FDA 510(k) clearances — page 889
clearances on record, most recent first.
Clearances — page 889
88,801–88,900 of 175,890- K982281 — SERAQUEST RUBELLA IGM
- K982497 — ARTHROTEK INTERFERENCE SCREW
- K982499 — COSMO PLUS WITH NICO, MODEL 8200
- K982508 — FLEXIMA
- K982530 — SULLIVAN MIRAGE FULL FACE MASK
- K982531 — HOWMEDICA LEIBINGER RESORBABLE FIXATION SYSTEM
- K982621 — QUICKSCREEN AT HOME DRUG TEST, MODEL 9149/9150
- K982786 — TRACCELL 2000 SLIDE MAPPING SYSTEM
- K982866 — NICHOLS ADVANTAGE CHEMILUMINESCENCE THYROID PEROXIDASE AUTOANTIBODIES IMMUNOASSAY, MODEL # 62-701521
- K982917 — B-SYSTEM SILICONE
- K982999 — GREINER MINICOLLECT EDTA BLOOD COLLECTION TUBE
- K983002 — MYSTIQUE ULTRASONIC NEBULIZER
- K983409 — V-CATH PICC (PERIPHERALLY INSERTED CENTRAL CATHETER) SEE APPENDIX 1
- K981360 — VINYL PATIENT EXAMINATION GLOVE, POWDERED
- K981565 — BIOCLEAR CONCENTRATE
- K981888 — SMOKE-EVAC
- K982209 — ACCUCLOT THROMBIN TIME REAGENT MODEL A8713/A4589
- K982220 — MODEL 2872 BIPOLAR LEAD ADAPTOR KIT
- K982492 — IMCOR DENTAL IMPLANT SYSTEM ACCESSORIES
- K982606 — AUROFLUID CPF
- K982658 — KSEA ENDOSCOPES FOR DENTAL PROCEDURES
- K982680 — CHIRON DIAGNOSTICS CORPORATION ACS: CENTAUR BR IMMUNOASSAY
- K982772 — SIGNA PROFILE QUADRATURE THORACIC/LUMBAR SPINE PHASED ARRAY COIL
- K982785 — FILM DIGITIZER MODEL 2905
- K982872 — TG MEDICAL POWDER-FREE LATEX EXAMINATION GLOVE PROTEIN LABELING CLAIM (50 MICROGRAMS OR LESS)
- K982879 — SHIELD DIASTAT ANTI-B2 GLYCOPROTEIN 1 IGG (ELISA) ASSAY
- K983391 — IMMULITE 2000 OM-MA MODEL L2KOP2
- K973198 — VGF-7 VASCULAR GRAFT FLOWMETER
- K974713 — BARD HYDROPHILLIC COATED GUIDE WIRE
- K981119 — CARDIOPAL MODEL NUMBER PM20
- K981697 — CAMBRIDGE HEART CH 2000 CARDIAC DIAGNOSTIC SYSTEM
- K981744 — COMBINATION TOA WITH NASAL MASK HOLDER AND UNIVERSAL NASAL MASK HOLDER
- K982470 — ECG ELECTRODES APRON
- K982479 — EXCEL AMBULATORY EEG
- K982487 — CPT, INC. METEOR HAND HELD RESPIRATORY MECHANICS MONITOR METEOR 100, CPT, INC. METEOR HAND HELD RESPIRATORY MECHANICS MO
- K982935 — SYNCHRON SYSTEMS DIGOXIN (DIGN) REAGENT, SYNCHRON SYSTEMS DRUG CALIBRATOR
- K974890 — ACUTEK'S HYDROCOLLOID WOUND DRESSING, TIB 997002
- K974892 — ACUTEK'S HYDROCOLLOID WOUND DRESSING, TIB 197012
- K980820 — PHILIPS EASYGUIDE
- K981634 — BIOCIRCUITS IOS PROSTATE SPECIFIC ANTIGEN (PSA) TEST CARTRIDGES, BIOCIRCUITS IOS PSA CONTROLS
- K981645 — TITANIUM HEMOSTATIC CLIP
- K981709 — COAGULATION FACTOR V DEFICIENT PLASMA
- K981841 — BREATHE EASY, MODELS AD AND CD
- K982688 — SPECTRUM DESIGNS PRE-FORM CONTOUR SILICONE CARVING BLOCK
- K982871 — DRUG CALIBRATOR II
- K982939 — BTF THIN FILM WOUND DRESSING
- K982982 — MINI-FIXATOR FOR COLLES FRACTURES
- K983056 — INNOVASIVE TIBIAL FASTENER
- K983175 — EXTRA-CARE POWDER-FREE EXAMINATION GLOVE
- K981323 — COMPAT MINI-G REPLACEMENT GASTROSTOMY TUBE
- K981591 — VORTEK URETERAL DOUBLE LOOP STENT, BIOSOFT URETERAL DOUBLE LOOP STENT
- K981597 — RADIONICS SLICE EDITOR IMAGING SOFTWARE UTILITY
- K982412 — MODIFICATION OF CRIT-LINE MONITOR III (CLM III)
- K982428 — CHRISTOUDIAS GAUZE DISSECTOR (LAPAROSCOPIC HAND INSTRUMENT)
- K982441 — CCA-220
- K982687 — DISPOSABLE VINYL EXAM GLOVES, POWDERED
- K982691 — MULTI-COMFORT POWDERED EXAMINATION GLOVES WITH PROTEIN CONTENT LABELING CLAIM (200 MICROGRAMS OR LESS)
- K982814 — MEDRAD VISTRON CT INJECTOR SYSTEM
- K982895 — STERNOMEGA COMPOMER CEMENT
- K983162 — PERI-GUARD, CV PERI-GUARD, OCU-GUARD, SUPPLE PERI-GUARD, PERI-STRIPS - SLEEVE, PERI-STRIPS-STRIPS, PERI-STRIPS DRY, VASC
- K983211 — CENTAURI
- K983327 — ACTIVE ECG ELECTRODES MAGNETOM VISION SYSTEMS
- K983387 — ONTRAK TESTCUP AND TESTSTIK CONTROLS
- K983492 — BOEHRINGER MANNHEIM ELECSYS PRESICONTROL CARDIAC
- K973410 — ULTRACAM
- K980585 — MILLENNIUM
- K981521 — AIA-PACK TPOAB ASSAY
- K981522 — AIA-PACK TGAB ASSAY
- K982436 — RELIEFBAND NST DEVICE, MODEL #'S WB-2, WB-6 AND WB-R
- K982484 — EBI VUECATH ENDOSCOPIC SPINAL SYSTEM
- K982547 — STERITEC CROSS-CHECKS EO GAS STERILIZATION INTEGRATOR
- K982590 — TEMPBOND CLEAR-2
- K982732 — SYNTHES (USA) DISTAL RADIUS PLATE SYSTEM (DRPS)
- K982820 — BARCO MEDIS 5MP 5 MEGAPIXEL MEDICAL DIAGNOSTIC DISPLAY SYSTEM
- K983222 — PHASED ARRAY CERVICAL SPINE COIL, MODEL #125GE-64
- K972960 — HEALTH CHECK URI-TEST PROTEIN IN URINE
- K974248 — WATCHCHILD OBSTERICAL PATIENT DATA MANAGEMENT SYSTEM
- K974854 — HYDRAGEL-MINI LIPO KIT-PN 4093, HYDRAGEL LIPO KIT-PN 4007, HYDRAGEL LIPO MAXI KIT-PN 4207
- K980186 — ZYMED TELEMETRY SYSTEM
- K980953 — ACCU-BITE HOME KIT DISCLUDER
- K981048 — HYDRAGEL 6 CSF KIT
- K981084 — URISCREEN
- K982389 — ODC B2 BIPOLAR CUP
- K982406 — COBE VACUUM RELIEF CHECK VALVE
- K982417 — INNERDYNE STEP TROCAR EXPANDABLE PORT, STEP
- K982425 — CODA MPX30 MOTION ANALYSIS SYSTEM
- K982603 — QUANTA LITE CHROMATIN ELISA
- K982659 — MEDIVISION HYSTEROSCOPE
- K982679 — MULTIQUANT (R) QUANTITATIVE MYOGLOBIN TEST
- K973970 — SPO2 FINGER PROBES
- K980906 — TRANSONIC HEMODIALYSIS MONITOR, CARDIAC OUTPUT, MODEL HD01-CO
- K981024 — QT DISPERSION AND T WAVE ANALYSIS PROGRAM (QT GUARD ANALYSIS SYSTEM)
- K982196 — DIGITAL RADIOGRAPHIC IMAGING SYSTEM
- K982245 — TRIAGE,PARASITE PANEL, TRIAGE CRYPTOSPORIDIUM AND ENTAMOEBA HISTOLYTICA, TRIAGE CRYPTOSPORIDIUM AND GIARDIA LAMBLIA
- K982387 — E.CAM EXTRA HIGH ENERGY COLLIMATOR
- K982444 — 7250 ULTRASOUND IMAGING SYSTEM
- K982563 — ULTRAPRO MODEL 98
- K982564 — DELTON FS DIRECT DELIVERY SYSTEM
- K982631 — PHILIPS TOMOSCAN CS
- K982683 — TELEX SELECT 1-40 WITH ADAPTIVE COMPRESSION
Data sourced from openFDA. This site is unofficial and independent of the FDA.