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
72289–72312 of 176,076
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Jul 01, 2003
JMS EXTENSION SET WITH PLANECTA, PLANECTA (STAND ALONE UNIT), PLANECTA LOCK &...
K023668 · FPA
Jms North America Corp.
General Hospital · 243d
Cleared Jul 01, 2003
MACROPORE OS RECONSTRUCTION
K024169 · EZX
Macropore Biosurgery, Inc.
General & Plastic Surgery · 195d
Cleared Jul 01, 2003
GIVEN DIAGNOSTIC SYSTEM
K031033 · NEZ
Given Imaging , Ltd.
Gastroenterology & Urology · 91d
Cleared Jul 01, 2003
MAS TOX AMMONIA CONTROLLIQUID ASSAYED TOX AMMONIA CONTROL
K031392 · DKC
Medical Analysis Systems, Inc.
Toxicology · 60d
Cleared Jul 01, 2003
URICHEMTRAK LIQUID ASSAYED URINE CONTROL
K031441 · JJW
Medical Analysis Systems, Inc.
Chemistry · 56d
Cleared Jul 01, 2003
MAINLINE MAXIE HCG URINE PREGNANCY TEST
K031445 · JHI
Mainline Technology, Inc.
Chemistry · 55d
Cleared Jul 01, 2003
TAG ROD BIORAPTOR SUTURE ANCHOR 7209317, 7209318
K031685 · HWC
Smith & Nephew, Inc.
Orthopedic · 29d
Cleared Jul 01, 2003
HL168R
K031695 · DXN
Health & Life Co., Ltd.
Cardiovascular · 29d
Cleared Jul 01, 2003
GENERATION 4 POLISHED FEMORAL HIP PROSTHESIS
K031734 · JDI
Biomet, Inc.
Orthopedic · 27d
Cleared Jul 01, 2003
SAFE-CONNECT DRUG DISPENSING SPIKE, MODELS SC 4020, SC 4015, SC 4010, SC 4005
K031783 · FPA
Intravascular Incorporated
General Hospital · 21d
Cleared Jul 01, 2003
DEPUY CERAMIC FEMORAL HEADS
K031803 · LZO
DePuy Orthopaedics, Inc.
Orthopedic · 20d
Cleared Jul 01, 2003
HL888RA
K031835 · DXN
Health & Life Co., Ltd.
Cardiovascular · 29d
Cleared Jun 30, 2003
ANTIMICROBIAL ALGINATE DRESSING
K024298 · FRO
Advanced Medical Solutions, Ltd.
General & Plastic Surgery · 188d
Cleared Jun 30, 2003
CENTURY SERIES HOLTER SCANNER SYSTEM, MODELS C3000, C2000 AND C1000
K024323 · MLO
Biomedical Systems Corp.
Cardiovascular · 186d
Cleared Jun 30, 2003
RUSCH POLYFLEX STENT FOR THE ESOPHAGUS W/INTRODUCER/DELIVERY SYSTEM
K030559 · ESW
Rusch Intl.
Gastroenterology & Urology · 129d
Cleared Jun 30, 2003
ASAP CYSTOSCOPE
K031141 · FAJ
Asap Endoscopic Products GmbH
Gastroenterology & Urology · 81d
Cleared Jun 30, 2003
MODIFICATION TO HERMES O.R. CONTROL CENTER
K031382 · GCJ
Computer Motion, Inc.
General & Plastic Surgery · 60d
Cleared Jun 30, 2003
APEX ELECTRIC HANDPIECE SYSTEM
K031540 · EKX
Lares Research, Inc.
Dental · 45d
Cleared Jun 30, 2003
FLEXISKIN POWDER FREE LATEX EXAMINATION GLOVES, NON STERILE
K031754 · LYY
Pt. Mandiri Inti Buana
General Hospital · 91d
Cleared Jun 30, 2003
INTERFERENTIAL STIMULATOR, MODEL NETWAVE
K031884 · IPF
Ryan Telemedicine
Physical Medicine · 12d
Cleared Jun 30, 2003
SONOVIEW PRO BY MEDISON CO., LTD.
K031886 · LLZ
Medison Co., Ltd.
Radiology · 12d
Cleared Jun 27, 2003
SMISSON STABILIZATION SYSTEM
K021979 · KWQ
Smisson-Cartledge
Orthopedic · 375d
Cleared Jun 27, 2003
ORIA CLARIS
K023378 · MNH
Ortho Tec, LLC
Orthopedic · 262d
Cleared Jun 27, 2003
RAPID IMF
K030605 · DYX
Zygomatics , Ltd.
Dental · 122d