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

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175,820 results
36121–36144 of 175,820
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Jan 09, 2015
t:flex Insulin Delivery System
K143189 · LZG
Tandem Diabetes Care, Inc.
General Hospital · 65d
Cleared Jan 09, 2015
INFX-8000V with Wireless Footswitch
K143225 · OWB
Toshibamedical Systems Corporation
Radiology · 60d
Cleared Jan 09, 2015
Range/Denali/Mesa Spinal System
K143334 · NKB
K2m, Inc.
Orthopedic · 50d
Cleared Jan 09, 2015
VaPro Pocket
K143594 · GBM
Hollister Incorporated
Gastroenterology & Urology · 22d
Cleared Jan 08, 2015
FREERIDER FR1, models FR1-13, FR1-15, FR1-17
K133187 · INI
Freerider Corp
Physical Medicine · 448d
Cleared Jan 08, 2015
S200, S300
K133412 · EIA
Cefla S.C.
Dental · 427d
Cleared Jan 08, 2015
DISPOSABLE NEBULIZER SET
K140237 · CAF
Suzhou Weikang Medical Apparatus Co.,...
Anesthesiology · 343d
Cleared Jan 08, 2015
OMEGA LABORATORIES HAIR DRUG SCREENING ASSAY FOR OPIATES, OXYCODONE AND...
K140671 · DJG
Omega Laboratories, Inc.
Toxicology · 296d
Cleared Jan 08, 2015
NUTRA STIM HAIR LASER COMB
K141588 · OAP
Nutra Luxe MD, LLC
General & Plastic Surgery · 209d
Cleared Jan 08, 2015
NUTRA STIM HAIR LASER COMB
K141596 · OAP
Nutra Luxe MD, LLC
General & Plastic Surgery · 209d
Cleared Jan 08, 2015
CrossTie Intraosseous Fixation System
K141857 · HWC
Orthodiscovery Group, LLC (D.B.A....
Orthopedic · 182d
Cleared Jan 08, 2015
3M STERI-VAC STERILIZER/AERATOR
K142034 · FLF
3M Company
General Hospital · 164d
Cleared Jan 08, 2015
BI-FUNNEL GASTROSTOMY FEEDING TUBE, TRI-FUNNEL GASTROSTOMY FEEDING TUBE
K142075 · PIF
Xeridiem (Formerly Mri)
Gastroenterology & Urology · 161d
Cleared Jan 08, 2015
ACCUCATH MIDLINE CATHETER SYSTEM
K142136 · FOZ
Vascular Pathways, Inc.
General Hospital · 157d
Cleared Jan 08, 2015
CONSTRUX MINI PEEK
K142152 · ODP
Orthofix, Inc.
Orthopedic · 155d
Cleared Jan 08, 2015
Endo Vive 3S Low Profile Balloon Kit, Endo Vive 3S Bolus Extension Sets, Endo...
K142297 · PIF
Xeridiem (Formerly Mri)
Gastroenterology & Urology · 143d
Cleared Jan 08, 2015
PK J-HOOK
K142350 · GEI
Gyrus Acmi, Inc.
General & Plastic Surgery · 139d
Cleared Jan 08, 2015
Genesis Reusable Rigid Container System
K142529 · KCT
Carefusion 2200, Inc.
General Hospital · 121d
Cleared Jan 08, 2015
EnteraLite Infinity Enteral Pump Delivery Set, 1200 mL Enteral Feeding...
K142539 · PIF
Zevex, Inc.
Gastroenterology & Urology · 121d
Cleared Jan 08, 2015
Dental Collagen Wound Dressing (Nova Tape and NovaPlug)
K142712 · KGN
Novabone Products, LLC
General & Plastic Surgery · 108d
Cleared Jan 08, 2015
TIVA
K142946 · JKA
Velano Vascular, Inc.
Chemistry · 90d
Cleared Jan 08, 2015
BioHorizons Tapered Internal Implants
K143022 · DZE
BioHorizons Implant Systems, Inc.
Dental · 79d
Cleared Jan 08, 2015
SIDEKICK EZ FRAME External Fixation System
K143220 · KTT
Wrightmedicaltechnologyinc
Orthopedic · 59d
Cleared Jan 08, 2015
IntellaMap Orion High Resolution Mapping Catheter
K143481 · DRF
Rhythmia Medical, Inc.
Cardiovascular · 31d