FDA 510(k) clearances — page 878
clearances on record, most recent first.
Clearances — page 878
87,701–87,800 of 176,637- K982145 — MEGA 3
- K984213 — NEARLY ME RETOUCH SILICONE SCAR REDUCTION SHEETS
- K990332 — DUMEX IODOFORM PACKING STRIP
- K990361 — HEADED BIO-ABSORBABLE CORKSCREW MODEL #AR-1921BU
- K990414 — SMITH & NEPHEW HANDPORT SYSTEM
- K990417 — DERMACOOL
- K990594 — INTEGRA REAGENT CASSETTE FOR APOLIPOPROTEIN A-1
- K990595 — INTEGRA REAGENT CASSETTE FOR APOLIPOPROTEIN B
- K990895 — OXYCON LENS
- K990999 — MODIFICATION OF: EBI SPINELINK SYSTEM
- K991150 — NELLCOR PURITAN BENNETT, GOODKNIGHT 418G
- K983461 — UNI-FLEX RESIN
- K983892 — COAGUCHEK PRO SYSTEM, APTT TEST CARTRIDGES FOR COAGUCHEK PRO SYSTEM, APTT CONTROLS FOR COAGUCHEK PRO SYSTEM, COAGUCHEK P
- K990170 — HOLTER 2000
- K990172 — TETRAONE SYSTEM FOR EPICS XL FLOW CYTOMETRY SYSTEMS WITH CYTO-STAT TETRACHROME CD45-FITC/CD4-RD1/CD8-ECD/CD3-PC5 MONOCLA
- K990231 — WILTEK HOT BIOPSY FORCEPS
- K990395 — BARRIER SURGICAL GOWNS
- K990418 — ONTRAK TESTCUP-ER M2K
- K990449 — HEMOCHRON ELECTRONIC SYSTEM VERIFICATION TUBE
- K990711 — CODAN CHEMOSPIKE
- K990845 — MODIFICATION TO PARTS NUMBERED CGT-SL AND CGT-SL-15
- K990983 — MODIFICATION TO IMTEC SENDAX MDI
- K982722 — AMBU MEDIBAG ADULT, AMBU MEDIBAG INFANT/CHILD
- K983102 — CARDIAC DIAGNOSTIC SYSTEM MODEL CH 2000
- K984056 — LTV 1000
- K990123 — PVR-100/VASOGRAM
- K990129 — TL250 INTERFERENTIAL/MUSCLE STIMULATOR INTERFERENTIAL CURRENT THERAPY MUSCLE STIMULATOR
- K990224 — LABTICIAN LID LOAD EXTERNAL EYELID SIZING SET
- K990370 — MSB (ELECTRICAL STIMULATION) ELECTRODES (DISPOSABLE). (TENS/FES/NMES)
- K990813 — REHCOR
- K990861 — WOUND DRESSING/ABD PAD, MODEL #10810
- K982137 — BLEASE FRONTLINE GENIUS RANGE ANAESTHESIA MACHINE
- K982617 — TRACER
- K984059 — ANGIOCATH AUTOGUARD CATHETER, INSYTE AUTOGUARD CATHETER
- K984337 — ELASTYLON POWDER-FREE SURGICAL GLOVE
- K984389 — TOP WHOLESOME FACE MASK
- K990082 — EPIC SPO2 FINGER SENSOR, MODEL E403-09, E412-09 AND EPIC OXIMETER CABLE, MODEL E710-09
- K990277 — O-RING ABUTMENT
- K990363 — BIOMESH BIODEGRADABLE GTR BARRIER
- K990539 — BRIGHTWAY BRAND LATEX EXAMINATION GLOVES (POWDER FREE)
- K990540 — BRIGHTWAY BRAND LATEX EXAMINATION GLOVE (LOW PROTEIN)
- K990541 — BRIGHTWAY BRAND NITRILE EXAMINATION GLOVE (POWDER FREE)
- K990542 — BRIGHTWAY BRAND NITRILE EXAMINATION GLOVE (LIGHTLY POWDERED)
- K990543 — BRIGHTWAY BRAND POLYMER COATED LATEX EXAMINATION GLOVE (POWDER FREE)
- K990827 — MICROPLATE NEONATAL GALT ASSAY
- K982365 — ATRAUMATIC VASCULAR CLAMPS, MODEL #'S 22-XXXX, 23-XXXX, 03-60XX, 25-XXXX MICRO VASCULAR CLAMPS MODEL # 75-0XXX, ATRAUMAT
- K982940 — LIGHTSHEER PULSED DIODE ARRAY LASER SYSTEM
- K984227 — OMEGA II MODULAR TOTAL HIP SYSTEM
- K984526 — ACUSEAL CARDIOVASCULAR PATCH
- K990302 — IL TEST LAC SCREEN (CLAIMS ADDED TO ACL FUTURA), IL TEST LAC CONFIRM (CLAIMS ADDAD TO ACL FUTURA)
- K990544 — TRX-CG POWER TILT AND RECLINE SYSTEM
- K990984 — VITROS IMMUNODIAGNOSTIC PRODUCTS CEA RANGE VERIFIERS
- K981191 — ITI INTRAMAX GUIDE CATHETER 91, 78 AND 65
- K981668 — SMARTVENT 201 PORTABLE VENTILATOR
- K983919 — EMS MOUTH TO MASK RESUSCITATORS
- K990262 — CLEARPLAN EASY HOME PREGNANCY TEST
- K990587 — ABBOTT LIQUID RF CONTROL, MODELS 2E04-01, 2E05-01, 2E06-01
- K990888 — MODIFICATION TO LIQUICHEK SPINAL FLUID CONTROL, ITEM NOS. 751, 752
- K990970 — SONOACE 6000C DIAGNOSTIC ULTRASOUND SYSTEM AND TRANSDUCERS, ALSO CALLED ULTRASOUND SYSTEM AND TRANSDUCERS
- K982029 — SHARPS COLLECTION CONTAINER - SAF-T-SHELL
- K982640 — MEDEX 3000 SERIES SYRINGE INFUSION PUMP
- K990737 — 'ECURLINE UMBILICAL CORD CLAMP #3500
- K990817 — IPS D.SIGN PORCELAIN
- K990863 — MODIFICATION TO FLEXFLO POLYG GASTROSTOMY TUBE
- K990886 — IMMULITE C-REACTIVE PROTEIN, MODEL LKCR1, LKCR5
- K990898 — PRODIGY 4
- K981036 — SMARTBOND
- K990491 — ANGIO-CT MIYABI
- K990567 — GLOBAL HEALTHCARE SELF-SEALING STERILIZATION POUCH
- K990064 — DI-RHEX OPHTHALMIC DIATHERMY SYSTEM
- K990091 — S.P.A.R STERILE AMBULATORY RESERVOIR
- K980745 — SECOND WIND AIR PURIFIER
- K981535 — FOCUS PILOT CONTOURING WORKSTATION
- K982505 — ULTRA CARE NON-STERILE POWDER FREE (GREEN) NATURAL RUBBER LATEX PATIENT EXAMINATION GLOVE
- K982708 — SPQ TEST SYSTEM
- K983022 — SMARTCELL PROCESSING SYSTEM
- K983115 — TREATMENT CONTROL STATION - MICROSELECTRON-HDR CLASSIC UPGRADE, VERSION 1.20
- K983337 — ROTTERDAM NASOPHAYRNX MOULD SET, PART #089.068
- K983343 — PLATO BRACHYTHERAPHY, MODEL V. 14.0
- K983467 — THERAPEP
- K983997 — STERICHEK TOTAL CHLORINE TEST KIT
- K984422 — STERILE BACK SURGICAL GOWN WITH HAND TOWEL
- K984513 — TROVAFLOXACIN ANTIMICROBIAL SUSCEPTIBILITY TEST DISC
- K990004 — DCI ENDOSCOPE
- K990314 — MULTI-CURE COMPOSITE CEMENT
- K990495 — POWDER FREE NITRILE EXAMINATION GLOVES
- K990499 — PREPOWDERED NITRILE EXAMINATION GLOVES
- K990501 — POWDER FREE LATEX EXAMINATION GLOVES, W/ PROTEIN LABELING CLAIM
- K990502 — PREPOWDERED LATEX EXAMINATION GLOVES WITH PROTEIN CONTENT LABELING CLAIM (100 MICROGRAMS OR LESS)
- K990670 — HELIOFORM GOLD-BASED ALLOY
- K990726 — ENVY GUIDING CATHETER
- K990749 — SOF-SUCTION FLUID EVACUATION SYSTEM
- K990790 — VISION PORCELAIN
- K982696 — INTERPLANT
- K983524 — LARES RESEARCH SUNLASE 800P LASER SYSTEM (TO BE SOLD AS PEIOLASE FOR LASERENAP)
- K984355 — POINT SETTER
- K990002 — QUICKRAY DSX 730
- K990007 — OPART, MODEL MRT-600
- K990028 — ENDOPATH OPTIVIEW OPTICAL SURGICAL OBTURATOR AND SLEEVE
- K990174 — ATLAS-ELITE,MODEL E-80,CORIUM 200,CORIUM 400, MODEL E-90, ELITE, MODEL E-80-II, ELITE ULTRA, MODEL E-80-IV
Data sourced from openFDA. This site is unofficial and independent of the FDA.