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

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RecordFirmDate
WESTMED PEDIATRIC AND ADULT AEROSOL MASK (K945472)Westmed Intl.1995-02-07
ROCHE-TDM ONLEIN(TM) CONTROLS (K946119)Roche Diagnostic Systems, Inc.1995-02-07
METZLER, ALPINA, MENRAD, POLICE, L. BIAGIOTTI, CFF, R. LAUREN, POLO, NEOMETAL, L'AMY, NEOSTYLE ETC. (K945680)Solex Marketing, Inc.1995-02-07
CERES 900C & CERES UV900C (K942923)Bio-Tek Instruments, Inc.1995-02-06
CHEMSPEX(TM) AMMONIA CONTROL (K946143)Clinical Controls, Inc.1995-02-03
ULTIMAX POWDER FREE SURGICAL GLOVES (UNBEADED) (K943566)Wembley Rubber Products (M) Sdn Bhd1995-02-03
SCIPOTEX POWDER FREE EXAM GLOVES (BEADED) (K942511)Wembley Rubber Products (M) Sdn Bhd1995-02-03
IMAGE TRANSPORT SERIES III (K925964)Dataview Imaging Intl., Inc.1995-02-03
CALIBRATION GAS (K944998)Sunox, Inc.1995-02-03
MULTIPLE (K945164)Protection Gloves Sdn. Bhd.1995-02-03
SCIPOTEX (K943868)Wembley Rubber Products (M) Sdn Bhd1995-02-03
CONSENUS HIP SYSTEM FEMORAL CANAL STARTER REAMER (K944946)U.S. Medical Products, Inc.1995-02-01
PACSPRO I (K940859)Advanced Video Products, Inc.1995-02-01
CAD ON WHEELS (K946079)Rehab 'N Motion Technologies1995-02-01
CLINICAL BLOOD GAS MIXTURE (K944812)Laboratory & Specialty Gases, Inc.1995-02-01
SUNGLASSES AND SPORT SUNGLASSES (K945528)Lily & Assoicates, Inc.1995-02-01
AVON SUNNY DAYS SUNGLASSES (K946092)Siegel,Mandell & Davidson,P.C.1995-01-31
TECHNOMED C-SCAN COLOR ELLIPSOID TOPOMETER (K945382)Expertech Assoc., Inc.1995-01-31
SK S-RAY GRIDS (K945697)Seibu Techno Coproration1995-01-31
FI, GORDY TOY, WELLJOY AND OTHERS (K946004)Fundamental Industrial Co., Ltd.1995-01-31
URETHRAL SUTURE GUIDE (K950267)Applied Medical Resources1995-01-31
AVON SUNNY DAYS SUNGLASSES (K946091)Siegel,Mandell & Davidson,P.C.1995-01-31
OTICON (K946045)Oticon, Inc.1995-01-30
MAICO IN-THE-EAR MODEL RD 201 (K946253)Maico Hearing Instruments, Inc.1995-01-30
CERTAIN(R) ELITE LEVEL 1, 2 AND 3 (K946224)Ciba Corning Diagnostics Corp.1995-01-30
DISCRETE PHOTOMETRIC CHEMISTRY ANALYZER (K943493)Hamilton Co.1995-01-30
UNITRON MODEL VISTA 1000 SIGMA, AIR CONDUCTION HEARING AID (K946323)Unitron Industries, Inc.1995-01-30
LX-ITC (K946071)Widex Hearing Aid Co., Inc.1995-01-30
MASSAGING HELMET C.F. HANSEN DESIGN (K940582)Philco Ushuaia1995-01-30
3M(TM) EAR IMPRESSION MATERIAL (K945726)3M Medical Products Group1995-01-27
RAPID YEAST PLUS SYSTEM (K943621)Innovative Diagnostic Systems, Inc.1995-01-27
CUSTOM MEDICAL SUSPENSION STRAP (K944988)Custom Medical Specialties, Inc.1995-01-27
CONSENUS HIP SYSTEM -- ACETABULAR REAMER (K945186)U.S. Medical Products, Inc.1995-01-27
CONSENSUS HIP SYSTEM -- CALCAR PLANER (K945189)U.S. Medical Products, Inc.1995-01-27
GLENROE ORTHO-SIL (K945535)Glenroe Technologies1995-01-27
PROLEX (STREPTOCCAL GROUPING LATEX KIT) (K934383)Pro-Lab, Inc.1995-01-27
MASK, GAS, ANESTHETIC (K945894)Hans Rudolph, Inc.1995-01-27
CHOLESTEROL QVET (K943027)Prisma Systems1995-01-27
M4 CONTRA-ANGLE HANDPIECE (K942480)Kerr Corporation (Danbury)1995-01-27
CONSENSUS HIP SYSTEM -- TROCHANTERIC CUTTER (K945208)U.S. Medical Products, Inc.1995-01-27
HUKUBA HYG ELECTRIC IONIC TOOTHBRUSH (K945248)Hukuba Dental Corp.1995-01-26
INTRASCAN II (K944771)Markcare Medical Systems, Inc.1995-01-26
TRU-TOUCH MEDICAL GLOVES (K944183)Bd Becton Dickinson Vacutainer Systems Preanalytic1995-01-26
PHONAK SONO-FORTE 332X-AZ (K946294)Phonak, Inc.1995-01-26
UNITRON MODEL SOUNG F/S (K946264)Unitron Industries, Inc.1995-01-26
ABUSCREEN ONTRAK POSITIVE CONTROL (K943999)Roche Diagnostic Systems, Inc.1995-01-25
CARDIOSPEX(TM) LIQUID CKMB/LD-1 IMMUNOINHIBITION (K946146)Clinical Controls, Inc.1995-01-24
CARDIOSPEX(TM) CKMB/LD-1 IMMUNOINHIBITION CONTROL (K946145)Clinical Controls, Inc.1995-01-24
3M MODEL 8233 HEARING INSTRUMENT (K943854)3M Company1995-01-24
3M(TM) SURGICAL SLIPPER, 9660 SERIES (K946162)Wahl Clipper Corp.1995-01-24
CYBERRX MODEL 7200 (K934434)Cybermed Control Systems, Inc.1995-01-24
SYMBIOSIS GASTROINTESTINAL BIOPSY FORCEPS (K946238)Symbiosis Corp.1995-01-20
HORMANN HEARING INSTRUMENTS (K945219)Hormann, Inc.1995-01-20
JPI X-RAY GRID (K945327)Jpi America, Inc.1995-01-20
NEONATAL RESTRAINT AND COMFORT SYSTEMS (K943017)K.Bowmed, Inc.1995-01-19
NASAL SPLINT (K945555)Ultracell Medical Technologies, Inc.1995-01-19
RESOUND PERSONAL HEARING SYSTEMS MODIFICATION (K934917)Resound Corp.1995-01-19
AGILANCE-GOLDEN SPOONS (K936178)Oismuller & Partner Keg1995-01-18
PREMIER MIRROR WARMER (K945395)Premier Dental Products Co.1995-01-18
SOUND SELECTOR ITE (SSI), BTE (SSB), MINI BTE( SSM) (K944980)Hearing Solutions, Inc.1995-01-18
ANTERIOR/POSTERIOR EPISTAXIS CATHETER (K945556)Ultracell Medical Technologies, Inc.1995-01-18
STERILE EXTRA PROTECION SURGEON'S GLOVES (K922979)Ansell Malaysia Sdn Bhd1995-01-18
STERISEAL OPHTHALMIC CANNULA (K943932)Pharma-Plast, Ltd.1995-01-18
KODAK EKTACCHEM 950IRC ANALYZER (K946090)Clinical Diagnostic Systems, Inc.1995-01-17
SPECTRUM CO-OXIMETER LINEARITY CONTROL (K945860)Phoenix Diagnostics, Inc.1995-01-17
SUNGLASSES (K946256)Chanel, Inc.1995-01-17
ELASTYREN(R) SURGICAL GLOVES (K945833)Eci Medical Technologies, Inc.1995-01-17
EYEWEAR/SPECTACLES (K945925)Kovision Mfg., Ltd.1995-01-17
DOCUMENT(R) HDL CHOLESTEROL CALIBRATION VERIFICATION TEST SET (K945718)Casco Standards1995-01-17
MODEL 2721 CLINICAL REFRACTOMETER (K941901)Vee Gee Scientific, Inc.1995-01-17
MODEL 2730 CLINICAL REFRACTOMETER (K941906)Vee Gee Scientific, Inc.1995-01-17
PROWAY (K946132)Union Industrial Co., Ltd.1995-01-17
QUANITITATE GBCC VERIFIER SET (K944454)Beckman Instruments, Inc.1995-01-17
SAS QUANT HCG SERUM (K944785)Sa Scientific, Inc.1995-01-17
EYE COOLER (K946231)Direct Import Marketing Co.1995-01-17
QUANTITATE ELECTROLYTE VERIFIER SET (SERUM RANGE) (K944455)Beckman Instruments, Inc.1995-01-17
LATEX EXAMINATION GLOVE, PATIENT (POWDER-FREE) (K946155)Mala Intertrade Co., Ltd.1995-01-17
MODEL 2740 CLINICAL REFRACTOMETER (K941903)Vee Gee Scientific, Inc.1995-01-17
SUNGLASSES (K945920)Glendale Protective Technologies, Inc.1995-01-17
SPIRO-FLEX (K945565)Inhalation Plastics1995-01-13
LATERAL FLEXION MACHINE (K940455)Rehab, Inc.1995-01-12
BIOSTRIP STERILE WOUND CLOSURE STRIP (K946321)Cornelia Damsky, Inc.1995-01-12
HEINE LAMBDA 100 (K944156)Heine USA , Ltd.1995-01-12
SUNGLASSES (K945988)R.J. Standard Corp.1995-01-12
HAIR REMOVAL SYSTEM (K945192)L.P. Systems Corp.1995-01-12
APILUS ELECTROPIL (K943928)Dectro Intl., Inc.1995-01-12
SPONGE COUNT (K945144)Michael Fischer Assoc.1995-01-12
CURAFOAM ANDD CURAFOAM PLUS HYDROPHILIC POLYURETHANE FOAM DRESSINGS (K946269)Kendall Healthcare Products Co. Div.Of Tyco Health1995-01-12
POWERR RANGERS SUNGLASSES (K945917)Dollar Land Stores, Inc.1995-01-12
ALLDRESS MULTI LAYERED WOUND DRESSING (K945206)Scott Health Care1995-01-12
MALA LATEX EXAM GLOVES AND SCAN-SUB (K946154)Lowenkamp Intl., Inc.1995-01-11
AMALGAM CARRIER (K945220)Buffalo Dental Mfg. Co., Inc.1995-01-11
ROYALSHIELD NON-STERILE POWDER-FREE (K945031)Shield Gloves Manufacturer (M) Sdn Bhd1995-01-11
IMAGEN (K943557)Dako Diagnostics , Ltd.1995-01-09
SUNGLASSES (K944568)Great Field Industries Co., Ltd.1995-01-09
PLATO 3300/1300 (K943454)Rosys, Inc.1995-01-09
POWER RANGERS SUNGLASSES (K945823)Avon Products, Inc.1995-01-09
SWIMEX MULTIDEPTH POOL (MODEL 600T) (K935011)Swimex Systems1995-01-09
VETTA LIGHTWEIGHT CYCLING EYEWEAR (K945683)Shaw, Pittman, Potts & Trowbridge1995-01-05
SUNLGASSES, SPORT SUNGLASSES & FISHING GLASSES (K945735)Shu Gie Industrial Co., Ltd.1995-01-05
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