Atlas FDA

1986

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

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RecordFirmDate
LM-850 AUTOMATIC LENSMETER (K861064)Nidek, Inc.1986-04-15
MODEL 525-25 WATT CO2 LASER FOR DERMA/PLASTIC (K860278)Britt Corp., Inc.1986-04-15
PHOTRON VISUAL FIELD ANALYZER (K860642)Biosan Laboratories, Inc.1986-04-15
CD-200 CARDIAC MONITOR (K860175)Cardio Display Corp.1986-04-15
STORZ/MAZZACCO LENS FORCEP (K860915)Storz Instrument Co.1986-04-15
ACCUPAC CUSTOM SKIN SCRUB KIT (K861219)Geneva Laboratories, Inc.1986-04-15
BEHRING NEPHELOMETER SYSTEM (K860894)Behring Diagnostics, Inc.1986-04-15
SUEL BLOOD LANCET (K861151)Exel Intl.1986-04-15
TIGER'S DIGITAL THERMOMETER (K854349)Tiger Electronics, Inc.1986-04-14
MASH DERMATOME (K861138)Mecron Medical Products, Inc.1986-04-14
EARLENS (K854311)Sound Acoustic Systems, Ltd.1986-04-14
HOWMEDICA BIPOLAR PROSTHESIS (K861105)Howmedica Corp.1986-04-14
ULTRASONIC COUPLANT GEL (K854996)Johnson & Johnson Professionals, Inc.1986-04-14
RESIDENTIAL TANNING UNIT (K861076)Sunmaker, Inc.1986-04-14
ZIMMER VACUUM MIXING SYSTEM (K861086)Zimmer, Inc.1986-04-14
BOMED-CDM (K853706)Bomed Medical Mfr., Ltd.1986-04-14
DISPETTE II (K860899)Ulster Scientific, Inc.1986-04-14
DU PONT SORVALL CENTRIFUGES (RAPIDSPIN R) (K860747)E.I. Dupont DE Nemours & Co., Inc.1986-04-14
MX4040 INTRAUTERINE PRESSURE MONITORING KIT (K860101)Medex, Inc.1986-04-14
TRACHEAL TUBES (K853051)Erie Medical1986-04-11
ECG-ELECTRODE(SWAROMED) (K853939)D. Swarovski & Co.1986-04-11
ABUSCREEN RADIOIMMUNOASSAY FOR LSD W/ REF STANDARD (K860525)Roche Diagnostic Systems, Inc.1986-04-11
MACCONKEY W/MUG (K861259)Remel Co.1986-04-11
FOX FASTIDIOUS TEST PANEL (K854525)Beckman Instruments, Inc.1986-04-11
STRAT THYROID UPTAKE FLUROMET ENZYME IMMUNOASSAY (K860422)American Dade1986-04-11
BLUE RIBBON PARAFFIN INFILTRATION/EMBEDDING MED. (K861270)Surgipath Medical Industries, Inc.1986-04-11
TISSUE CULTURE FLASK PL 732 PLASTIC (K861253)Travenol Laboratories, S.A.1986-04-11
GAS SAMPLING KIT (K861286)Respiratory Support Products, Inc.1986-04-11
PRESSURE REGULATOR (K853039)Erie Medical1986-04-11
EMIT D.A.U. CANNABINOID 20NG ASSAY (K860500)Syva Co.1986-04-11
EXEL DENTAL NEEDLE (K861150)Exel Intl.1986-04-11
FLUOROSEAL, DENTIN SEALER AND CAVITY LINER (K860633)Scientific Pharmaceuticals, Inc.1986-04-11
MICRO-EIA THEOPHYLLINE TEST KIT MONOCLONAL (K855227)Bioclinical Systems, Inc.1986-04-11
DAHLBERG MODEL UT IN-THE-EAR HEARING AID (K860670)Dahlberg Electronics, Inc.1986-04-11
ORTHOSOURCE ETCH SYSTEMS (K861245)Ortho Source1986-04-11
ECHOCLONAL HTSH IRMA (K860288)Bio-Rad1986-04-11
AMRESCO FLOW PAC CREATINE PHOSPHOKINASE REAGENT (K860663)Amresco, Inc.1986-04-11
LASERSCOPE OMNIPLUS PHOTOSURGICAL SYST/ND:YAG OTOL (K855146)Laserscope1986-04-11
ENZYMATIC CHOLESTEROL REAGENT (SINGLE VIAL) (K860717)Trace Scientific , Ltd.1986-04-11
FORMALDEHYDE SOLUTION, 37% (K861201)Surgipath Medical Industries, Inc.1986-04-11
PROPHYLACTIC (CONDOM) (K854622)Medelec Intl. Corp.1986-04-11
CEFOTETAN 30 MCG ANTIMICROBIAL SUSCEPTIBILITY DISK (K860895)Organon Teknika Corp.1986-04-11
TOTAL IGE-IRMA RIA KIT (K860032)Diagnostic Products Corp.1986-04-11
ANESTHESIA VENTILATOR MODEL 100 (K854202)Rusz Instruments, Inc.1986-04-11
MAGNESIUM (SUBSTRATE, ENZYME, REAGENT) (K860367)Alpkem Corp.1986-04-11
ANSWER PLUS AT HOME PREGNANCY TEST (K860090)Armkel, LLC1986-04-11
SICKLE CELL REAGENT SET (K860812)Michclone Associates, Inc.1986-04-11
CHARISMA HEARING AID (K860759)Bernafon, Inc.1986-04-11
THERACHEM, TDC THERAPEUTIC DRUG CONTROLS (K860919)Fisher Scientific Co., LLC1986-04-11
MODEL 509A PHYSIOCORDER AMBULATORY RECORDER (K854269)Del Mar Avionics1986-04-11
SECHRIST AIRWAY PRESSURE MONITOR MODEL 600 (K861330)Sechrist Industries, Inc.1986-04-11
THRUST-AIRE MODEL 2001 (K860618)Charron Industries, Inc.1986-04-10
BARD ABSORPTION DRESSING (K861024)C.R. Bard, Inc.1986-04-10
ACCESSUS CRYOPRESERVATION PKG. STERILE TISSUE STOR (K853663)Travenol Laboratories, S.A.1986-04-09
AR-1100 AUTOMATIC REFRACTOR (K861065)Nidek, Inc.1986-04-09
GAMMA RADIATION STERILIZED ALCOHOL PREP PADS (K860961)H & P Industries, Inc.1986-04-09
MEDCO-SONIC NQ-2000 (K860099)Medco Products, Co., Inc.1986-04-09
MODEL 900 INFUSION PUMP (K860229)C.R. Bard, Inc.1986-04-09
NITROGLYCERIN INTRAVASCULAR ADMINISTRATION SET (K860157)Quest Medical, Inc.1986-04-09
DISPOSABLE RESCUE BREATHING DEVICE (K861054)B & F Medical Products, Inc.1986-04-09
DISPOSABLE HYPODERMIC NEEDLE SAFETY SHEATH (K861081)Perkins & Perkins, Inc.1986-04-09
KONTRON CUTANEOUS PO2 MONITOR 820 (K860951)Kontron Instruments, Inc.1986-04-09
IV FILTER EXTENSION SET (K860803)Med Fusion Systems, Inc.1986-04-09
INSPIRON DOUBLE SWIVEL TRACH ADAPTER (K860838)Inspiron Corp.1986-04-09
EASY-TEST (GGT) REAGENT, ITEM NO. 67526/93 (K860640)Em Diagnostic Systems, Inc.1986-04-09
EZ DETECH-URINE BLOOD TEST STICKS (K854358)Self Care Systems, Inc.1986-04-09
LONG TERM RECORDER RAG 1200 (K854866)Nihon Kohden America, Inc.1986-04-09
NUTRIMIX EMPTY CONTAINER (K860042)Abbott Laboratories1986-04-09
SHAMPAINE RADI-OP MODEL 1700RC (K860620)Smith & Nephew, Inc.1986-04-08
NORTA TEFLON COATED LATEX BALLOON CATHETERS (K861181)Beiersdorf, Inc.1986-04-08
TECNOL SECURE-ALL FETAL MONITOR STRAP (K861189)Tecnol New Jersey Wound Care, Inc.1986-04-08
MARX PLAN, RADIATION THERAPY TREATMENT PLAN SYSTEM (K860849)Marx Pland1986-04-08
NIDEK US-1600 A-SCAN (K854389)Nidek, Inc.1986-04-08
NUCOR COMPOSITE RESTORATIVE MATERIAL PASTE/LIQUID (K860626)Scientific Pharmaceuticals, Inc.1986-04-08
SUPERCATH A.V. FISTULA (K854773)Togo Medikit Co., Ltd.1986-04-08
COMPAT ENTERAL DELIVERY SYSTEMS (K855098)Sandoz Nutrition1986-04-08
DISPO-URETTE (K860796)Roland J. Zwick, Inc.1986-04-08
COMPAT ENTERAL DELIVERY SYSTEMS (K855097)Sandoz Nutrition1986-04-08
MEDCOMP'S FEMORAL VEIN CATHETERS (K860810)Medical Components, Inc.1986-04-08
FLAME PHOTOMETER STANDARD (K860501)Medical Specialties, Inc.1986-04-07
EIA MONOCLONAL TOTAL IGE KIT (K860033)Diagnostic Products Corp.1986-04-07
ACTHK-PR RIA KIT (K860311)Compagnie Oris Industrie, S.A.1986-04-07
VICKERS MEDICAL MODEL 272 TEMPERATURE MONITOR (K854598)Vickers , Ltd.1986-04-07
ALT(GPT) (ALANINE AMINOTRANSFERASE) REAGENT (K860727)Trace Scientific , Ltd.1986-04-07
MIRAGE INTRAVENOUS INFUSION SET OLOVSON-STERILE (K852616)Medical Hospital Equipment1986-04-07
EASY-TEST URIC ACID (URIC), #67516/93 (K860916)Em Diagnostic Systems, Inc.1986-04-07
EASY-TEST TOTAL PROTEIN (TP), #67513/93 (K860917)Em Diagnostic Systems, Inc.1986-04-07
TRANSFER SET (K860595)Migada, Ltd.1986-04-07
GILFORD UNIQUAL NORMAL CONTROL SERUM - ASSAYED (K861068)Ciba Corning Diagnostics Corp.1986-04-07
CELLEMATICS VIRAL/CHLAMYDAL TRANSPORT PACK(MODIFI) (K861080)Difco Laboratories, Inc.1986-04-07
MARQUEST QC-IV TONOMETER (K855024)Marquest Medical Products, Inc.1986-04-07
CAPD DISCONNECT SYSTEM 5C4182, 5C4183, 5C4186 (K860700)Travenol Laboratories, S.A.1986-04-07
DIAMATIC, AUTOMATIC INSULIN INJECTOR (K860284)Ulster Scientific, Inc.1986-04-07
ION-SPECIFIC ELECTRODE, CHLORIDE (K860668)Em Diagnostic Systems, Inc.1986-04-07
DOUBLE ANTIBODY ALBUMIN FOR DETECT MICROALBUMINURI (K851338)Diagnostic Products Corp.1986-04-07
POLYCATH-H CATHETER (K854308)Abbott Laboratories1986-04-07
CHALLENGER HOT BIOPSY FORCEPS (K860366)Microvasive1986-04-07
DRS-4 DIALYZER REPROCESSING SYSTEM (K860674)Seratronics, Inc.1986-04-07
INFLATOR/DEFLATOR PISTON SYRINGE (K860589)Microvasive1986-04-07
CREATINE KINASE, N-ACETYL-L-CYSTIENE (K860669)Em Diagnostic Systems, Inc.1986-04-07
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Track 1986 automatically

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