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
152449–152472 of 176,076
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Aug 15, 1984
PATIENT BREATHING CIRCUIT
K843036 · BZO
Infrasonics Corp.
Anesthesiology · 13d
Cleared Aug 14, 1984
CLEAR POROUS PLASTIC-HYPOALLERGENIC
K840948 · GKX
Gainor Medical
Hematology · 39d
Cleared Aug 14, 1984
HEMOCLIP LIGATING CLIPS MED/SML
K841547 · FZP
Edward Weck, Inc.
General & Plastic Surgery · 120d
Cleared Aug 14, 1984
HEMOCLIP LIGATING CLIPS M/LARGE
K841548 · FZP
Edward Weck, Inc.
General & Plastic Surgery · 120d
Cleared Aug 14, 1984
HEMOCLIP AUTOMATIC CLIPS MEDIUM
K841549 · FZP
Edward Weck, Inc.
General & Plastic Surgery · 120d
Cleared Aug 14, 1984
FIRST RESPONSE EMERG. MEDICSL - BURNS
K841898 · FPY
Reed Products, Inc.
General & Plastic Surgery · 99d
Cleared Aug 14, 1984
RIONET HEARING AID HI-03
K841935 · ESD
Rion Acoustic Instruments, Inc.
Ear, Nose, Throat · 95d
Cleared Aug 14, 1984
MIC GASTROSTOMY TUBE
K842076 · KNT
Medical Innovations Corp.
Gastroenterology & Urology · 83d
Cleared Aug 14, 1984
VENTREZYME PHENOBARBITAL KIT IMMUNO
K842264 · DLZ
Ventrex Laboratories, Inc.
Toxicology · 68d
Cleared Aug 14, 1984
ULTRASONIC COOL SPRAY HUMIDIFIER
K842275 · KFZ
Sunbeam Corp.
Anesthesiology · 67d
Cleared Aug 14, 1984
IVAC KEOFEED HYDROPHILIC FEEDING TUBE
K842589 · KNT
Y
Gastroenterology & Urology · 42d
Cleared Aug 14, 1984
HOOK PUNCH FORCEPS FOR ARTHROSCOPY
K842819 · HTD
Medtech Industries, Inc.
General & Plastic Surgery · 26d
Cleared Aug 14, 1984
ARTHROSCOPY KNIVES
K842820 · HTS
Medtech Industries, Inc.
Orthopedic · 26d
Cleared Aug 14, 1984
VIVONEX TUNG STEN TIP TUBE
K842841 · KNT
Norwich Eaton Pharmaceuticals, Inc.
Gastroenterology & Urology · 25d
Cleared Aug 14, 1984
MED. 199 CATALOG M3769 W/EARLE'S SALT
K843043 · KIT
Sigma Chemical Co.
Chemistry · 12d
Cleared Aug 14, 1984
MINIM. ESSENTIAL MED. EAGLE M4144 W/
K843044 · KIT
Sigma Chemical Co.
Chemistry · 12d
Cleared Aug 12, 1984
FLUSH DEVICE
K833170 · DRS
Transamerica Delaval, Inc.
Cardiovascular · 331d
Cleared Aug 12, 1984
ORTHO RESPIRATORY SYNCYTIAL VIRUS-
K841527 · LKT
Ortho Diagnostic Systems, Inc.
Microbiology · 122d
Cleared Aug 12, 1984
NOVA BALLOON THERMODILUTION CATH.
K841639 · DYG
Nova Medical Specialties
Cardiovascular · 114d
Cleared Aug 12, 1984
NOVA BALLOON THERMODILUTION INFUSION
K841640 · DYG
Nova Medical Specialties
Cardiovascular · 114d
Cleared Aug 12, 1984
TOYO JOZO URIC ACID TEST
K842103 · KNK
Advocacy International, Ltd.
Chemistry · 79d
Cleared Aug 12, 1984
SIGMA 58-UV ASPARTATE AMINOTRANSFERAS
K842411 · CIT
Sigma Chemical Co.
Chemistry · 54d
Cleared Aug 12, 1984
AST/GOT REAGENT SET UV RATE
K842521 · CIT
Sterling Biochemical, Inc.
Chemistry · 46d
Cleared Aug 12, 1984
IMMPULSE CORTISOL ASSAY REAGENTS
K842554 · CGR
Aktis Corp.
Chemistry · 41d