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32,815 FDA 510(k) clearances · Device class

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RecordFirmDate
SPYROSORB FOAM ISLAND WOUND DRESSING (K980673)Innovative Technologies (Us), Inc.1998-05-21
COPPER TONGUE SCRAPER (K980842)Ontel Products Corp.1998-05-20
SKAR-KARE SHEET (K980563)Life Medical Sciences, Inc.1998-05-20
TIBC (K981279)Abbott Laboratories1998-05-20
SKINGARD TPF/AOSSTEX TPF/SENSIFREE/ESSENTIAL TPF/AMERIGLO TPF LATEX EXAMINATION GLOVES (K973615)Macro Rubber Industrial, Inc.1998-05-20
SENSI-DERM LATEX SURGICAL GLOVES (POWDERED) (K980880)Ansell Perry1998-05-20
SOVEREIGN CATARACT EXTRACTION SYSTEM (K981116)Allergan, Inc.1998-05-19
BOEHRINGER MANNHEIM PRECINORM PRECIPATH PROTEIN CONTROLS (K981401)Boehringer Mannheim Corp.1998-05-18
CIR LATEX EXAMINATION GLOVES, NON-STERILE, POWDERED, WITH PROTEIN LABELING CLAIM OF <=200 UG/G (K980754)Crocker Industrial Resources Sdn. Bhd.1998-05-18
MICRO-PLATE COTININE EIA (K974534)OraSure Technologies, Inc.1998-05-18
SMART-FEEL POWDER FREE NITRILE EXAMINATION GLOVES (K981349)Smart Glove Corp. Sdn Bhd1998-05-18
SMARTTEX PREPOWDERED LATEX EXAMINATION GLOVES (K981348)Smart Glove Corp. Sdn Bhd1998-05-18
SMARTTEX POWDER FREE LATEX EXAMINATION GLOVES, WITH PROTEIN LABELING CLAIM (K981347)Smart Glove Corp. Sdn Bhd1998-05-18
LOVYTEX POWDER-FREE NITRILE EXAMINATION GLOVES (K981179)Lovytex Sdn Bhd1998-05-15
EYE IRRIGATOR MODEL #2020 (K980647)Eye-Deal Ocular Safety Products, Inc.1998-05-15
MICRO-PLATE COTININE EIA (K974234)OraSure Technologies, Inc.1998-05-14
THIRD GENERATION PSA CONTROL MODULE (K981455)Diagnostic Products Corp.1998-05-13
LYPHOCHEK IMMUNOASSAY PLUS CONTROL (K981532)Bio-Rad1998-05-12
PREMIER PLATINUM HPSA (K980076)Meridian Diagnostics, Inc.1998-05-12
DUMEX PAK-ITS NON-WOVEN DRESSING IMPREGNATED SITH SODIUM CHLORIDE (HYPERTONIC) (K980863)Dumex Medical Surgical Products, Ltd.1998-05-11
REGENT BIOGEL INDICATOR INNER SURGICAL GLOVE (K980942)London International Group, Inc.1998-05-11
ELITE MARK IV POWDER FREE POLYURETHANE SYNTHETIC SURGICAL GLOVE (K981392)Ansell Perry1998-05-11
AXYA MEDICAL, INC. AUTOMATIC SUTURING AND LIGATING SYSTEM-(ASLS) (K980988)Axya Medical, Inc.1998-05-11
PRINCESS SYRINGE (K980577)Sodexco1998-05-08
URIC ACID (K981189)Abbott Laboratories1998-05-07
CARDIAC STATUS CONTROLS (CK-MB/MYOGLOBIN/TROPONIN I) (K981474)Spectral Diagnostics, Inc.1998-05-07
VR NETSERVE (K980684)I.S.G. Technologies, Inc.1998-05-06
IL SYNTHESIS--ADDITION OF BILIRUBIN AS A MEASURED PARAMETER FOR NEONATE WHOLE BLOOD SAMPLES (K980646)Instrumentation Laboratory CO1998-05-06
LATEX FINGER COT, POWDER-FREE, WITH PROTEIN LABELING (K980827)Tucker & Associates1998-05-04
REP CHOLESTEROL PROFILE TEMPLATE-30, -16, -8; REP VIS CHOLESTEROL (K980650)Helena Laboratories1998-05-01
SCMD-1000 (K980985)Howard Instruments, Inc.1998-05-01
OAC (OPTICAL ASPIRATING CURETTE) (K980096)Imagyn Medical Technologies, Inc.1998-05-01
BACTEC MGIT 960 SYSTEM (K974883)Bd Becton Dickinson Vacutainer Systems Preanalytic1998-05-01
KERATOME BLADE (135 MICRON, MODEL 300135), (160 MICRON, MODEL 300160), (200 MICRON, MODEL 30020) (K980510)Micro Specialties, Inc.1998-05-01
KERATOME BLADE, CHIROM MODEL ALK 500500; KERATOME BLADE, S.C.M.D. MODEL TUROKERATOME 400400 (K980508)Micro Specialties, Inc.1998-05-01
HEELBO WAIST AND CHEST VEST (K980640)Heelbo, Inc.1998-05-01
MG (K981192)Abbott Laboratories1998-05-01
BIO-POST DENTAL POST SYSTEM (K974649)Advanced Aeromedical, Inc.1998-05-01
IRON (K981241)Abbott Laboratories1998-05-01
IMMULITE PYRILINKS-D MODEL NUMBERS LKPD1, LKPD5 (K980833)Diagnostic Products Corp.1998-05-01
EBNA-1 IGM ELISA TEST SYSTEM (K980598)Clark Laboratories, Inc.1998-05-01
GREATBATCH SCIENTIFIC MR COMPATIBLE LARYNGOSCOPE (K971377)Wilson Greatbatch Technologies, Inc.1998-04-30
QUATRO SP SAMPLE PROCESSING SYSTEMS (200-499, INCLUSIVE) (K973335)Zenyx Scientific , Ltd.1998-04-30
KLEENASEPTIC (K981023)Metrex Research Corp.1998-04-30
HYPOALLERGENIC LATEX PATIENT EXAM GLOVES-PREPOWDERED (K980848)P.T. Irama Dinamika Latex1998-04-28
HDL-CHOLESTEROL PRECIPITATING REAGENT, CATALOGUE NUMBER 205-51 (K980772)Diagnostic Chemicals , Ltd.1998-04-27
ELECSYS CALCHECK FERRITIN (K981281)Roche Diagnostics GmbH1998-04-24
POWDER FREE CHLORINATED GLOVES-(TEXTURED) (K981164)Pan-Century Rubber Products Sdn. Bhd.1998-04-23
REGENT BIOGEL ORTHOPEDIC SURGICAL GLOVE (K980516)London International Group, Inc.1998-04-23
ELECSYS CALCHECK CA 125II (K981278)Roche Diagnostics GmbH1998-04-23
SERAQUEST MUMPS IGG (K980059)Quest Intl., Inc.1998-04-23
COMFORT RUBBER GLOVES INDUSTRIES SDN BHD (K974424)Comfort Rubber Gloves Industries Sdn. Bhd.1998-04-23
PROSPECT SHIGA TOXIN MICROPLATE ASSAY (K980507)Alexon - Trend, Inc.1998-04-23
MICROKERATOME OR THE MATE (K974598)Howard Instruments, Inc.1998-04-22
POWDERFREE GREEN NITRILE EXAMINATION GLOVES (POLYMER COATED) (K981039)Sri Johani Sdn. Bhd.1998-04-21
CLK INT'L POWDER FREE LATEX EXAMINATION GLOVE (K974371)Clk Intl., Inc.1998-04-21
SIMPLEX SALIVA ABSORBER/COLLECTOR, MODEL SSA-5 (K980783)Irt Management Corp.1998-04-21
INFINITY CHOLESTEROL REAGENT (PROCEDURE NO. 401) (K980667)Sigma Diagnostics, Inc.1998-04-21
QUICKCHECK LYOPHILIZED CHEMISTRY CONTROL CONFORMANCE CHEMISTRY CONTROL C3 (K981339)Consolidated Technologies, Inc.1998-04-21
HDL UNI-PAKS (PTA), CATALOGUE NUMBER 215-51 (K980770)Diagnostic Chemicals , Ltd.1998-04-21
JTECH COMMANDER AND ALGOMETER (K971407)J-Tech Medical, Inc.1998-04-20
POWER COINS GLOW IN THE DARK LIGATURES (K980864)Ortho Kinetics Corp.1998-04-20
GLADRAGS COTTON MENSTRUAL PAD (K980395)Keepers!, Inc.1998-04-16
MACRALP(A) ENZYME IMMUNOASSAY KIT (K971157)Strategic Diagnostics, Inc.1998-04-15
PLANCON MICROLAMELLAR KERATOME EVOLUTION (K980924)Plancon Instruments1998-04-15
NONWOVEN PAD (K980720)Convatec, A Division of E.R. Squibb & Sons1998-04-15
LOW PROTEIN LATEX PATIENT EXAMINATION GLOVES (POWDER-FREE) (K980605)Pt. Sarana Indoprotex1998-04-14
AR SAFE NITRILE EXAMINATION GLOVES (K980589)Alliance Rubber Products Sdn. Bhd.1998-04-14
TELICAM (K980474)Dental/Medical Diagnostic Systems, Inc.1998-04-13
BIODERM CALCIUM ALGINATE DRESSING (K980451)Bioderm, Inc.1998-04-09
BARCO MGD 521 5 MEGAPIXEL DIAGNOSTIC DISPLAY (K980541)Barco NV Display Systems1998-04-09
LIGHT DIAGNOSTICS SIMULFLUOR FLU A/FLU B (K974302)Light Diagnostics1998-04-08
COLOURED POWDWR-FREE SURGICAL GLOVES (K980412)Kenwell International , Ltd.1998-04-08
LYPHOCHEK WHOLE BLOOD CONTROL (K980871)Bio-Rad1998-04-06
IV STANDS (K980336)Clinton Industries, Inc.1998-04-06
SAFETY POWDERFREE BLUE LATEX EXAMINATION GLOVES (POLYMER COATED) (K980941)Besglove Medicare Sdn. Bhd.1998-04-03
STERILE POWDER-FREE LATEX EXAMINATION GLOVES (K980803)Kenwell International , Ltd.1998-04-03
REJUVENESS (K974380)Rejuveness Pharamceuticals, Inc.1998-04-03
SAFETY POWDERED BLUE LATEX EXAMINATION GLOVES (K980939)Besglove Medicare Sdn. Bhd.1998-04-03
SAFETY POWDERFREE BLUE LATEX EXAMINTION GLOVES (K980940)Besglove Medicare Sdn. Bhd.1998-04-03
PARAMETER DEVELOPMENTS DICOM ARCHIVAL SERVER, (DAS)/DICOM INTRANET SERVICE (DIS) (K980243)Parameter Developments, Inc.1998-04-03
PARA-PAK SPINCON (K980077)Meridian Diagnostics, Inc.1998-04-02
SILIMED NASAL RETAINER (K980221)Silimed, LLC1998-04-02
NITRILE EXAMINATION GLOVES- PRE-POWDERED (SMALL, MEDIUM & LARGE) (K980729)Pt. Eka Wira Asia1998-04-02
ALEXANDER MANUFACTURING CO. RECHARGEABLE BATTERY PART NUMBER MS822 (K980224)Alexander Mfg. Co.1998-04-02
LATEX EXAMINATION GLOVE (K974660)Ideal Quality Sdn., Bhd.1998-04-02
POWDER-FREE LATEX EXAMINATION GLOVE (K974662)Ideal Quality Sdn., Bhd.1998-04-02
NITRILE EXAMNATION GLOVES- POWDERFREE (SMALL, MEDIUM AND LARGE) (K980807)Pt. Eka Wira Asia1998-04-02
POWDERED LATEX EXAMINATION GLOVES (K980611)Servicom Services Sdn Bhd1998-04-02
UROMED PATCH (K974600)Uromed Corp.1998-03-31
SILGEL TOPICAL GEL SHEET (K974172)Nagor , Ltd.1998-03-30
KMC NEWSKIN (K974143)Kmc Intl. Co.1998-03-27
EA-D IGG ELISA TEST SYSTEM (K973123)Clark Laboratories, Inc.1998-03-26
MEDI-GRIP (BEIGE 43)SURGICAL GLOVES (K980564)Ansell Perry1998-03-25
NITRILE EXAM GLOVE, POWDER-FREE, BLUE (K980802)Tucker & Associates1998-03-25
TRIAGE C. DIFFICILE, TRIAGE C. DIFFICILE PANEL, TRIAGE C. DIFFICILE TOXIN A (K974881)Biosite Incorporated1998-03-20
TYROSINE 50-HOUR REAGENT KIT (K970093)Astoria-Pacific, Inc.1998-03-19
NETCO MEDICAL DATA TRANSPORTATION SERVICE SOFTWARE (K980241)Netco Communications Corp.1998-03-17
SHIELD HELICO-G2 ELISA KIT (K972981)Shield Diagnostics, Ltd.1998-03-17
IMMUNOSUPPRESSANT (WHOLE BLOOD) CONTROL, LEVEL 1 250-1, IMMUNOSUPPRESSANT (WHOLE BLOOS) CONTROL, LEVEL 2, 250-2, IMMUN\S (K980331)More Diagnostics1998-03-16
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