FDA 510(k) clearances — page 935
clearances on record, most recent first.
Clearances — page 935
93,401–93,500 of 175,890- K970812 — PM 2002 CC PROLINE
- K971673 — 40 CC SUMO
- K971684 — MAGNETOM PROJECT 047 SYSTEM (NUMARIS 3.5 SOFTWARE)
- K971731 — UNIGLOVES
- K971747 — AMPLAID 460
- K972042 — PARI PEP THERAPY SYSTEM
- K972233 — STRYKER WEDGE INTERFERENCE SCREW SYSTEM
- K972755 — V-12 LONG LIFE 675 HEARING AID
- K970508 — ECHO VIEW/SHIMASONIC DIAGNOSTIC ULTRASOUND SYSTEM
- K972167 — PLASMA CATECHOLAMINE KIT
- K972459 — RHINOCELL NASAL PACKINGS
- K972492 — BELL PROSTHESIS (PARTIAL)
- K972526 — METHADONE EIA ASSAY
- K972585 — AERIAL PROSTHESIS, AERIAL PROSTHESIS, MODEL DUSSELDORF, DRESDEN AERIAL PROSTHESIS, AERIAL PROSTHESIS, MODEL TUBINGEN
- K972608 — RANDOX ASSAYED SPECIFIC PROTEIN CONTROL
- K961050 — RELIEFBAND TENS UNIT (MODIFICATION)
- K964292 — N-ASSAY TIA APO A1 TEST KIT
- K964294 — N-ASSAY TIA APO A1/B MULTI CALIBRATOR
- K964296 — N-ASSAY TIA APO B TEST KIT
- K965187 — SPECTRUM II, SPECTRUM PLUS, AND SPECTRUM MAX-SD
- K970048 — SYNTHES(USA)TITANIUM LOCKING PLATE SYSTEM(TILPS)
- K970401 — MEDI-DYNE GUIDING CATHETER
- K970561 — GRAFT PATCH
- K970664 — GLUCOSE REAGENT
- K970669 — AEROQUIP SAFESTART IV CATHETER
- K970926 — DOUBLE LUMEN PICC
- K971043 — GOLDEN EAGLE
- K971050 — GOLDEN HAWK
- K971309 — UREA
- K971645 — REGANES SPINAL NEEDLE (VARIOUS)
- K971814 — IMPROVEMENTS TO THE MEHL RUBY LASER
- K971933 — PORT-NEB
- K971950 — INFINITECH MULTI-SPOT SLIT LAMP LASER ADAPTER
- K971992 — UROMED ALTERNATIVE BLADDER CONTROL CONTINENCE DEVICE(ABCPN-0026)
- K972105 — PHONAK EPICA
- K972160 — CRP-LEX SYSTEM: C-REACTIVE PROTEIN ANTIGEN DETECTION IN SERUM: SLIDE AGGLUTNATION LATEX TEST
- K972180 — DRIED GRAM-NEGATIVE MIC/COMBO PANELS
- K972239 — ELITE H-D VINYL POLYSILOXANE IMPRESSION MATERIALS .PUTTY SOFT/NORMAL SETTING /PUTTY SOFT/FAST SETTING
- K972331 — INNOFLUOR GENTAMICIN ASSAY SYSTEM
- K972682 — QUICKSTICK ONE STEP HCG PREGNANCY TEST
- K972756 — MODIFICATION OF EST CULTURE SYSTEM II - MYCO
- K963512 — BENZ B17 (KOLFOCON A) RIGID GAS PERMEABLE (HYDROPHOBIC DAILY WEAR CONTACT LENS (CLEAR AND TINTED, LATHE-CUT FROM LENS BL
- K963744 — BENZ B36 (KOLFOCON B) RIGID GAS PERMEABLE (HYDROPHOBIC) DAILY WEAR CONTACT LENS (TINTED, LATHE-CUT FROM LENS BLANK)
- K964092 — TMS COMFORT SERIES NASAL CPAP MASK
- K965001 — INTUITIVE SURGICAL MONARCH LAPAROSCOPIC MANIPULATOR
- K970207 — MEDI-TECH 5 FRENCH NIGHTHAWK SELECTIVE ANGIOGRAPHIC CATHETERS
- K970470 — EVT EXPANDABLE SHEATH
- K970644 — AEROQUIP SAFESTART (TM) IV CATH (TM) SYSTEM
- K971617 — ENDOSCOPIC VENTRICULAR CATHETER
- K971770 — APOLLO KNEE FEMORAL SPACERS
- K971832 — IVALON PVA SURGICAL SPEAR, IVALON EYE DRAIN, 80CC, IVALON EYE DRAIN, 400CC, IVALON EYE WICK
- K971996 — MEDIVISION ARTHROSCOP
- K972100 — VENTED EXTERNAL MALE URINARY CATHETER(VENTED CATH 5000)
- K972153 — ALTERNATING PRESSURE AIR FLOTATION MATTRESS
- K972237 — HAND HELD MEDISPACER
- K972550 — AUDIFON H24 AGC/AUDIFON H25 AGC/AUDIFON H30 AGC
- K972590 — NEVADA EYEWORKS, LUIGI LANATTA SUNGLASSES
- K972794 — DIGOXIN DG-II FPIA REAGENT SET
- K955668 — INTRACAVITY NEEDLE GUIDE KIT
- K963780 — DUAL ROD ANTERIOR FIXATOR SYSTEM
- K964282 — TINA-QUANT FERRITIN ASSAY
- K970793 — IMPLANTABLE CLIP
- K971721 — WHITESIDE BIOMECHANICS, INC. ZIRCONIA CERAMIC FEMORAL HEAD
- K971723 — FASTAK SUTURE ANCHOR (11.7MM)/(7.5MM)
- K971752 — ZIRCONIA CERAMIC FEMORAL HEAD (12/14 TAPER)
- K971791 — VAGINAL SUTURING KIT FOR LAPAROTOMY BLADDER NECK SUSPENSION
- K971800 — OSTEO CANNULATED SCREW SYSTEM
- K971802 — VAGINAL SUTURING KIT FOR BLADDER NECK SUSPENSION
- K971854 — OSTEOLOCK ACETABULAR SHELL SYSTEM
- K972024 — CODA AUTOMATED EIA ANALYZER
- K972056 — STANDARD ENDOSCOPE
- K972097 — PHONAK MICROZOOM P 2
- K972132 — SIGMA DIAGNOSTICS VALPROIC ACID FPIA REAGENT SET, SIGMA DIAGNOSTICS VALPROIC ACID FPIA CALIBRATORS
- K972552 — AUDIFON H20 PC/AUDIFON H32 PP
- K963195 — WIRELESS EEG RECORDING SYSTEM MODEL W32
- K964886 — GE LOGIQ 700 DIAGNOSTIC ULTRASOUND SYSTEM
- K970384 — VELOS CONSTANCY CHECK DEVICE, MODEL 55-145
- K970566 — ARGLAES FILM DRESSING
- K970920 — SIEMENS SC9000/SC9015 BEDSIDE MONITORING SYSTEM
- K971009 — SCAR CARE
- K971181 — THE MIDVIEW-MEDCON'S DICOM VIEWER
- K971571 — RM3 RENAL PRESERVATION SYSTEM--CONTROL UNIT
- K971597 — COMFEEL PURILON GEL,15G(3900)/COMFEEL PURILON GEL,25G(3903)
- K971671 — HEIDELBERG RETINA ANGIOGRAPH FA/ICGA (HRA/C)
- K971687 — HEMODIALYSIS VENOUS BLOOD TUBING SET OR SIMILAR TRADE NAME
- K971734 — VG 200 VIDEO GASTROSCOPE
- K971764 — WELCON HUE-VU URINARY DRAINAGE BAG
- K971782 — BONE AND MARROW COLLECTION SYSTEM KIT
- K971916 — MEDICAL Z, S.A. MEDIGEL Z SCAR MANAGEMENT GEL
- K972069 — STRYKER INTERPULSE HANDPIECE SET, SPLASH SHIELDS, IRRIGATION AND SUCTION TIPS, RECHARGEABLE BATTERY PACK
- K972126 — MYRINGOTOMY TUBE
- K972177 — POWDERED NITRILE EXAMINATION GLOVE, BLUE OR WHITE (NON-COLORED)
- K972195 — POWDER-FREE NITRILE EXAMINATION GLOVE, BLUE OR WHITE (NON-COLORED)
- K972252 — VISTA UNIVERSAL HANDPIECE
- K972253 — P3 UNIVERSAL PHACO HANDPIECE
- K972266 — GALLINI COAXIAL INTRODUCER
- K972272 — LASER PERIPHERALS HOLMIUM BARE FIBERS
- K972336 — DERMAMEND HYDROGEL GAUZE DRESSING
- K972373 — OVATION HDP
- K972672 — BRACHYSTEPPER STEPPING UNIT, BRACHYSTEPPER NEEDLE GUIDE TEMPLATE, BRACHYSTAND SUPPORT AND MANUAL ADJUSTMENT ACCESSORY
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