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
170353–170376 of 176,076
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Apr 04, 1979
ISOTONIC DILUENT
K790442 · GIF
Royco Instruments
Hematology · 28d
Cleared Apr 04, 1979
HEMOGLOBIN CONTROLS
K790457 · JPK
Data Medical Associates, Inc.
Hematology · 30d
Cleared Apr 04, 1979
STREP BLOOD AGAR-5% SHEEP BLOOD
K790469 · JSI
Biomedia, Inc.
Chemistry · 30d
Cleared Apr 04, 1979
ITIMIZED INSTRUMENTS
K790491 · FZT
E.M. Adams
General & Plastic Surgery · 27d
Cleared Apr 04, 1979
SPONGE COUNTER
K790538 · LWH
Devon Industries, Inc.
General & Plastic Surgery · 15d
Cleared Apr 04, 1979
MEDISTOR II
K790579 · BTY
Cybermedic, Inc.
Anesthesiology · 8d
Cleared Apr 04, 1979
TOGUARD
K790652 · IPG
Togard, Inc.
Physical Medicine
Cleared Apr 03, 1979
HEALTH POINT
K781651 · BWK
Anritsu America Co.
Neurology · 188d
Cleared Apr 03, 1979
LANCER ICE CUBE
K782077 · JRM
Sherwood Medical Industries
Pathology · 111d
Cleared Apr 03, 1979
ELECTRODES, FERRIS ECG, TYPES 905,906
K790305 · DRX
Ferris Mfg. Corp.
Cardiovascular · 49d
Cleared Apr 03, 1979
ZIMMER SURGICAL INSTRUMENT LUBRICANT
K790331
Zimmer, Inc.
General & Plastic Surgery · 46d
Cleared Apr 03, 1979
LEAD MODELS MUM 1260, MUM 1290
K790386 · DTB
Ela Medical, Inc.
Cardiovascular · 36d
Cleared Apr 03, 1979
TRACH CARE KIT
K790437 · BTO
Abco Dealers, Inc.
Anesthesiology · 27d
Cleared Apr 03, 1979
MODEL 78801A PATIENT MONITORS
K790454 · DRT
Hewlett-Packard Co.
Cardiovascular · 29d
Cleared Apr 03, 1979
A-GENT IMMUNOGLOBULINE TEST SYSTEM
K790479 · CZP
Abbott Laboratories
Chemistry · 26d
Cleared Apr 03, 1979
TULANE HEAT-PACK
K790480 · IMD
Tulane
Physical Medicine · 26d
Cleared Apr 03, 1979
MODEL FS1
K790481 · KHL
Starkey Laboratories, Inc.
Ear, Nose, Throat · 26d
Cleared Apr 03, 1979
MODEL 4107-2S, HEARING AID
K790482 · ESD
Starkey Laboratories, Inc.
Ear, Nose, Throat · 26d
Cleared Apr 03, 1979
LISS REAGENT
K790498 · KSG
Fisher Scientific Co., LLC
Hematology · 21d
Cleared Apr 03, 1979
BEHIND-THE-EAR HEARING AID
K790515 · ESD
Danavox, Inc.
Ear, Nose, Throat · 19d
Cleared Apr 03, 1979
HEMATROL S HEMATOLOGY CONTROLS
K790525 · JPK
Fisher Scientific Co., LLC
Hematology · 19d
Cleared Apr 03, 1979
THERAPY GYROSCOPE
K790528 · KNL
Maddak, Inc.
Physical Medicine · 19d
Cleared Apr 03, 1979
WALKING AID
K790529 · ITJ
Maddak, Inc.
Physical Medicine · 19d
Cleared Apr 03, 1979
PUSH BALL INCLINE
K790530 · ION
Maddak, Inc.
Physical Medicine · 19d