Atlas FDA

1986

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

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RecordFirmDate
ANA-ENZYME IMMUNOASSAY (ANA-EIA) DIAGNOSTIC KIT (K862969)Biohytech International, Inc.1986-10-24
'MYOSTIM EX' (K863568)Electro Therapeutic Devices, Inc.1986-10-24
SOLUTION/TEST STANDARD/CONDUCT. DIALY.&MULT.SOLUT. (K863824)D.R.G. Scientific Industries1986-10-24
DEXTRA DISPOSABLE BLADES (K863867)Storz Instrument Co.1986-10-24
BARD ESKA JONAS SILICONE-SILVER PENILE PROSTHESIS (K864040)C.R. Bard, Inc.1986-10-24
4-WIRE (CARSON) STONE EXTRACTOR (K863081)Cook Urological, Inc.1986-10-24
2X2 SPONGES, NON-STERILE, COTTON FILLED (K863761)The Medical Group, Inc.1986-10-24
FLEXIBLE VISUALIZATION CATHETER (K862872)American Edwards Laboratories1986-10-24
SABLE BLADES (K863885)Sable Industries1986-10-24
ION 2/4 FLOW CELL CLEANER (PRODUCT #88656) (K863617)Hi Chem, Inc.1986-10-24
P.S.I.-DISPOSABLE METAL HANDLE SURGEONS SCALPEL (K863950)Precision Surgical Industries, Inc.1986-10-24
MODEL 20-C W/FL-20A/U FOR SURGERY & DERMATOLOGY (K862864)Directed Energy, Inc.1986-10-24
(STAMEY) T.U.R.P. SUPRAPUBIC CATHETER SET (K863120)Cook Urological, Inc.1986-10-24
IMZ INTRAMOBILE CYLINDER IMPLANT SYSTEM COMPONENTS (K863680)Interpore Intl.1986-10-24
AMENDMENT ULTRASOUND SCANNER TYPE 1842/1846/1849 (K852502)Bruel & Kjaer Industri A/S1986-10-23
PULSESTAR EXERCISE BIKE (K863884)Battle Creek Equipment Co.1986-10-23
UNIVERSAL CANNULA SYSTEM (K863590)Aspen Laboratories, Inc.1986-10-23
SULKY SPECIAL (K863450)Asc Corp.1986-10-23
THERACARE LOUNGER (K863892)American Theracare1986-10-23
SURGICAL DRAPE & DRAPE ACCESSORIES (K863732)Intera Corp.1986-10-23
RE-HEATER, HOT PACK (K863654)K & L Ent.1986-10-23
STARCRAFT ELITE AUTOCLAVE (K862495)Starcraft Medical Corp.1986-10-22
OXY-OFF(TM) (K863510)B&B Medical Technologies, Inc.1986-10-22
MEDI-PLAST DISPOSABLE MANIFOLD (K863402)Medi-Plast Intl., Inc.1986-10-22
TEMPERATURE SENSING ESOPHAGEAL TRANSDUCER (K862548)Lawrence Medical Systems, Inc.1986-10-22
SUCTION CATHETER KIT (K861949)Medi-Craft , Ltd.1986-10-22
OBSTETRICAL KIT (K863504)Dyna-Med1986-10-22
PATHFINDER ROTAVIRUS CHEMILUMINESCENT (K862917)Kallestad Laboratories, Inc.1986-10-22
DOUBLE LUMEN E T ADAPTOR (K862435)Acutronic Medical Systems AG1986-10-22
I.V. START KIT, STERILE, DISPOSABLES (K863712)Busse Hospital Disposables, Inc.1986-10-22
ASSERACHROM B-TG KIT (K862775)American Bioproducts Co.1986-10-22
ULTRAWASH I (K863623)Dynatech Laboratories, Inc.1986-10-21
SOLUTION B- NA 50MEQ/L, K 40 MEQ/L (K863502)Reagent Laboratory, 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
STEINMANN(THREADED/CALIBRATED),KNOWLES&HOGIE PINS (K863734)Micro-Aire Surgical Instruments, Inc.1986-10-20
OPHTHALMIC SURGICAL OCULAR MARKERS (K863663)Myocure, Inc.1986-10-20
THE SAVER KIT (K863666)Myocure, Inc.1986-10-20
RAINCOAT (K863910)Artec Environmental Monitoring Division1986-10-20
MEDITRADE ARTIFICIAL EYES AND IMPLANTS (K862977)Meditrade, Inc.1986-10-20
OXYGENATOR MODEL NO. BENTLEY-10 PLUS (K863249)American Bentley1986-10-20
RK VACUUM FIXATION RING SYSTEM (K863775)Ameritek, Inc.1986-10-20
OPHTHALMIC SURGICAL DRAPE (K863662)Myocure, Inc.1986-10-20
MILITARY PRESCRIPTION FRAME (K863862)Halo Optical Products, Inc.1986-10-20
VERSAFLEX(TM) DELTA ST(TM) MONITOR (K863922)Versaflex Delivery Systems, Inc.1986-10-20
SYNECTICS MOTILITY SYSTEM (K862929)Synectics-Dantec1986-10-20
STUDEX EAR PIERCING GUNS (K860622)Onyx Industries, Inc.1986-10-17
AUTO-VAC (TM) AUTOTRANSFUSION RESERV, MODEL 7900 (K862684)Boehringer Laboratories1986-10-17
CHLAMYDIA TISSUE CULTURE CONFIRMATION TEST (EIA) (K862948)Intercare Diagnostics, Inc.1986-10-17
IMPROVED COMSPAN (K863552)Dentsply Intl.1986-10-17
ACTIN FSL ACTIVATED PTT REAGENT (K863594)American Dade1986-10-17
ROTARY* POWERED SCALPEL (K863731)Self Sharpening Surgical Steel, Inc.1986-10-17
DP32 HAND HELD DENTAL PROPHYLAXIS UNIT (K861601)Stewart J. Lustgarten1986-10-17
FOUNDATIONS PLUS FACIAL-CHIN-NECK SUPPORTER 1000 (K863754)Foundations Plus, Inc.1986-10-17
ACID PHOSPHATASE (ACP) REAGENT (K863851)Sigma Diagnostics, Inc.1986-10-16
BARD IRYFIX(TM) STOMA CAP (K862631)C.R. Bard, Inc.1986-10-16
HYDRO-CLENZ UNIT (K863539)Atlantic Health Group1986-10-16
SODIUM BICARBONATE POWDER/BICARBONATE HEMODIALYSIS (K863631)American Healthcare Corp.1986-10-16
CHLORIDE PROCEDURE (K863585)Data Medical Associates, Inc.1986-10-16
FOLLICLE STIMULATING HORMONE IMMUNOASSAY SYSTEM (K863678)Nichols Institute Diagnostics1986-10-16
PATIENT MON 1280/1281/120C/121C & MULTI-PARA CART (K860646)Analogic Corp.1986-10-16
BAUSCH & LOMB CLEANING PAD (K843511)Bausch & Lomb, Inc.1986-10-16
HEPACRON PUREAIR-ZONE SYSTEM (K862432)Hepacron, Inc.1986-10-16
MODEL 545-45 FOR NEUROLOGICAL SURGICAL APPLICATION (K860977)Britt Corp., Inc.1986-10-16
CONSEAL(TM) COLOSTOMY CONTINENCE SYSTEM (K863830)Coloplast A/S1986-10-16
COMMVIEW SYSTEM (K862715)A T & T Technologies, Inc.1986-10-16
SAFETY PINS, ELASTIC BANDAGES & STOCKINETTES (K863633)Biological & Environmental Control Laboratories1986-10-16
KONTRON VITALMON 5010 PATIENT MONITOR (K852249)Kontron Instruments, Inc.1986-10-16
GSC 1000 (K863566)Genetic Systems Corp.1986-10-16
HS-15M MICROWAVE SURGERY EQUIPMENT, MICROTAZE (K861904)Cooper Lasersonics, Inc.1986-10-16
ALLEGRO LUTEINIZING HORMONE IMMUNOASSAY SYSTEM (K863679)Nichols Institute Diagnostics1986-10-16
MODEL A-1 OXYGEN ANALYZER (K863806)Medical, Inc.1986-10-15
CORDIS ANGIOPLASTY HEMOSTASIS DEVICES (K863177)Cordis Corp.1986-10-15
CSI LIQUID OXYGEN SYSTEM (K863556)Cryogenic Services, Inc.1986-10-15
RESPIRONICS PROTECTEASY (K863171)Respironics, Inc.1986-10-15
OXYGEN CONSERVATOR (K863657)Salter Labs1986-10-15
SALTER LABS MODEL 4000 NASAL CO2 SAMPLE LINE (K863703)Salter Labs1986-10-15
CARDIONOSTICS HOLTER DURA-LITE RECORDER (CASSETTE) (K863863)Cardionostics, Inc.1986-10-15
MYOLEX (K863730)Orion Corp.1986-10-15
MONAGHAN RVM, MODEL 760 AND 761 (K863612)Monaghan Medical Corp.1986-10-15
MODELS 2R AND 3R PNEUPAC VENTILATOR/RESUSCITATOR (K862830)Pneupac , Ltd.1986-10-15
COMPANION OXYGEN SAVER (K863695)Puritan Bennett Corp.1986-10-15
BIVONA FOME-CUF LASER ENDOTRACHEAL TUBE (K862238)Bivona Medical Technologies1986-10-15
EXACTECH TOTAL HIP SYSTEM (K862234)Exactech, Inc.1986-10-15
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
C-REACTIVE PROTEIN (CRP), FOR TECHNICON RA SYSTEMS (K863628)Technicon Instruments Corp.1986-10-15
COMFORTRON (K862092)M. D. Supply, Inc.1986-10-15
MAMM-AIRE (K863890)Ar Custom Medical Products, Ltd.1986-10-14
PA EQUALIZER (K863787)Electone, Inc.1986-10-14
CIBA CORNING PRISMA T4 LIPIA (LIPOSOME) (K862233)Ciba Corning Diagnostics Corp.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
ALPHA S/D DIAGNOSTIC X-RAY MAMMOGRAPHY UNIT (K863710)Ausonics Pty , Ltd.1986-10-14
S-RAY CAMERA (K863856)Uni-Quatro Industries1986-10-14
MANAN BREST TUMOR LOCALIZATION NEEDLE (K863848)Manan Manufacturing Co., Inc.1986-10-14
STAND, IRRIGATOR, STEEL, FOLDING (K863690)Brenner Metal Prod Corp.1986-10-14
PEAK OVULATION PREDICTOR (K863121)Micron Technology, Inc.1986-10-14
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Track 1986 automatically

Every clearance here is in the API, with alerts when new ones post.