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
82969–82992 of 176,076
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Jun 03, 2000
MEROGEL OTOLOGIC PACK
K001148 · KHJ
Xomed, Inc.
Ear, Nose, Throat · 54d
Cleared Jun 03, 2000
TRIFIX SPINAL FIXATION SYSTEM
K001627 · MNH
Endius, Inc.
Orthopedic · 8d
Cleared Jun 02, 2000
COMPLETE BRAND COMFORTPLUS MULTI-PURPOSE SOLUTION
K000164 · LPN
Allergan, Inc.
Ophthalmic · 135d
Cleared Jun 02, 2000
RETRAX RETRACTING NEEDLE SYRINGE, SIZE 3CC
K001017 · MEG
Retrax Safety Systems, Inc.
General Hospital · 65d
Cleared Jun 02, 2000
AUDIOSCREENER OAE + ABR
K001058 · EWO
Kedly, Inc.
Ear, Nose, Throat · 60d
Cleared Jun 02, 2000
AMMONIA-L3K ASSAY, MODEL 263-17, AMMONIA-L3K ASSAY, MODEL 263-30
K001285 · JIF
Diagnostic Chemicals , Ltd.
Chemistry · 42d
Cleared Jun 02, 2000
DR9000 DIGITAL RADIOGRAPHY X-RAY SYSTEM
K001336 · KPR
Analogic Corp.
Radiology · 36d
Cleared Jun 02, 2000
DR5000 DEDICATED CHEST X-RAY SYSTEM
K001341 · KPR
Analogic Corp.
Radiology · 36d
Cleared Jun 02, 2000
ELOX 45-BP, MODEL 330 132, EFH-27, MODEL 331 549, EXTENSION TOOL, MODEL 331 668
K001413 · DTB
Biotronik, Inc.
Cardiovascular · 29d
Cleared Jun 02, 2000
PSN HEMODIALYZER, MODELS PSN 170, PSN 210
K001422 · KDI
Baxter Healthcare Corp
Gastroenterology & Urology · 28d
Cleared Jun 02, 2000
MODIFICATION TO FASTTAKE COMPACT BLOOD GLUCOSE MONITORING SYSTEM
K001427 · CGA
Selfcare, Inc.
Chemistry · 28d
Cleared Jun 02, 2000
VIKING OPTIMA GUIDING CATHETER
K001435 · DQY
Guidant Corp.
Cardiovascular · 25d
Cleared Jun 02, 2000
SYNCHRON CONTROL
K001458 · JJX
Beckman Coulter, Inc.
Chemistry · 23d
Cleared Jun 02, 2000
PHOENIX EPIDURAL & SPINAL NEEDLES
K990519 · BSP
Myco Medical Supplies, Inc.
Anesthesiology · 470d
Cleared Jun 02, 2000
XPLORER 1000
K992955 · MQB
Imaging Dynamics Corp.
Radiology · 275d
Cleared Jun 02, 2000
PHARMASEED, MODEL BT-103-2
K993700 · KXK
Syncor International, Inc.
Radiology · 213d
Cleared Jun 02, 2000
OPTIRAD
K993895 · MUJ
Permedics, Inc.
Radiology · 199d
Cleared Jun 02, 2000
OLYMPUS UM-S30-25R ULTRASONIC PROBE AND ASSOCIATED ANCILLARY EQUIPMENT FOR...
K994069 · ITX
Olympus America, Inc.
Radiology · 183d
Cleared Jun 02, 2000
OLYMPUS UM-S30-25R ULTRASONIC PROBE AND ASSOCIATED ANCILLARY EQUIPMENT FOR...
K994106 · ITX
Olympus America, Inc.
Radiology · 179d
Cleared Jun 02, 2000
INSTANT-VIEW MARIJUANA URINE CASSETTE TEST
K994405 · DKE
Alfa Scientific Designs, Inc.
Toxicology · 157d
Cleared Jun 01, 2000
HARVEST TECHNOLOGIES DUAL LIQUID APPLICATOR, MODEL SK/S: HARVEST DUAL LIQUID...
K000456 · FMF
Harvest Technologies, LLC
General Hospital · 111d
Cleared Jun 01, 2000
IMMULITE H. PYLORI IGG AND IMMULITE 2000 H. PYLORI IGG
K000463 · LYR
Diagnostic Products Corp.
Microbiology · 111d
Cleared Jun 01, 2000
TRI-FIX SPINAL FIXATION SYSTEM
K000766 · MNI
Endius, Inc.
Orthopedic · 84d
Cleared Jun 01, 2000
KSEA MANHES PNEUMOTROCAR
K000769 · GCJ
KARL STORZ Endoscopy-America, Inc.
General & Plastic Surgery · 84d