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

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RecordFirmDate
THERMAFIL ENDODONTIC OBTURATOR (K900986)Tulsa Dental Products, Ltd.1990-11-13
RAICHEM (TM) SPIA (TM) - ACID GLYCOPROTEIN REAGENT (K904175)Reagents Applications, Inc.1990-11-13
ACCUPROBE STREPTOCOCCUS PYOGENES CULTURE CONFIRM. (K904268)Gen-Probe, Inc.1990-11-13
DENTAL CLEANING RINGS (K902325)H. Bernath & Assoc.1990-11-13
R-800-SF (K904182)Advantech1990-11-13
TEC 1410 (K904397)Bay Shore Medical Equipment Corp.1990-11-13
ACCUPROBE MYCOBACTERIUM KANSASII CULT CONFIRM TEST (K904463)Gen-Probe, Inc.1990-11-13
EXTENDED LIFE CIRCUITS (K903055)Pharma Systems, Inc.1990-11-09
BEST LABS MODEL S (K903473)Best Labs1990-11-09
BACT-HME (TM) (K903058)Pharma Systems, Inc.1990-11-09
REP ULTRA HDL,VLDL/LDL CHOLESTEROL SYSTEM (K904035)Helena Laboratories1990-11-09
KODATROL I AND II CONTROL AND DILUENT SET (K904768)Eastman Kodak Company1990-11-09
OROSCOPE MODEL NUMBER COS-100 (K903718)Cygnus Instruments, Inc.1990-11-09
LANCER ORIGINAL, SIERRA, GENERAL PURPOSE (K904092)Lancer Orthodontics, Inc.1990-11-09
BEST LABS MODEL P (K903471)Best Labs1990-11-09
BEST LABS MODEL M (K903472)Best Labs1990-11-09
DIOLASE (K904753)Scanditronix, Inc.1990-11-09
BEST LABS MODEL C (K903474)Best Labs1990-11-09
PERFORMED TEMPLATE W/FRAGRANCE FOR TOOTH POSTIONER (K904128)American Orthodontics1990-11-09
PATIENT EXAMINATION GLOVES (K904936)Slim River Latex Sdn. Bhd.1990-11-08
CIBA CORNING ACS PROLACTIN IMMUNOASSAY (K904714)Ciba Corning Diagnostics Corp.1990-11-07
HANDI-TRAK WHEELCHAIR SNOW CHAINS (K904913)Handi-Trak, Inc.1990-11-07
BUCCAL TUBE, BUCCAL ATTACHMENT (K904093)Lancer Orthodontics, Inc.1990-11-07
STERILE SURGEONS GLOVES (ULTRA-TOUCH-LATEX) (K904320)R.K.F. Laboratories, Inc.1990-11-07
BIOCLONES ELEGANCE LH ELISA KIT (K904387)Bioclone Australia Pty , Ltd.1990-11-06
TITANAL,STERLING SPRING,DUAL FLEX,MEMOREX,BENDALLO (K904091)Lancer Orthodontics, Inc.1990-11-05
ELEGANCE PROLACTIN ELISA (K904483)Bioclone Australia Pty , Ltd.1990-11-05
CHILDRENS SUNGLASSES (K904197)Jasco Products Co., Inc.1990-11-05
GASTROGRAPH (K903646)Medics Instrument Corp.1990-11-05
SOLARSHIELDS ENCORE (K903487)Dioptics1990-11-05
ALLERGY CONTROL COVERS (K903382)Allergy Control Products, Inc.1990-11-02
SERACON CR REFERENCE (K904503)Bhp Diagnostix, Inc.1990-11-02
BRADLEY TENACULUM HOLDER (K903649)Marlo Surgical Technology1990-11-02
QUALICHECK 3 (K904733)Radiometer America, Inc.1990-11-02
LATEX EXAMINATION GLOVES (K902956)Pacificlink Export Industries Private , Ltd.1990-11-02
PERMA MESH (K904089)Lancer Orthodontics, Inc.1990-11-02
HEVEASHIELD EXAMINATION GLOVES (K902700)Pacificlink Export1990-11-02
C.A.T.,SINTERLINE,NATURAL ARCH,MICROTWIN,BIOTORQUE (K904094)Lancer Orthodontics, Inc.1990-11-02
TDM PLUS XL ENHANCED LIQ DRUG CONTROL I,II,III (K904141)Medical Analysis Systems, Inc.1990-11-01
OTICAON BTE MODEL E34P (K904673)Oticon Corp.1990-11-01
CLINICAL BLOOD GAS MIXTURES (K904163)Norco, Inc.1990-11-01
OXYGEN, AIR, VACUUM & NITROUS-OXIDE COUPLERS (K904757)Medical Fittings, Inc.1990-10-31
ELLA BREAST FORM (K904085)Coloplast A/S1990-10-31
ISLAM STERNAL PUNCTURE NEEDLE, CAT # AG-592-00-U (K903747)Downs Surgical , Ltd.1990-10-31
ISLAM STERNAL PUNCTURE NEEDLE, CAT #AG-598-OO-E (K903750)Downs Surgical , Ltd.1990-10-31
MEDI FITT/OXEQUIP OXYGEN/AIR MALE QUICK CONNECTS (K904702)Medical Fittings, Inc.1990-10-31
MEDI FITT/OHMEDA OXY/AIR/VAC&NIT-OXI MALE QK CONN (K904701)Medical Fittings, Inc.1990-10-31
HME-10 (TM) (K903054)Pharma Systems, Inc.1990-10-31
TKO TELESCOPING LITHOTOMY STIRRUP (K904826)D.L. Nelson and Assoc., Inc.1990-10-31
ISLAM STERNAL PUNCTURE NEEDLE, CAT #AG-596-00-U (K903749)Downs Surgical , Ltd.1990-10-31
PRIZM HEARING SYSTEM (K902846)Audioscience, Inc.1990-10-31
SUCTION SYSTEM (K904218)Axiom Medical, Inc.1990-10-31
ISLAM STERNAL PUNCTURE NEEDLE, CAT # AF-594-00-V (K903748)Downs Surgical , Ltd.1990-10-31
LASER TRAP 100 LASER PLUME SMOKE EVACUATION FILTER (K902056)Hollister, Inc.1990-10-30
MODIFICATION AUTO SUTURE(R) ENDOSCOPIC CLAMP (K904578)United States Surgical, A Division of Tyco Healthc1990-10-30
SOPHYCAMERA DSM 315 (K903030)Provino1990-10-29
NON-STERILE LATEX DENTAL PROCEDURE GLOVES (K903857)Formtex Medical Sdn. Bhd.1990-10-29
AMPRO LATEX EXAM GLOVE (K904740)American Pro Latex, Inc.1990-10-26
BLIND CONTROLS FOR DRUGS OF ABUSE TESTING (K903909)Rapid Diagnostic Laboratories, Inc.1990-10-26
BIOCLONES ELEGANCE FSH ELISA KIT (K904405)Bioclone Australia Pty , Ltd.1990-10-26
POST MYDRIATIC SPECTACLES (K904585)Yorktowne Optical Co., Inc.1990-10-26
SAFTE ORIONE HERNIA BELT ITEMS NO. 316, 515, 536 (K901922)Safte S.P.A.1990-10-26
URIC ACID/IRON/MAGNESIUM LINEARITY STANDARDS (K904099)Hichem Diagnostics1990-10-26
IRRICLEAR EAR IRRIGATION SYRINGE (K903759)Nortech Laboratories, Inc.1990-10-26
BAXTER SINGLE PATIENT USE PRESSURE INFUSOR (K904484)Tecnadyne Scientific, Inc.1990-10-26
ILC LEG BAG HOLDER (K903611)Inman Liebelt Corp.1990-10-26
SURGIMEDICS, SLP LAPAROSCOPIC CHOLANGIOGRAM CATH (K903709)Lifestream Int'L, Inc.1990-10-26
SUNGLASSES (K903902)K & P Trading Co., Inc.1990-10-26
LATEX EXAMINATION GLOVES (K903111)Kaen Yang Industry Co., Ltd.1990-10-26
LUBRICATING JELLY (K903910)Lake Pharmaceutical, Inc.1990-10-26
AUKUFLEX(TM) RADIATION RESISTANT GLOVES (K903142)Aukland Mfg., Inc.1990-10-26
RECEIVING BLANKET (K904274)Anago, Inc.1990-10-26
A-DEC DECADE CUSPIDOR (K903455)A-Dec, Inc.1990-10-24
A-DEC DECADE 1010 CHAIR (K903454)A-Dec, Inc.1990-10-24
SUPER STRENGTH DENTURE ADHESIVE CREAM (K903568)Teledyne Getz1990-10-24
A-DEC DECADE 1015 CHAIR (K903450)A-Dec, Inc.1990-10-24
A-DEC IC CONTROL HEAD (K903452)A-Dec, Inc.1990-10-24
A-DEC IC MICRO-CART (K903453)A-Dec, Inc.1990-10-24
A-DEC PAC I PORTABLE UNIT (K903451)A-Dec, Inc.1990-10-24
DEODORIZING AND SOUND MUFFLING ANAL PAD (K903342)Biological Resistance, Inc.1990-10-23
RESU-GARD CATHETER SUCTION (K902093)Amg Medical Equipments, Inc.1990-10-23
ALLEVYN DRESSING CLAIMS CHANGE (K904412)Smith & Nephew United, Inc.1990-10-23
SUNSHADES, ACRYLIC LENSES #SG-01 (K902301)Tel-Time Products1990-10-23
49-610 NIKO-NOSE FIXATION TAPE (K902896)Nikomed U.S.A., Inc.1990-10-23
PANORAMIC OMEGA IMAGING TABLE (K903988)Med-Tron Products, Inc.1990-10-23
PATIENT EXAMINATION GLOVES (K903703)P.T. Tulip Indah Agung1990-10-22
SEROTONIN ENZYME IMMUNOASSAY (K903609)Immunotech Corp.1990-10-22
SYNCHRON CX 7 CLINICAL ANALYZER (K904219)Beckman1990-10-22
CLUB FOOT CPM MACHINE (K903851)Smith & Nephew Richards, Inc.1990-10-19
LATEX EXAMINATION GLOVES(MFG: MODLOOK INDUSTRIES) (K904641)Predex Co. , Ltd.1990-10-19
VINYL EXAMINATION GLOVES(MFG:KAO YING INDUSTRIAL) (K904642)Predex Co. , Ltd.1990-10-19
KERATOME (K903912)Micro Precision Instrument Co.1990-10-17
PATIENT EXAMINATION GLOVES (K904443)Pisak Enterprise Co., Ltd.1990-10-17
VIRAL ACCU-CULSHURE TM (K903406)Medical Laboratory Automation Systems, Inc.1990-10-16
CHLAMYDIA ACCU-CULSHURE TM (K903405)Medical Laboratory Automation Systems, Inc.1990-10-16
EBV/EA-CHECK TM TEST KIT (K903612)Diagnostic Technology, Inc.1990-10-16
BIOMEK AUTOMATED LABORATORY WORKSTATION W/GENELISA (K903626)Beckman Instruments, Inc.1990-10-15
DSL SEX HORMONE BINDING GLOBULIN (SHBG) (DSL 6300) (K904100)Diagnostic Systems Laboratories, Inc.1990-10-15
SYNCHRON CX4-CE (K904220)Beckman1990-10-15
DUPONT DRUG CALIBRATOR-A (K904306)E.I. Dupont DE Nemours & Co., Inc.1990-10-15
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