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

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RecordFirmDate
SUR-FIT FACE MASK (K854161)Anesthesia Respiratory Technology, Inc.1985-11-05
MULTIPLE (K853297)Sun Air, Inc.1985-11-05
THE MOVER (K853424)Invacare Corp.1985-11-05
ROTACLONE ROTAVIRUS DIAGNOSTIC KIT (K852969)Cambridge Bioscience Corp.1985-11-05
TECHNICON RA SYSTEMS FOR TRIGLYCERIDES ANALYSIS IN (K854152)Technicon Instruments Corp.1985-11-05
OPHTHALMIC KNIFE W/REMOVALE DEPTH GUIDE (K853598)Myocure, Inc.1985-11-04
VERSABLADE (K852706)Alphamedix, Inc.1985-11-04
BEAVER R-K KNIFE (K852828)Rudolph Beaver, Inc.1985-11-04
STORZ DIAMOND KNIFE (K853403)Storz Instrument Co.1985-11-04
SMARTKNIFE SYSTEM (K853063)CooperVision, Inc.1985-11-04
VERSABLADE (K852633)Alphamedix, Inc.1985-11-04
PORTA-POLE TM MEDICAL EQUIPMENT POLE W/FOLD (K854082)Gray Wave Corp.1985-11-01
ANTISERUM TO HUMAN APOLIPOPROTEIN B (K850690)Kent Laboratories, Inc.1985-11-01
ANTISERUM TO HUMAN APOLIPOPROTEIN A-I (K850691)Kent Laboratories, Inc.1985-11-01
MENTOR BRIGHTNESS ACUITY TESTER (K853736)Mentor O & O, Inc.1985-11-01
PERSONAL AMPLIFIER SLIMLINE III (K853605)Electone, Inc.1985-11-01
ANTISERUM TO HUMAN PREALBUMIN (K850686)Kent Laboratories, Inc.1985-11-01
DUROMEDICS CARDIAC VALVE SIZER SET (K853313)Hemex Scientific, Inc.1985-11-01
COLUMBIA 5% BLOOD AGAR (K854228)R. Kent Richards, Inc.1985-10-31
INTERPORE 200 POROUS HYDROXYAPATITE (K852975)Inrterpore Intl.1985-10-31
MICRO-MAT SYSTEM (K854121)Prevo Micro-Mat System1985-10-31
POLYCHROME IV STAIN (K854176)Devetec, Inc.1985-10-31
PLASTIC MOUTH BARRIER HSV-I (K853266)Westmark Enterprises, Inc.1985-10-29
MEDIPART DISPOS. NOSE CLIP MP-2001 (K853578)Medipart Jerry Alexander1985-10-29
DENTOCULT CULTURE-PADDLE (K851164)Orion Corp.1985-10-29
MEDIPART DISPOS. MOUTHPIECE W/2MM I.D. MP-4410 (K853572)Medipart Jerry Alexander1985-10-29
MEDIPART DISPOS. MOUTHPIECE W/22MM O.D. MP-4411 (K853574)Medipart Jerry Alexander1985-10-29
VISTECH VCTS GLARE TESTER (K853481)Vistech Consultants, Inc.1985-10-29
MEDIPART SODA LIME MP-3522 (K853571)Medipart Jerry Alexander1985-10-29
MEDIPART MOUTHPIECE MP-1010 (K853575)Medipart Jerry Alexander1985-10-29
DYNAMIC CARDIAC PHANTOM 74-347 (K853756)Victoreen, Inc.1985-10-29
SELECT FLOWMETER (K854067)Precision Medical, Inc.1985-10-29
FLS MED. PROD. RACINE TYPE ADAPTOR (K853828)Fls Medical Products, Inc.1985-10-29
MEDIPART FACE MASK HEADSTRAP MP-9100 (K853573)Medipart Jerry Alexander1985-10-29
WELLINGTON HOSPITAL PATTERN SELF RETAINING VAGINAL (K853640)Downs Surgical , Ltd.1985-10-29
VICKERS ERGOMATIC MICROS INSTR-LONG R OR L HANDED (K853180)Keeler Instruments, Inc.1985-10-28
VICKERS ERGOMATIC MICROS INSTR-FINE R OR L HANDED (K853181)Keeler Instruments, Inc.1985-10-28
HITACHI 704 (K854025)Boehringer Mannheim Corp.1985-10-28
ASTRA SYSTEMS CHOLESTEROL REAGENT (K853854)Beckman Instruments, Inc.1985-10-28
LASER ASO KIT (K854039)Behring Diagnostics, Inc.1985-10-28
LACTOPLATE (K852737)Mackeen Consultants, Ltd.1985-10-25
ACCURACY (K854119)Columbia Diagnostics, Inc.1985-10-25
FREEDOM LINE LUBRICATED MODELS LS-2-5, LT-6-10 (K852816)Apollo Dental Products, Inc.1985-10-24
CANON X-RAY I.I. RAPID SEQUENCE CAMERA CRS-105 (K853861)Canon USA, Inc.1985-10-24
PHADIRECT STREP A TEST (K854150)Pharmacia, Inc.1985-10-23
BCYE (BUFFERED CHARCOAL YEAST EXTRACT) AGAR (K854064)Bd Becton Dickinson Vacutainer Systems Preanalytic1985-10-23
E-Z-GUARD MOUTHPIECE (K853402)E-Z-Em, Inc.1985-10-23
SYVA MYCOTRANS MYCOPLASMA TRANSPORT SYSTEM (K854061)Syva Co.1985-10-23
FIAX TEST KIT FOR MEASLES-G ANTIBODIES FLYORESCENT (K853067)Idt, A Division of Whittaker M.A. Bioproducts1985-10-22
XYLENE SUBSTITUTE (K853694)Lerner Laboratories, Inc.1985-10-22
BIO-TEK EL 401 HANDHELD MICROPLATE WASHER (K853920)Bio-Tek Instruments, Inc.1985-10-22
XYLENE SUBSTITUTE MONTANT (K854083)Lerner Laboratories, Inc.1985-10-22
GRAM STAIN KIT (K853896)Sigma Diagnostics, Inc.1985-10-22
EROSA DISPOSABLE HYPODERMIC NEEDLE (K853980)Rose KG1985-10-18
STERILE SOFT TISSUE BIOPSY NEEDLE (K854003)Co-Medical, Inc.1985-10-18
MOBILE OPERATING TABLE FOR ORL MICROSURGERY (K853720)Carl Zeiss, Inc.1985-10-18
KAY PLUS ADULT DIAPER (K853740)Beghin_Say Intl., Inc.1985-10-17
TECHNA VISION, INC. ELECTRIC CHAIR (K853743)Techna Vision1985-10-17
TECHNA VISION, INC.ELECTRIC TABLE (K853744)Techna Vision1985-10-17
INTERNATIONAL MODEL SC CANAL IN THE EAR HEARING AI (K853172)Int'L Hearing Aids, Inc.1985-10-17
SURGICAL TAPES CLOTH, PAPER & PLASTIC-BASE (K853820)Abco Dealers, Inc.1985-10-16
PEE WEE THERMOMETERS (K853515)Joel R.L. Ehren Kranz1985-10-16
DOWNS VPAP CIRCUIT (K852333)Vital Signs, Inc.1985-10-16
KNEE MACHINE (K852977)Kaiser Medical1985-10-16
H-H HUNTER PASSIVE TENDON IMPLANT (K853436)Holter-Hausner Intl.1985-10-16
INTERFACE MODULES IM 1000 IMAGE COMMUNI-NETWORK (K850417)Impact Systems Corp.1985-10-16
ATTENDS DISPOS. UNDERPAD (K853880)Procter & Gamble Mfg. Co.1985-10-16
ENDODONTIC ELECTRONIC SPREADER HEATER (K853183)Sturgeon Engineering Co.1985-10-16
V-TREND ASO PLUS LATEX TEST (K853857)Texas Immunology, Inc.1985-10-16
LH/FSH RADIOIMMUNOASSAY KIT (K853837)Bioclinical Group1985-10-16
OMNI-TRACT CHEST WALL & LUNA RETRACTOR (K853947)Minnesota Scientific, Inc.1985-10-16
ALL KINDS OF SUNGLASSES (K853921)Winsburn Company , Ltd.1985-10-15
ORC ORACLE (K853668)Optical Radiation Corp.1985-10-15
ZEISS OPERATING KERATOMETER (K853723)Carl Zeiss, Inc.1985-10-15
XTAL X-150 OPERATING MICROSCOPE (K853855)Xtal Corp.1985-10-15
THE FIELDMASTER MODEL 275 (K852936)Synemed, Inc.1985-10-15
PANTEX DIRECT ESTRADIOL COATED TUBE RADIOIMMUNOASS (K853866)Pantex, Div. Bio-Analysis, Inc.1985-10-15
FETAL BOVINE/FETAL CALF SERUM, NEWBORN, HORSE, RAB (K853803)Z.L. Bocknek Laboratories, Inc.1985-10-15
PANTEX DIRECT TESTOSTERONE COATED TUBE RADIOIMMUNO (K853865)Pantex, Div. Bio-Analysis, Inc.1985-10-15
MST-1050-II X-RAY UNIT (K853210)Radiological Engineering, Inc.1985-10-10
SPLASH ADAPTOR (K853665)Ohio Medical Research, Inc.1985-10-10
LX 300 TISSUE PROCESSOR (K853938)Innovative Medical Systems, Inc.1985-10-10
PRESSURE GAUGE (K853040)Erie Medical1985-10-10
FINGER TOURNIQUETTE (K853472)Joseph B. Marogil1985-10-10
SUTURE REMOVAL KIT (K853910)Scientific & Medical Care Co.1985-10-08
GAUZE SPONGE (K853742)South Mountain Medical1985-10-08
CANTROL URINE DIPSTICK CONTROL TWO LEVELS (K853603)Canyon Diagnostics, Inc.1985-10-08
ATS 500 TOURNIQUET (K853802)Aspen Laboratories, Inc.1985-10-07
RAYLOR RETRACTORS (K853796)Cedar Surgical, Inc.1985-10-07
DRILLING TEMPLATE (K853761)Orthopedic Systems, Inc.1985-10-07
ISOMETRIC ACL DRILL GUIDE (K853762)Orthopedic Systems, Inc.1985-10-07
QUANTIMETRIX HUMAN SERUM THERAPEUTIC DRUG CONTROL (K853933)Quantimetrix Corp.1985-10-04
LASERSAFE EYE SHIELDS (K852404)Lasersafe, Inc.1985-10-04
RELIANCE PENDULUM OPHTHALMIC DELIVERY SYSTEM (K853358)Dentsply Intl.1985-10-04
PANTEX DIRECT DHEA-S COATED TUBE RADIOIMMUNOASSAY (K853867)Pantex, Div. Bio-Analysis, Inc.1985-10-04
INTERNATIONAL MODEL SC CUSTOM IN THE EAR HEARG AID (K853170)Int'L Hearing Aids, Inc.1985-10-04
LIQUI-SERA CHEMISTRY CONTROLS (COMPREHENSIVE) (K853906)Biodiagnostic Intl1985-10-04
URODYN 1000 (K853119)Dantec Electronics, Inc.1985-10-04
QUANTIMETRIX HUMAN SERUM CHEMISTRY CONTROL (K853931)Quantimetrix Corp.1985-10-04
MYREADER 7 (K853284)Scientific Sales Intl., Inc.1985-10-04
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