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
80041–80064 of 176,076
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared May 03, 2001
TANTALUM BEADS - RADIOGRAPHIC MARKER
K010348 · NEU
Biomet, Inc.
General & Plastic Surgery · 87d
Cleared May 03, 2001
POWDERFREE COLORED LATEX EXAMINATION GLOVES (PINK, BLUE, GREEN, AND WHITE)...
K010483 · LYY
Pt. Medisafe Technologies
General Hospital · 72d
Cleared May 03, 2001
BIPOLAR PENCIL, MODEL 3901-002, 3900-002
K010487 · GEI
Medtronic PS Medical
General & Plastic Surgery · 72d
Cleared May 03, 2001
SYNTHES (USA) MIDFACE DISTRACTOR
K010499 · JEY
Synthes (Usa)
Dental · 71d
Cleared May 03, 2001
NEUROPLUS, MODEL A10040, A10041, A10042, A10043
K010638 · GXY
Vermont Medical, Inc.
Neurology · 59d
Cleared May 03, 2001
MODIFICATION TO TISSUELINK BIPOLAR FORCEPS
K010661 · GEI
Tissuelink Medical, Inc.
General & Plastic Surgery · 63d
Cleared May 03, 2001
KOALA CLAMP
K010695 · HFW
Maternus, Inc.
Obstetrics & Gynecology · 56d
Cleared May 03, 2001
LAGLOVE BRAND NITROPRENE POWDER FREE EXAMINATION GLOVES (MADE OF...
K010863 · LZA
La Glove (M) Sdn. Bhd.
General Hospital · 42d
Cleared May 03, 2001
KILEJIAN CIRCUMCISOR
K010867 · HFX
Iris Surgical, LLC
Obstetrics & Gynecology · 42d
Cleared May 03, 2001
SEEDNET, MODELS FP6T5, FP5T5, FP5T3
K010991 · GEH
Galil Medical , Ltd.
General & Plastic Surgery · 30d
Cleared May 03, 2001
COOK IVF CRYOPRESERVATION KIT AND THE COOK IVF THAW KIT
K011157 · MQL
Cook Urological, Inc.
Obstetrics & Gynecology · 17d
Cleared May 02, 2001
VASCULAR ASSIST
K002186 · DPW
Huntleigh Healthcare, Inc.
Cardiovascular · 286d
Cleared May 02, 2001
MACROPORENS CRANILOC
K002334 · GXR
Macropore Biosurgery, Inc.
Neurology · 274d
Cleared May 02, 2001
SYNETEC
K002817 · DQK
Ela Medical, Inc.
Cardiovascular · 233d
Cleared May 02, 2001
PTA-OS SIZING BALLOON, MODEL 360
K003320 · MJN
NuMED, Inc.
Cardiovascular · 190d
Cleared May 02, 2001
HEARTSTREAM ATTENUATED DEFIBRILLATION PADS, MODEL M3870A
K003819 · MKJ
Agilent Technologies, Inc.
Cardiovascular · 142d
Cleared May 02, 2001
GLOBAL BY BLASTOCYST MEDIA
K010183 · MQL
Intl., Inc.
Obstetrics & Gynecology · 103d
Cleared May 02, 2001
SURE CHECK OVULATION PREDICTOR
K010244 · CEP
Chembio Diagnostic Systems, Inc.
Chemistry · 97d
Cleared May 02, 2001
WEISS RETINAL CANNULA
K010305 · HMX
Micron Surgical, Inc.
Ophthalmic · 90d
Cleared May 02, 2001
MODULAR FOOT SYSTEM - 2.7 MM MODULE
K010321 · KTW
Synthes (Usa)
Orthopedic · 89d
Cleared May 02, 2001
ISKD (INTRAMEDULLARY SKELETAL KINETIC DISTRACTOR)
K010322 · HSB
Orthodyne, Inc.
Orthopedic · 89d
Cleared May 02, 2001
KSEA SAWAHLE ELECTROMECHANICAL MORCELLATOR
K010346 · GCJ
KARL STORZ Endoscopy-America, Inc.
General & Plastic Surgery · 86d
Cleared May 02, 2001
ECLIPSE 6.5
K010975 · IYE
Varian Medical Systems, Inc.
Radiology · 30d
Cleared May 02, 2001
WHITE MTA MATERIAL
K011009 · KIF
Dentsply International
Dental · 28d