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

Filters: Cleared only ×
176,076 results
153481–153504 of 176,076
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared May 14, 1984
FEMORAL CEMENT REMOVAL INSTRUMENT
K840735 · HWX
Amtech Scientific, Inc.
Orthopedic · 83d
Cleared May 14, 1984
KYOTEST 5V
K840827 · CEN
Kyoto Diagnostics, Inc.
Chemistry · 80d
Cleared May 14, 1984
KYOTEST 8V
K840828 · JMT
Kyoto Diagnostics, Inc.
Hematology · 80d
Cleared May 14, 1984
CHESTAC-25F SPIROMETER
K840908 · BZG
Medical Equipment Designs, Inc.
Anesthesiology · 75d
Cleared May 14, 1984
FRC 85 SERIES SPIROMETER
K840929 · BZG
Medical Equipment Designs, Inc.
Anesthesiology · 73d
Cleared May 14, 1984
ANESTHETIC GAS MONITOR SYS
K840966 · CCK
Marquest Medical Products, Inc.
Anesthesiology · 69d
Cleared May 14, 1984
DELTA MULTIPLE NON RETURN CONNECTOR
K841106 · FPA
Tefra Med, Inc.
General Hospital · 63d
Cleared May 14, 1984
GLAS IONOMER CEMENT
K841195 · EMA
Shofu Dental Corp.
Dental · 54d
Cleared May 14, 1984
BBL GASPAK POUCH
K841307 · FKJ
Bd Becton Dickinson Vacutainer...
Microbiology · 45d
Cleared May 14, 1984
PROVIDER IV MODEL 2000 INFUSIN SYS
K841373 · FRN
Pancretec, Inc.
General Hospital · 41d
Cleared May 14, 1984
COROMETRICS 815 FETAL ECG RECORDER
K841477 · HGM
Ge Medical Systems Information...
Obstetrics & Gynecology · 35d
Cleared May 14, 1984
C02 MONITOR-OIR-7101
K841498 · CCK
Nihon Kohden America, Inc.
Anesthesiology · 34d
Cleared May 14, 1984
H-H SHUNT PASSERS
K841553 · GYK
Holter-Hausner Intl.
Neurology · 28d
Cleared May 14, 1984
MEDTRONIC RESUME SE-4 3587-LEAD-SPINAL
K841584 · GZB
Medtronic Vascular
Neurology · 27d
Cleared May 14, 1984
SELENITE CYSTINE BROTH BASE
K841660
Oxoid U.S.A., Inc.
Microbiology · 21d
Cleared May 14, 1984
MASS SPECTROMETER INTERFACE
K841722 · BZO
Dryden Corp.
Anesthesiology · 19d
Cleared May 14, 1984
MUELLER-HINTON AGAR
K841755 · JTZ
The Montana Deaconess Medical Center
Microbiology · 17d
Cleared May 14, 1984
ULTRA-LITE PREMIER
K841830 · IOR
Everest & Jennings, Inc.
Physical Medicine · 11d
Cleared May 14, 1984
CULTURE MEDIUM FOR PATHOGENIC NEISSER
K841833 · JTY
Microline Scientific
Microbiology · 27d
Cleared May 14, 1984
CULTURE MEDIUM FOR ANTIMICROBIAL SUSCEP
K841834 · JTZ
Microline Scientific
Microbiology · 27d
Cleared May 14, 1984
MULTIPURPOSE CULTURE MEDIUM
K841835 · JSG
Microline Scientific
Microbiology · 27d
Cleared May 14, 1984
SELECTIVE CULTURE MED. TRICHOMONAS
K841836 · JSD
Microline Scientific
Microbiology · 27d
Cleared May 14, 1984
ISOSTATION SHOULDER MACHINE
K841849 · IKK
Isotechnologies, Inc.
Physical Medicine · 11d
Cleared May 11, 1984
DIFFU-GEN APOLIPOPROTEIN A-I RADIAL -
K834218 · MSJ
Tago, Inc.
Immunology · 155d