Search FDA 510(k) Clearance Records

Use this 510(k) search tool to find FDA medical device clearance records by K-number, device name, manufacturer, product code, or regulatory consultant. Explore individual submissions, review timelines, predicate device information, and links to official FDA records. Search the database for free, with no registration required.

176,583 clearances · 1976 to present · Updated monthly from FDA records · Free access · No registration required

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176,076 results
171553–171576 of 176,076
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Sep 01, 1978
MYCOPLASMA HYORHINIS (BTS-7)
K781390 · KPB
Flow Laboratories, Inc.
Pathology · 22d
Cleared Aug 31, 1978
STERILE URETHRAL CATHETER KIT
K760897 · KOD
Diamed Division Ill. Tool Works, Inc.
Gastroenterology & Urology · 674d
Cleared Aug 31, 1978
PACEMAKER, ELECTRODE, PERMANENT & TEMP.
K780246 · DTB
Daig Corp.
Cardiovascular · 199d
Cleared Aug 31, 1978
MODEL 80 CONDUCTIVITY/TEMP.TEST UNIT
K780932 · FIZ
Western Laboratories Corp.
Gastroenterology & Urology · 86d
Cleared Aug 31, 1978
MODEL 20 DIGITAL PULSE RATE MONITOR
K780937 · DRT
Sentronix, Inc.
Cardiovascular · 84d
Cleared Aug 31, 1978
MODEL 1812 CONTROL CONSOLE, ACCESSORIEX
K780952 · DWA
Medtronic Vascular
Cardiovascular · 83d
Cleared Aug 31, 1978
MODEL 1861 BLOOD PUMP
K780953 · KFM
Medtronic Vascular
Cardiovascular · 83d
Cleared Aug 31, 1978
IMMUNOCHEMISTRY SYS. MANUAL MODE
K781006 · JZW
Beckman Instruments, Inc.
Immunology · 73d
Cleared Aug 31, 1978
OXY-ON DIGITAL OXYGEN TIMER
K781039 · BXP
Chambers & Sadler Mfg.
Anesthesiology · 73d
Cleared Aug 31, 1978
OXYGEN RICH AIR SUPPLY UNIT-MODEL 390
K781074 · CAW
Xorbox
Anesthesiology · 63d
Cleared Aug 31, 1978
DENTAL SILICONE IMPRESSION MATERIAL
K781083 · ELW
Crown Delta Corp.
Dental · 63d
Cleared Aug 31, 1978
MICROCULT-GC CULTURE TEST
K781108 · JSX
Miles Laboratories, Inc.
Microbiology · 62d
Cleared Aug 31, 1978
LEAD CONVERSION KIT, MODEL 341
K781111
Edwards Pacemaker Systems
Cardiovascular · 59d
Cleared Aug 31, 1978
LIPOPROTEIN STAIN
K781122 · HZG
Electrophoresis Corp. of America
Microbiology · 59d
Cleared Aug 31, 1978
ACCESSORY TO 4-24 RECORDER
K781129 · GWQ
Oxford Medilog, Inc.
Neurology · 57d
Cleared Aug 31, 1978
ELECTROSURGICAL PENCIL SYSTEM
K781148 · GEI
Medical Plastics, Inc.
General & Plastic Surgery · 51d
Cleared Aug 31, 1978
REPROSIL
K781151 · ELW
Dentsply Intl.
Dental · 52d
Cleared Aug 31, 1978
ELECTROCARDIOGRAPHIC ECG RECORDER
K781152 · DSM
Cardio-Dynamics Laboratories, Inc.
Cardiovascular · 52d
Cleared Aug 31, 1978
GENERATOR, PULSE, PACEMAKER
K781168 · DXY
Vitatron Medical BV
Cardiovascular · 49d
Cleared Aug 31, 1978
IMAGE
K781169 · EJT
Deringer-Ney, Inc.
Dental · 49d
Cleared Aug 31, 1978
U-DRAPE, BOUNDARY
K781172 · KKX
Procter & Gamble Mfg. Co.
General Hospital · 49d
Cleared Aug 31, 1978
TEST MODULE MODEL DM-352
K781215
Extracorporeal Medical Specialities,...
Gastroenterology & Urology · 45d
Cleared Aug 31, 1978
ECON-O2
K781219
Mountain Medical Equipment, Inc.
Cardiovascular · 45d
Cleared Aug 31, 1978
GLOBULIN TEST, HUMAN THYROXINE BINDING
K781225 · CEE
Hyland Therapeutic Div., Travenol...
Chemistry · 44d