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
174553–174576 of 176,076
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Mar 14, 1977
I.V. LOK TM
K770119 · KMK
Jelco Laboratories
General Hospital · 52d
Cleared Mar 14, 1977
DISPOS-A-CARE THERMOMETER SHEATH
K770125 · FLK
Chesebrough-Pond'S U.S.A. Co.
General Hospital · 52d
Cleared Mar 14, 1977
RH CONTROL DILUENT
K770185 · KSZ
Bd Becton Dickinson Vacutainer...
Hematology · 46d
Cleared Mar 14, 1977
FRACTURE REDUCTION SYS., MODEL OR 1001
K770388 · JEC
Sisan Assoc.
Orthopedic · 14d
Cleared Mar 14, 1977
LENS SET, MENTOR TRIAL
K770389 · HPC
Codman & Shurtleff, Inc.
Ophthalmic · 14d
Cleared Mar 14, 1977
FORCEPS, ANKLE INSERTING, CON-AXIAL
K770420 · HSN
Depuy, Inc.
Orthopedic · 7d
Cleared Mar 14, 1977
COMPONENTS, ANKLE, TRIAL, CON-AXIAL
K770421 · HSN
Depuy, Inc.
Orthopedic · 7d
Cleared Mar 14, 1977
PUNCTURE KIT, INTERNAL JUGULAR
K770462 · DQO
Arrow Intl., Inc.
Cardiovascular · 5d
Cleared Mar 10, 1977
SYN-O-SCOPE NASAL INHALER
K760674 · KCO
Mcdonald and Assoc., Inc.
Ear, Nose, Throat · 175d
Cleared Mar 10, 1977
CONVERSE ALTAR RETRACTOR
K760851 · KAL
V. Mueller O.V. Baxter Healthcare Corp.
Ear, Nose, Throat · 146d
Cleared Mar 10, 1977
TUBE HOLDING DEVICE
K770108 · FPK
Pharmaseal Div., Baxter Healthcare Corp.
General Hospital · 52d
Cleared Mar 10, 1977
SPECTROPHOTOMETERS, INFRARED MODELS X99
K770278 · JJQ
The Perkin-Elmer Corp.
Chemistry · 24d
Cleared Mar 10, 1977
SPECTROPHOTOMETER, MODEL 597 IR
K770288 · JJQ
The Perkin-Elmer Corp.
Chemistry · 24d
Cleared Mar 10, 1977
MONITOR, RADIOISOTOPE, MODEL 9273A
K770397
Amersham Corp.
Radiology · 8d
Cleared Mar 10, 1977
RADIOEAR MODEL 1072
K770402
Radioear Corp.
Gastroenterology & Urology · 7d
Cleared Mar 10, 1977
OVERLOAD WARNING DEVICE
K770405 · IRN
Synthes (Usa)
Physical Medicine · 7d
Cleared Mar 10, 1977
LEAD, HEART, BUTTERFLY CLAMP
K770416 · DTB
Arco Medical Products Co.
Cardiovascular · 6d
Cleared Mar 10, 1977
GAR, COLUMBIA, W/5% HORSE BLOOD
K770441 · JSO
Bd Becton Dickinson Vacutainer...
Microbiology · 3d
Cleared Mar 09, 1977
BAND-AID BRAND OF ADHESIVE BANDAGES
K770081 · FPX
Johnson & Johnson Professionals, Inc.
General & Plastic Surgery · 54d
Cleared Mar 09, 1977
PROLITH MODEL 21S CARDIAC PULSE GEN.
K770212 · DXY
Edwards Pacemaker Systems
Cardiovascular · 37d
Cleared Mar 09, 1977
ARGYLE RAPID GASTRIC LAVAGE KIT
K770248 · KDH
Sherwood Medical Industries
Gastroenterology & Urology · 30d
Cleared Mar 09, 1977
ELECTROTHERAPY APPARATUS E.T. 720
K770276 · IPF
Fort & Assoc.
Physical Medicine · 23d
Cleared Mar 09, 1977
MONITOR, FETAL HEART, MODEL 1980
K770292 · HGI
Berkeley Bio-Engineering
Obstetrics & Gynecology · 23d
Cleared Mar 09, 1977
ABDOMINAL ECG PROCESSOR FOR FETAL MONI.
K770295 · HGI
Brattle Instrument Corp.
Obstetrics & Gynecology · 23d