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

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RecordFirmDate
DENTI-TRAY(TM) (K871493)Advanced Medical, Inc.1987-06-24
MACCONKEY W/SORBITOL (K872188)Remel Co.1987-06-24
ARTHROPLASTY MALLET (K872209)New England Surgical Instrument Corp.1987-06-23
PERIOTEST (K872171)Siemens Medical Solutions USA, Inc.1987-06-23
KCK INDUSTRIES' SURGICAL INSTRUMENTS (K871894)Kck Industries1987-06-23
KINDERWRAP (K872003)The Kinder Co.1987-06-23
KODAK EKTACHEM 700XR ANALYZER (K872105)Eastman Kodak Company1987-06-23
OSTEOTOME SET, HOKE, STRAIGHT, SET OF 5 (K872092)Military Engineering, Inc.1987-06-23
TRANSTUBE MW176 OT MD176 (K872213)Medical Wire & Equipment Co.1987-06-23
CLASSIC (TM) 200 OXYGEN FLOWMETER (K871452)The Timeter Group1987-06-22
FLETCHER'S MEDIUM & FLETCHER'S MEDIUM W/5-FU (K872193)Bd Becton Dickinson Vacutainer Systems Preanalytic1987-06-22
CK 7000 SERIES 5 IN 1 CONNECTOR AND Y-CONNECTOR (K871737)Currie Medical Specialties, Inc.1987-06-22
IMPRESSION TRAY (K872210)Dentsply Intl.1987-06-22
CANON SURGICAL AUTO KERATOMETER SK-1 (K871936)Canon USA, Inc.1987-06-19
OPHTHALMIC CANNULA (K872151)Pharmacia, Inc.1987-06-19
MORGAN THERAPEUTIC LENS (K871454)Mortan, Inc.1987-06-19
MVS 2.5MM, 4.0MM, 6.0MM INFUSION CANNULA (K871605)Advanced Surgical Products, Inc.1987-06-19
PROVIEW (E7015) & PROLINK IMAGE DISPLAY SYSTEM (K872245)General Electric Co.1987-06-19
D-SCOPE II AND D-SCOPE IIC (K872127)Medx, Inc.1987-06-18
NEUROTIPS(TM) (K871571)Ulster Scientific, Inc.1987-06-18
KODAK EKTACHEM 700S ANALYZER (K872103)Eastman Kodak Company1987-06-17
PATHO DX LATEX AGGLUTINATION STREP GROUPING KIT (K871831)Diagnostic Products Corp.1987-06-17
LYFO KWIK(TM) RUS KIT (K870731)Micro-Bio-Logics1987-06-17
LIQUID TDM CONTROLS (K871788)Biological Industries1987-06-17
ALLELIX GROUP A STREPTOCOCCUS DETECTION KIT (K871620)Allelix, Inc.1987-06-17
BILATERAL CONTINUOUS PASSIVE MOTION DEVICE (K871981)Avec Scientific Design Corp.1987-06-17
TECHNICON RA(R) SYSTEMS & ASSIST(R) CLIN. ANALYZER (K871892)Technicon Instruments Corp.1987-06-17
THEOPHYLLINE FPIA CONTROLS (K871589)Sigma Chemical Co.1987-06-17
SPIRASEAL(TM) FACE MASK (VARIOUS SIZES) (K872015)Brigam, Inc.1987-06-17
KODAK EKTACHEM 700P ANALYZER (K872104)Eastman Kodak Company1987-06-17
8000 SERIES GAS CHROMATOGRAPHS (K872122)The Perkin-Elmer Corp.1987-06-17
ALLEVYN HYDROPHILIC POLYURETHANE DRESSING (K871166)Smith & Nephew, Inc.1987-06-16
OVER DRAPE LEG HOLDER (K871900)Avec Scientific Design Corp.1987-06-16
RAICHEM(TM) SPIA(TM) APO A-1 REAGENTS (K872079)Reagents Applications, Inc.1987-06-15
MMG DELEE SUCTION CATHETER W/MUCOUS TRAP (K871949)Medical Technologies of Georgia1987-06-15
NASOPHARYNGEAL AIRWAY (K871673)Harding Industries, Inc.1987-06-15
(MSI) PATH-SAVER (K872140)Medical Specialties, Inc.1987-06-15
MODIFIED (DIRECTIONS FOR USE) FOR IDEIA(TM) TEST (K872056)Boots-Celltech Diagnostics, Inc.1987-06-15
ACUSYST-JR (K872086)Endotronics, Inc.1987-06-15
IONESCU-SHILEY PERICARDIAL XENOGRAFT (ISU) (K871596)Shiley, Inc.1987-06-15
MECONIUM ASPIRATOR (K871407)Intertech Resources, Inc.1987-06-15
CORNING DISPOSABLE ROLLER BOTTLES (K872076)Corning Medical & Scientific1987-06-15
WH150 ROOM HUMIDIFIER (K871661)Associated Mills, Inc.1987-06-15
MCBRIDE MEDIUM CM 819 (K872135)Oxoid U.S.A., Inc.1987-06-15
K-GEL (K872128)Taro Pharmaceuticals, Inc.1987-06-12
EYEDENTITY EYEWEAR (K872062)Vitech Research C/O Johnsen, Manfredi & Thorpe1987-06-12
QUIK-BRUSH (K870414)Intl. Medication Systems, Ltd.1987-06-11
MICROCHECK LH OVULATION TEST (K871602)Syntron Bioresearch, Inc.1987-06-11
IL MONARCH 1000 CLINICAL CHEMISTRY ANALYTICAL SYS. (K871973)Instrumentation Laboratory CO1987-06-11
GAMMA GLUTAMYLTRANSFERASE REAGENT (K871979)Intersect Systems, Inc.1987-06-11
ULTRA MAXITHINS PADS (K871716)Tambrands, Inc.1987-06-11
SUMMIT OPTICS POST-MYDRIATIC SPECTACLES (K871800)Summit Optics, Inc.1987-06-11
SYNECTICS LIBERTY SYSTEM AMPLIFIER AND SOFTWARE (K871282)Synectics-Dantec1987-06-10
ORICULT-N CULTURE-PADDLE (K872058)Orion Corp.1987-06-10
RABBIT PLASMA FIBRINOGEN SUPPLEMENT SR 122 (K870945)Oxoid U.S.A., Inc.1987-06-10
GRASPING FORCEP, 1.7MM (K871926)Arthropedics, Inc.1987-06-09
CUP BIOPSY FORCEP, 1.7MM (K871927)Arthropedics, Inc.1987-06-09
LYOSHEET SURGICAL SHEET FOR BURNS (K871740)Acme United Corp.1987-06-09
TOURNIQUET PRESSURE REGULATOR (K871982)Avec Scientific Design Corp.1987-06-09
DSL ESTRADIAL RADIOIMMUNOASSAY (DSL-4400) (K870405)Diagnostic Systems Laboratories, Inc.1987-06-08
COSMETIC SINGLE SPAN BRIDGE (K871439)Cosmetic Dental Technologies, Inc.1987-06-08
RIBBED CUSHION MASK (K871851)Engineered Medical Systems1987-06-08
ACCUDENT ACCUPROBE (K870280)Accudent, Inc.1987-06-08
BTE HEARING AID OTICON MODEL E30P (K872017)Oticon Corp.1987-06-08
TELSTAR MODEL FS HEARING AID (K871520)Telstar Electronics, Inc.1987-06-08
IMPRESSION SYRINGE (K871937)Dentsply Intl.1987-06-05
TELSTAR MODEL C HEARING AID (K871522)Telstar Electronics, Inc.1987-06-05
AMERICAN LUBRICATING JELLY STERILE 2.7G & 5G (K870742)Span-America Medical Systems, Inc.1987-06-05
TELSTAR MODEL F3TS HEARING AID (K871518)Telstar Electronics, Inc.1987-06-05
KARL STORZ MODEL 28184 PNEUMATIC SHUTTLE SHAVER (K871891)KARL STORZ Endoscopy-America, Inc.1987-06-05
FULL SHELL ITE HEARING AID (K871521)Telstar Electronics, Inc.1987-06-05
MODEL 28200C MICRO-ARTHROPLASTY SYSTEM (K871717)KARL STORZ Endoscopy-America, Inc.1987-06-05
ADENOLEX (R) LATEX AGGLUTINATION TEST (K864645)Orion Diagnostica, Inc.1987-06-04
KODNER ANAL PERIONEAL RETRACTOR (K870897)Sur-Med Instruments, Inc.1987-06-04
MULTIPLE SPECTACLE LENS (K871961)Korea Asahi Optical Co., Ltd.1987-06-03
THE URIC ACID REAGENT SET (K871902)Macomb Biotechnology, Inc.1987-06-03
MUCATE AGAR, SLANTS AND MUCATE BROTH (K872020)Bd Becton Dickinson Vacutainer Systems Preanalytic1987-06-02
STERILIZATION TRAY, TMJ INSTRUMENT SET (K871924)Arthropedics, Inc.1987-06-01
MICRO SCISSOR, 1.7MM (K871923)Arthropedics, Inc.1987-06-01
TRACHEOSTOMY & NASAL SUCTIONING KIT, 3C-TNS-1 (K871692)Automatic Liquid Packaging, Inc.1987-06-01
STRAIGHT CUP CURRETTE, 1.7MM (K871925)Arthropedics, Inc.1987-06-01
NOVAPATH C. TRACHOMATIS DIRECT SPEC COLLECTION KIT (K871860)Bio-Rad1987-05-29
VASOTRAIN 447 (K871107)Henley Intl.1987-05-29
BREATHING CIRCUIT (K871386)Dryden Corp.1987-05-29
SPECTACLE FRAME - LORRAINE (K871689)Roseburg SA1987-05-29
SPECTACLE FRAME - DANIELLE (K871688)Roseburg SA1987-05-29
MICROLAB AT (K871945)Hamilton Co.1987-05-29
CHECK-MATE AND CHECK-MATE [+] (K871359)Veritech, Inc.1987-05-29
SOLA UV GARD(TM) SUNGLASSES (K870997)Sola-Syntex Ophthalmics1987-05-29
BKS-1000 REFRACTIVE SET USE IN KERATOREFRACTIVE (K870807)Allergan, Inc.1987-05-29
LD PRESUMPTO QUAD (K871907)Bd Becton Dickinson Vacutainer Systems Preanalytic1987-05-28
SCHULTZ PHALANGEAL COMP RASP/METACARPAL COMP RASP (K870842)Warsaw Orthopedic, Inc.1987-05-27
COMPOSITE RESTORATIVE CARRIER (K871909)Dentsply Intl.1987-05-27
CANNULATED INSTRUMENT CLEANERS (K870765)Treace Medical, Inc.1987-05-27
TOP FORM II TRAYS, DISPOS FOAM-LINED TOP GEL APPLI (K871784)Colgate-Hoyt Laboratories1987-05-27
SCHULTZ PHALANGEAL COMP TRIAL/METACARPAL COMP TRIA (K870843)Warsaw Orthopedic, Inc.1987-05-27
CARERITE BIOPACK GINGIVAL RETRACTION CORD (K871736)Cost Rite Health Products, Inc.1987-05-27
TECHNICON RA-XT(TM) SYSTEM IMMUNOASSAYS (K870998)Technicon Instruments Corp.1987-05-26
MCCONNELL ORTHOPEDIC TIBIAL POSITIONER (K871823)Mcconnell Orthopedic1987-05-26
ULTRAVIOLET ALANINE AMINO-TRANS (UV-ALT/UV-GPT) (K871782)Biochemical Trade, Inc.1987-05-26
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Every clearance here is in the API, with alerts when new ones post.