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

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RecordFirmDate
NOVAPATH SP ADVANCED LIQUID HANDLING SYSTEM (K900775)Bio-Rad1990-03-09
POWDER-FREE VINYL GLOVES (K900149)Good Glove Corp.1990-03-09
ANSELL E.P. EXTRA-PROTECTION EXAMINATION GLOVES (K895781)Ansell Intl.1990-03-09
VENT-TRAP CAT# WR1000 (K900591)Ventlab Corp.1990-03-09
NON-STERILE LATEX PROCEDURE GLOVE (K900869)Sri Johani Sdn. Bhd.1990-03-09
COULTER TRIGLYCERIDES GPO REAGENT (K897159)Coulter Electronics, Inc.1990-03-09
IMMUNOTECH HDL-CHOLESTEROL TEST (K900036)Immunotech Corp.1990-03-09
PATIENT EXAMINATION GLOVES (K893606)Aukland Mfg., Inc.1990-03-09
LATEX PATIENT EXAMINATION GLOVES (K900811)Kenwell International , Ltd.1990-03-09
STERILE LATEX EXAMINATION GLOVE (K900868)Sri Johani Sdn. Bhd.1990-03-09
COULTER ALT (GPT) REAGENT (K897163)Coulter Electronics, Inc.1990-03-09
ROCHE SEPARATING REAGENT FOR HDL CHOLESTEROL (K900120)Roche Diagnostic Systems, Inc.1990-03-09
NICOLET BEAM II SYSTEM (K894629)Nicolet Instrument Corp.1990-03-09
PATIENT EXAMINATION GLOVES (LATEX) (K895941)Gim'S Trading Corp.1990-03-08
LATEX EXAMINATION GLOVES (K900650)Shenzhen Guang JI Emulsion Products Co., Ltd.1990-03-08
MODIFIED SAFE VINYL EXAMINATION GLOVES (K900092)Universal Gloves Corp.1990-03-08
STERLING STYLE 90 SURGICAL GLOVES (K896675)Steril Rubber Sdn. Bhd.1990-03-08
LATEX PATIENT EXAMINATION GLOVES (K896672)U.O.P. Rubber Products Sdn Bhd1990-03-08
POLY PATIENT EXAMINATION GLOVES (K900152)Shanghai Strong Plastic Products Co., Ltd.1990-03-08
LATEX PATIENT EXAMINATION GLOVES (K896673)Alliance Rubber Products Sdn. Bhd.1990-03-08
NIL STERILE LATEX EXAMINATION GLOVES (K900648)United Lion Rubber Industries Sdn. Bhd.1990-03-08
ADD'L USES FOR THE KODAK SURECELL CHLAMYDIA KIT (K900402)Eastman Kodak Company1990-03-08
BIODYNE INSTRUMENT WIPES (K900691)Bio-Dyne, Inc.1990-03-08
POWDER-FREE DANTEX VINYL EXAMINATION GLOVES (K896527)Dan Co., Ltd.1990-03-08
P2/CHEMO PLUS GLOVES (K900368)Biosafety Systems, Inc.1990-03-08
HANDPIECE SYSTEM WITH MOTOR (SEVERAL MODELS) (K896878)Micro Motors, Inc.1990-03-08
LATEX PATIENT EXAMINATION GLOVES (K900499)Premium Fit1990-03-08
DENTAL AIR MOTORS (SEVERAL MODELS) (K896877)Micro Motors, Inc.1990-03-07
ORAD TOOTHBRUSH CLEANER (K895345)Orad, Inc.1990-03-07
ORAL SURGERY HANDPIECE AND ATTACHMENTS (K896879)Micro Motors, Inc.1990-03-07
DYNATORQ DENTAL HANDPIECE ATTACHMENTS (K896876)Micro Motors, Inc.1990-03-07
EXPLORER 24 DENTAL HAND INSTRUMENT (K896843)American Medical Ceramics, Inc.1990-03-06
ALPHA URINE SAMPLE (K900626)Toxi-Lab, Inc.1990-03-06
IMMUNOTECH CHOLESTEROL TEST (K897036)Immunotech Corp.1990-03-06
IN THE EAR HEARING AID (K895368)Hearing Crafters of America1990-03-05
FILPOST (K896928)Ivoclar North America, Inc.1990-03-05
MOBILIMB H3 HAND CPM UNIT (K900794)Toronto Medical Corp.1990-03-02
CMW CEMENT PRESSURISATION SYSTEM (K897134)Dentsply Intl.1990-03-02
APOLIPOPROTEIN B (APO B) (K900124)Sigma Chemical Co.1990-03-02
CONSTI-SSAGE VIBRATOR/MASSAGE (K900674)Bio-Tech Co.1990-03-02
STAT FAX(TM)-2100 (K900224)Awareness Technology, Inc.1990-03-01
CLP CK/LD ISOENZYME/IMMUNO CONTROL (K896465)Creative Laboratory Products, Inc.1990-03-01
STERILE CARBON STEEL SURGICAL BLADE (K900266)Rahn Laboratories1990-03-01
FIAGEN(TM) HLH.S (K900621)Cyberfluor, Inc.1990-03-01
UMI BRAIDED CATHETER CONNECTOR (K897128)Universal Medical Instrument Corp.1990-03-01
COULTER URIC ACID REAGENT (K897161)Coulter Electronics, Inc.1990-03-01
SCHOLTEN FRAME (K900405)Scholten Surgical Instruments, Inc.1990-03-01
ABBOTT COMMANDER PARALLEL PROCESSING CENTER (K897158)Abbott Laboratories1990-03-01
REPEL SURGICAL GLOVE LINERS (K900310)Depuy-Raynham1990-03-01
SPECIMEN CONTAINER (K896794)Westmark, Sterile Packing Systems, Inc. (Sps)1990-03-01
DISCO SUNGLASSES (NON-PRESCRIPTION) (K900387)Le-I Electronic Co. , Ltd.1990-02-28
AIV SYSTEMS' IV POLES (K895776)Automated IV Systems, Inc.1990-02-28
CRYOTRON-UL30 (K900419)Henley Intl.1990-02-27
MODEL F3 FLIP-UP SUNGLASSES W/ACRYLIC ORANGE COMP. (K900523)J & B Assoc.1990-02-27
MODEL F 1 FLIP-UP SUNGLASSES W/POLYCARBONATE BLUE (K900525)J & B Assoc.1990-02-27
LATEX SURGICAL GLOVES (K890019)Argos S.A.1990-02-27
KEY VASCULAR LOOPS (K896676)Key Surgical, Inc.1990-02-27
AUTOREADER CALIBRATION TEST PLATE (K900579)Bio-Tek Instruments, Inc.1990-02-27
POSITIVE AND NEGATIVE HCG SERUM CONTROLS (K896875)Armkel, LLC1990-02-26
VIDAS RESPIRATORY SYNCYTIAL VIRUS (RSV) ASSAY (K896097)Vitek Systems, Inc.1990-02-26
PFM-90 CEILING TUBE SUPPORT (K900234)Fischer Imaging Corp.1990-02-26
REP SPE PLUS-8 (PONCEAU S) 3165, PLUS-8 NO. 3175 (K900251)Helena Laboratories1990-02-26
HOFMANN-NAGEL (HOFNA) X-RAY TUBES (K900367)Hofmann1990-02-26
LIPASE COLOR [TOYO] SERUM LIPASE TEST KIT (K897150)Toyo Jozo Co., Ltd.1990-02-26
BIOTRACK IMMUNOCHEMISTRY MONITOR (K900372)Biotrack, Inc.1990-02-23
HYPEX (K895274)Global Business, Inc.1990-02-23
QUIKREAD(R) WHOLE BLOOD TRIGLYCERIDE TEST KIT (K897169)Photec Diagnostics, Inc.1990-02-23
ABBOTT SPECTRUM URIC ACID REAGENT KIT (K896954)Abbott Laboratories1990-02-23
BICORE VARIFLEX(R) FLOW TRANSDUCER (K896718)Bicore Monitoring Systems1990-02-22
VENTLAB EXHALATION MANIFOLD VX-2000 A & VX-2000 B (K900115)Ventlab Corp.1990-02-22
MIRACLE EAR MODEL SK IN-THE-EAR HEARING AID (K900238)Miracle-Ear, Inc.1990-02-22
MIRACLE EAR MODEL SM IN-THE-EAR HEARING AID (K900237)Miracle-Ear, Inc.1990-02-22
STERILE SURGEON'S GLOVES (C T R GLOVES) (K895230)Tan D. W. Trading Co., Inc.1990-02-22
HYDRASORB(TM) (K897156)Avitar, Inc.1990-02-21
WOODLYN FULL APERTURE TRIAL LENS SET (K900478)Woodlyn, Inc.1990-02-21
TOI-LIFT (K896814)Mill-Tech Ent., Inc.1990-02-20
SKYTRON MODEL 1100 AND MODEL 142 (K900290)Skytron, Div. the Kmw Group, Inc.1990-02-20
SORBEX(TM) SOFT SPONGE (K895654)Fountain Pharmaceuticals, Inc.1990-02-20
DANNIFLEX CPM 880(TM) (K900581)Buckman Co., Inc.1990-02-20
4 SURE URINARY LEG BAG (K896728)The Boston & Pacific Co., Inc.1990-02-20
EXEL INDWELLING CATHETER (K895772)Exel Intl.1990-02-16
RHINOTHERM ULTRA 2 (K894734)Twinmed Products, Inc.1990-02-16
QUIDEL GROUP B STREP TEST (K896265)Quidel Corp.1990-02-16
WILLIAMS PENILE ANESTHETIC RETAINER (K896160)Cook Urological, Inc.1990-02-16
COBAS READY STAT PROFILE REAGENT STRIP (K896234)Roche Diagnostic Systems, Inc.1990-02-16
CRONEX QUANTA RAPID SR397 RARE EARTH INTENS SCREEN (K900448)E.I. Dupont DE Nemours & Co., Inc.1990-02-16
COBAS READY ALT REAGENT (K896237)Roche Diagnostic Systems, Inc.1990-02-16
A-SCAN ROLL-AROUND STAND (K900161)Jedmed Instrument Co.1990-02-16
CHOLESTEROL TEST KIT (K895951)Elite Technology, Inc.1990-02-16
COBAS READY TRIGLYCERIDE REAGENT (K896231)Roche Diagnostic Systems, Inc.1990-02-16
SUCTION CATHETER KIT (K896797)Westmark, Sterile Packing Systems, Inc. (Sps)1990-02-16
IMAGES-ON-CALL TELERADIOLOGY SYSTEM (K896095)Devices & Services Co.1990-02-16
KENLOR PYROGALLOL RED MICROPROTEIN ASSAY KIT (K896440)Kenlor Industries, Inc.1990-02-16
COBAS READY URIC ACID REAGENT (K896227)Roche Diagnostic Systems, Inc.1990-02-16
CENTRIPREP 100 (K900280)Amicon, Inc.1990-02-16
COBAS READY CHOLESTEROL REAGENT (K896239)Roche Diagnostic Systems, Inc.1990-02-16
MODIFIED PARAMAX URIC ACID REAGENT (K896521)Baxter Healthcare Corp1990-02-16
SURGICAL GLOVES (K895018)Lon Tai Chemical Industrial Co., Ltd.1990-02-16
MOBILE X-RAY PERSONNEL PROTECTIVE SCREENS (K896949)Innovative Products Mfg.1990-02-16
TRIFLEX ORTHOPEDIC STERILE SURGEON'S GLOVE (K897192)Baxter Healthcare Corp1990-02-15
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