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
172537–172560 of 176,076
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Feb 28, 1978
CAULK TYLOK
K780301 · EMA
L.D. Caulk Co.
Dental · 6d
Cleared Feb 28, 1978
IN-THE-EAR HEARING AID, MODEL CE-3
K780309 · ESD
Starkey Laboratories, Inc.
Ear, Nose, Throat · 5d
Cleared Feb 27, 1978
PREDICTOR
K780240 · LCX
Organon, Inc.
Chemistry · 14d
Cleared Feb 27, 1978
IMPCO DISPOSABLE AORTIC PUNCH
K780247 · DWS
Thoratec Laboratories Corp.
Cardiovascular · 14d
Cleared Feb 27, 1978
COMPUTER AUDIOMETER - MA25
K780269 · EWO
Maico Hearing Instruments, Inc.
Ear, Nose, Throat · 6d
Cleared Feb 27, 1978
COMPUTER AUDIOMETER - MA26
K780270 · EWO
Maico Hearing Instruments, Inc.
Ear, Nose, Throat · 6d
Cleared Feb 27, 1978
DAY HEAR HOOK
K780287 · JYL
Edward Weck, Inc.
Ear, Nose, Throat · 6d
Cleared Feb 24, 1978
CATHETERIZATION KIT 732016-732018
K772340 · FCM
Latex Ind., Inc.
Gastroenterology & Urology · 64d
Cleared Feb 24, 1978
BLADDER KIT - 734000
K772341 · FCM
Latex Ind., Inc.
Gastroenterology & Urology · 64d
Cleared Feb 24, 1978
ROBINSON KIT - 750014 & 750016
K772342 · FCM
Latex Ind., Inc.
Gastroenterology & Urology · 64d
Cleared Feb 24, 1978
EXERCISER, RESP., DEEP BREATHING
K780037 · BWF
Medical Technologies of Georgia
Anesthesiology · 46d
Cleared Feb 24, 1978
AMPLIFIER, PC-700
K780116 · DQC
Burdick Corp.
Cardiovascular · 35d
Cleared Feb 24, 1978
ORTHOSISES DEVICES
K780225 · IQI
Biomet, Inc.
Physical Medicine · 15d
Cleared Feb 24, 1978
CATH TRAY W/OUT CATHETER
K780267 · EYZ
Latex Ind., Inc.
Gastroenterology & Urology · 7d
Cleared Feb 24, 1978
BLADDER CATH KIT W/OUT CATHETER
K780268 · FCM
Latex Ind., Inc.
Gastroenterology & Urology · 7d
Cleared Feb 24, 1978
THERAPY SCOOTER
K780296 · KNL
Convaid Product Development
Physical Medicine · 3d
Cleared Feb 23, 1978
ELECTRODE, DISPERSIVE, DISP. NEOPAD
K780118 · HAM
Neomed Corp.
General & Plastic Surgery · 31d
Cleared Feb 23, 1978
T3 STI KIT
K780146 · KHQ
Polysciences, Inc.
Microbiology · 24d
Cleared Feb 23, 1978
ISOENZYME SERUM CONTROL
K780147 · JJT
Corning Medical & Scientific
Chemistry · 24d
Cleared Feb 23, 1978
SPECTROPHOTOMETER, MODEL 380
K780156 · JJQ
Turner Assoc.
Chemistry · 24d
Cleared Feb 23, 1978
ORABRITE
K780174 · JER
Norcliff Thayer, Inc.
Dental · 21d
Cleared Feb 23, 1978
LIQUID SCINTILLATION COUNTER
K780179 · JJJ
Roche Medical Electronics, Inc.
Toxicology · 20d
Cleared Feb 23, 1978
LIQUISOL DIGOXIN RIA TEST KIT
K780207 · DON
Damon Corp.
Toxicology · 16d
Cleared Feb 23, 1978
TRACTION UNITS
K780228 · HST
Biomet, Inc.
Neurology · 14d