FDA 510(k) clearances — page 894
clearances on record, most recent first.
Clearances — page 894
89,301–89,400 of 175,890- 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
- K981892 — QUICK & SURE ONESTEP HOME PREGNANCY TEST
- K981905 — STERILE SALINE SOLUTION 0.9%- CATALOG NO, 10290, STERILE WATER- CATALOG NO. 10291
- K981948 — APOLLO 95E
- K981953 — VARIOUS TRADE TAMPONS SOLD UNDER PRIVATE LABELS
- K981962 — CUDA PRODUCTS CORP. MODEL M300 (M-300) LIGHTSOURCE
- K982004 — CT CORONARY ARTERY CALCIFICATION SCORING (CACS) OPTION FOR ADVANTAGE WINDOWS
- K982087 — ROCHE CRP T CONTROL N
- K982251 — SIGMA DIAGNOSTICS INFINITY URIC ACID REAGENT KIT
- K982263 — MB/BACT BLOOD CULTURE BOTTLE
- K982267 — DPX-RX BONE DENSITOMETER
- K982327 — INFRAMETRICS INFRACAM-MED
- K982377 — OPC LOWWEAR PORCELAIN
- K982395 — DYTRACT FLOW RESTORATIVE
- K982551 — ROCHE C0BAS INTEGRA SERUM BARBITURATES REAGENT CASSETTE, ABUSCREEB ONLINE SERUM BARBITURATES CALIBRATORS, ROCHE COBAS IN
- K982632 — ENVOY AND VISTA BRITE TIP
- K982770 — 6F ENVOY GUIDING CATHETER
- K971434 — A.M.T. G-TUBE BALLOON REPLACEMENT GASTROSTOMY FEEDING DEVICE
- K980083 — 3I ORTHODONTIC ABUTMENT, ORTHOBUTMENT
- K981792 — SOLUTION ADMINISTRATION SET
- K964437 — GB-1002 TENS WITH MASSAGE
- K974535 — DISCAM DIGITAL IMAGING SYSTEM
- K980876 — ASTHMA MONITOR AM2
- K981155 — FLAPMAKER DISPOSABLE MICROKERATOME
- K981761 — SYSMEX KX-21, AUTOMATED HEMATOLOGY ANALYZER
- K981809 — CAROLINE GUIDE
- K981966 — NOSEBLEED NOSECLIP
- K982057 — BC 900 SLIT LAMP
- K982239 — CIRCUIT GUARD
- K982342 — DINAMAP MPS SELECT PORTABLE MONITOR
- K980174 — DUREX COLORS AND SCENTS
- K980888 — GLYCACOR
- K981244 — BW-1 (CODE NAME RD-0807)
- K981257 — JELFINE-52 (CODE NAME RD-0901)
- K981364 — PYRILINKS-D ASSAY KIT
- K981541 — CLEARSTAR ENTERAL NUTRITION PUMP
- K981751 — SINUSCOPE AND ACCESSORIES
- K982150 — EL-ANA PROFILES: EL-ENA/4
- K982229 — BI-DENT
- K982292 — PREALBUMIN CALIBRATOR
- K982622 — EL-ANA PROFILES: EL-ENA/5
- K973426 — ANS 2000 ECG MONITOR AND RESPIRATION PACER
- K980287 — SIEMENS SC9000/SC9015 TCP02/C02 MODULE
- K980600 — D903 AVANT ADULT HOLLOW FIBER OXYGENATOR
- K981284 — BETTER-BLADDER (BB)
- K981478 — ACS:CENTAUR CEA
- K981703 — KSEA UNIMAT 45
- K981782 — LOW PROFILE PORT ATTACHABLE CATHETER WITH BLUE FLEX TIP / 8FR. INRODUCER KIT IMPLANTABLE VASCULAR ACCESS SYSTEM
Data sourced from openFDA. This site is unofficial and independent of the FDA.