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

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RecordFirmDate
WIDEX HEARING AID MODEL ES6 (K872375)Widex Hearing Aid Co., Inc.1987-07-28
POST-AURICULAR HEARING AID MODEL PE 805 SCD2 (K872474)Phonic Ear, Inc.1987-07-28
EASY-TEST GAMMA-GLUTAMYL TRANSFERASE (GGT) 16616 (K872320)Em Diagnostic Systems, Inc.1987-07-27
OVUQUICK SELF-TEST (OVUQUICK; RAMP LH ASSAY) (K871726)Monoclonal Antibodies, Inc.1987-07-27
MELANITE I (K872506)Aura Lens Products1987-07-27
TAPELESS EYE SHIELD (K872659)Precision Therapeutics, Inc.1987-07-27
FH LEN (K872503)Fu Heng First Industrial Co., Ltd.1987-07-27
EMDS GAMMA-GLUTAMYL TRANSFERASE (GGT) 67680/95 (K872322)Em Diagnostic Systems, Inc.1987-07-27
CART, EMERGENCY, CARDIOPULMONARY (K872558)Nico Metal Products Corp.1987-07-24
AEROCHAMBER (K872037)Monaghan Medical Corp.1987-07-24
DEXTRANOMER (K872117)Interworld, Inc.1987-07-24
1.1 SCREWDRIVERS (K872490)Micro-Aire Surgical Instruments, Inc.1987-07-23
NAIL SET (K872388)Med-Tool, Inc.1987-07-23
FLUORTRAN - C(TM) (K872751)Para Scientific Co.1987-07-23
INFUSION STAND (K872729)Camtec1987-07-23
AN3000 MAHONEY DRAIN (K872460)H.W. Andersen Products, Inc.1987-07-23
AN3100 MULHOLLAND DRAIN (K872459)H.W. Andersen Products, Inc.1987-07-21
VITALLIUM WIRE (K872746)Austenal Dental, Inc.1987-07-21
EYE GARD (K872000)Treace Medical, Inc.1987-07-21
RGB CAMERA SYSTEM (K872661)Aspen Laboratories, Inc.1987-07-21
TRAKEFIT TRACHEOSTOMY TUBE HOLDER (K872277)Ackrad Laboratories1987-07-21
AN3500 WORTH DRAIN (K872457)H.W. Andersen Products, Inc.1987-07-21
1.1 COUPLERS AND 1.2 ADAPTERS (K872550)Micro-Aire Surgical Instruments, Inc.1987-07-21
HILARIS-NORI ENDOMETRIAL APPLICATOR (K871216)Mick Radio-Nuclear Instruments, Inc.1987-07-21
FSH SEROZYME IMMUNOENZYMETRIC ASSAY KIT/MAG SEP PH (K872627)Serono Diagnostics, Inc.1987-07-21
S.T.A.C.E.M. EXTERNAL BREAST PROSTHESIS MAMMARY (K872714)Roseburg SA1987-07-21
MODIFIED NOFLO I (K871262)Design Technologies, Inc.1987-07-21
CORD-ASSURE UMBILICAL BLOOD GAS KIT (K872244)Lake Medical Products, Inc.1987-07-21
DYNATECH SPD 3000, #002-900-0000 (K872363)Dynatech Laboratories, Inc.1987-07-16
V-MARC 88A COMPUTER (K871853)V.Marc, A Div. of Pictorial, Inc.1987-07-16
HEARING AID 49 SERIES (K872554)Electone, Inc.1987-07-16
HEARING AID S45 SERIES (K872553)Electone, Inc.1987-07-16
HEARING AID M35/M36 SERIES (K872556)Electone, Inc.1987-07-16
CHOLESTEROL REAGENT (K872295)Sigma Diagnostics, Inc.1987-07-16
1.1 TWIST DRILLS AND 1.2 CORTICAL DRILLS (K872491)Micro-Aire Surgical Instruments, Inc.1987-07-16
UROVIEW (K872022)Oec-Diasonics, Inc.1987-07-16
HIGH PRESSURE LIQUID CHROMATOGRAPHY SYSTEM (K872582)Millipore Corp.1987-07-16
HENSCHKE AFTERLOADING APPLICATOR (K871217)Mick Radio-Nuclear Instruments, Inc.1987-07-16
KUMAR CERVICAL APPLICATOR (K871213)Mick Radio-Nuclear Instruments, Inc.1987-07-16
GENETIC SYSTEMS RSV IMMUNOFLUORESCENCE TEST KIT (K870176)Genetic Systems Corp.1987-07-16
LEAD GLASS SHIELDS (K872656)Viox Corp.1987-07-16
HDL CHOLESTEROL REAGENT (K872575)Sigma Chemical Co.1987-07-16
STANDARD SCREW DRIVER (K872387)Med-Tool, Inc.1987-07-16
VICE OR BENCH VICE (K872385)Med-Tool, Inc.1987-07-16
CURETTE SET, ANTRUM, COAKLEY (K872609)Military Engineering, Inc.1987-07-15
TRANSWORLD 360V, MODEL A1-4040 (K872357)Transworld X-Ray Corp.1987-07-15
PRECISION SCREW DRIVER SET (K872389)Med-Tool, Inc.1987-07-15
CENTRALITE (K872489)Diacor, Inc.1987-07-15
CIVCO STEPPER (K871413)CIVCO Medical Instruments Co., Inc.1987-07-14
KONTOUR ULTRA SOFT SPONGE #SS144.50 (K872069)Winfield Laboratories, Inc.1987-07-14
HEARING AID 47 SERIES (K872555)Electone, Inc.1987-07-10
HEARING AID (ALL-IN-THE-EAR) (K872212)Marketing Specialist, Inc.1987-07-10
PERIO-TEST (K872215)Dr. Bernard Loewenthal1987-07-10
BIOPSY NEEDLE GUIDE KIT, STERILE (K871503)Amedic USA1987-07-10
HARRIS HEMATOXYLIN (K872498)Anatech, Ltd.1987-07-09
HITACHI 717 CHEMISTRY ANALYZER (K872494)Boehringer Mannheim Corp.1987-07-09
DULBECCO'S MODIFIED EAGLE'S MEDIUM (DME) (K872465)J R Scientific1987-07-09
SURVIVAL KIT, INDIVIDUAL, TROP, TACTICAL AIR CREW (K871458)Fraass Survival Systems, Inc.1987-07-09
ABBOTT A-GENT LIQUID MAGNESIUM REAGENT (K872311)Abbott Laboratories1987-07-09
DADE MONI-TROL CHEMISTRY CONTROL/CALIBRATOR (K871977)American Dade1987-07-09
ANATECH HEMATOXYLIN-NORMAL STRENGTH (K872499)Anatech, Ltd.1987-07-09
PRECISION CULTURE C.A.T.S. COLLECT/TRANS HSV I/II (K872507)Precision Dynamics Corp.1987-07-09
ANATECH HEMATOXYLIN-EXTRA STRENGTH (K872500)Anatech, Ltd.1987-07-09
PALEX (R) OSTOMY (K871628)Industrias Palex C/O Dma Med-Chem Corp.1987-07-08
THE WOOG ORABRUSH (K871406)Woog Intl.1987-07-07
UNASSAYED CONTROL SERUM, NORMAL (BOVINE) (K872304)Vanguard Diagnostic Systems1987-07-07
HYPERFORMANCE CONTROLS (HP-CONTROLS) (K871694)Rapid Diagnostic Laboratories, Inc.1987-07-07
UNASSAYED CONTROL SERUM, ABNORMAL (BOVINE) (K872303)Vanguard Diagnostic Systems1987-07-07
DIGOXIN FPIA CONTROLS (K872347)Sigma Diagnostics, Inc.1987-07-07
PARAMAX CHOLESTEROL REAGENT (K872050)American Dade1987-07-07
CORNING EASY WASH ELISA PLATES (K872273)Corning Medical & Scientific1987-07-07
LIQUICHEK PEDIATRIC CONTROL LEVELS I AND II (K872227)Bio-Rad1987-07-06
ABRASIVE DISC - POLISHING WHEEL (K872251)Dentsply Intl.1987-07-02
SIDE CUTTING PARALLEL ACTION PLIERS (K872384)Med-Tool, Inc.1987-07-02
PLAK VAK - PV-10 (K864540)Paul S. Barclay, D.D.S. , Ltd.1987-07-02
SPATULA, DENTAL, CEMENT (K871818)Military Engineering, Inc.1987-07-02
SURGICAL BUR (K872475)Tava Surgical Instruments1987-07-02
C CLAMP (K872386)Med-Tool, Inc.1987-07-02
PHENYTOIN FPIA CONTROLS (K871567)Sigma Diagnostics, Inc.1987-07-01
PFI-20 POLARIZING FLUORIMETER (K871550)The Perkin-Elmer Corp.1987-07-01
EASY-TEST AMMONIA (AMON) ITEM NO. 16695 (K872110)Em Diagnostic Systems, Inc.1987-07-01
SUPER POLI-GRIP & WERNET'S DENTURE ADHES. POWDER (K872225)Block Drug Company, Inc.1987-06-30
BIOFILM TRANSORBENT ULCER AND WOUND DRESSING (K872100)The Bfgoodrich Co.1987-06-30
BIOFILM TRANS. ISLAND, ISLAND ULCER & WOUND DRESS. (K872099)The Bfgoodrich Co.1987-06-30
BIOFILM TRANS. POUCH ULCER & WOUND DRESSING (K872101)The Bfgoodrich Co.1987-06-30
LES RAD FILTER (K871227)M. D. Products1987-06-29
MECONIUM SUCTION CATHETER (K871825)Concord Laboratories, Inc.1987-06-29
ANTIBODY ASSAY FOR DETECTION OF ADENOVIRUS IN CELL (K871229)Microscan Div. Baxter Healthcare Corp.1987-06-26
ANTIBODY ASSAY FOR DETECT. OF PARAINFLUENZA TYPE 1 (K871234)Microscan Div. Baxter Healthcare Corp.1987-06-26
ANTIBODY ASSAY FOR DETECTION OF INFLUENZA B (K871231)Microscan Div. Baxter Healthcare Corp.1987-06-26
ANTIBODY ASSAY FOR DETECT. OF PARAINFLUENZA TYPE 2 (K871228)Microscan Div. Baxter Healthcare Corp.1987-06-26
ANTIBODY ASSAY FOR DETEC. OF RESP. SYNCYTIAL VIRUS (K871230)Microscan Div. Baxter Healthcare Corp.1987-06-26
ANTIBODY ASSAY FOR DETECTION OF INFLUENZA A (K871233)Microscan Div. Baxter Healthcare Corp.1987-06-26
ANTIBODY ASSAY FOR DETECT. OF PARAINFLUENZA TYPE 3 (K871232)Microscan Div. Baxter Healthcare Corp.1987-06-26
VARIOUS SIZES & STYLES OF MONOPOLAR FORCEPS (K872271)New England Surgical Instrument Corp.1987-06-26
EBV-CHECK(TM) TEST KIT (IGG) (K871373)Diagnostic Technology, Inc.1987-06-25
COOL SHADES (K872218)Mattel, Inc.1987-06-25
HAMACHER BULLET POINT OPHTHALMIC NEEDLE (K872200)R. J. Doyle, Inc.1987-06-25
EBNA ACIF ASSAY KIT (K871298)Granbio, Inc.1987-06-25
COMFORTWEIGH (K871771)Curlington Industrial Electronics, Inc.1987-06-24
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Every clearance here is in the API, with alerts when new ones post.