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.

176,325 clearances · 1976 to present · Updated monthly from FDA records · Free access · No registration required

Filters: Cleared only ×
175,820 results
47521–47544 of 175,820
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared May 10, 2011
PEARL DIABETES MANAGEMENT SYSTEM
K100567 · LZG
M2 Group Holdings, Inc.
General Hospital · 435d
Cleared May 10, 2011
K-Y BRAND LONG LASTING VAGINAL MOISTURIZER
K101585 · NUC
Johnson & Johnson Consumer & Personal...
Obstetrics & Gynecology · 337d
Cleared May 10, 2011
CROSSBOSS CATHETER MODEL M-2000, STINGRAY ORIENTING BALLOON CATHETER MODEL...
K102725 · DQY
Bridge Medical, Inc.
Cardiovascular · 231d
Cleared May 10, 2011
TORNIER BIOFIBER SCAFFOLD
K102788 · FTL
Tornier, Inc.
General & Plastic Surgery · 228d
Cleared CT May 10, 2011
ALCON MULTI-PIRPOSE DISINFECTING SOLUTION
K102860 · LPN
Alcon Research, Ltd.
Ophthalmic · 222d
Cleared May 10, 2011
DYNACOR LUBRICATION GEL
K103718 · KMJ
Medline Industries, Inc.
General Hospital · 140d
Cleared May 10, 2011
WEXLER ENDOSCOPE ACCESSORIES
K110121 · GCJ
Microsurgical Laboratories,Inc.Dba...
General & Plastic Surgery · 112d
Cleared May 10, 2011
STRETCH VINYL EXAMINATION GLOVE, POWDER FREE (YELLOW/WHITE/CLEAR(NON-COLORED)
K110314 · LYZ
True Glove Factory
General Hospital · 97d
Cleared May 10, 2011
CELOX RAPID GAUZE
K110386 · QSY
Medtrade Products , Ltd.
General & Plastic Surgery · 89d
Cleared May 10, 2011
GLADIATOR PLASMA CLASSIC HIP STEM
K110399 · KWA
Wrightmedicaltechnologyinc
Orthopedic · 88d
Cleared May 10, 2011
AGILIS NXT STEERABLE INTRODUCER
K110450 · DYB
St Jude Medical
Cardiovascular · 83d
Cleared May 10, 2011
BAHA 3 POWER SOUND PROCESSOR
K110996 · LXB
Cochlear Americas
Ear, Nose, Throat · 29d
Cleared May 09, 2011
RANDOX METHAMPHETAMINE ASSAY
K092266 · DKB
Randox Laboratories, Ltd.
Toxicology · 650d
Cleared May 09, 2011
DIOPSYS NOVA VEP VISION TESTING SYSTEM
K101763 · GWE
Diopsys, Inc.
Neurology · 320d
Cleared May 09, 2011
MAQUET FLOW-I C20, MAQUET FLOW-I C30, MODEL 66 77 200, 66 77 30
K102182 · BSZ
Maquet Critical Care AB
Anesthesiology · 279d
Cleared May 09, 2011
UROLOGY MONOPOLAR SNARE FOR TISSUE TRANSECTION
K103611 · FDI
United States Endoscopy Group, Inc.
Gastroenterology & Urology · 151d
Cleared May 09, 2011
CODMAN BACTISEAL ENDOSCOPIC VENTICULAR CATHETER
K110751 · JXG
Codman & Shurtleff, Inc.
Neurology · 52d
Cleared May 06, 2011
ELITECH CLINICAL SYSTEMS PHOSPHORUS, URIC ACID MONO SL AND UREA UV SL REAGENTS
K100263 · CEO
Seppim S.A.S.
Chemistry · 463d
Cleared May 06, 2011
LIC INSTRUMENT PROCESSING SYSTEM
K101158 · FEB
Langford IC Systems, Inc.
General Hospital · 375d
Cleared May 06, 2011
COOK WORD BARTHOLIN GLAND CATHETER (FINAL TRADE NAME NOT YET DETERMINED)
K102141 · KNA
Cook Urological, Inc.
Obstetrics & Gynecology · 281d
Cleared May 06, 2011
NANOGEN
K102208 · LYC
Orthogen, LLC
Dental · 274d
Cleared May 06, 2011
URIC ACID MODEL 3P39
K102568 · KNK
Abbott Laboratories
Chemistry · 241d
Cleared May 06, 2011
FORCETRIAD
K102913 · GEI
Covidien, Formerly Valleylab, A...
General & Plastic Surgery · 217d
Cleared May 06, 2011
APEX MEDICAL WIZARD SERIES CPAP MASK
K103174 · BZD
Apex Medical Corp.
Anesthesiology · 191d