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

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RecordFirmDate
EMDS(TM) PHOSPHORUS (PHOS) TESTPACKS, #67678/95 (K863718)Em Diagnostic Systems, Inc.1986-10-29
ELASTIC STAIN (K864074)Sigma Diagnostics, Inc.1986-10-29
IMMUNOCHEMICAL ASSAY OF APOLIPOPROTEIN A1 (K861883)Orion Corp.1986-10-29
IMMUNOCHEMICAL ASSAY APOLIPOPROTEIN B (K861882)Orion Corp.1986-10-29
MCARTHUR MICROSCOPE, STANDARD METAL VERSION (K864049)Portable Medical Laboratories, Inc.1986-10-29
ERS SYSTEM (K863286)General Electric Co.1986-10-27
IVORY PREMIUM RUBBER DAM (K863816)Columbus Dental Mfg. Co.1986-10-27
SALIVA EJECTORS (K863768)The Medical Group, Inc.1986-10-27
THE MMG 5 IN 1 CONNECTOR (K863912)Medical Marketing Group1986-10-27
COTTON ROLLS, NON-STERILE (K863764)The Medical Group, Inc.1986-10-27
ADVANCED NUCLEAR COMPUTER (K862842)Advanced Nuclear Imaging Corp.1986-10-27
MAMMOGRAPHIC MODEL CXR 51 MO-6'/0.6 SH (K864042)Absolute X-Ray Corp.1986-10-27
VALTRAC (BAR) REMOVER DEVICE (K863752)Davis & Geck, Inc.1986-10-24
P.S.I.-DISPOSABLE SCALPEL SURGEONS HANDLE (K863951)Precision Surgical Industries, Inc.1986-10-24
COATED SUTURE NEEDLE (K863595)Sharpoint, Inc.1986-10-24
UNITRON MODEL UL21 HEARING AID (K863225)Unitron Industries, Inc.1986-10-24
VAS-CATH PERICARDIOCENTESIS CATHETER, SET & TRAY (K863982)Vas-Cath of Canada , Ltd.1986-10-24
SUNGLASSES (NON-PRESCRIPTION) (K860953)Roseburg SA1986-10-24
DEXTRA DISPOSABLE BLADES (K863867)Storz Instrument Co.1986-10-24
FLEXIBLE VISUALIZATION CATHETER (K862872)American Edwards Laboratories1986-10-24
SABLE BLADES (K863885)Sable Industries1986-10-24
P.S.I.-DISPOSABLE METAL HANDLE SURGEONS SCALPEL (K863950)Precision Surgical Industries, Inc.1986-10-24
SULKY SPECIAL (K863450)Asc Corp.1986-10-23
THERACARE LOUNGER (K863892)American Theracare1986-10-23
RE-HEATER, HOT PACK (K863654)K & L Ent.1986-10-23
OXY-OFF(TM) (K863510)B&B Medical Technologies, Inc.1986-10-22
SUCTION CATHETER KIT (K861949)Medi-Craft , Ltd.1986-10-22
PATHFINDER ROTAVIRUS CHEMILUMINESCENT (K862917)Kallestad Laboratories, Inc.1986-10-22
DOUBLE LUMEN E T ADAPTOR (K862435)Acutronic Medical Systems AG1986-10-22
ULTRAWASH I (K863623)Dynatech Laboratories, Inc.1986-10-21
ULTRAWASH II (K863624)Dynatech Laboratories, Inc.1986-10-21
IQ IMMUNOCHEMISTRY SYSTEM (K863531)Bd Becton Dickinson Vacutainer Systems Preanalytic1986-10-20
TECHNICON RA-XT SYSTEM WITH ANALYTES (K862561)Technicon Instruments Corp.1986-10-20
OPHTHALMIC SURGICAL OCULAR MARKERS (K863663)Myocure, Inc.1986-10-20
RAINCOAT (K863910)Artec Environmental Monitoring Division1986-10-20
RK VACUUM FIXATION RING SYSTEM (K863775)Ameritek, Inc.1986-10-20
MILITARY PRESCRIPTION FRAME (K863862)Halo Optical Products, Inc.1986-10-20
SYNECTICS MOTILITY SYSTEM (K862929)Synectics-Dantec1986-10-20
STUDEX EAR PIERCING GUNS (K860622)Onyx Industries, Inc.1986-10-17
CHLAMYDIA TISSUE CULTURE CONFIRMATION TEST (EIA) (K862948)Intercare Diagnostics, Inc.1986-10-17
DP32 HAND HELD DENTAL PROPHYLAXIS UNIT (K861601)Stewart J. Lustgarten1986-10-17
BARD IRYFIX(TM) STOMA CAP (K862631)C.R. Bard, Inc.1986-10-16
FOLLICLE STIMULATING HORMONE IMMUNOASSAY SYSTEM (K863678)Nichols Institute Diagnostics1986-10-16
CONSEAL(TM) COLOSTOMY CONTINENCE SYSTEM (K863830)Coloplast A/S1986-10-16
COMMVIEW SYSTEM (K862715)A T & T Technologies, Inc.1986-10-16
GSC 1000 (K863566)Genetic Systems Corp.1986-10-16
ALLEGRO LUTEINIZING HORMONE IMMUNOASSAY SYSTEM (K863679)Nichols Institute Diagnostics1986-10-16
RESPIRONICS PROTECTEASY (K863171)Respironics, Inc.1986-10-15
OXYGEN CONSERVATOR (K863657)Salter Labs1986-10-15
FLOW INTERRUPTION INDICATOR (K863659)Salter Labs1986-10-15
OTICON I31 INITIALES HEARING AID (K862981)Oticon Corp.1986-10-15
INHALATION AID (K863049)Boehringer Ingelheim Pharmaceuticals, Inc.1986-10-15
MAMM-AIRE (K863890)Ar Custom Medical Products, Ltd.1986-10-14
PA EQUALIZER (K863787)Electone, Inc.1986-10-14
DISPOSABLE LASER SPONGE SURGIMEDICS, 902001-000 (K863089)Lifestream Int'L, Inc.1986-10-14
POST TRAY (K863836)Market Masters, Inc.1986-10-14
MANAN BREST TUMOR LOCALIZATION NEEDLE (K863848)Manan Manufacturing Co., Inc.1986-10-14
PEAK OVULATION PREDICTOR (K863121)Micron Technology, Inc.1986-10-14
ENDOSCOPIC VIDEO CAMERA (K863800)Technology For Imaging, Inc.1986-10-14
INSTRUMENT STERILIZATION TRAY (K863726)Medical Technology Development Corp.1986-10-14
THE S. CORDERO STYLUS (K863808)S. Cordero Co.1986-10-14
SAWBLADE (K863788)Tava Surgical Instruments1986-10-14
DRAINOVAC COMPLETE CLOSED WOUND DRAINAGE DEVICE (K863482)Cardio Metrics, Inc.1986-10-14
VIVADENT FILPIN (K863831)Vivadent (Usa), Inc.1986-10-14
HISTAMINE RIA TEST FOR HISTAMINE BIOLOGICAL FLUIDS (K854236)Nms Pharmaceuticals, Inc.1986-10-10
PATHFINDER(TM) SPECIMEN COLLECTION KIT (K863682)Kallestad Laboratories, Inc.1986-10-10
POLAREX AND POLAREX MLD (K863651)Selex, Inc.1986-10-10
HOSPITAL BED (K863748)Global Medical Prods, Inc.1986-10-09
DRI-FORM: GBNA LISTERIA MEDIUM NO. M22300 (K863820)Gibco Laboratories Life Technologies, Inc.1986-10-08
ORTHO-BITE WAX WAFER (K863758)Columbus Dental Mfg. Co.1986-10-07
SUCTION-OFF (K863653)B&B Medical Technologies, Inc.1986-10-07
CANNON NASAL SPLINT (K863382)Treace Medical, Inc.1986-10-07
ABNORMAL SPINAL FLUID CONTROL (K863745)Ciba Corning Diagnostics Corp.1986-10-07
SUCTION CATHETER KIT (K863497)Welmed Systems, Inc.1986-10-06
TRADITION HIGH SPEED HANDPIECE (K863677)Midwest1986-10-06
SIREDOC 60 AND SIREDOC 220 (K863331)Siemens Medical Solutions USA, Inc.1986-10-06
CORNING ELISA PLATES (K863789)Corning Medical & Scientific1986-10-03
ACTIVATED PARTIAL THROMBOPLASTIN TIME TEST (K862669)U. S. Diagnostics, Inc.1986-10-03
BEHRING RAPIMAT II (K861263)Behring Diagnostics, Inc.1986-10-03
HEMOLYSE (K863503)Reagent Laboratory, Inc.1986-10-03
GAMMA GLUTAMYL TRANSFERASE PROCEDURE (K863586)Data Medical Associates, Inc.1986-10-03
VIDEO CAMERA SYSTEM (K863598)American Edwards Laboratories1986-10-02
MODEL MC-1 SURGICAL VIDEO CAMERA (K863376)Biometric Products, Inc.1986-10-02
POTASSIUM HYDROXIDE 10% W/V (K863550)Reagent Laboratory, Inc.1986-10-02
CM-II, CM-I WATER UNIT (K863021)Sds Dental, Inc.1986-10-01
DENTATUS L SET (K863016)Sds Dental, Inc.1986-10-01
GRAM POSITIVE FLUORESCENT IDENTIFICATION PANEL (K863038)American Micro Scan1986-09-30
REUSABLE/DISPOSABLE AUTOPSY KNIFE SET (K863549)Surgipath Medical Industries, Inc.1986-09-30
BUFFERED GLYCEROL SALINE (K863602)Bd Becton Dickinson Vacutainer Systems Preanalytic1986-09-30
STARCH AGAR W/BROM CRESOL PURPLE (K863599)Bd Becton Dickinson Vacutainer Systems Preanalytic1986-09-30
MOTILITY INDOLE LYSINE SULFIDE (MILS) MEDIUM (K863600)Bd Becton Dickinson Vacutainer Systems Preanalytic1986-09-30
ONPG SOLUTION (K863601)Bd Becton Dickinson Vacutainer Systems Preanalytic1986-09-30
XANTHINE/TYROSINE/CASEIN AGAR (K863572)Bd Becton Dickinson Vacutainer Systems Preanalytic1986-09-30
COMPLEMENT-FIXATION TEST FOR CAMPYLOBACTER JEJUNI (K862814)Institute Virion , Ltd.1986-09-30
GI MOTILITY TEST MEDIUM W/TTC (K863603)Bd Becton Dickinson Vacutainer Systems Preanalytic1986-09-30
BIRD SEED AGAR (K863573)Bd Becton Dickinson Vacutainer Systems Preanalytic1986-09-30
PROLACTIN RIABEAD II DIAGNOSTIC KIT (K863240)Abbott Laboratories1986-09-29
PATHFINDER(TM) RESPIRATORY SYNCYTIAL VIRUS (K862743)Kallestad Laboratories, Inc.1986-09-29
HDL/CHOLESTEROL TEST SYSTEM (K861244)Chrometrics Laboratories, Inc.1986-09-29
ARTICULAR MOTION DEVICE (AMD4000) (K863639)Med Surg Designs, Inc.1986-09-29
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