Atlas FDA

1986

4,347 FDA 510(k) clearances · Clearance year

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RecordFirmDate
BREMI BEAUTY BRONZE (K863555)Handelsonderneming Bremi B.V.1986-10-02
MODEL MC-1 SURGICAL VIDEO CAMERA (K863376)Biometric Products, Inc.1986-10-02
SWIVEL COUPLER (K863205)Venmill Swivel, Co.1986-10-02
GENTEEL (K863676)Luben Dental Co., Inc.1986-10-02
URESIL RADIOPAQUE SILICONE BANDS (K863563)Uresil Corp.1986-10-02
POTASSIUM HYDROXIDE 10% W/V (K863550)Reagent Laboratory, Inc.1986-10-02
DISPOSABLE PNEUMOPERITONEUM NEEDLE (K863330)United States Surgical, A Division of Tyco Healthc1986-10-02
MODEL LS-870 CO2 SURGICAL LASER SYSTEM (MODIFIED) (K860831)Cooper Lasersonics, Inc.1986-10-02
BIPOLFORCEPS (K863413)Treace Medical, Inc.1986-10-02
COLORADO MEDICAL MODEL PTC 1000 (K863471)Colorado Medical, Inc.1986-10-02
MICRO SURGICAL DRILL SYSTEM (K863627)Acumed Instruments Corp.1986-10-02
EUROFLEX F-IV, ISOFLEX III (K863007)Sds Dental, Inc.1986-10-01
QUANTIMUNE(R) FERRITIN IRMA (K863487)Bio-Rad1986-10-01
AMRESCO FLOW PAC UREA NITROGEN REAGENTS #1346 (K863425)American Research Products Co.1986-10-01
CYTOMEGALOVIRUS IGG EIA TEST KIT (K862705)Labsystems, Inc.1986-10-01
TRACKER INFUSION CATHETER (K862117)Target Therapeutics1986-10-01
CM-II, CM-I WATER UNIT (K863021)Sds Dental, Inc.1986-10-01
STOCKERT-SHILEY CAPS TIMER MODULE (K862973)Shiley, Inc.1986-10-01
ISOLAX PEDAL SET (K863013)Sds Dental, Inc.1986-10-01
ISOPRAT F-III SET/ISOLAX CHAIR (K863014)Sds Dental, Inc.1986-10-01
IMMUNO BIOTECH MUGWART ALLERGEN DISC (K863123)Immuno Nuclear Corp.1986-10-01
ISOPRAT C-III SET/ISOCART III AUXILIARY UNIT (K863015)Sds Dental, Inc.1986-10-01
MINILAX SET (K863012)Sds Dental, Inc.1986-10-01
DENTATUS L SET (K863016)Sds Dental, Inc.1986-10-01
NOVEMPERC DOUBLE LUMEN INTRA-AORTIC BALLOON (K860638)Kontron Instruments, Inc.1986-10-01
TENDERM TAPE (K863194)Lectec Corp.1986-09-30
GRAM POSITIVE FLUORESCENT IDENTIFICATION PANEL (K863038)American Micro Scan1986-09-30
HYDROCOLLOID DRESSINGS - STERILE (K863390)Convatec, A Division of E.R. Squibb & Sons1986-09-30
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
SHARPOINT STAINLESS STEEL SUTURE (K863034)Chathamborough Research Group, Inc.1986-09-30
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
SINGLE CHANNEL BRAIN STEM RESPONSE AUDIOMETER BSR2 (K854533)Madsen Electronics (Canada) , Ltd.1986-09-30
BIRD SEED AGAR (K863573)Bd Becton Dickinson Vacutainer Systems Preanalytic1986-09-30
DRAPE STERICOVER (K863512)Sterimed, Inc.1986-09-30
ELECTRONIC METAL LOCATOR MODEL MD-1 (K863516)Advanced Instruments, Inc.1986-09-30
PROLACTIN RIABEAD II DIAGNOSTIC KIT (K863240)Abbott Laboratories1986-09-29
UPDATED STERILE PROCEDURAL KIT (K863632)Biological & Environmental Control Laboratories1986-09-29
PATHFINDER(TM) RESPIRATORY SYNCYTIAL VIRUS (K862743)Kallestad Laboratories, Inc.1986-09-29
AMYLASE PROCEDURE (K863588)Data Medical Associates, Inc.1986-09-29
HDL/CHOLESTEROL TEST SYSTEM (K861244)Chrometrics Laboratories, Inc.1986-09-29
BICONDYLAR TOE PROSTHESIS (K863528)Depuy, Inc.1986-09-29
PREGNASLIDE (K863198)Armkel, LLC1986-09-29
UPDATED STERILE GOWNS, MASKS AND TOWELS (K863637)Biological & Environmental Control Laboratories1986-09-29
TOTAL PROTEIN PROCEDURE (K863258)Data Medical Associates, Inc.1986-09-29
ARTICULAR MOTION DEVICE (AMD4000) (K863639)Med Surg Designs, Inc.1986-09-29
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
PHENYTOIN, AS PERFORMED ON TECHNICON RA SYSTEMS (K863403)Technicon Instruments Corp.1986-09-29
LE VEEN WOUND SPLINT (K863570)Tek-Aid, Inc.1986-09-29
GAMBRO LUNDIA 10-1L, 1N, 1H, 3H, 4N, 4H, 5H, 6N (K862840)Gambro, Inc.1986-09-29
KUNDIN WOUND GAUGE (K863409)Jane I. Kundin1986-09-29
MEDCOMP DISPOSABLE MANIFOLD SYSTEM (K863661)Medical Components, Inc.1986-09-29
COAGULATOR (8 CHANNEL) (K862047)Med USA1986-09-29
QUANTIMETRIX DRUG FREE SERUM CONTROL (K863388)Quantimetrix Corp.1986-09-29
AMYLASE SR LIQUID STABLE REAGENT SET (K862733)Medical Analysis Systems, Inc.1986-09-29
BARD WILLIAM HARVEY CARDIOTOMY RESERVOIR (K862920)C.R. Bard, Inc.1986-09-29
EMDS(TM) ALCOHOL TESTPACKS, #67691/95 (K863419)Em Diagnostic Systems, Inc.1986-09-29
ALKALINE PHOSPHATASE PROCEDURE (K863268)Data Medical Associates, Inc.1986-09-29
CORDIPAK CARDIAC CATHETERIZATION PACK (K863337)Angi-Pak Corp.1986-09-29
PROGRAMMER MODEL 2035/ELECTROGRAM CABLE MODEL 6580 (K863045)Cardiac Pacemakers, Inc.1986-09-29
URESIL 150CC BELLOWS RESERVOIR (K863562)Uresil Corp.1986-09-29
POTASSIUM TEST (K863486)Sclavo, Inc.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
PARAMAX ELECTROLYTE CALIBRATOR (K863489)American Dade1986-09-29
STRYKER ORTHOPOWER 90 & ORTHOPOWER 90 SYSTEM II (K863447)Stryker Corp.1986-09-29
HEPARIN-COATED EXTRACORPOREAL CIRCUITS (K861641)American Bentley1986-09-29
EASY-TEST CARBON DIOXIDE (CO2) ITEM #67649/95 (K863544)Em Diagnostic Systems, Inc.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
ATAC 4300 HEMATOLOGY CELL COUNTER (K863332)Turpen Laboratory Systems, Inc.1986-09-29
LOVESAFE CONTRACEPTIVE CONDOMS, TYPE SC-40 (K863707)Manexim Multicorp, Ltd.1986-09-26
ACE II (TRI-LEVEL) (K863095)Medical Analysis Systems, Inc.1986-09-26
TRIGLYCERIDE (TRINDER) PROCEDURE (K863254)Data Medical Associates, Inc.1986-09-26
EMDS(TM) LACTIC DEHYDROGENASE TESTPACKS, #67660/95 (K863477)Em Diagnostic Systems, Inc.1986-09-26
ACA(R) C-REACTIVE PROTEIN (CRP) CALIBRATOR (K863329)E.I. Dupont DE Nemours & Co., Inc.1986-09-26
ACA(R) C-REACTIVE PROTEIN (CRP) ANALYTICAL TEST (K863328)E.I. Dupont DE Nemours & Co., Inc.1986-09-26
EUROCART SR-4, EUROCART M-IV, ISOCART III (K863010)Sds Dental, Inc.1986-09-26
RAICHEM(TM) CHLORIDE REAGENT (K863620)Reagents Applications, Inc.1986-09-26
PROTEX, TAHITI CONDOM (K860680)U. C. Import & Co.1986-09-26
SENSORMEDICS OXYSHUTTLE(TM) (K862617)Sensor Medics Corp.1986-09-26
LOVESAFE CONTRACEPTIVE CONDOMS, TYPE NL-50 (K863706)Manexim Multicorp, Ltd.1986-09-26
URIC ACID PROCEDURE (K863251)Data Medical Associates, Inc.1986-09-26
DERMATEC BURN PADS (K863379)Dermatec, Inc.1986-09-26
SIEGEN HEADPHONES (K862430)Siegen Corp.1986-09-26
CALCIOMETER (K863059)J. D. Assoc.1986-09-26
DEMAND TOTAL PROTEIN (K863301)Cooper Biomedical, Inc.1986-09-26
BILIRUBIN TOTAL DIRECT (K863057)J. D. Assoc.1986-09-26
ENZLIPASE, ENZYMATIC LIPASE KIT (K862312)Nuclear Diagnostics, Inc.1986-09-26
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Every clearance here is in the API, with alerts when new ones post.