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
63625–63648 of 176,076
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Feb 13, 2006
MODIFICATION TO CD HORIZON SPINAL SYSTEM
K060203 · NKB
Medtronic Sofamor Danek
Orthopedic · 18d
Cleared Feb 10, 2006
WWMED, MODEL 401
K051961 · ILY
Wong Way Corporation
Physical Medicine · 206d
Cleared Feb 10, 2006
WILLCARE, MODEL GW-1020
K052594 · FRN
Icu Medical, Inc.
General Hospital · 142d
Cleared Feb 10, 2006
FLUOROPERM 151 (PAFLUFOCON D) AND PARAGON HDS 100 (PAFLUFOCON D) RIGID GAS...
K052983 · HQD
Paragon Vision Sciences
Ophthalmic · 109d
Cleared Feb 10, 2006
HEARID WIDEBAND MIDDLE EAR POWER ANALYZER
K053216 · EWO
Mimosa Acoustics, Inc.
Ear, Nose, Throat · 85d
Cleared Feb 10, 2006
PROCERA SOFTWARE, MODEL 33145
K053602 · NHA
Nobel Biocare AB
Dental · 49d
Cleared Feb 10, 2006
MODIFICATION TO: VACLOK SYRINGE
K060095 · FMF
Wrightmedicaltechnologyinc
General Hospital · 28d
Cleared Feb 10, 2006
MEDIPORT
K060210 · LLZ
Maxant Technologies, Inc.
Radiology · 14d
Cleared Feb 10, 2006
WUZHOU SYRINGE, WITH/WITHOUT NEEDLE
K060211 · FMF
Wenzhou Wuzhou Group Co. , Ltd.
General Hospital · 14d
Cleared Feb 09, 2006
NANOPIA WIDE RANGE C-REACTIVE PROTEIN (CRP) REAGENT KIT
K052591 · DCK
Clinical Data, Inc.
Chemistry · 141d
Cleared Feb 09, 2006
SOOTHIES GEL PADS
K052858 · NXH
Puronxy, Inc.
General Hospital · 121d
Cleared Feb 09, 2006
ACRO BIOTECH LLC RAPID AMPHETAMINE URINE TEST
K053032 · DKZ
Acro Biotech, LLC
Toxicology · 105d
Cleared Feb 09, 2006
IPLAN
K053127 · HAW
Brainlab AG
Neurology · 94d
Cleared Feb 09, 2006
C-REACTIVE PROTEIN (LATEX) HIGH SENSITIVE TEST SYSTEM FOR COBAS INTEGRA...
K053603 · NQD
Roche Diagnostics Corp.
Chemistry · 48d
Cleared Feb 09, 2006
THROMBIGEL THROMBIN/GELATIN FOAM HEMOSTAT
K053644 · QSX
Vascular Solutions, Inc.
General & Plastic Surgery · 41d
Cleared Feb 09, 2006
NRBC-CHEX FOR LH
K060083 · GJR
Streck
Hematology · 29d
Cleared Feb 09, 2006
PBS MODEL 701A COMPRESSION THERAPY DEVICE
K060220 · JOW
Mego Afek
Cardiovascular · 10d
Cleared Feb 08, 2006
OPTECURE
K050806 · MBP
Exactech, Inc.
Orthopedic · 315d
Cleared Feb 08, 2006
CARBONAID GAS DIFFUSER
K052125 · HIF
Cardia Innovation AB
Obstetrics & Gynecology · 187d
Cleared Feb 08, 2006
EMBRACE WETBOND CLEAR SEALANT
K052281 · EBC
Pulpdent Corporation
Dental · 170d
Cleared Feb 08, 2006
DIASORIN LIAISON TOXO IGG AND LIAISON TOXO IGM ASSAYS
K052499 · LGD
Diasorin S.P.A
Microbiology · 148d
Cleared Feb 08, 2006
ADVANCED UROLOGICAL CATHETER
K053429 · EZL
Entracare, LLC
Gastroenterology & Urology · 61d
Cleared Feb 08, 2006
SIMPLANT DR. JAMES
K053592 · LLZ
Materialise NV
Radiology · 47d
Cleared Feb 08, 2006
INSPECTRA TISSUE SPECTROMETER SYSTEM, MODEL 325
K053618 · MUD
Hutchinson Technology, Inc.
Cardiovascular · 42d