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
170497–170520 of 176,076
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Mar 07, 1979
MANIFOLD, FOR DOUBLE SUPPLY
K790154 · CAF
Airlife, Inc.
Anesthesiology · 54d
Cleared Mar 07, 1979
DRAGER ORM
K790334 · BYR
Draeger Medical, Inc.
Anesthesiology · 19d
Cleared Mar 06, 1979
CATHETER, TRANSLUMINAL BALLOON
K781772 · GBA
Medi-Tech, Inc.
General & Plastic Surgery · 141d
Cleared Mar 06, 1979
KANGA PANTS
K781901 · EYQ
H.A. & J.E. Wood, Inc.
Gastroenterology & Urology · 113d
Cleared Mar 06, 1979
DIALYZER, MODEL F.M.D 150
K790001 · FJG
Hospal Medical Corp.
Gastroenterology & Urology · 63d
Cleared Mar 06, 1979
TAPE MEASURE
K790089 · FTY
Pfizer, Inc.
General & Plastic Surgery · 48d
Cleared Mar 06, 1979
FILTERSET 0.22, I.V. PUMP
K790108 · FPA
Imed Corp.
General Hospital · 49d
Cleared Mar 06, 1979
INFANT CARE SYSTEM
K790137 · FMT
Narco Air-Shields
General Hospital · 43d
Cleared Mar 06, 1979
MONITOR PLUG-IN MODEL M1106 ECG
K790198 · DRT
Electronics For Medicine, Inc.
Cardiovascular · 40d
Cleared Mar 06, 1979
TRAY AND BAG, CATHETERIZATION
K790271 · FCM
Snyder Laboratories, Inc.
Gastroenterology & Urology · 56d
Cleared Mar 06, 1979
TRAY, URETHRAL CATHETERIZATION
K790272 · FCM
Snyder Laboratories, Inc.
Gastroenterology & Urology · 52d
Cleared Mar 06, 1979
CATHETER, MMG LATEX EXTERNAL
K790279 · KNX
Medical Marketing Group
Gastroenterology & Urology · 21d
Cleared Mar 06, 1979
FLUID ADMINISTRATION SETS, 15 MICRON
K790314 · FPB
Medex, Inc.
General Hospital · 21d
Cleared Mar 06, 1979
ANAMETRIC TIBIAL COMPONENT METAL TRAY
K790348 · HRY
Howmedica Corp.
Orthopedic · 13d
Cleared Mar 06, 1979
TOTAL CONDYLAR KNEE PROSTHESIS
K790349 · HRY
Howmedica Corp.
Orthopedic · 13d
Cleared Mar 06, 1979
POSTERIOR CRUCIATE CONDYLAR TIBIAL
K790350 · HRY
Howmedica Corp.
Orthopedic · 13d
Cleared Mar 06, 1979
MODEL 342 HEARING AIDS
K790354 · ESD
Telex Communications, Inc.
Ear, Nose, Throat · 12d
Cleared Mar 06, 1979
MODEL 342D HEARING AIDS
K790355 · ESD
Telex Communications, Inc.
Ear, Nose, Throat · 12d
Cleared Mar 02, 1979
RIA KIT, PROGESTERONE
K782009 · JLS
The Upjohn Co.
Chemistry · 91d
Cleared Mar 02, 1979
UNITEST AMYLASE
K782032 · CIW
Boehringer Mannheim Corp.
Chemistry · 86d
Cleared Mar 02, 1979
THERA CHEM
K782128 · DIF
Fisher Scientific Co., LLC
Toxicology · 65d
Cleared Mar 02, 1979
UNITEST CREATINE KINASE
K782156 · JLB
Boehringer Mannheim Corp.
Chemistry · 70d
Cleared Mar 02, 1979
STIMULATOR, MENTOR 100 NERVE
K790011 · GZJ
Mentor Corp.
Neurology · 59d
Cleared Mar 02, 1979
DIGITAL BPM
K790036 · DXO
Narco Air-Shields
Cardiovascular · 53d