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
76273–76296 of 176,076
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared May 16, 2002
ACCOMMODATOR WHEELCHAIR, MODEL #2000X
K021145 · IOR
Marken International, Inc.
Physical Medicine · 37d
Cleared May 16, 2002
QACA IGG/IGM ELISA KIT HRP
K021192 · MID
Cheshire Diagnostics , Ltd.
Immunology · 31d
Cleared May 16, 2002
CONSTELLATION CATHETERS, MODEL 8031M
K021232 · MTD
Boston Scientific Corp
Cardiovascular · 28d
Cleared May 16, 2002
PORTALLOY 54
K021242 · EJT
Wieland Dental + Technik GmbH & Co. KG
Dental · 27d
Cleared May 16, 2002
STERNGOLD 66, MODEL #1180230
K021367 · EJS
Sterngold
Dental · 16d
Cleared May 16, 2002
SUNSPEX TECHNOLOGIES MODEL SE 02
K021371 · INI
Sunpex Technology Co., Ltd.
Physical Medicine · 16d
Cleared May 16, 2002
SYNTHES (USA) AUTOMATED TACK DRIVER
K021382 · JEY
Synthes (Usa)
Dental · 14d
Cleared May 16, 2002
DERMAGRIP AND MULTIPLE POWDER FREE PURPLE NITRILE EXAMINATION GLOVES,...
K021396 · LZA
Wrp Specialty Products Sdn. Bhd.
General Hospital · 14d
Cleared May 16, 2002
PHILIPS PLS9W/12/2P UVB
K021514 · FTC
Philips Lighting Co.
General & Plastic Surgery · 7d
Cleared May 15, 2002
BOEHRINGER LABORATORIES PNEUMATIC AMBULATORY COMPRESSION SYSTEM 8200 SERIES
K020538 · DWL
Boehringer Laboratories
General Hospital · 85d
Cleared May 15, 2002
NATURAL AND COLORED LATEX CONDOM WITH FLAVORS
K020633 · HIS
Ls Rubber Sdn Bhd
Obstetrics & Gynecology · 77d
Cleared May 15, 2002
HERNIAMESH T-SLING
K020652 · PAH
Herniamesh
Gastroenterology & Urology · 76d
Cleared May 15, 2002
DUKAL DISPOSABLE VAGINAL SPECULUM, SMALL, MEDIUM, AND LARGE
K020726 · HIB
Dukal Corp.
Obstetrics & Gynecology · 70d
Cleared May 15, 2002
ACON ONE STEP DRUG SCREEN TEST CARD
K020771 · DIO
ACON Laboratories, Inc.
Toxicology · 68d
Cleared May 15, 2002
VITAL SCIENTIFIC PT WITH CALCIUM
K020840 · GJS
Vital Scientific N.V.
Hematology · 61d
Cleared May 15, 2002
ERTAPENEM 10UG BBL SENSI-DISC
K020842 · JTN
Becton, Dickinson & CO
Microbiology · 61d
Cleared May 15, 2002
CEFOTAXIME
K020859 · JWY
Trek Diagnostic Systems, Inc.
Microbiology · 58d
Cleared May 15, 2002
THERMO FORMA, CRYOMED, CONTROLLED RATE FREEZERS
K021042 · MQG
Thermo Forma, Inc.
Obstetrics & Gynecology · 44d
Cleared May 15, 2002
FORTAFLEX SURGICAL SLING
K021107 · FTM
Organogenesis, Inc.
General & Plastic Surgery · 40d
Cleared May 15, 2002
UNI-PATCH ULTRASOUND COUPLING GEL
K021132 · MUI
The Ludlow Company LP
Radiology · 36d
Cleared May 15, 2002
AERONEB PROFESSIONAL NEBULIZER SYSTEM, MODEL#AG-AP6000
K021175 · CAF
Aerogen, Inc.
Anesthesiology · 33d
Cleared May 15, 2002
BIO-LOGIC ABAER CUB
K021215 · GWJ
Bio-Logic Systems Corp.
Neurology · 28d
Cleared May 15, 2002
HI-TORQUE BALANCE, BALANCE MIDDLEWEIGHT, BALANCE HEAVYWEIGHT, BALANCE TREK...
K021228 · DQX
Guidant Corp.
Cardiovascular · 27d
Cleared May 15, 2002
SURGASSIST FLEXSHAFT 2, MODEL FS2 14
K021249 · GDW
Power Medical Interventions, Inc.
General & Plastic Surgery · 26d