FDA 510(k) clearances — page 842
clearances on record, most recent first.
Clearances — page 842
84,101–84,200 of 175,890- K984297 — MAGNA ABUTMENT
- K990340 — ARTHREX PLA TISSUETAK, MODEL # AR-1940 BU
- K991162 — BIOLOX ALUMINA CERAMIC FEMORAL HEAD
- K992273 — HP VIRIDIA MULTI-MEASUREMENT SERVER/COMPACT PORTABLE PATIENT MONITOR M3000A/M3046A/M3016A,REL B
- K992604 — HENRY SCHEIN SURGICAL MASK
- K992957 — ADVANCED D-DIMER
- K993595 — NOBEL BIOCARE'S MODIFIED SURFACE IMPLANT (INTENDED FOR IMMEDIATE LOADING UPON PLACEMENT)
- K993667 — SULZER VASCUTEK SEALPTFE VASCULAR PROSTHESIS
- K993713 — RIM-FIX, ACETABULAR CUP
- K993900 — COAGULATION ELECTRODE, MODEL 2000; RADIOFREQUENCY GENERATOR, MODEL 20-115
- K994064 — BLUE NITRILE EXAMINATION GLOVES - POWDER FREE
- K994082 — POWDERED LATEX EXAMINATION GLOVES (PROTEIN LABEL CLAIM) (50 MICROGRAM OR LESS)
- K994085 — IMMULITE TURBO HCG, MODELS LSKCG1, LSKCG5
- K994115 — TOTAL IRON BINDING CAPACITY (IBCT) FLEX REAGENT CARTRIDGE
- K994192 — IMPREGUM PENTA M MONOSOFT
- K994193 — IMPREGUM PENTA DUOSOFT
- K994248 — SENSI-PRO, DISPOSABLE PRE-POWDERED SYNTHETIC VINYL PATIENT EXAMINATION GLOVES WITH BEIGE PIGMENT ADDITIVES
- K990039 — GAMBRO DQM 200
- K991023 — STERITITE PERFORATED BOTTOM RIGID REUSABLE STERILIZATION CONTAINER SYSTEM WITH SCF02 - POLYPROPYLENE NON-WOVEN DISPOSABL
- K991355 — METERED DOSE INHALER ADAPTER-DISPOSABLE, ADAPTER REUSABLE
- K991935 — EPILIGHT HAIR REMOVAL SYSTEM, PHOTODERM HR SYSTEM
- K992045 — ELECTROSURGICAL ELECTRODE FAMILY
- K992504 — EMS KERMIT
- K992632 — IMMULITE AMPHETAMINE, MODELS LKAM1, LKAM5
- K992914 — EXCIMER LASER PHOTOTHERAPY SYSTEM, AL7000
- K992991 — ATRIUM MEDICAL CORPORATION ADVANTA PTFE FACIAL IMPLANT
- K993026 — ABBOT AEROSET PHENYTOIN ASSAY & ABBOT AEROSET PHENYTOIN CALIBRATORS
- K993028 — ABBOTT AEROSET CARBAMAZEPINE ASSAY AND CALIBRATORS; MODELS 1E12 AND 6E90
- K993029 — ABBOTT AEROSET THEOPHYLLINE ASSAY AND CALIBRATORS; MODELS 1E09 AND 6E89
- K993031 — ABBOTT AEROSET PHENOBARBITAL ASSEY AND CALIBRATORS;MODELS 1E08 AND 5F54
- K993639 — RX VIATRAC 18 PERIPHERAL DILATATION CATHETER, OTW VIATRAC 18 PERIPHERAL DILATATION CATHETER
- K993654 — NEUROCOMP
- K993784 — UNIGRAFT
- K993848 — MILLENNIUM HUBER PLUS SAFETY INFUSION SET
- K993982 — SYVA EMIT II PLUS AMPHETAMINE/METHAMPHETAMINE ASSAY 9C029UL/9C129UL
- K993983 — SYVA EMIT II PLUS PHENCYCLIDINE ASSAY, MODEL 9J029UL
- K993985 — SYVA EMIT II PLUS BENZODIAZEPINE ASSAY, MODELS 9F029UL/9F129UL
- K993986 — SYVA EMIT II PLUS METHAQUALONE ASSAY, MODEL 9Q029UL/9Q129UL
- K993987 — SYVA EMIT II PLUS BARBITURATE ASSAY, MODEL 9D029UL/9D129UL
- K993988 — SYVA EMIT II PLUS COCAINE METABOLITE ASSAY, MODEL 9H029UL
- K994004 — QUANTA LITE LYME B. BURGDORFERI IGG/IGM ELISA KIT
- K994017 — ONTRAK TESTCUP 5 M2K, CAT. 11 1850 1
- K994020 — ONTRAK TESTSTIK FOR PCP, CAT. 07 6654 2
- K994030 — ONTRAK TESTCUP 5, CAT. 07 6481 7
- K994077 — AROMA FINE (NORMAL AND FAST SET)
- K994190 — IMPREGUM GARANT L DUOSOFT
- K994216 — PLASTIC PORT IMPLANTABLE VENOUS ACCESS SYSTEM
- K990569 — BABY DOPPLEX 4000, MODEL BD 4000
- K992786 — PURE WATER, INC.'S WATER PURIFICATION SYSTEMS
- K993058 — PURE WATER INC'S ACIDIFIED STORAGE AND DISTRIBUTION SYSTEM WITH OPTIONAL REMOTE FILL
- K993200 — MD 420/440/460/470/480/490
- K993533 — POWERHEART AECD
- K993622 — NEUROTREK PHYSIOLOGICAL NAVIGATION SYSTEM FOR NEUROSURGERY
- K993671 — CANDELA SCLERO LONG PULSE DYE LASER
- K993961 — RAPID DRUG SCREEN 3-PANEL TEST FOR COCAINE, MARIJUANA (THC) (CANNABINOIDS) AND OPIATES (3 PANEL TEST FOR CTO)
- K994263 — SECURLINE UMBILICAL CORD CLAMP CLIPPER #3540
- K994418 — VERSAPOINT ELECTROSURGERY SYSTEM (SCUBA)
- K992286 — DERMAFREEZE
- K992403 — MRP-TITAN
- K992855 — XPS STRAIGHTSHOT OR MODEL 2000 MICRODEBRIDER SYSTEM OR XPS POWERSCULPT
- K993415 — GDC-10 STRETCH RESISTANT GUGLIELMI DETACHABLE COIL, GDC-10 2-DIAMETER STRETCH RESISTANT GUGLIELMI DETACHABLE COIL, GDC-1
- K993417 — GDC-10 GUGLIELMI DETACHABLE COIL (GDC) (3D SHAPE GDC), GDC-18 GUGLIELMI DETACHABLE COIL (GDC) (3D SHAPE GDC)
- K993418 — FIBERED GDC-18 VORTX SHAPE GUGLIELMI DETACHABLE COIL
- K993629 — ABI VEST AIRWAY CLEARANCE SYSTEM
- K993768 — CITATION TMZF HA STEM
- K994331 — REVEAL PLUS INSERTABLE LOOP RECORDER SYSTEM, MODEL 9526 IMPLANTED RECORDER AND MODEL 6191 PATIENT ACTIVATOR
- K000067 — ALKALINE PHOSPHATASE LIQUID REAGENT-KINETIC, MODELS A504-150 AND A504-500H
- K992436 — GOWN BACK, MODEL 13-403N; 13-404N; 13-405N
- K992634 — IMMULITE METHAMPHETAMINE, MODEL LKMA1, LKMA5
- K992675 — PATIENT NITRILE EXAMINATION GLOVES (POWDERED)
- K993483 — ACON ONE STEP HOME PREGNANCY TEST STRIP
- K993582 — MODIFICATION TO LASER-SHIELD II
- K993587 — HP M2376A DEVICE LINK SYSTEM
- K993598 — MAMMOGRAPHY PRO, MODEL 13017, DIAGNOSTIC PRO W/ MAMMOGRAPHY OPTION, MODEL 13205
- K993682 — MRI EQUIPMENT COVER
- K993736 — EXACTECH ACUMATCH INTEGRATED HIP SYSTEM M-SERIES FEMORAL STEM COMPONENT
- K993797 — EC-7701 FLUID WARMING CABINET
- K993824 — MSAS PROFESSIONAL
- K993827 — UFI GEL HARD
- K993864 — COLORED AND FLAVORED POWDER FREE LATEX EXAMINATION GLOVES
- K993865 — GREEN PEPPERMINT FLAVORED POWDERED LATEX EXAMINATION GLOVES
- K994005 — SYVA EMIT II PLUS METHADONE ASSAY, MODELS 9E029UL/9E129UL
- K994013 — POWDERED LATEX EXAMINATION GLOVES WITH PROTEIN CONTENT LABELING CLAIM (100 MICROGRAMS OR LESS)
- K994019 — CAUTERY GRASPER/DISSECTOR
- K994066 — MTP DISPOSABLE TROCARS
- K994070 — REVELATION POROUS HIP STEM
- K994084 — SMITH & NEPHEW XENON LIGHT SOURCES AND ACCESSORIES
- K994114 — DIMENSION TOTAL IRON BINDING CAPACITY (IBCT) CALIBRATOR
- K994173 — STELLARTECH RADIOFREQUENCY GENERATOR,MODEL 1025A-115, STELLARTECH RADIOFREQUENCY GENERATOR, MODEL 1025A-230
- K994189 — OLYMPUS CREATINE KINASE REAGENT OSR6179/6279
- K994258 — SENSI-PRO DISPOSABLE POWDER FREE SYNTHETIC VINYL PATIENT EXAMINATION GLOVES WITH BEIGE PIGMENT ADDITIVES
- K994273 — MODEL 1000 HOLMIUM LASER SYSTEM
- K000030 — SONOACE 600 DIAGNOSTIC ULTRASOUND SYSTEM
- K991545 — WATCH STYLE WRIST DIGITAL BLOOD PRESSURE MONITOR, MODEL: KLOCK
- K993869 — INTER-OS BONE GENERATOR
- K984083 — MULTIFUNCTION KEITO K5
- K990445 — LPG THERAPEUTIC MASSAGER, MODELS -ESI, THERAPEUTIC MASSAGER/VIBRATOR
- K991390 — 1.5 M PROPANEDIOL FREEZING MEDIUM, 1.5 PROPANEDIOL 0.1 SUCROSE FREEZING MEDIUM, 9% GLYCEROL, 0.2 M SUCROSE FREEZING MEDI
- K991861 — 1ST RESPONSE INFANT MANUAL RESUSCITATOR, BAG RESEVOIR, 1ST RESPONSE PEDIATRIC MANUAL RESUSCITATOR, BAG RESERVOIR, 1ST RE
- K991936 — 3.0 ML RESERVOIR, MODEL 103/193
Data sourced from openFDA. This site is unofficial and independent of the FDA.