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
157561–157584 of 176,076
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared May 25, 1983
OMNISTICK
K830310 · CBT
Marquest Medical Products, Inc.
Anesthesiology · 119d
Cleared May 25, 1983
AUTO STIK
K830311 · CBT
Marquest Medical Products, Inc.
Anesthesiology · 119d
Cleared May 25, 1983
ASPIRATOR
K830312 · CBT
Marquest Medical Products, Inc.
Anesthesiology · 119d
Cleared May 25, 1983
CFE TOTAL HIP FEMORAL COMPONENT
K830313 · JDI
Biomet, Inc.
Orthopedic · 114d
Cleared May 25, 1983
FIRST AID BAGS #1,2,3
K830375 · FRO
Akla, Inc.
General & Plastic Surgery · 110d
Cleared May 25, 1983
RECORDER DMI
K830489 · DSH
Diagnostic Medical Instruments
Cardiovascular · 99d
Cleared May 25, 1983
DOSIMETRIC RELEASE
K830546 · KQT
American Hospital Supply Corp.
Gastroenterology & Urology · 92d
Cleared May 25, 1983
CONVERTER UNIT FOR ECG TRACE DISPLAY
K830566 · DPS
Honeywell, Inc.
Cardiovascular · 91d
Cleared May 25, 1983
LINEAR PUMP #4370975
K830577 · JOW
Wright Linear Pump, Inc.
Cardiovascular · 91d
Cleared May 25, 1983
HI FLEX D-700 MODULAR BUBBLE OXYGENA-
K830639 · DTZ
Electromedics, Inc.
Cardiovascular · 85d
Cleared May 25, 1983
NORELCO VIBRATING BOARD V900
K830715 · IRO
North American Philips Corp.
Physical Medicine · 77d
Cleared May 25, 1983
AZLIN AZLOCILIN SODIUM-DIAG. REAGENT
K830758 · JTT
Miles Laboratories, Inc.
Microbiology · 76d
Cleared May 25, 1983
WALK N ROLL
K830784 · ITJ
Meta-Morris
Physical Medicine · 75d
Cleared May 25, 1983
NEDS-01 & EPR-500
K830862 · DXY
Biotronik Sales, Inc.
Cardiovascular · 68d
Cleared May 25, 1983
MINITROP AEROSAL, PRODOMO AEROSAL AND
K830913 · BTT
Medlog GmbH Marketing Services
Anesthesiology · 65d
Cleared May 25, 1983
AMERLEX FREE T-3 RIA KIT
K830980 · CDP
Amersham Corp.
Chemistry · 57d
Cleared May 25, 1983
DIAGNOSTICS PH ELECTRODE CLEANING SOLUT
K831015 · CHL
Fisher Scientific Co., LLC
Chemistry · 56d
Cleared May 25, 1983
WILLIAM HARVEY H-1700 ADULT BLOOD OXYG-
K831122 · DTZ
C.R. Bard, Inc.
Cardiovascular · 50d
Cleared May 25, 1983
DIGICATH
K831171 · DQO
Argon Medical Corp.
Cardiovascular · 44d
Cleared May 25, 1983
SERUM IRON-PTF-600
K831201 · JIY
American Monitor Corp.
Chemistry · 42d
Cleared May 25, 1983
SERUM UIBC-PTF-600 METHOD
K831202 · JMO
American Monitor Corp.
Chemistry · 42d
Cleared May 25, 1983
GENTAMICIN TEST PACK-ACA
K831210 · DJB
E.I. Dupont DE Nemours & Co., Inc.
Toxicology · 41d
Cleared May 25, 1983
WALRUS PERCUTANEOUS INTRODUCER SET
K831239 · DOY
Medical Parameters, Inc.
Toxicology · 40d
Cleared May 25, 1983
DATA IV AMBULATORY MONITOR
K831262 · DSH
Cardio-Scan of Texas
Cardiovascular · 37d