FDA 510(k) clearances — page 901
clearances on record, most recent first.
Clearances — page 901
90,001–90,100 of 176,637- 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
- K982460 — VIVACAP HR
- K982461 — GLASIONOMER CEMENT CX PLUS
- K982537 — TOKUYAMA SOFRELINER
- K982587 — MPS FIXED FLOW RATE SET
- K982615 — AIRDENT RADIANCE CURING LIGHT
- K982730 — SC 7000 & SC 9000 XL INFINITY MODULAR BEDSIDE MONITOR
- K972587 — ELECTROCARDIOGRAPHS
- K974269 — SA8800 DIAGNOSTIC ULTRASOUND SYSTEM AND TRANSDUCERS,
- K980238 — GYNEX EXTENDED REACH NEEDLE
- K980885 — SHIELD ACTIVATED FACTOR XII (ELISA) ASSAY
- K980976 — AMEDA DISPOSABLE VACUUM ASSIST CUP WITH FLUID RETENTION TRAP
- K981028 — ULTRA IMAGE AND ULTRA SCAN
- K981120 — ZEUS SCIENTIFIC INC., ANTI-EBV EA IGG ELISA
- K981238 — BIPOLAR FEMORAL HEAD
- K981451 — ARGOMEDICAL BIPOLAR SYSTEM
- K981498 — IS-TOXOPLASMA IGG TEST SYSTEM
- K981568 — MASCOT MD HEMATOLOGY ANALYZER, MODEL MD 800
- K981993 — OLYMPUS INTEGRATED ENDOSURGERY SYSTEM ENDOALPHA
- K981998 — PEDIATRIC INSTATRAK SYSTEM
- K982238 — BINAX NOW LEGIONELLA URINARY ANTIGEN TEST MODEL 852-020 AND BINAX NOW LEG IONELLA URINARY ANTIGEN CONTROL KIT MODEL 8522
- K982336 — KUSCHALL DESIGN K3/K4 SERIES OF MANUAL WHEELCHAIRS
- K982409 — VES 1501-M
- K982628 — MEDWORKS INSEMINATION CATHETER
- K982638 — 3M TEGAGEN HI ALGINATE DRESSING & 3 M TEGAGEN HG ALGINATE DRESSING, MODEL #'S 90110,90112,90114,90120, 90210,90212,90214
- K982845 — CARDIAC MARKERS CONTROL (SINGLE USE)-LEVELS, 1,2,3, MODELS NUMBER 175-1, 175-2, 175-3
- K980390 — PTA BALLOON CATHETER
- K980411 — NPB3900 SERIES PATIENT MONITORS
- K980619 — SABRATEK PATIENT HOME MANAGEMENT SYSTEM
- K980995 — PLAQ-ATAQ-I
- K981636 — INTEGRATED DRIVE/PUMP SYSTEM
- K981747 — BIOTRANS PRESSURE MONITORING KIT MODEL NUMBER BT XXXXXX
- K981870 — VISAGE COSMETIC SURGERY SYSTEM
- K981939 — AUTOCORR PLUS; 3404 OXIMETER/ECG MONITOR
- K981969 — ULTIMA BODY POSITION SENSOR
- K982112 — THERMATREK IRIS-3 INFRARED IMAGING SYSTEM
- K982597 — FIBRCOL PLUS COLLAGEN WOUND DRESSING WITH ALGINATE
- K982626 — URETHROPEXY SUTURE PLACEMENT KIT MODEL NUMBERS UM-300, MW-100, MINI-LAPAROTOMY MMK KIT MODEL UM-250, LAPAROSCOPIC BURCH0
- K982755 — MODIFICATION OF AUTOTRANSFUSION APPARATUS (AUTOLOG)
- K963271 — FUTREX-6100/XL
- K980884 — SIEMENS SEVOFLURANE VAPORIZER SV 953
- K981130 — KSEA ENDO TIP SYSTEM
- K981807 — CARDIOVISION SOFTWARE, MODEL S-CV5-96
- K982289 — HEAT PROBE UNIT HPU-20, HEAT PROBE CD-110##/120##
- K982383 — PLATEX GENTLE GLIDE, SILK GLIDE, SLIMFITS, SOFT COMFORT AND PORTABLES TAMPONS
- K982469 — HICHEM CHOLESTEROL REAGENT KIT
- K982608 — SANGUI BIOTECH, INC. ACTH (ADRENOCORTICOTROPIC HORMONE) ELISA KIT
- K980109 — CYCLOTECH CYCLOSPORINE ORAL SOLUTIONS DISPENSER
- K980588 — CLARUS ENDOSCOPIC DISCECTOMY SYSTEM SITETRAC MODEL 6000
- K980916 — POWDER-FREE LATEX EXAMINATION GLOVES WITH PROTEIN LABELING CLAIM
- K981788 — SCIMED 6 FRENCH WISEGUIDE GUIDE CATHETER
- K981846 — PARENCHYMAL BOLT PRESSURE MONITORING KIT
- K981854 — OLYMPUS SERUM PROTEIN MULTICALIBRATOR,
- K981890 — SYNTHES (USA) [SYNTHES] MMFS - 2.0 MM SAGITTAL SPLIT PLATES
Data sourced from openFDA. This site is unofficial and independent of the FDA.