Medical Device Manufacturer · US , Mchenry , IL

Hogan & Hartson

26 submissions · 25 cleared · Since 1980
26
Total
25
Cleared
0
Denied

Hogan & Hartson — FDA 510(k) Submissions

Hogan & Hartson has submitted 26 FDA 510(k) premarket notifications since 1980, of which 25 received clearance as substantially equivalent to a predicate device.

The company's most frequent device categories include System, Test, Anticardiolipin Immunological, Unit, Electrosurgical, Endoscopic (with Or Without Accessories), Powered Laser Surgical Instrument, Antinuclear Antibody (enzyme-labeled), Antigen, Controls, Anti-ribosomal P Antibodies . Use the specialty filter in the sidebar to narrow results.

26 devices
1–25 of 26
COOPERSURGICAL INFRARED COAGULATOR
K974168 · KNS Unit, Electrosurgical,... · Gastroenterology & Urology
Jan 1998 79d
BIOABSORBABLE BANKART TACK
K973849 · MAI Fastener, Fixation,... · Orthopedic
Jan 1998 90d
DUAL RADIATION TARGETING SYSTEM DRTS DRAPE
K973162 · IWE Monitor, Patient... · General Hospital
Nov 1997 90d
RIBOSOMAL P EIA TEST SYSTEM
K950169 · MQA Anti-ribosomal P Antibodies · Immunology
May 1996 492d
TROCARS, TROCAR SLEEVES AND REDUCTION SLEEVES
K942389 · HET Laparoscope, Gynecologic... · Obstetrics & Gynecology
Feb 1996 639d
CARDIOLIPIN G EIA TEST SYSTEM
K946215 · MID System, Test,... · Immunology
Jan 1996 399d
CARDIOLIPIN A EIA TEST SYSTEM
K946216 · MID System, Test,... · Immunology
Jan 1996 399d
CARDIOLIPIN M EIA TEST SYSTEM
K946217 · MID System, Test,... · Immunology
Jan 1996 399d
CHAL-2500
K946186 · IPF Stimulator, Muscle, Powered · Physical Medicine
Aug 1995 237d
COMPUSPEAK
K941566 · LLZ System, Image Processing,... · Radiology
Jun 1995 455d
MARDX ENA EIA TEST SYSTEM
K946218 · LJM Antinuclear Antibody... · Immunology
May 1995 145d
MARDX MITOCHONDRIA EIA TEST SYSTEM
K950110 · LJM Antinuclear Antibody... · Immunology
May 1995 124d
REDFIELD INFRARED COAGULATOR
K950836 · KNS Unit, Electrosurgical,... · Gastroenterology & Urology
Mar 1995 28d
MOTIVATOR FTR 2000
K942229 · IKK System, Isokinetic... · Physical Medicine
Feb 1995 297d
INTERGRATED MONITORING ARCHIVING AND COMMUNICATIONS SYSTEMS (IMACS)
K941762 · DQK Computer, Diagnostic,... · Cardiovascular
Feb 1995 317d
MEGABEAM FIBER OPTIC DELIVERY SYSTEM
K946336 · GEX Powered Laser Surgical... · General & Plastic Surgery
Feb 1995 43d
EMERGENCY/ACCIDENT TROLLEY 550
K946101 · FPO Stretcher, Wheeled · General Hospital
Feb 1995 55d
NORELCO CLEAN AIR SYSTEM CAS950
K945161 · FRF Cleaner, Air, Medical... · General Hospital
Nov 1994 42d
VITAFLON PLUS/VASCULON
K941417 · FOZ Catheter, Intravascular,... · General Hospital
Oct 1994 197d
454A ELECTROSURGICAL ANALYZER
K942627 · GEI Electrosurgical, Cutting... · General & Plastic Surgery
Aug 1994 74d
IMPULSE 4000 DEFIBRILLATOR/TRANSCUTANEOUS PACER ANALYZER
K941404 · DRL Tester, Defibrillator · Cardiovascular
Jun 1994 98d
LIQUID OXYGEN STORAGE SUBSYSTEM
K941819 · BYJ Unit, Liquid-oxygen,... · Anesthesiology
May 1994 40d
MEGA BEAM LATERAL FIRE
K941909 · GEX Powered Laser Surgical... · General & Plastic Surgery
May 1994 34d
RESPITRACE PLUS
K894973 · FLS Monitor, Apnea, Facility Use · Anesthesiology
Oct 1989 84d
I.M. RETROGRADE BLADES
K810045 · GFA Blade, Saw, General &... · General & Plastic Surgery
Feb 1981 35d
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