FDA 510(k) clearances — page 893
clearances on record, most recent first.
Clearances — page 893
89,201–89,300 of 175,890- K980883 — N-ASSAY GLU-UL
- K981639 — SYSTEM U3 FOR CIPROFLOXACIN
- K981644 — BINDAZYME ANTIGLIADIN IGG
- K981929 — BINDAZYME ANTIGLIADIN IGG/IGA COMBI KIT
- K981973 — SAFE-T-FILL CAPILLARY BLOOD COLLECTION SYSTEM
- K981981 — ELECTROSURGICAL UNIT (ESU) (115 VOLT) MODEL 4810, ELECTROSURGICAL UNIT (ESU) (230 VOLT) MODEL 4811, INSTRUMENT CABLE, 19
- K981994 — VASCATH OPTI-FLOW LONG TERM DUAL LUMEN HEMODIALYSIS CATHETER
- K982089 — ACCU-CHEK ADVANTAGE TEST STRIPS AND ACCU-CHEK ADVANTAGE H TEST STRIPS
- K982491 — SANGUI BIOTECH, INC. CALCITONIN ELISA KIT
- K982709 — MODIFICATION TO PROSPECT CRYPTOSPORIDIUM MICROTITER ASSAY
- K974062 — MEDSCI 3% GLUTARALDEHYDE
- K974770 — ACQPLAN
- K980686 — AESCULAP HILAN MOTOR SYSTEM
- K981032 — PIV SYSTEM
- K981970 — ALGETRAL, CAVEX CHROMATIC, CA 37 SUPERIOR PINK, CA 37 FAST SET, CAVEX RAINBOW, CAVEX IMPRESSIONAL NORMAL SETTING, CAVEXI
- K982002 — ACCU-CHEK COMFORT CURVE TEST STRIP
- K982005 — WALLSTENT TRANSHEPATIC BILIARY ENDOPROSTHESIS
- K982044 — NUCAMMA R+
- K982045 — NUCAMMA RX
- K982050 — MODEL MS-2 HANDPIECE
- K982060 — VOLUMAX CT IMAGING SYSTEM
- K982157 — TREX MRI MAGNETIC RESONANCE DIAGNOSTIC DEVICE
- K982578 — QUANTI-TEST SYSTEM
- K982613 — OMNI PRO LATEX SURGICAL GLOVE, POWDERED
- K982645 — PYRAMID
- K982706 — PHILIPS BV300 SERIES RELEASE 2.1
- K982774 — SOFT (HYDROPHILIC) CONTACT LENSES
- K980721 — SULLIVAN AUTOSET
- K980762 — PALL STAT-PRIME D BLOOD FILTER FOR EXTRACORPOREAL SERVICE
- K981168 — COMPLETE BRAND MULTI-PURPOSE SOLUTION, COMPLETE BRAND LUBRICATING AND REWETTING DROPS
- K981952 — COMBINATION ND:YAG AND FREQUENCY DOUBLED SOLID STATE GREEN LASER
- K982193 — ESOPHAGEAL STETHOSCOPE
- K982345 — VASCO SCANNING BEAM DIGITAL X-RAY SYSTEM
- K982501 — ELECTROLYTE BUFFER A443-325, ELECTROLYTE REFERENCE REAGENT A443-315, CO2 ACID REAGENT A443-330, CO2 ALKALINE BUFFER A44
- K982904 — ESSTECH MULTI ASPHERIC (MULTIFOCAL) (HIOXIFILCON B) SOFT (HYDROPHILIC) CONTACT LENS
- K964977 — IVOC- INTEGRATED VOICE OPERATED CONTROL UNIT (IVOC-1)
- K973649 — HEMOSITE TEST SYSTEM
- K980489 — VAPAMASTA 6
- K981066 — FUKUDA DENSHI: CARDIOMAX, MODEL FX-4010 MULTI CHANNEL ELECTROCARDIOGRAPH
- K981934 — THE BAGNOLI-4 EMG SYSTEM
- K982066 — MP-3 POWER BASE CHAIR
- K982068 — HOWMEDICA TITANIUM HOFFMANN FIXATION PIN SYSTEM
- K982141 — ARROW 5FX60CM BALLOON EMBOLECTOMY CATHETER, MODEL # EM-56025
- K982155 — SHORT STRAIGHT-IN BONE SCREW FIXATION SYSTEM
- K982158 — SCOUT
- K982248 — HOWMEDICA ASYMMETRIC STEM VITALOCK CLUSTER & SPIKED SHELLS, AND ACETABULAR SHELLS WITH MESH INGROWTH SURFACE WITH PERI-A
- K982347 — DEPUY ACE TIMAX PILON PLATE
- K982607 — MANUAL WHEELCHAIR
- K982677 — UNI/MONOPOLAR HF CABLE
- K982900 — PHANTOM SOFTHREAD SOFT TISSUE INTERFERENCE SCREW
- K981011 — POS-T-VAC (REJOYN VACUUM ERECTION DEVICE)
- K981180 — REJOYN CONSTRICTION RING KIT, POS-T-VAC B-100 RING KIT, POS-T-VAC B-25 RING KIT AND POS-T-VAC B-10 RING KIT
- K981653 — AMY
- K981916 — LIGASURE VESSEL SEALING SYSTEM
- K982079 — ACCU-CHECK VOICEMATE
- K982740 — CORDIS WEBSTER PREFACE BRAIDED GUIDING SHEATH & PERRY EXCHANGE DILATOR, MODEL #'S 301-803A, 301-803P, 301-803M, 301-813S
- K982908 — MODIFICATION TO EBI SPINELINK SYSTEM
- K972689 — CAOW HEMOSTASIS SYSTEM
- K973943 — INSTRUMENTS FOR ENDOSCOPIC SUBFASCIAL HARVESTING OF VEINS (ESHV), INSTRUMENTS FOR ENDOSCOPIC SUBFASCIAL DISCISION OF PER
- K974090 — 95 C/1.5 CITRIC ACID HEAT PROCESSING OF POLYSULFONE DIALYZERS
- K980550 — WHISTLE WATCH
- K980831 — IMAGE POST-PROCESSING TECHNIQUES
- K981041 — SLT BIPOLAR SHEATH
- K981696 — IL TEST PLASMIN INHIBITOR
- K981705 — 'RAPID DRUG SCREEN' 8 PANEL-LOW VOLUME
- K982366 — QUANTA LITE TTG (TISSUE TRANSGLUTAMINASE) ELISA
- K982594 — ENDO-SCRUB/ENDO-SCRUB 2
- K980468 — AU5 ULTRASOUND IMAGING SYSTEM
- K981329 — FETH-R-KATH
- K981897 — ROCHE COBAS INTEGRA ALKALINE PHOSPHATASE IFCC LIQUID REAGENT CASSETTE, ROCHE COBAS INTEGRA PANCREATIC A-AMYLASE EPS REAE
- K982265 — AQUILION CT SCANNER, MODEL TSX-101A
- K982378 — HEMSOL-ACID CONCENTRATE LIQUID HEMOGRAN ACID CONCENTRATE POWDER, NEPHROSOL-ACETATE CONCENTRATE POWDER, BICARBOSOL-BICARE
- K982707 — EC6 PLETHYSMOGRAPH
- K973593 — BRIDGE SENTRY BEDSIDE UNIT, BRIDGE SENTRY ADMINISTRATION SET-STANDARD CONFIGURATION, BRIDGE SENTRY ADMINISTRATION SET 5
- K973735 — MICROVIT MT-100
- K973751 — MT-200
- K974220 — MICROMEDICAL 12 LEAD SIMULTANEOUS CABLE
- K981742 — ONE UP DISPOSABLE KERATOME HEAD
- K981801 — ACCUSIGN TCA, BIOSIGN TCA, STAUS DS TCA
- K981931 — CEDIA RED BLOOD CELL FOLATE REAGENT PACK, CEDIA FOLATE ASSAY AND ELECSYS FOLATE ASSAY
- K981989 — THE WAVE DIGITAL PHACO SYSTEM
- K982061 — STC COCAINE METABOLITE MICRO-PLATE EIA (ORASURE DEVICE)
- K982429 — ZSTATFLU TEST FOR INFLUENZA TYPES A AND B VIRUSES
- K982442 — C-TRAK AUTOMATIC ANALYZER (NAME CHANGE FROM ONCOPROBE II TO C-TRAK)
- K982880 — DIMENSION(R) VALPROIC (VALP) ACID METHOD
- K961903 — MAGELLAN
- K980559 — PEGASUS ND:YAG LASER SYSTEM
- K980725 — EXHALATION VALVE (BE 30-115-B, NS 30-115-U, NS 30-115-5, PS 54-A)
- K980786 — COBE CLOSED VENOUS RESERVOIR BAGS WITH SMARX T, MODELS VRB 1200 AND VRB 1800
- K981272 — ADDIQUIP DISPOSABLE ACUPUNCTURE NEEDLES
- K981910 — SUCTION CATHETER
- K981923 — THE SNORE PEACE
- K981937 — WELCH ALLYN REVEAL INTRAORAL CAMERA SYSTEM
- K981944 — BREATHERITE
- K981971 — TBIRD VS/AVS VOLUME VENTILATOR, MODELS 15568, 15570 , LP10 VOLUME VENTILATOR WITH PRESSURE LIMIT MODEL 00-004130, BEAR 3
- K982367 — REACH HIP COMPONENT
- K982369 — CONVERTORS, SPUNBONDED, FLASHSPUN POLYOLEFIN GOWNS
- K982420 — MITEK MICRO ANCHOR
- K982456 — AMALCAP PLUS
- K982458 — VIVALLOY HR
Data sourced from openFDA. This site is unofficial and independent of the FDA.