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

Filters: Cleared only ×
176,076 results
160825–160848 of 176,076
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Jun 09, 1982
DYNAMIC FUNTIONAL POSITIONER
K821458 · KMY
Dynamic Functional Positioner, Inc.
Dental · 33d
Cleared Jun 09, 1982
DAWN LOW SPEED HANDPIECE SYSTEM
K821484 · EFB
Young Dental Manufacturing Co. 1, LLC
Dental · 22d
Cleared Jun 09, 1982
MICRO DRILLS
K821486 · GFG
Spire Medical, Inc.
General & Plastic Surgery · 22d
Cleared Jun 09, 1982
CORDIA TG
K821489 · JZO
Cordis Corp.
Chemistry · 22d
Cleared Jun 09, 1982
RIONET HEARING AID
K821508
Rion Acoustic Instruments, Inc.
Gastroenterology & Urology · 19d
Cleared Jun 09, 1982
A THENIUM
K821510 · EJS
Williams Gold Refining Co., Inc.
Dental · 20d
Cleared Jun 09, 1982
VENTED NITROGLYCERIN I.V. SET
K821515 · FPA
Abbott Laboratories
General Hospital · 20d
Cleared Jun 09, 1982
STABILOR NF
K821521 · EJT
J. Aderer, Inc.
Dental · 19d
Cleared Jun 09, 1982
SYRINGE, PISTON
K821528 · FMF
Medcare Disp Products, Inc.
General Hospital · 19d
Cleared Jun 09, 1982
DISPOSABLE HYPODERMIC NEEDLES
K821529 · FMI
Medcare Disp Products, Inc.
General Hospital · 19d
Cleared Jun 09, 1982
MONITORING DEVICE ENURESIS ALARM & ACC.
K821546 · KPN
Wetbell, Inc.
Gastroenterology & Urology · 15d
Cleared Jun 09, 1982
EOSIN Y SOLUTION ALCHOLIC
K821573 · HYB
Sigma Chemical Co.
Pathology · 13d
Cleared Jun 09, 1982
MODEL 580 DIGITAL RADIOGRAPHY SYSTEM
K827501
Technicare Corp.
Radiology · 30d
Cleared Jun 09, 1982
MODEL DPS-4050 DIGITAL RADIOGRAPHY SYSTEM
K827502
Adac Laboratories
Radiology · 36d
Cleared Jun 09, 1982
SIZE SENSING CASSETTE TRAY
K827504
Midwest X-Ray Equipment Co.
Radiology · 36d
Cleared Jun 07, 1982
REIGNING DENTURE
K821217 · EBI
Oki Shiks USA , Ltd.
Dental · 41d
Cleared Jun 07, 1982
DENTAL IMPRESSION MATERIAL
K821221 · ELW
Crown Delta Corp.
Dental · 41d
Cleared Jun 07, 1982
DENTAL AMALGAM ALLOY
K821226 · EJJ
Dental Alloyers Intl., Inc.
Dental · 41d
Cleared Jun 07, 1982
HEAD-UP SUPINE SAFETY SUPPORT CUSHION
K821306 · EPW
Med-Life, Inc.
General & Plastic Surgery · 34d
Cleared Jun 07, 1982
OTICON
K821325 · ESD
Oticon Corp.
Ear, Nose, Throat · 34d
Cleared Jun 07, 1982
GAS STERILIZATION POUCHES
K821330 · FRG
Medical Industries Packaging, Inc.
General Hospital · 34d
Cleared Jun 07, 1982
MEDI-SEAL STERILIZATION POUCHES & TUB
K821331 · FRG
Medical Industries Packaging, Inc.
General Hospital · 34d
Cleared Jun 07, 1982
CUSTOM, IN-THE-EAR HEARING AID
K821390 · ESD
Ear-Tronics, Inc.
Ear, Nose, Throat · 27d
Cleared Jun 04, 1982
E.G. BRIDGE GOLD
K821613 · EJT
J. Aderer, Inc.
Dental · 2d