FDA 510(k) clearances — page 948
clearances on record, most recent first.
Clearances — page 948
94,701–94,800 of 175,890- K970985 — WAKO TOTAL BILIRUBIN V
- K971005 — TRIGLYCERIDES
- K971255 — IMAGYN EXPANDABLE LAPAROSCOPIC INTRODUCER
- K971323 — ALT OR SGPT
- K971344 — AST OR SGOT
- K971363 — SYNCHRON CX SYSTEMS PHOSPHORUS REAGENT
- K955487 — GAMBRO POLYFLUX 14, 17, & 21 HEMODIALYZERS
- K961972 — MODEL AMI INFANT CENTRAL APHEA/HEART RATE MONITOR
- K963761 — QUARTET CLINICAL SYSTEM
- K963889 — QFC UMBILICAL CLAMP
- K970209 — CAPNOCHECK PLUS
- K970381 — POWERED TOOTHBRUSH
- K963305 — ALEXANDER BOX, BATTERY, RECHARGEABLE
- K964585 — RESPOSABLE OMNI TIP(TM) SWITCHABLE TIPS (MULTIPLE)
- K965035 — IMMAGE IMMUNOCHEMISTRY SYSTEM MICROALBUMIN (MA) REAGENT
- K970373 — RAICHEM RHEUMATOID FACTOR SPIA
- K970382 — VS-100 VIDEO SIGMOIDOSCOPE
- K970580 — SASI-DC1TS
- K970778 — LEAD CONTROL (WHOLE BLOOD) LEVELS 1,2,3,4
- K970834 — GRAM SWAB
- K971022 — CHASE SUCKER
- K971210 — SYNCHRON SYSTEMS 10 NG/ML & 40 NG/ML THC URINE CONTROLS
- K952905 — MINIMATIC VARIOUS IMPLANT SYSTEMS
- K960421 — SINUSCAN 102/SINUSPRINT
- K963646 — STRYKER STRYKEFLOW SUCTION IRRIGATOR GRAVITY FLOW
- K963793 — OPTIVENT
- K964151 — BARD AND BTA TEST
- K964193 — CHASE AORTIC ARCH CANNULA
- K964194 — CHASE CURVED LEFT HEART VENT CATHETER
- K964200 — CHASE MULTIPLE PERFUSION SET
- K964307 — EXPANDED REFERENCE VALUES FOR DPX BON DENSITOMETERS
- K964447 — PICC CATHETER/MIDLINE CATHETER
- K964556 — HR POLYURETHANE PICC AND MIDLINE CATHETERS
- K965113 — N-ASSAY TIA FIBRINOGEN TEST KIT
- K970099 — SIMON NITINOL FILTER/STRAIGHT LINE SYSTEM
- K970173 — MODEL 1700 TRANQUILITY BILEVEL SYSTEM
- K970224 — PIXI BONE DENSITOMETER
- K970246 — EDTA CAVIT
- K970316 — INNOVASIVE 8MM LIGAMENT FASTENER
- K970331 — CBC-4K HEMATOLOGY CONTROL
- K970439 — PROXIDERM (D-460,D 90 460,D 180,460, PS 460)
- K970495 — FOUNDATION INDIRECT COMPOSITE RESIN
- K970525 — STATNET
- K970719 — 700-MP DISPOSABLE RADIOLUCENT MULTI-PAD ELECTRODES
- K970751 — HEIDELBERG EXTERNAL FIXATOR
- K970827 — PRECISE
- K970886 — HANAULUX BLUE 80 HOSPITAL
- K970941 — SLIPPERY GLASS
- K971040 — CABLE HOLDER, SUCTION TUBE HOLDER
- K955666 — EGS4000
- K962129 — CONTINUOUS FLUSH DEVICE
- K964382 — HUMID-VENT FILTER COMPACT ANGLED (18402)/HUMID-VENT FILTER COMPACT STRAIGHT(19402)
- K970137 — EXL-12SP,12DP,15DP,20DP LINAC
- K970164 — ROLL AID
- K970289 — COMPRESSOR/NEBULIZER #3650
- K970533 — MODEL 1100 COLD THERAPY DEVICE
- K970602 — VAGINAL 2 ELECTRODE STIMULATION/EMG PROBE-SMALL
- K970755 — STEALTHSHIELD
- K970953 — E-TYPE SPEED REDUCER CONTRA ANGLE
- K971192 — IMPRA EPTFE ARTERIOVENOUS CUFFED GRAFT
- K962814 — DENVER PLEURAL EFFUSION SHUNT WITH EXTERNAL PUMP CHAMBER
- K963063 — SNORE TEC
- K963501 — HERRICK ULTIMATE PUNCTUM PLUG
- K963708 — HERRICK ULTIMATE PUNCTUM PLUG
- K964849 — ARTHROCARE DERMATOLOGIC ELECTROSURGERY SYSTEM
- K964900 — RAPID DRUG SCREEN
- K964918 — NIMA NEEDLELESS INJECTIONSITE MASTER ADAPTER WITH POSIFLOW POSITIVE DISPLACEMENT FEATURE, AND I.V. SETS
- K970133 — AMERIGEL OINTMENT
- K970194 — PROFORM CEMENTED TITANIUM REVISION FEMORAL COMPONENT
- K970203 — EPIX VT
- K970214 — 3 DIMENSIONAL VIDEO ENDOSCOPE
- K970255 — KIPP MED I.V. MANIFOLD
- K970330 — DADE INDIRECT IMT SYSTEM WITH TCO2 ELECTRODE
- K970369 — VISTA MINI CAMERA SYSTEM
- K970483 — AQUALITE INTACT PTH
- K970894 — VITROS IMMUNODIAGNOSTICS PRODUCTS TOTAL B-HCG REAGENT PACK (GEM.1075), TOTAL B-HCG CALIBRATORS (GEM.C075)
- K971120 — DISPENS-O-DISC (TM) LEVOFLOXACIN
- K971133 — URIC, UA, OR URIC ACID
- K971211 — DISPENS-O-DISC SPARFLOXACIN
- K955653 — VENISECT LASER LANCET
- K961924 — IBI-1100 STEERABLE ELECTROPHYSIOLOGY CATHETER SYSTEM
- K963030 — LEIBINGER IMF SCREW
- K964253 — DERMA 20 LASER SYSTEM
- K964261 — SMF STAINLESS STEEL BONE SCREWS
- K964867 — HYBRID RESIN COMPOSITE
- K970123 — DENTSPLY CAVITRON SPS SCALER SYSTEM
- K970128 — ISOCAM I (SINGLE HEAD GAMMA CAMERA)/ISOCAM II (DUAL HEAD GAMMA CAMERA)
- K970184 — OLYMPUS UES-20 ELECTROSURGICAL SYSTEM AND ITS ASSOCIATED ACCESSORIES
- K970272 — PATIENT RESTRAINT
- K970273 — PATIENT RESTRAINTS
- K970274 — PATIENT RESTRAINTS
- K970275 — PATIENT RESTRAINTS
- K970278 — MICROVASIVE GOLD PROBE
- K970453 — B. BRAUN MEDICAL INC. TRANSORBENT AND THINSITE BORDER DRESSING
- K970563 — OLYMPUS NA-10J-1 ASPIRATION NEEDLE
- K970911 — LEE PLATE
- K962937 — CARDIO TEAM II
- K964446 — MYELOPEROXIDASE ELISA TEST SYSTEM
- K964448 — PROTEINASE-3 IGG ELISA TEST SYSTEM
- K964449 — ANCA SCREEN ELISA TEST SYSTEM
Data sourced from openFDA. This site is unofficial and independent of the FDA.