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.

176,325 clearances · 1976 to present · Updated monthly from FDA records · Free access · No registration required

Filters: Cleared only ×
175,820 results
150001–150024 of 175,820
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Mar 01, 1985
ADAC MODEL DPS-3300M DIGITAL PROCESSING SYSTEM
K844298 · LLZ
Adac Laboratories
Radiology · 122d
Cleared Mar 01, 1985
HEAD-SPINE STABILIZER HSS-1
K844549 · IWY
Imaging Accessories, Inc.
Radiology · 100d
Cleared Mar 01, 1985
OSMOLARITY STANDARDS
K844589 · JMZ
Rna Medical Corp.
Chemistry · 95d
Cleared Mar 01, 1985
IMA-TROL IMMUNOASSAY CONTROL
K844848 · JJY
Dimension Diagnostics
Chemistry · 78d
Cleared Mar 01, 1985
RICO RS4-XP EMERGENCY MEDICAL ASPIRATOR
K844881 · GCX
Rico Suction Laboratories, Inc.
General Hospital · 74d
Cleared Mar 01, 1985
RICO RS-6X EMERGENCY MEDICAL ASPIRATOR
K844882 · GCX
Rico Suction Laboratories, Inc.
General Hospital · 74d
Cleared Mar 01, 1985
ACOUSTIC OTOCOPE RECORDER
K850007 · ETY
Endeco Medical, Inc.
Ear, Nose, Throat · 58d
Cleared Mar 01, 1985
KOTEX MAXI PADS
K850033 · HHD
Kimberly-Clark Corp.
Obstetrics & Gynecology · 57d
Cleared Mar 01, 1985
KOTEX THIN MAXI PADS
K850034 · HHD
Kimberly-Clark Corp.
Obstetrics & Gynecology · 57d
Cleared Mar 01, 1985
ECG PATIENT MONITOR 302
K850155 · DRT
Rigel Medical Electronics, Inc.
Cardiovascular · 45d
Cleared Mar 01, 1985
ECG PATIENT MONITOR 301
K850156 · DRT
Rigel Medical Electronics, Inc.
Cardiovascular · 45d
Cleared Mar 01, 1985
PENPOINT, FLEXIBLE & SPOT MARKERS & RADOACTIVE RUL
K850207
Syncor Intl. Corp.
Radiology · 42d
Cleared Mar 01, 1985
ABBOTT RF EIA DIAGNOSTIC KIT
K850373 · DHR
Abbott Laboratories
Chemistry · 29d
Cleared Mar 01, 1985
LDH REAGENT FOR DEMAND ANALYZER
K850378 · CFJ
Advanced Biomedical Methods, Inc.
Chemistry · 29d
Cleared Mar 01, 1985
DIRECT BILIRUBIN FOR DEMAND ANALYZER
K850379 · CIG
Advanced Biomedical Methods, Inc.
Chemistry · 29d
Cleared Mar 01, 1985
INORGANIC PHOSPHOROUS FOR DEMAND ANALYZER
K850380 · CEO
Advanced Biomedical Methods, Inc.
Chemistry · 29d
Cleared Mar 01, 1985
MAGNESIUM REAGENT FOR DEMAND ANALYZER
K850381 · JGJ
Advanced Biomedical Methods, Inc.
Chemistry · 29d
Cleared Mar 01, 1985
PRL QUIK RIA KIT
K850383 · CFT
Pacific Biotech, Inc.
Chemistry · 28d
Cleared Mar 01, 1985
CARDIO-3 CHANNEL ELECTROCARDIOGRAPH
K850454 · DPS
Zimmer Elektromedizin GmbH
Cardiovascular · 23d
Cleared Mar 01, 1985
MICRO-AIRE STERNUM SAW REPLACEMENT BLADES
K850483 · DWH
Micro-Aire Surgical Instruments, Inc.
General & Plastic Surgery · 22d
Cleared Mar 01, 1985
MICRO-AIRE GENERIC BURS & DRILLS
K850497 · GFF
Micro-Aire Surgical Instruments, Inc.
General & Plastic Surgery · 21d
Cleared Mar 01, 1985
LISTER BANDAGE SCISSORS 6-0063(3,5 - 500 PCS
K850500
The Huxley Instrument Corp.
General & Plastic Surgery · 21d
Cleared Mar 01, 1985
LISTER BANDAGE SCISSORS (6-0064)-4.5 500PCS.
K850501
The Huxley Instrument Corp.
General & Plastic Surgery · 21d
Cleared Mar 01, 1985
H/G CUP POSITIONER (1520) LEFT-500PCS RIGHT 500PCS
K850502
The Huxley Instrument Corp.
General & Plastic Surgery · 21d