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

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RecordFirmDate
HYDROCELL NASAL AND SINUS PACKS (K954491)Smith & Nephew Richards, Inc.1995-11-15
JACOBYSCOPE (K953912)Perioview, Inc.1995-11-15
MEROCEL SOFT WOUND DRESSING (K954919)Merocel Corp.1995-11-14
ENT PACKINGS, WICKS, WIPES, AND SPONGES (K954449)Oasis1995-11-14
ACCESS LOW LEVEL IGE CONTROLS (K953883)Bio-Rad Laboratories, Inc.1995-11-14
WELCH ALLYN BI-OTOSCOPE (K955043)Welch Allyn, Inc.1995-11-14
LYOFOAM EXTRA (K952565)Acme United Corp.1995-11-14
PREMIER EHEC (K953362)Meridian Diagnostics, Inc.1995-11-14
COMFEEL:ALGINATE FILLER (K954857)Coloplast Corp.1995-11-14
EVT-3300 (K953621)U.S. Table, Inc.1995-11-14
AURAFLEX TESTOSTERONE CALIBRATOR PACK (K951685)Organon Teknika Corp.1995-11-14
HEARING TODAY HEARING AID (K953603)Hearing Today Laboratory, Inc.1995-11-13
OTICON (K954794)Oticon, Inc.1995-11-13
ARCHIVEMANAGER (K950513)Cemax, Inc.1995-11-13
COAST HEARING CHS (CUSTOM HEARING SYSTEM) (K954937)Coast Hearing Services1995-11-13
JED-LIGHT FIBEROPTIC LIGHT SOURCE (K954184)Jedmed Instrument Co.1995-11-13
IMMUCHEM GAL-MW EA (K951329)Icn Pharmaceuticals, Inc.1995-11-09
BUONAFEDE PNEUMATIC SLEEVE (K954201)Promedic, Inc.1995-11-09
MAS LIQUID URINALYSIS CONTROL (K954323)Medical Analysis Systems, Inc.1995-11-09
SORBSAN PLUS TOPICAL WOUND DRESSING (K954230)Dow Hickam Pharmaceuticals, Inc.1995-11-08
GENERAL HYGIENE KIT (K954068)Physician Industries, Inc.1995-11-08
DISPOSABLE PROPHY HANDPIECE (K954012)Denticator Intl., Inc.1995-11-08
RITE-ANGLE DISPOSABLE PROPHY ANGLES (K954802)Ash-USA1995-11-08
AVOXIMETER 4000 (K951485)A-Vox Systems, Inc.1995-11-06
DERRICK SAFETOUCH (K953709)M.P.S. Pharm'L Int'L1995-11-06
BARRAQUER-KRUMEICH REFRACTIVE SET (K954058)Eyetech M.V.A.1995-11-06
PYRILINKS ASSAY KIT (K952506)Metra Biosystems, Inc.1995-11-03
PYRILINKS POLYCLONAL ASSAY KIT (K952026)Metra Biosystems, Inc.1995-11-03
FACE (FLUOROPHORE-ASSISTED-CARBOHYDRATE-ELECTROPHORESIS) URINARY CARBOHYDRATE ANALYSIS SYSTEM (K945519)Pharmaquest Corp.1995-11-03
TOURNI-COMP (K954103)Scandinavian Medical JW AB1995-11-01
UNSCENTED ULTRATHIN MAXI PAD (K953668)Paragon Trade Brands, Inc.1995-11-01
UNSCENTED MENSTRUAL PAD (K953633)Tendasoft, Inc.1995-11-01
VIROTROL IV (K954298)Blackhawk Biosystems, Inc.1995-11-01
UNSCENTED CURVED ULTRATHIN MAXI PADS (K953667)Paragon Trade Brands, Inc.1995-11-01
RESTORE, THERMACELLS (HOT PACK I) (K953442)Neal Dunning Assoc., Inc.1995-10-31
THE REIFF QUANTUM WHEELCHAIR, OR QUANTUM WHEELCHAIRS (K954568)Reif Wheelchairs and Accessories, Inc.1995-10-31
DERMIVIEW HYPOALLERGENIC CLEAR TAPE (K944587)Johnson & Johnson Medical, Inc.1995-10-30
INCLINOMETER (K954647)J-Tech, Inc.1995-10-30
COLDGEL (K953542)Prism Technologies, Inc.1995-10-30
PRESSORE MONITOR (K954670)Cleveland Medical Devices, Inc.1995-10-30
SCINITREX (POWDERED NITRILE EXAMINATION GLOVESD) (K952052)Wembley Rubber Products (M) Sdn Bhd1995-10-30
PATIENT EXAMINATION GLOVES (NON-CHLORINATED POWDER FREE, NON-STERILE) (K954081)Tan Chong Rubber Gloves Sdn Bhd1995-10-30
SCINITREX (GREEN POWDERED NITRILE EXAMINATION GLOVES) (K951921)Wembley Rubber Products (M) Sdn Bhd1995-10-30
NUCLEOTOME L KIT (K942987)Surgical Dynamics, Inc.1995-10-30
REDI-VU SYSTEMS (SEND & RECEIVE) (K954008)Jd Technical Services, Inc.1995-10-27
UNSCENTED MENSTRAL PAD (K953553)Paragon Trade Brands, Inc.1995-10-27
BURGET NASAL STENT (K942025)Bivona Medical Technologies1995-10-27
UNSCENTED MENSTRUAL PAD (K953517)Paragon Trade Brands, Inc.1995-10-26
CHEMSTRIP MICRAL URINE TEST STRIPS (K954346)Boehringer Mannheim Corp.1995-10-26
COMMANDER MARK II HAIR REMOVAL SYSTEM (K943872)The Helene Edgar Corp.1995-10-26
PODOSPRAY DRILL SYSTEM (K951773)Darco Intl., Inc.1995-10-26
DISPOSABLE FLEX TUBE (K954197)Engstrom Medical1995-10-26
NEW SUN OPTICAL NON PRESCRIPTION SUNGLASSES (K953627)New Sun Optical Enterprise Co., Ltd.1995-10-25
AMITA CORPORATION VARIOUS MODELS OF SUNGLASSES (K953744)Amita Corp.1995-10-25
SINCLAIR NON-PRESCRIPTION SUNGLASSES (K954393)Sinclair Corp.1995-10-25
BLINDE OPTICS (K954636)Blinde Eyewear, Inc.1995-10-25
CHENG CHEN HSING NON-PRESCRIPTION SUNGLASSES (K953808)Cheng Chen Hsing Enterp. & Fact. Co. , Ltd.1995-10-25
DRIVING GLASSES (K951757)Proview Optical Group Corp.1995-10-25
ELX808 AUTOMATED MICROPLATE READERS (K953710)Bio-Tek Instruments, Inc.1995-10-25
SUNGLASSES (K954639)Walmart Stores1995-10-25
GUEDEL AIRWAY (K953400)Mallinckrodt Medical1995-10-24
SIENET SPI SPOOLER (K953552)Siemens Medical Solutions USA, Inc.1995-10-24
TRIGLYCERIDES REAGENT (K954187)Schiapparelli Biosystems, Inc.1995-10-23
NIOMED NON-SKID SHOE COVERS (K952937)Amerasia Corp.1995-10-23
CENTRALITE BACKPOINTER (K954414)Diacor, Inc.1995-10-23
CHEMSTRIP CRITERION URINE ANALYZER (K954024)Boehringer Mannheim Corp.1995-10-23
NIOMED SHOE COVERS (K952897)Amerasia Corp.1995-10-23
PH-DETECT TEST (K952178)Diagnostic Reagents, Inc.1995-10-20
BREATHE RIGHT NASAL STRIP (K953772)Cns, Inc.1995-10-20
QUICKVUE IN-LINE ONE STEP STREP A TEST (MODIFICATION) (K954257)Quidel Corp.1995-10-20
DIRECTIGEN 1-2-3 GROUP A STREP TEST (K951542)Bd Becton Dickinson Vacutainer Systems Preanalytic1995-10-20
DISPOSABLE HME/FILTER (K954194)Engstrom Medical1995-10-20
OLYMPUS ANTI-STERPTOLYSIN O IMMUNOTURBIDIMETRIC REAGENT (K953437)Olympus America, Inc.1995-10-20
ACCESS PROLACTIN ASSAY (MODIFICATION) (K954680)Bio-Rad Laboratories, Inc.1995-10-20
POWDERFREE LATEX GLOVE (K953986)Steriltx1995-10-19
EPILATOR (K952117)Burke Neutech, Inc.1995-10-19
ROYAL SHIELD NON-STERILE POWDER-FREE RUBBER DAMS (K952628)Elastomade Accessories Sdn Bhd1995-10-19
ELX800UV (K953572)Bio-Tek Instruments, Inc.1995-10-19
BIOFEEDBACK SYSTEM FOR SPEECH DISORDERS (K942651)Casa Futura Technologies1995-10-19
EASY BREATHING NASAL STRIPS (K954252)Corbett Lair, Inc.1995-10-18
LUMISYS DICOM TOOKLIT (K953371)Lumisys, Inc.1995-10-18
STEREX STERILE DISPOSALE ELECTROLYSIS NEEDLE FOR USE IN EPILATION (K952611)Sterex Electrolysis Intl., Ltd.1995-10-18
WIDEX SENSO DIGITAL (PX) (K954526)Widex Hearing Aid Co., Inc.1995-10-18
MIDAS REX DRILL ATTACHMENTS & TWIST DRILLS (K954076)Midas Rex Pneumatic Tools, Inc.1995-10-18
MYCOPLASMA PNEUMONIAE ANTIBODY LATEX AGGLUTINATION TEST SYSTEM (K950073)Shared Systems, Inc.1995-10-17
MEDTEC AUTOBLOT 2000 (K951753)Medtec, Inc.1995-10-17
I-SPOUSE (K953089)Products For Medicine1995-10-16
SODEM HIGH SPEED SYSTEM (K954080)Sodem Diffusion SA1995-10-16
POLYKOTE POWDER FREE STERILE LATEX SURGEONS GLOVES (K954462)Intl. Trade Management Co.1995-10-13
CUSTOMCARE SEATING SYSTEM (K954117)Span-America Medical Systems, Inc.1995-10-13
RUSSON INDUSTRIES FURNITURE QUALITY WHEELCHAIR (K954344)Russon Industries1995-10-13
LANDEEZ ALL-TERRAIN WHEELCHAIR (K954261)Natural Access1995-10-13
ROYAL SHIELD NON-STERILE LATEX EXAMINATION GLOVES (K952588)Shield Gloves Manufacturer Sdn. Bhd. C/O Lenty, Inc.1995-10-12
DERRICK SURESHIELD (K953712)M.P.S. Pharm'L Int'L1995-10-12
NEUTRALON BROWN LATEX SURGICAL GLOVES (K953639)Johnson & Johnson Medical, Inc.1995-10-12
ACRYLIC DIPPED LATEX EXAMINATION GLOVES (K945506)Ganz Industries Sdn. Bhd.1995-10-12
POWDER-FREE LATEX EXAMINATION GLOVE (K952473)M.M.R. Gloves Private , Ltd.1995-10-12
FOR MED HIGH RISK (K953740)For Med, Inc.1995-10-12
TRI-POINT LIQUIMMUNE LIQUID ASSAYED IMMUNOASSAY CONTROL (K954322)Medical Analysis Systems, Inc.1995-10-11
UNITRON MODEL SOUND F/X II (K954516)Unitron Industries, Inc.1995-10-07
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