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

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RecordFirmDate
ELECSYS CALCHECK ESTRADIOL (K970148)Boehringer Mannheim Corp.1997-02-10
AMBIDERM (WHITE POW LATEX EXAM GLOVES W/ PROTEIN) (K963866)Supertex Industrial, S.A. DE C.V.1997-02-10
PATIENT EXAMINATION GLOVES : NITRILE EXAMINATION GLOVES (K963804)Hartalega Sdn Bhd1997-02-10
RECOVER INFANT HEEL WARMER (5100) (K964523)Florida Medical Industries, Inc.1997-02-10
REMEL STAPH LATEX KIT (K964315)Remel, L.P.1997-02-07
FEMEXAM TESTCARD (K962718)Litmus Concepts, Inc.1997-02-07
POWDER-FREE VINYL PATIENT EXAMINATION GLOVES (K964964)Sunmax Enterprise Shanghai Co. , Ltd.1997-02-07
PATIENT EXAMINATION GLOVES; CHLORINATED POWDERFREE NITRILE EXAMINATION GLOVES (K964148)Hartalega Sdn Bhd1997-02-07
AMBIDERM (COLOR POW LATEX EXAM GLOVES W/ PROTEIN) (K962737)Supertex Industrial, S.A. DE C.V.1997-02-07
STABLELIN ENZYME LINEARITY TEST SET C (ITEM NO. 003) (K965169)Specialized Assays, Inc.1997-02-06
LYFO(TM) DIFFERENTIAL DISK-BACITRACIN (K970009)Microbiologics, Inc.1997-02-06
ULTRAFERA WOUND DRESSING (K964614)American White Cross, Inc.1997-02-06
HCG CONTROLS (K970176)International Newtech Development, Inc.1997-02-06
STABLELIN ENZYME LINERARITY TEST SET A (ITEM NO. 001) (K965166)Specialized Assays, Inc.1997-02-04
DE-TOX CONTROL 1 AND DE-TOX CONTROL 19 (K964771)Dyna-Tek Industries1997-02-04
MIRACLE - EAR (ITE/ITC/CIC) (K964419)Miracle-Ear, Inc.1997-02-04
RAPID GRAM-POSITIVE ID SYSTEM (K961730)Becton Dickinson Microbiology Systems1997-02-04
ACCESS CHLAMYDIA ASSAY (K960850)Bio-Rad Laboratories, Inc.1997-02-04
STABLELIN ENZYME LINEARITY TEST SET B (ITEM NO. 002) (K965168)Specialized Assays, Inc.1997-02-04
VITROS IMMUNODIAGNOSTICS PRODUCTS FSH REAGENT PACK (GEM. 1005) FSH CALIBRATORS (GEM.C005) (K964720)Johnson & Johnson Clinical Diagnostics, Inc.1997-02-04
PROSPECT II CLOSTRIDIUM DIFFILLIE TOXIN A MICROPLATE ASSAY (K964864)Alexon Biomedical, Inc.1997-02-04
BBLCRYSTAL GRAM-POSITIVE ID SYSTEM (K961968)Bd Becton Dickinson Vacutainer Systems Preanalytic1997-02-04
PRECISE, TYNMPANETTE, AND XACTO IMPRESSION KITS (K964245)Starkey Laboratories, Inc.1997-02-04
MINK LUNG CELL CULTURE (K965047)Neogenex1997-02-04
PATIENT EXAMINATION GLOVE (K961521)Shanghai PT Plastics Enterprise Company, Ltd.1997-01-30
ELECSYS CALCHECK TESTOSTERONE (K970146)Boehringer Mannheim Corp.1997-01-30
OCTOPUS TISSUE STABILIZER (28001/28002/28003/28004/28005/28006) (K964445)Dlp, Inc.1997-01-30
DEXTREN CLEAR POWDER-FREE HYPOALLERGENIC SURGICAL GLOVES (K962813)Maxxim Medical1997-01-30
PH ANALYSIS MODULE (K961346)Synectics-Dantec1997-01-29
EAGLE EYES (K964366)Mech-Tronic Precision Mfg., Ltd.1997-01-29
SENNA (K964744)Trans-America Enterprises Corp.1997-01-29
SUNGLASSES (K964564)Micron Metal & Plastic Manufactory Co.1997-01-29
DALE ENDOTRACHEAL TUBE HOLDER 270/280 (K964399)Dale Medical Products, Inc.1997-01-28
AUDIOTONE (A-552) (K965063)Miracle-Ear, Inc.1997-01-27
AUDIOTONE (A554H) (K965057)Miracle-Ear, Inc.1997-01-27
H.PYLORI CONTROLS (K964675)Pyramid Biological Corp.1997-01-27
DAHLBERG (A-554) (K965049)Miracle-Ear, Inc.1997-01-27
VITROS IMMUNODDIAGNOSTICS PRODUCTS RE CONTROLS (GEM.5015) (K965048)Johnson & Johnson Clinical Diagnostics, Inc.1997-01-27
FOXELL, MEDIGUARD, PLUS MULTIPLE BRAND NAMES (K964317)Nantong Ruchang Latex Products Co., Ltd.1997-01-24
MEDTEXX (K963331)Regalfield Sdn. Bhd.1997-01-24
THE ROBOLITE (K964460)Shai Syg Motion and Innovations, Ltd.1997-01-24
M11 SERIES: M11, M11M (K965088)Philips Hearing Instruments Co.1997-01-24
WHEELCHAIR BELT (K963479)Deroyal Industries, Inc.1997-01-24
MICRO H2 (K963376)Micro Direct, Inc.1997-01-24
COMFORTAID HEARING AID (K964680)Ethical Hearing Instruments1997-01-24
ELECSYS LH ASSAY (K964694)Boehringer Mannheim Corp.1997-01-24
DERLIN (K964817)Derlin Company , Ltd.1997-01-24
SENSO DIGITAL (C18) (K965218)Widex Hearing Aid Co., Inc.1997-01-24
TUXEDO VEST RESTRAINT (K963474)Deroyal Industries, Inc.1997-01-22
RESTRICTIVE LIMB HOLDER (K963468)Deroyal Industries, Inc.1997-01-22
MULTI-PURPOSE UTILITY RESTRAINT/BODY HOLDER (K963480)Deroyal Industries, Inc.1997-01-22
A.C.T. I (K965149)Remel Co.1997-01-22
DISPOSABLE LIMB HOLDER (K963476)Deroyal Industries, Inc.1997-01-22
DELIVERY SYSTEM(SDS 1400 XL)/DELIVERY SYSTEM CUSPIDOR(SDS1450,SDS1650 XL) (K964619)Sds Dental, Inc.1997-01-22
A.C.T. II (K965152)Remel Co.1997-01-22
A.C.T. III (K965151)Remel Co.1997-01-22
DENTAPURE DENTAL UNIT WATER LINE FILTER-IODINATED (K963548)Mrlb Intl., Inc.1997-01-22
HCL - 200 BIOCHEMISTRY ANALYZER (K964409)Hcl Laboratory Systems, Inc.1997-01-22
PONCHO VEST RESTRAINT (K963475)Deroyal Industries, Inc.1997-01-22
SEALITE SCIENCES, INC. AQUALITE LH (K964925)Sealite Sciences, Inc.1997-01-22
A.C.T. IV (K965150)Remel Co.1997-01-22
IMMUNOCARD H. PYLORI (K961508)Meridian Diagnostics, Inc.1997-01-21
ELECSYS PROLACTIN ASSAY (K964748)Boehringer Mannheim Corp.1997-01-21
TELEX IN-THE-EAR CUSTOM HEARING AID WITH THRESHOLD COMPRESSION-II (K964639)Telex Communications, Inc.1997-01-21
SIRIUS 10, 10L, 40, 40L (K961275)Micro-Mega Societe Anonyme1997-01-17
CEDIA DAU MULTI-DRUG CONTROL CEDIA DAU SPECIALTY CONTROL SET 1 (K965157)Boehringer Mannheim Corp.1997-01-17
AUDINA 153 BEHIND THE EAR AND AUDINA 158 BEHIND THE EAR (K964816)Audina Hearing Instrument1997-01-17
ORTHODOC PREOPERATIVE PLANNER MODEL 500 (K960685)Integrated Surgical Systems, Inc.1997-01-17
OLYMPUS LIPASE REAGENT (K963424)Olympus America, Inc.1997-01-14
PHOENIX ETE TISSUE EXTENSION SYSTEM (K962144)Phoenix Biomedical Corp.1997-01-14
SKYWAY (K964682)Kid'S Wheel-Chairs1997-01-13
LIQUICHEK URIANLYSIS CONTROL (CAT. NO. 420,421,422,425,426) (K965171)Bio-Rad1997-01-13
ROCHE COBAS IBTEGRA REAGENT CASSETTES (K964457)Roche Diagnostic Systems, Inc.1997-01-13
REP 3 QUTO-FLUR CHOLESTEROL-30 (K962914)Helena Laboratories1997-01-13
WRITESTAR, AND VIEWSTAR (K964274)Comview Corp.1997-01-10
BIODERM EID MALE EXTERNAL INCONTINENCE DEVICE (K963950)Bioderm, Inc.1997-01-10
GIANNI VERSACE SUNGLASSES, VERSUS SUNGLASSES, DIABLO SUNGLASSES (K964505)I C Optics, Ltd.1997-01-10
CAP-AID (IMPROVED) (K964580)Nebel, Inc.1997-01-10
GAMMA-GLUTAMYL TRANSPEPTIDASE (K964916)Derma Media Lab., Inc.1997-01-10
AMOILS EPITHELIAL SCRUBBER (K962989)S. Percy Amoils1997-01-09
TENET RADIOLUCENT HAND TABLE (K963506)Tenet Medical Engineering1997-01-09
EYECHEK (K964290)Reichert Ophthalmic Instruments, Div. Leica, Inc.1997-01-09
VIDAS PROESTERONE (PRG) (30 409) (K965084)bioMerieux, Inc.1997-01-09
VOLLMAN PRONE POSITIONER (K963091)Hill-Rom, Inc.1997-01-09
RI-TINISCOPE-SLIT/RI-TINISCOPE SPOT/RI-VISION-SLIT/RI-VISION-SPOT (K964338)Rudolf Riester GmbH & Co. KG1997-01-09
GLOVE, PATIENT EXAMINATION, VINYL (POWDERED) (K964321)Shijiazhuang Hongray Plastic Products Co., Ltd.1997-01-09
DURA-BOARD ARMBOARD (K964273)Allen Medical Systems, Inc.1997-01-08
SIRIUS 180, 180L, 230, 230L (K961235)Micro-Mega Societe Anonyme1997-01-08
ROLL BELTS (K963467)Deroyal Industries, Inc.1997-01-03
TIELLE HYDROPOLYMER FOAM DRESSING (K964016)Johnson & Johnson Medical, Inc.1996-12-31
DASH, SULLIVAN, VITAL GARD HYPOALLERGENIC WITH PROTEIN CONTENT LABELING CLAIM (K955425)Dash Medical Gloves Sdn Bhd1996-12-30
OMNI GRIP LATEX EXAMINATION GLOVE, POWDER-FREE (K964563)Omni Sales Corp.1996-12-30
SHOE COVER, NON-STERILE (K961342)Copioumed Intl., Inc.1996-12-30
INJECTO FLUSH (K964120)Robert J. Jynch, Jr.1996-12-30
POWDER FREE VINYL EXAMINATION GLOVE (K964545)Shanghai Poseidon Plastic Products Co., Ltd.1996-12-30
IMAGEN RESPIRATORY SCREEN (K962037)Dako Diagnostics , Ltd.1996-12-26
MIRACLE-EAR OR AUDIOTONE (K964669)Miracle-Ear, Inc.1996-12-26
MODEL 5500 CEAS (K963938)Esa, Inc.1996-12-26
CULTURE COLLECTION AND TRANSPORT SYSTEM, MODIFIED AMIES MEDIA (K964637)Medical Packaging Corp.1996-12-24
BRIO AUTOMATIC SAMPLINC UNIT (K961209)Seac S.R.L.1996-12-24
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