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

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RecordFirmDate
THERMAPREP (K910224)Tulsa Dental Products, Ltd.1991-03-29
SWIRL PROPHYLAXIS PASTE (K903986)Bio-Medica Concepts1991-03-28
SURGICAL TISSUE POUCH (K910914)Cook Urological, Inc.1991-03-28
MEGA GENERAL PURPOSE INSTRUMENT KIT (K910366)Megadyne Medical Products, Inc.1991-03-28
INCISION AND DRAINAGE KIT (K910369)Megadyne Medical Products, Inc.1991-03-28
SURGICAL CLIPPER (K910524)Baxter Healthcare Corp1991-03-28
SUTURE REMOVAL KIT (K910361)Megadyne Medical Products, Inc.1991-03-27
SLT MICROPLATE WASHER (K910740)Tecan U.S., Ltd.1991-03-27
X-RAY TUBE HOUSING ASSEMBLY POLARIX II GEN/XO 110 (K910308)Inmark Corp.1991-03-27
CIBA CORNING MAGIC LITE CHLAMYDIA IMMUNOASSAY (K904189)Ciba Corning Diagnostics Corp.1991-03-27
ES/ULTRA DISPLAY AND PROCESSING STATION (K905412)Toshiba America Medical Systems, In.C1991-03-25
DYNAMIC SPECTRAL PHONOCARDIOGRAPH (K902185)Reeves Scientific, Inc.1991-03-25
NEEDLESTICK PROTECTIVE GLOVE (K905527)Medev Corp.1991-03-22
PORTA GAS COMPRESSED GAS CYLINDER CART (K910071)Sen Tech Medical Corp.1991-03-22
U.S. MEDICAL PS-2000 PEDIATRIC SCALE (K910582)U.S. Medical Corp.1991-03-21
MCCONNELL SHOULDER BRACE (K910974)Mcconnell Orthopedic1991-03-21
DAHLBERG MODEL LZ BTE HEARING AID (K911096)Miracle-Ear, Inc.1991-03-21
DAHLBERG MODEL LG BTE HEARING AID (K911064)Miracle-Ear, Inc.1991-03-21
LATEX PATIENT EXAMINATION GLOVES (K911081)Medical Device Inspection Co., Inc.1991-03-21
TRICHINELLA SEROLOGY MICROTITER ELISA (K904613)Lmd Laboratories1991-03-21
STETHOSCOPE (K904547)Kimball Industries Co., Ltd.1991-03-21
MINICLINIC OVULATION PREDICTION TEST (K910351)Vanguard Biomedical Corp.1991-03-21
EXPANDACEL NASAL TAMPONS (K904624)Ron Shippert, MD1991-03-21
DAHLBERG MODEL LU BTE HEARING AID (K911063)Miracle-Ear, Inc.1991-03-21
P.I.V. COMPLEMENT-FIXATION (C.F.) ANTIGEN (K905385)Virion (U.S.), Inc.1991-03-21
U.S. MEDICAL PS-1000 PEDIATRIC SCALE (K910581)U.S. Medical Corp.1991-03-21
DAHLBERG MODEL LT BTE HEARING AID (K910979)Miracle-Ear, Inc.1991-03-21
FORTRESS AEROEDGE 3-WHEEL MANUAL RACING WHEELCHAIR (K910747)Fortress Litestyle1991-03-21
U.S. MEDICAL PS-3000 NEONATAL SCALE (K910583)U.S. Medical Corp.1991-03-21
DAHLBERG MODEL LB BEHIND-THE-EAR HEARING AID (K910809)Miracle-Ear, Inc.1991-03-21
JACKSON-PRATT, HIGH LUBRICITY AND WOUND DRAINS (K905614)Baxter Healthcare Corp1991-03-20
HPI SENSI-SHIELD GLOVE KIT (K910383)Hpi, Inc.1991-03-20
ELASTIC ADHESIVE BANDAGE (K910436)Byron Medical1991-03-19
MEDICOPASTE BANDAGE WITH CALAMINE/MODIFICATION (K904904)Graham-Field, Inc.1991-03-19
ORTHO* CHLAMYDIA ANTIGEN ELISA TEST/MODIFICATION (K910668)Ortho Diagnostic Systems, Inc.1991-03-19
REDDICK IRRIGATION/ASPIRATION SYSTEM (K910117)Ideal Medical, Inc.1991-03-19
IPAZYME (TM) CHLAMYDIA IGG-IGA (K910644)Savyon Diagnostics , Ltd.1991-03-19
CHEMTRAK ACCUMETER CHOLESTEROL TEST (K905405)Chemtrak, Inc.1991-03-19
PANTEX IRMA LH 1251 KIT (K910717)Pantex, Div. Bio-Analysis, Inc.1991-03-19
C ABRA MODEL LINEAR, LOW DRAIN CUST CANAL HEAR AID (K910312)Ototech, Ltd.1991-03-18
CUSTOM ITE HEARING AID (K905784)Hearing Aid Co.1991-03-18
ABRA IPC MODEL INPUT COMPRES AGCCUST ITE HEAR AID (K910313)Ototech, Ltd.1991-03-18
ABRA MODEL LINE LOW DRAIN CUST IN-THE-EAR HEAR AID (K910311)Ototech, Ltd.1991-03-18
C ABRA MODEL LINEAR, LOW DR. CUSTOM CANAL HEAR AID (K910314)Ototech, Ltd.1991-03-18
ACCU-MIX AMALGAMATOR (K910632)Wykle Research, Inc.1991-03-15
SENTRY SCALE (K905122)Apollo Enterprise, Ltd. Co.1991-03-15
MATRICS (K904756)Kerr Corporation (Danbury)1991-03-15
ITE HEARING AID (K905371)Audicare Hearing Center1991-03-15
OPTICAL FRAME (HELEN,ARNOLD,VANA,BRUCE,MATT) (K910134)Kentucky Optical Co.1991-03-15
INTEGO (K910904)Racal Health & Safety, Inc.1991-03-15
SUNGLASSES/NON-PRESCRIPTION (LA GIARDINIERA) (K910125)The Limited Stores, Inc.1991-03-14
SUNGLASSES (NON-PRESCRIPTION) (K905864)The Limited Stores, Inc.1991-03-14
SUNGLASSES, NON-PRESCRIPTION (ITALO CREMONA) (K910126)The Limited Stores, Inc.1991-03-14
SUNGLASSES, NON-PRESCRIPTION (POLINELLI) (K910127)The Limited Stores, Inc.1991-03-14
INFANT REFLUX SLING (K905630)Pedicraft, Inc.1991-03-13
MANHANDLER (K905381)Lifeport, Inc.1991-03-13
PEDICRAFT INFANT REFLUX WEDGE (K905629)Pedicraft, Inc.1991-03-13
3M MODEL 8240 ITE HEARING AID (K910690)3M Company1991-03-13
CLOSTRIDIUM DIFFICILE TOXIN A ENZYME IMMUNOASSAY (K904329)Baxter Healthcare Corp1991-03-12
SYVA MICROTRAK CHLAMLYDIA EIA, MODIFICATION (K905179)Syva Co.1991-03-12
SUNGLASSES (K910329)Cutler & Gross Sloan Optical , Ltd.1991-03-12
BACT/ALERT (TM) (K903505)Organon Teknika Corp.1991-03-12
NEXT WAVE(R) PHYSIOACCOUSTIC(TM) CHAIR (K905256)Next Wave, Inc.1991-03-12
RETAINER, SCREW EXPANSION ORTHODONTIC (K903498)Masel Industries, Inc.1991-03-12
STERILE SURGEON'S GLOVES (K902449)Unigloves , Ltd.1991-03-12
LARES APOLLO CS AND S HANDPIECE LIGHTING SYSTEMS (K905542)Lares Research, Inc.1991-03-11
ABUSCREEN(R) ONLINE CONTROLS (K910689)Roche Diagnostic Systems, Inc.1991-03-11
CHEMA CHOL CHOLESTEROL SYSTEM (K904031)Texas Intl. Laboratories, Inc.1991-03-11
SYSTEMATE TRIGLYCERIIDES (EPOS APPLICATION) #65477 (K910638)Em Diagnostic Systems, Inc.1991-03-11
BACTEC NR-860 (K910835)Bd Becton Dickinson Vacutainer Systems Preanalytic1991-03-11
PVC VINYL GLOVE (K910891)Pioneer Sundries Products , Ltd.1991-03-11
543 SERIES BTE (K905680)Hearing Tech, Inc.1991-03-08
NON-STERILE PATIENT EXAMINATION GLOVES (K905755)Superior Healthcare Group, Inc.1991-03-08
POST AURICULAR HEARING AID MODEL PICO SC-H (K910028)Phonak, Inc.1991-03-08
PATIENT EXAMINATION GLOVES (K904697)Shamrock Marketing Co.1991-03-08
IPAZYME(TM) CHLAMYDIA TRUE IGM(TM) (K901975)Savyon Diagnostics , Ltd.1991-03-08
LARES 757 WORKHORSE HIGHSPEED HANDPIECE (K905541)Lares Research, Inc.1991-03-07
AM GLOVES STERILE VINYL EXAMINATION (K910774)Am Gloves Co., Ltd.1991-03-07
SUNTEX STERILE EXAM GLOVES (K910631)P.T. Latexindo Prautama1991-03-07
VPW 2877E6 X-RAY POWER SUPPLY (K910820)Varian Canada, Inc.1991-03-07
AUTO SUTURE(R) POLYMER SKIN GRAFT STAPLER* (K910586)United States Surgical, A Division of Tyco Healthc1991-03-07
BOSTON(R) BRAND LATEX EXAM GLOVES/HYPOALLERGENIC (K910660)Boston Medical Corp.1991-03-07
JM GLOVES STERILE VINYL EXAMINATION (K910775)Jm Gloves Co., Ltd.1991-03-07
SENSI RADS LEAD LATEX RADIATION PROT. GLOVE, STER. (K904878)Hpi, Inc.1991-03-07
X-RAY TUBE HOUSING ASSEMBLY SOREDEX DC/CIR 51 (K910276)Inmark Corp.1991-03-06
ORTHOVISION TABLE (K905816)American Sterilizer Co.1991-03-06
DISPOSABLE YANKAUER SUCTION TUBE (K904881)Pilling Medical S.A.1991-03-06
INAMED RUIZ-COHEN INTRAOPERATIVE TISSUE EXPANDER (K904265)Inamed Development Co.1991-03-06
CRP LIPID REAGENT TEST PACK (K905648)Cirrus Diagnostics, Inc.1991-03-06
KEY COMFORT GRIPS (K910328)Key Surgical, Inc.1991-03-06
MICRO-X 80HF (K905695)Fischer Imaging Corp.1991-03-06
CONVATEC ABSORBENT BANDAGE (K904233)Convatec, A Division of E.R. Squibb & Sons1991-03-06
LAPAROTOMY SPONGES (K905135)American Healthcare Corp.1991-03-06
OMIBAND (K904445)Omikron Scientific, Ltd.1991-03-06
ELLIPSE PUNCH (K904869)Kramer Const1991-03-06
DRAINAGE TUBE RESTRAINT/WOUND COVER (K905766)M. Imonti and Associates Inc.,1991-03-06
DI2000/HS-45-150 X-RAY TUBE INSERT (K910842)Comet Ltd. C/O Radiology Resources, Inc.1991-03-06
MONTROSE DRESSING APPLICATORS (K905519)Olemunda Pty , Ltd.1991-03-06
SOLID CORE GUTTA PERCHA CARRIER (K905640)The Hygenic Corp.1991-03-05
FORTRESS EDGE MANUAL RIGID WHEELCHAIR (K910748)Fortress Litestyle1991-03-05
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