FDA 510(k) clearances — page 849
clearances on record, most recent first.
Clearances — page 849
84,801–84,900 of 176,637- K991379 — QUINN'S SPERM WASHING MEDIUM
- K991393 — HYALURONIDASE, 80 U/ML
- K992322 — SNAP MODEL 5
- K992787 — EPICON (CARBOSILFOCON A) RIGID GAS PERMEABLE CONTACT LENS DAILY WEAR
- K993580 — SPECIALTY 55 (METHAFILCON A) SOFT (HYDROPHILIC) CONTACT LENSES FOR DAILY WEAR
- K993742 — SUPER TISSUE
- K993750 — PROSOLV ECHOVIEWER, PROSOLV ECHOVIEWER SE, PROSOLV ECHOANALYZER, PROSOLV ECHOSERV, PROSOLV ECHO
- K993751 — COROMETRICS MODEL 173 FETAL MONITOR
- K993779 — SIMPLEX CONDOMS, LATEX CONDOMS-FLAVORED AND LUBRICATED
- K993781 — SIMPLEX CONDOMS, LATEX CONDOMS-SILICON LUBRICATED
- K993782 — SIMPLEX CONDOMS, LATEX CONDOMS-WITH SPERMICIDAL LUBRICANT (NONOXYNOL-9)
- K993786 — RUSCH ORAL/NASAL (SAFETY CLEAR PLUS) TRACHEAL TUBE CUFFED, MAGILL/MURPHY
- K993917 — TOKUYAMA ONE-UP-BOND F
- K994261 — ULTRATEMP TEMPORARY POLYCARBOXYLATE CEMENT
- K000044 — ARTHROCARE CONTROLLER, ARTHROCARE CABLE, FOOTSWITCH, POWERCORD, ARTHROWANDS AND SPINEWANDS
- K992708 — IONTOPATCH
- K993085 — AUTOSTAT II ANTI-CARDIOLIPIN SCREEN ELISA
- K993547 — BECKMAN COULTER IMMAGE IMMUNOCHEMISTRY SYSTEM LOW CONCENTRATION IMMUNOGLOBULIN M (IGMLC) REAGENT, BECKMAN COULTER CEREB
- K993549 — BECKMAN COULTER IMMAGE IMMUNOCHEMISTRY SYSTEM LOW CONCENTRATION IMMUNOGLOBULIN A (IGALC) REAGENT, BECKMAN COULTER CEREBR
- K993553 — GTI-FVIII INHIBITOR ASSAY
- K993724 — HSV-2 ELISA IGG, MODEL EL0920G
- K993828 — CERALAS D10 810NM DIODE LASER
- K993878 — JE 2000
- K993904 — INTRASTENT DOUBLESTRUT LD
- K993910 — TAC' PIN
- K993911 — CERALAS D DIODE LASER SYSTEM, MODEL D15, D25,D50
- K993980 — SYVA EMIT II PLUS ETHYL ALCOHOL ASSAY, MODELS 9K309UL/9K409UL
- K993981 — SYVA EMIT II PLUS PROPOXYPHENE ASSAY, MODELS 9G029UL/9G129UL
- K994035 — IMMUNODIP URINARY ALBUMIN SCREEN, MODEL 790-01, 790-15
- K994046 — HARDYDISK CEFACLOR 30MCG
- K994148 — 3I MODEL(S)7426 AND 7427 CELSEP CENTRIFUGE SYSTEM
- K994346 — ABL 77 PH, BLOOD GAS AND ELECTROLYTE ANALYSIS SYSTEM
- K000048 — SEALOUETTE FIBRIN SEALANT EXTENDED DROPLET APPLICATOR, MODEL TE-1
- K990227 — ULTRASHAPER KERATOME
- K990530 — KERLIX MD ANTIMICROBIAL GAUZE DRESSING
- K992648 — ROTARY MASTER
- K993840 — BARD UROFORCE BALLOON DILATION CATHETER
- K993857 — THE ORIGINAL PERRY, STYLE 42 WHITE LATEX POWDERED SURGICAL GLOVES WITH PROTEIN CONTENT LABELING CLAIM (60 MICROGRAMS OR
- K993906 — NANMA NON-ADJUSTABLE CONSTRICTION RING
- K993908 — NANMA AJUSTABLE CONSTRICTION RING
- K994042 — SHARP 9000 PHASED ARRAY BRAIN COIL
- K994224 — PRIME-DENT CHEMICAL CURE COMPOSITE RESTORATIVE MATERIAL
- K994246 — OMNI GRACE NITRILE, BLUE, EXAMINATION GLOVE, POWDER-FREE, POLYMER COATED
- K994354 — POLYMER COATED, POWDER FREE, LATEX EXAMINATION GLOVES WITH PROTEIN CONTENT LABELING CLAIM (50 MICROGRAMS OR LESS)
- K000065 — CAMLOG CYLINDER IMPLANT SYSTEM
- K000099 — CAMLOG SCREW IMPLANT SYSTEM
- K000100 — CAMLOG ROOTFORM IMPLANT SYSTEM
- 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
Data sourced from openFDA. This site is unofficial and independent of the FDA.