
- K970386 — ACS ESTADIOL-6 II
- K970497 — PACE 101H
- K970506 — HILUX 200,250,275,300,350,500 DENTAL CURING LIGHT
Data sourced from openFDA. This site is unofficial and independent of the FDA.