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3,051 FDA 510(k) clearances · Device class

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RecordFirmDate
SANG-A PETROLATUM GAUZE USP STERILE (K843035)Tech-Cons Ltd., Intl.1984-09-20
CURITY SUPRAPUBIC DRAINAGE SYSTEM (K842899)The Kendal Co.1984-09-10
DUODERM FLEXIBLE HYDROACTIVE DRESSINGS (K841287)Convatec, A Division of E.R. Squibb & Sons1984-08-20
RADOVAN TISSUE EXPANDER (K842883)Mentor Corp.1984-08-17
E-Z-EM PERCUTANEOUS NEPHROSTOMY SETS (K841720)E-Z-Em, Inc.1984-07-26
LFT - 212 (K841879)Medical Monitoring Systems, Inc.1984-07-26
DACOMED RIGISCAN SYSTEM (K841202)Dacomed Corp.1984-07-06
BENZETHONIUM CHLORIDE (K833903)Blairex Laboratories, Inc.1984-05-30
THROAT MOI-STIR (K840807)Kingswood Laboratories, Inc.1984-05-25
HYDRON WOUND DRESSING FAST SEAT KIT (K832699)National Patent Development Corp.1984-04-27
STERILE ABSORBENT GAUZE BURN & SOUND (K840745)Chesebrough-Pond'S U.S.A. Co.1984-04-23
ACUPUNCTURE INSOLES (K840995)Lu LU Enterprise Co. , Ltd.1984-03-27
PULSELIFE STIMULATOR (K840983)Pulse Life, Inc.1984-03-27
EMIT ST SERUM PHENCYCLIDINE ASSAY (K840199)Syva Co.1984-03-22
EMIT ST URINE PHENCYCLIDINE ASSAY (K840061)Syva Co.1984-03-19
BIO-BAND BANDAGES (K822306)Robert Hirschfield1984-03-15
TISSUE EXPANDER (K840464)Surgitek1984-03-12
BIOREM 3000 & 4000 (K833454)Biorem1984-02-21
PERCUTANEOUS RETROGRADE NEPHROSTOMY (K833762)Vpi1984-02-10
NEPHROSTOMY/BILIARY DRAINAGE BAG (K834476)Vertex Medical Corp.1984-02-04
RADOVAN SUBCUTANEOUS TISSUE EXPANDER (K833502)American Heyer Schulte1984-02-03
ALCOHOL SWABS (K833993)Concord Laboratories, Inc.1984-01-30
ACETONE ALCOHOL SWABS (K833936)Concord Laboratories, Inc.1984-01-30
NON ADHERENT BANDAGE/SHEET (K833730)American Medical Disposable, Inc.1984-01-27
PAREMA K BAND NON-STERILE (K833867)Mark One Healthcare Products1984-01-27
SELECTRODE SYSTEM (K832634)Bio-Stimu Trend Corp.1984-01-25
DECUBITUS CARE ABSORBENT DRESSING (K832407)American Pharmaseal Div. Ahsc1984-01-19
BARD ABSORPTION DRESSING (K831710)C.R. Bard, Inc.1984-01-03
NON - ADHERENT BANDAGE (K833733)American Medical Disposable, Inc.1983-12-27
EMIT & METHOFREXATE ASSAY (K833634)Syva Co.1983-12-22
ACETONE ALCOHOL PREP PAD (K833185)Aplicare, Inc.1983-10-31
ONE TIME ACETONE/ALCOHOL;SWAB STICKS (K833141)Acme United Corp.1983-10-31
APLICARE ONE ACETONE ALCOHOL SWABSTICK (K833183)Aplicare, Inc.1983-10-31
APLICARE THREE ALCOHOL SWABSTICKS (K833184)Aplicare, Inc.1983-10-27
APLICARE ALCOHOL PREP PAD (K833182)Aplicare, Inc.1983-10-27
PERCUTANEOUS NEPHROSTOMY CATHETER (K833008)Medical Engineering Corp.1983-10-19
HARD CONTACT LENS CASE (K831973)Moonbeam International, Inc.1983-10-19
SENSITIVE EYES (K832706)Bausch & Lomb, Inc.1983-10-04
HARD CONTACT LENS CLEANER (K832810)Blairex Laboratories, Inc.1983-09-29
VILENE COTTON GAUZE II (K831917)Hall-Tech1983-09-26
AUTOMATED 8400 BLOOD CELL SEPARATOR (K831004)Intl. Business Machines1983-09-12
TACTIL EAR (K831501)Ear Three Systems1983-08-26
ALKA FIRST AID KIT (K831657)Alka, Inc.1983-08-24
GELIPERM TRANSPARENT GEL-FILM DRESSING (K822058)Hamel, Park, Mccabe & Saunders1983-08-12
CUI MAMMARY PROTHESIS SIZER (K831566)Cox-Uphuff Intl.1983-08-12
GELIPERM DRY (K822073)Hamel, Park, Mccabe & Saunders1983-08-12
GAUZE SPONGE NON-STERILE (K832174)Sudreca Surgical Dressings, Inc.1983-08-12
GAUZE SPONGE STERILE (K832173)Sudreca Surgical Dressings, Inc.1983-08-12
GELIPERM GRANULES (K823225)Geistlich-Pharma1983-08-12
GAUZE CONVERSION CLASS II STERILE (K832213)Winn Hirsch & Assoc.1983-07-26
GAUZE CONVERSION CLASS I-NON-STERILE (K832214)Winn Hirsch & Assoc.1983-07-26
DACOMED SNAP-GAUGE (K832121)Dacomed Corp.1983-07-18
SUTURE KITS STERILIZED W/GAMA RADIATION (K831806)South Mountain Medical1983-06-29
MODEL GAMMACELL 1000 (K837346)Atomic Energy of Canada1983-06-24
AUTOMATED BLOOD CELL SEPARATOR (K830831)Cryosan, Inc.1983-06-16
NEEDLE GUIDE MODEL 21285A (K830753)Hewlett-Packard Co.1983-06-16
GAUZE SPONGE-NON-STERILE SPONGE (K831182)Den Med, Inc.1983-06-08
FLORET STRUNG GAUZE SPONGES (K830261)Ritmed, Inc.1983-06-08
FLORET SPECIAL GAUZE SPONGES (K830267)Ritmed, Inc.1983-06-08
FLORET CYLINDRICAL/BRONCHOSCOPIC/LAMIN (K830268)Ritmed, Inc.1983-06-08
GAUZE SPONGE STERILE SPONGE (K831183)Den Med, Inc.1983-06-08
FLORET KITTNER OR K DISSECTOR (K830266)Ritmed, Inc.1983-06-08
TUMISENSOR 1524 (K831251)Life-Tech Intl., Inc.1983-06-03
FLORET TONSIL & ADENOID SPONGES (K830264)Ritmed, Inc.1983-06-03
FLORET NEURO SPONGE (K830269)Ritmed, Inc.1983-06-02
CLERZ LUBRICATING & REWETTING EYE DROPS (K830740)CooperVision, Inc.1983-06-02
LAPET & LAPWALL LAPAROTOMY SPONGES (K830271)Ritmed, Inc.1983-06-02
FIRST AID BAGS #1,2,3 (K830375)Akla, Inc.1983-05-25
TUMISTORE RECORDER 1311 (K831252)Life-Tech Intl., Inc.1983-05-18
FIRST AID KIT (K830373)Akla, Inc.1983-05-13
YIELD NON-ADHERENT DRESSING (K830825)Professional Medical Products, Inc.1983-05-13
DUO DERM FLEX HYDROACTIVE DRESSINGS & (K830708)Convatec, A Division of E.R. Squibb & Sons1983-05-05
URINARY DIVERSION STENT (K830803)Van-Tec, Inc.1983-05-05
BOO-BOO STRIP (K830640)Colossus Corp.1983-05-04
CONVERTORS PRIMARY WOUND DRESSING II (K822990)American Hospital Supply Corp.1983-04-12
POINT, PAPER ENDODONTIC (K830814)Endodent, Inc.1983-04-06
FLORET DRAIN/TRACHEOTOMY SPONGE (K830265)Ritmed, Inc.1983-03-29
FLORET GAUZE PACKING (K830278)Ritmed, Inc.1983-03-29
ABUSCREEN RADIOIMMUNOASSAY-PHENCYCLIDINE (K830481)Hoffmann-La Roche, Inc.1983-03-24
SAVETT ALCOHOL PREP (K830330)Cederroth, Inc. USA1983-03-17
RIGHT TIME RHYTHM CLOCK (K823463)P.K. Morgan Instruments, Inc.1983-03-17
BEDSIDE N.P.T. 9900 - PRINTER 9800 (K830221)Browne Medical, Inc.1983-03-17
TACTAID (K830418)Audiological Engineering Corp.1983-03-10
TDX METHOTREXATE (K830398)Abbott Laboratories1983-03-10
FLORET PEANUT SPONGE/STICK & GAUZE PREP (K830274)Ritmed, Inc.1983-03-08
BIOSELF 101 (K823209)Bioself, Inc.1983-02-15
SURGITEK PERCUTANEOUS NEPHROSTOMY CATH (K830226)Medical Engineering Corp.1983-02-09
OREXAS POTENTEST (K830158)Orexas Medical Corp.1983-02-07
NEPHROSTOMY CATHETER (K823382)Umi, Inc.1983-01-28
MOLNLYCKE MESALT STERILE DRESSING (K830051)Lada Intl., Inc.1983-01-26
PERFILM MEMBRANE DRESSING (K822467)Chesebrough-Pond'S U.S.A. Co.1982-12-30
GLISLENS (K823528)Bio-Products, Inc.1982-12-22
CURITY TRANSPARENT FILM DRESSING (K822424)The Kendal Co.1982-12-17
DOSOMETRIC RELEASE STERILIZATION (K823058)Stan-Pak Ent.1982-12-09
HEYER-SCHUTE UNIVERSAL URETERAL STENT (K823418)American Hospital Supply Corp.1982-12-03
SURE SNIP (K823485)South Mountain Medical1982-12-03
SALIVA SUBSTITUTE (K822971)Roxane Laboratories, Inc.1982-11-16
GFB-B CONTACT LENS BLANKS (K822315)Hamel, Park, Mccabe & Saunders1982-11-16
DEVICE FOR THE TREATMENT OF HEMORRHOIDS (K822649)Dunmore Corp.1982-11-03
PRE-SERT (K822706)Allergan, Inc.1982-10-22
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