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
161857–161880 of 176,076
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Mar 01, 1982
CALIPER-OPTHALMIC
K813315 · HOE
Design Research Assoc., Inc.
Ophthalmic · 97d
Cleared Mar 01, 1982
GROSSE AND KEMPF LOCKING NAIL SYS.
K813371 · HSB
Howmedica Corp.
Orthopedic · 91d
Cleared Mar 01, 1982
SSD-203 ULTRASONIC SCANNER
K813398 · IYO
U. S. A. Imaging Corp.
Radiology · 87d
Cleared Mar 01, 1982
MADAYAG TYPE NEEDLE
K813462 · KNW
Ocean Medical Products, Ltd.
Gastroenterology & Urology · 80d
Cleared Mar 01, 1982
VITAL METRICS URINE MONITORING SYSTEM
K813641 · FFG
Vital Metrics, Inc.
Gastroenterology & Urology · 61d
Cleared Mar 01, 1982
TITANIUM IMPLANT DEVICES
K820013 · DZE
Bofors Nobelpharma, Inc.
Dental · 55d
Cleared Mar 01, 1982
PIONEER II BACK PLATE ELECTRODE
K820122 · DRX
Life Science Instrumentation, Inc.
Cardiovascular · 42d
Cleared Mar 01, 1982
SUNFLOWER
K820123 · FTC
Solana, Inc.
General & Plastic Surgery · 42d
Cleared Mar 01, 1982
TAYLOR & TYCOS ACOUSTIC SPHYGMOMANOMETER
K820135 · DXN
Sybron Corp.
Cardiovascular · 42d
Cleared Mar 01, 1982
BONE BIOPSY SET
K820293 · KNW
The Anspach Effort, Inc.
Gastroenterology & Urology · 26d
Cleared Mar 01, 1982
H-H RICKHAM TYPE RESERVOIR
K820312 · JXG
Holter-Hausner Intl.
Neurology · 24d
Cleared Mar 01, 1982
VPI-FAIR URETHRAL STENT
K820313 · KOD
Vance Products, Inc.
Gastroenterology & Urology · 24d
Cleared Mar 01, 1982
MODEL 3030 ATOMIC ABSORPTION SPECTRO-
K820320 · JXR
The Perkin-Elmer Corp.
Toxicology · 24d
Cleared Mar 01, 1982
RIONET HEARING AID HB-69AS
K820348 · ESD
Rion Acoustic Instruments, Inc.
Ear, Nose, Throat · 21d
Cleared Mar 01, 1982
RIONET HEARING AID HB-71H
K820349 · ESD
Rion Acoustic Instruments, Inc.
Ear, Nose, Throat · 21d
Cleared Mar 01, 1982
RIONET HEARING AID HB-71S
K820350 · ESD
Rion Acoustic Instruments, Inc.
Ear, Nose, Throat · 21d
Cleared Mar 01, 1982
ATMOS MIRROR WARMER
K820354 · KAI
Jedmed Instrument Co.
Ear, Nose, Throat · 21d
Cleared Mar 01, 1982
BECSIC COLLAR
K820366 · IQK
Blackstone & Breglio Industries
Physical Medicine · 20d
Cleared Mar 01, 1982
CURVED FINGER SPLINT
K820380 · ILH
Conco Medical Co.
Physical Medicine · 20d
Cleared Mar 01, 1982
FINGER PROTECTOR
K820381 · ILH
Conco Medical Co.
Physical Medicine · 20d
Cleared Mar 01, 1982
FROG SPLINT
K820382 · ILH
Conco Medical Co.
Physical Medicine · 20d
Cleared Mar 01, 1982
PEEP VALVE
K820404 · BYE
Vital Signs, Inc.
Anesthesiology · 17d
Cleared Feb 24, 1982
AIR ALIVE
K812320 · FRF
Western Systems, Inc.
General Hospital · 191d
Cleared Feb 24, 1982
NLD IMPLANT SET
K813314 · HMX
Design Research Assoc., Inc.
Ophthalmic · 92d