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

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RecordFirmDate
URESIL STD FLAT/ROUND & FLAT/ROUND SPLIT. SILI/DRA (K863560)Uresil Corp.1986-09-29
MONOFLUOR CHLAMYDIA TRACHOMATIS DIR SPEC TEST KIT (K862354)Synbiotics Corp.1986-09-29
OLYMPUS AU 5000 FLAME PHOTOMETER MODULE (K862148)Olympus Corp.1986-09-29
LE VEEN WOUND SPLINT (K863570)Tek-Aid, Inc.1986-09-29
KUNDIN WOUND GAUGE (K863409)Jane I. Kundin1986-09-29
QUANTIMETRIX DRUG FREE SERUM CONTROL (K863388)Quantimetrix Corp.1986-09-29
URESIL 150CC BELLOWS RESERVOIR (K863562)Uresil Corp.1986-09-29
CHOLESTEROL PROCEDURE (K863252)Data Medical Associates, Inc.1986-09-29
BOUFFANT-STYLE SURGICAL CAP (K863359)Kimberly-Clark Corp.1986-09-29
URIC ACID (URICASE) METHOD-II (K863287)Catachem, Inc.1986-09-29
ARTHROSCOPIC SURGICAL POWER DEVICE (K863696)American Edwards Laboratories1986-09-29
ANGIOMED VAC-U-CUT BIOPSY NEEDLE (K862805)Angiomed U.S., Inc.1986-09-29
STRYKER ORTHOPOWER 90 & ORTHOPOWER 90 SYSTEM II (K863447)Stryker Corp.1986-09-29
AVL ISE-TROL ELECTROLYTE CONTROL (K863333)Avl Scientific Corp.1986-09-29
F-11 REFLECTOR / F-II STANDARD REFLECTOR (K863019)Sds Dental, Inc.1986-09-29
NOVA II SODIUM/POTASSIUM/LITHIUM ANALYZER (K863438)Nova Biomedical Corp.1986-09-29
TRIGLYCERIDE (TRINDER) PROCEDURE (K863254)Data Medical Associates, Inc.1986-09-26
EUROCART SR-4, EUROCART M-IV, ISOCART III (K863010)Sds Dental, Inc.1986-09-26
URIC ACID PROCEDURE (K863251)Data Medical Associates, Inc.1986-09-26
DERMATEC BURN PADS (K863379)Dermatec, Inc.1986-09-26
ENZLIPASE, ENZYMATIC LIPASE KIT (K862312)Nuclear Diagnostics, Inc.1986-09-26
TRIGLYCERIDES-E (K863075)J. D. Assoc.1986-09-26
THE WOOG AND THE WOOG D. POWERED TOOTHBRUSHES (K862224)Xouth, Inc.1986-09-26
DR-2C (MODIFICATION) (K862596)General Devices1986-09-26
FORMALENS 2000 (K863367)Vision-Sciences, Inc.1986-09-26
KNIFE MAKER (K863616)Surgipath Medical Industries, Inc.1986-09-25
RABINOWITZ GUM MASSAGER (K862635)Arnell, Inc.1986-09-25
PROPHY CARE PASTE (K863133)Imd, Inc.1986-09-25
CABINET II AUXILIARY UNIT (K863023)Sds Dental, Inc.1986-09-25
HPL RIA KIT (K863188)Biotecx Laboratories, Inc.1986-09-25
OPHTHALMIC SURGICAL SPECULUM (K863664)Myocure, Inc.1986-09-25
THE ULTIMATE (K863665)Myocure, Inc.1986-09-25
ABBOTT SPECTRUM PHOSPHORUS REAGENT (K863088)Abbott Laboratories1986-09-25
GNATUS ARTICULATOR 4.300/4.300GP 8.600 & ORTOFLEX (K863009)Sds Dental, Inc.1986-09-25
IMMOBILIZING VACUUM MATRESS (IVM) (K863511)Omnium Services Partners, Inc.1986-09-25
HIGH PERFORMANCE CANNABINOID CONTROLS (K863117)Rapid Diagnostic Laboratories, Inc.1986-09-25
CHOLESTEROL-E (TOTAL) (K863062)J. D. Assoc.1986-09-25
SERINGA TRIPLICE S.L. (K863024)Sds Dental, Inc.1986-09-25
RAYLOR MINI-PROBE (K863416)Cedar Surgical, Inc.1986-09-24
RAYLOR BONE IMPACTORS (K863415)Cedar Surgical, Inc.1986-09-24
KASEY EYE SHIELD (K863474)Kasey Enterprises, Inc.1986-09-24
-OM WEST 2000 GNATUS CHAIR (K863008)Sds Dental, Inc.1986-09-24
DENTIMEDIC DENTAL EMERGENCY KIT (K861681)Dentimedic1986-09-23
ANGIOMED HIGH PRESSURE CONNECTORS (K863446)Angiomed U.S., Inc.1986-09-23
ULS 8-86 (K863163)American Instrument Manufacturer'S, Inc.1986-09-22
STAINLESS STEEL DEN. CROWN REMOVER & AMA./COMP.CAR (K863500)Pacific Union Dental, Inc.1986-09-22
TOC (TWEEN 80 - OXGALL-CAFFEIC ACID) AGAR (K863523)Bd Becton Dickinson Vacutainer Systems Preanalytic1986-09-19
CARY-BLAIR TRANSPORT MEDIUM (K863527)Bd Becton Dickinson Vacutainer Systems Preanalytic1986-09-19
SEA-BOND (K863375)Combe, Inc.1986-09-19
YEP (YEAST EXTRACT PHOSPHATE) AGAR (K863526)Bd Becton Dickinson Vacutainer Systems Preanalytic1986-09-19
SIEMENS SIRONA(R) DENTAL CHAIR (K863484)Pelton & Crane Co.1986-09-19
VIBROFLEX (K863197)Stoffregen & Co., Inc.1986-09-19
ROTARY MICROTOME (K863548)Surgipath Medical Industries, Inc.1986-09-19
DERMATOPHYTE TEST MEDIUM, SLANTS AND MYCOFLASKS (K863525)Bd Becton Dickinson Vacutainer Systems Preanalytic1986-09-19
PHYSI. & NURSES BRAND INSTANT KOLD & HOT KOMPRESS (K863507)Physician & Nurses Mfg. Corp.1986-09-19
CAL (CELLOBIOSE-ARGININE-LYSINE) AGAR (K863519)Bd Becton Dickinson Vacutainer Systems Preanalytic1986-09-19
NOZEES NOSTRIL DILATOR (K862406)Nozees Co.1986-09-19
REGAN-LOWE CHARCOAL AGAR (K863524)Bd Becton Dickinson Vacutainer Systems Preanalytic1986-09-19
OXYGEN CANNULA EAR WRAP (STYLE B) (K863432)Salter Labs1986-09-18
OXYGEN CANNULA EAR WRAP (STYLE A) (K863431)Salter Labs1986-09-18
URESIL CLOSED DRAINAGE RESERVOIR (K863505)Uresil Corp.1986-09-18
MODIFICATION OF CDT(TM) CLOSTRIDIUM TEST (K863485)Marion Laboratories, Inc.1986-09-17
CHOLINESTERASE (BTC) REAGENT (K863203)Sigma Diagnostics, Inc.1986-09-17
DUAL FORCEPLATE (K863443)Neurocom International, Inc.1986-09-17
CODE-A-WELL SERIES 1-1000 AND SERIES 1-1100 (K863423)Plastic Injectors, Inc.1986-09-16
ALT/GPT PROCEDURE (K863253)Data Medical Associates, Inc.1986-09-16
CASSETTE EMBOSSEER (K863483)Surgipath Medical Industries, Inc.1986-09-16
FSH MAIACLONE IMMUNORADIOMETRIC ASSAY KIT (K862813)Serono Diagnostics, Inc.1986-09-16
ABBOTT TESTPACK (TM) ACUTE HEP A CONTROL KIT (K863099)Abbott Laboratories1986-09-16
FEKAL CHECK PARASITOLOGY CONTROL SLIDE (K862914)Trend Scientific, Inc.1986-09-16
QUANTIMETRIX DRUG FREE HUMAN URINE CONTROL (K861420)Quantimetrix Corp.1986-09-16
RIGHT-DAY OVULATION HOME TEST (K861354)Leeco Diagnostics, Inc.1986-09-16
ABBOTT RSV EIA (K862429)Abbott Laboratories1986-09-16
RESPIRASTICK ENZYME IMMUNOASSAY TEST (K862475)Orion Diagnostica, Inc.1986-09-16
CHOLINESTERASE (PTC) REAGENT (K863202)Sigma Diagnostics, Inc.1986-09-16
BONE MARROW TRAY (K863326)Packaging Technologies, Inc.1986-09-16
AMRESCO FLOW PAC TOTAL IRON REAGENT SET #1241 (K863426)American Research Products Co.1986-09-16
FACIAL MASSAGER, BATTERY POWERED (K863383)General Physiotherapy, Inc.1986-09-15
TESTPACK ACUTE HCG URINGE CONTROLS (K863127)Abbott Laboratories1986-09-15
NEIS NZY (K863216)Carr-Scarborough Microbiologicals, Inc.1986-09-15
THERAPEUTIC DRUG MONITORING CONTROL SET (K862963)American Monitor Corp.1986-09-15
ULTRASCAN CLINICAL ANALYZER (K862999)Specialty Medical Industries, Inc.1986-09-15
SERO-STAT R II STAPHYLOCOCCUS TEST (K863025)Scott Laboratories, Inc.1986-09-15
BACTEC 13A MEDIUM (7H13) (K863191)Bd Becton Dickinson Vacutainer Systems Preanalytic1986-09-15
AKERSCAN COLORIMETRIC ANALYZER (K862908)Akers Medical Technologies1986-09-15
LS9000 SUCTION BIOPSY NEEDLE (K862749)Engineering, Inc.1986-09-15
TESTPACK ACUTE HCG SERUM CONTROLS (K863126)Abbott Laboratories1986-09-15
MODEL 1010 AMBULATORY PH MONITORING SYSTEM (K862536)Oxford Medilog, Inc.1986-09-12
INORGANIC PHOSPHORUS PROCEDURE (K863264)Data Medical Associates, Inc.1986-09-11
FAST MUCOPROTEINS (K863070)J. D. Assoc.1986-09-11
MAGNESIUM PROCEDURE (K863267)Data Medical Associates, Inc.1986-09-11
CHOLINESTERASE (K863111)J. D. Assoc.1986-09-11
GRAM NEGATIVE FLUORESCENT IDENTIFICATION PANEL (K862642)American Micro Scan1986-09-11
HEALTHCHECK THERM-STRIP (K863181)Healthcheck Corp.1986-09-11
CODE-A-WELL SERIES 1-600, 1-625 (K863374)Plastic Injectors, Inc.1986-09-11
CHOLESTEROL-E (FREE) (K863064)J. D. Assoc.1986-09-11
IRON PROCEDURE (K863266)Data Medical Associates, Inc.1986-09-11
AEROSOL-T (K863318)Southmedic, Inc.1986-09-11
CHOLESTEROL-E FAST (TOTAL) (K863063)J. D. Assoc.1986-09-09
MODIFIED Q50 MEDICAL TREADMILL (K863299)Quinton, Inc.1986-09-09
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