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

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RecordFirmDate
ANSWER DENTAL IMPLEMENT, EXPLORER (K894896)Tern Chien Ent. Co., Ltd.1989-10-30
VMA EIA KIT YAMASA (K895287)Yamasa Shoy Co., Ltd.1989-10-30
AEROVENT (K894969)Monaghan Medical Corp.1989-10-30
ANSWER DENTAL IMPLEMENTS, MIRROR (K894895)Tern Chien Ent. Co., Ltd.1989-10-30
CIBA CORNING CERTAIN LYTE (K894576)Ciba Corning Diagnostics Corp.1989-10-30
ANSWER DENTAL IMPLEMENT, FORCEPS (K894897)Tern Chien Ent. Co., Ltd.1989-10-30
LARYNGOSTAT LARYNGOSCOPE HANDLE (K895954)Michigan Instruments, Inc.1989-10-30
LATEX PATIENT EXAMINATION GLOVES (K894908)Shanghai Shen Hua Rubber and Plastics Co. , Ltd.1989-10-27
FILMFAX (K895209)Discovery Systems, Inc.1989-10-27
DIRD INGANT O2 (BIO 2 HOOD) (K895866)Bird Products Corp.1989-10-27
SURGICAL GLOVES (K894010)Green Cross Medical Supplies Corp.1989-10-27
HEDY PATIENT EXAMINATION GLOVES (LATEX) (K891671)Hedd Industry Corp.1989-10-27
SHILEY ELBOW 15MM SWIVEL CONNECTOR (K895388)Shiley, Inc.1989-10-27
RELOADING OF X-RAY TUBE HOUSING ASSEM., VARIOUS (K894742)Inmark Corp.1989-10-27
SOPHYCAMERA DSX RECTANGULAR (K894931)Sopha Medical Systems, Inc.1989-10-27
PAQ10 PAPER CHART RECORDER (K894607)Protocol Systems, Inc.1989-10-26
GEL ALKALINE PHOSPHATASE ISOENZYME CONTROL NO.5104 (K895528)Helena Laboratories1989-10-25
PLASMA CATECHOLAMINES BY HPLC (K894966)Bio-Rad1989-10-25
BACKGROUND SUCTION MATT (K895727)Applied Medical Technologies, Inc.1989-10-24
FDL, INC.'S TRANSPORT SYSTEM (K895187)Fairleigh Dickinson Laboratories, Inc.1989-10-24
VESSEL LOOPS (K895682)Applied Medical Technologies1989-10-24
BERNARD VESSEL APPROXIMATOR (K895683)Applied Medical Technologies1989-10-24
PEMACO ECONOMY BASE PLATE WAX-MEDIUM HARD (K895565)Pemaco, Inc.1989-10-24
DE-BOND 200 (K883418)Scheu-Dental1989-10-24
HEARING AID (IN-THE-EAR) (K894428)Hearing Aid Express1989-10-24
QUANTEX ASO PLUS (LATEX,BUFFER STANDARD,CONTROL) (K894486)Biokit USA, Inc.1989-10-24
3M INSTANT FIT CUSTOM EARMOLD (K895134)3M Company1989-10-24
VESSEL OCCLUDER (K895726)Applied Medical Technologies1989-10-24
CONTRAST BACKGROUND MATERIAL (K895681)Applied Medical Technologies1989-10-24
FOLLICLE STIMULATING HORMONE MAB SOLID PHASE COM. (K895108)Bd Becton Dickinson Vacutainer Systems Preanalytic1989-10-23
URIC ACID PAP (K895665)Boehringer Mannheim Corp.1989-10-23
MICRO-PLATE READER, MDX-1 (K894400)Medix Biotech, Inc.1989-10-23
SILICONE INSTRUMENT SHODS (K895591)Key Surgical, Inc.1989-10-20
PATIENT EXAMINATION GLOVES (LATEX) (K891301)Taiping Leasing Corp. Sdn. Bhd.1989-10-20
DELTA-TECH(TM) CAST REMOVAL SYSTEM (K895861)Johnson & Johnson Professionals, Inc.1989-10-19
ANETHESIA BREATHING CIRCUIT (K895357)F.L.W. Plastics, Inc.1989-10-19
IRRI-EVACUATOR (K895757)Mikro-Tek Laboratories1989-10-19
SLEEPAP MASK (K894642)Medical Industries America, Inc.1989-10-19
INTERTECH METERED DOSE ELBOW (K895144)Intertech/Ohio1989-10-19
EXUSORB(TM) GEL DRESSING (K895606)Controlled Therapeutics Corp.1989-10-19
CANULA SUCTION FOR SURGICAL GENERAL AND PLASTIC (K895762)Kolster Methods1989-10-18
PRECISION DENTAL ATTACHMENTS (K895986)Implant Support Systems, Inc.1989-10-18
DIAMOND BLADE SURGICAL KNIVES (K895752)Magnum Diamond, Inc.1989-10-17
SR1 PROLACTIN (PRL IMMUNOENZYMETRIC ASSAY (K895380)Serono-Baker Diagnostics, Inc.1989-10-17
MICROLITE ML 1000 (MODEL 3) MICROPLATE LUMINOMETER (K895313)Dynatech Laboratories, Inc.1989-10-17
CLINISTAT POTASSIUM REAGENT TEST (K895047)Heraeus Kulzer, Inc.1989-10-17
IMMULON 1,2,3,AND 4 DIVIDASTRIPS TM (K894645)Dynatech Laboratories, Inc.1989-10-17
SOURCERER (K894902)Oakfield Instruments, Ltd.1989-10-17
MENTOR DUCTAL CATHETERS (K895285)Mentor Corp.1989-10-17
EPSTEIN-BARR VIRUS-NUCLEAR ANTIGEN (K894626)Bion Ent., Ltd.1989-10-16
RESPIRATORY SYNCYTIAL VIRUS (K894623)Bion Ent., Ltd.1989-10-16
CLP CK/LD ISOENZYME CONTROL (K894554)Creative Laboratory Products, Inc.1989-10-16
UNI-STICK PLASTIC LIGATURES (K891331)American Orthodontics1989-10-16
IMMUNO/ASO (K894780)Immunostics Co., Inc.1989-10-16
VIBRA-TRAC TRACTION TABLE (K895382)Vibra-Trac Industries1989-10-16
MUMPS VIRUS (K894624)Bion Ent., Ltd.1989-10-16
OPTICAL CATHETER(TM) INTRODUCER SETS (K895041)Medical Dynamics, Inc.1989-10-16
STERILE LATEX SURGEON'S GLOVES (K891404)Shinheng Corp.1989-10-16
FIAX EB VCA-M TEST KIT (K894932)Whittaker Bioproducts, Inc.1989-10-16
DEVILBISS MODEL 6610D (K894441)Devilbiss Health Care, Inc.1989-10-13
JOHNSON & JOHNSON TUBE SECUREMENT DEVICE (K895431)Johnson & Johnson Patient Care, Inc.1989-10-13
PATIENT EXAMINATION GLOVES (LATEX) (K892313)Glove Lines Private , Ltd.1989-10-13
STERILE SURGICAL GOWN (K895667)Clinitech, Inc.1989-10-13
ALLPAC(TM) MATERIAL (K894759)Barrier Concepts, Inc.1989-10-13
MICRO-AIRE HIGH SPEED DRILL (2910-000) (K894606)Micro-Aire Surgical Instruments, Inc.1989-10-13
CITREX LATEX EXAMINATION GLOVES (K895722)Pt Citra Latex Lestari1989-10-13
PATIENT EXAMINATION GLOVES (K892311)Southern Rubber Industries Co., Ltd.1989-10-13
LATEX PATIENT EXAMINATION GLOVES (K895743)Rubbertech Industry Co., Ltd.1989-10-13
NIPRO DENTAL NEEDLE (K894373)Pharma-Plast USA, Inc.1989-10-13
CARNATION TRACHEOSTOMY MASKS (K894457)Dadsun Corp., Ltd.1989-10-13
MIC NON-STERILE LATEX GLOVES (K891160)Asia Dynamics, Inc.1989-10-13
CLEARPLAN EASY (K894579)Unipath , Ltd.1989-10-12
CREATININE FOR MANUAL OR AUTOMATED APPLICATIONS (K894389)Catachem, Inc.1989-10-12
CIBA CORNING MAGIC LITE PROLACTIN IMMUNOASSAY (K894988)Ciba Corning Diagnostics Corp.1989-10-12
APDYNE PHENOL APPLICATOR KIT (K894369)Apdyne Medical Co.1989-10-12
PERLIDENT (K894933)Germiphene Corp.1989-10-12
KORN MANDIBULAR ADVANCER (K893482)American Orthodontics1989-10-12
CUSTOM IN-THE-CANAL (ITC) HEARING AID MODEL I54 (K895140)Oticon Corp.1989-10-11
SAFETY SURGEONS GLOVES (K892499)Advance Rubber, Inc.1989-10-11
MODIFIED SUTURE USED IN CATHETER INSERTION TRAYS (K892450)Quinton, Inc.1989-10-11
HUMIDI-FLEX TM (K885313)Life Design Systems, Inc.1989-10-11
SURGEON'S GLOVES (K892495)Care-Pro Industries, Inc.1989-10-11
RUBBER LATEX SURGICAL GLOVES, STERILE (K895448)Dah Lee Rubber Industries (Thai) , Ltd.1989-10-10
HYDRAULIC FOOT OPERATED STOOL (K893598)Arthro-Medic, Inc.1989-10-10
HYDRAULIC IV POLE (K893597)Arthro-Medic, Inc.1989-10-10
BIOTRACK PDS MONITOR (K895102)Biotrack, Inc.1989-10-10
AMMEL PATIENT EXAMINATION GLOVES (K894502)Mauricio Menconi1989-10-10
DEVILBISS MODEL 8500D AND 8500D-608 (K894244)Devilbiss Health Care, Inc.1989-10-06
MITEK ANCHOR DRILL (K892903)Mitek Surgical Products, Inc.1989-10-06
HIGH PRESSURE INERT PLASTIC COLUMNS FOR CLIN. USE (K895105)Waters Chemical Products1989-10-06
ROCKET BONE MARROW NEEDLE (K895551)A & A Medical, Inc.1989-10-06
ORTHO *APO A-1 ELISA TEST SYSTEM (K895160)Medical Marketing Consultants, Inc.1989-10-06
S.S.T. SURGICAL THIMBLE (K895603)Healthcare Technologies Resources, Inc.1989-10-06
MARK IV HAND, THUMB AND WRIST (CPM) UNIT (K894907)Innovative Medical Engineering, Inc.1989-10-06
SINGLE LUMEN O'NEIL ASPIRATION & IRRIGATION NEEDLE (K895594)Go Medical Industries Pty. , Ltd.1989-10-06
BIOTRACK ALT TEST CARTRIDGE (K895128)Biotrack, Inc.1989-10-06
THE NEEDLE COUNT AND SHARPS DISPOSAL SYSTEM (K895527)Quantitative Technologies, Inc.1989-10-06
LATEX PATIENT EXAMINATION GLOVES (K894453)Mittal Meditex Pvt. , Ltd.1989-10-05
ATTENUATING SURGICAL GLOVE (K891315)F & L Medical Products Co.1989-10-05
NIL PATIENT EXAMINATION GLOVES (K895641)United Lion Rubber Industries Sdn. Bhd.1989-10-04
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