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
61633–61656 of 176,076
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Sep 20, 2006
THE PHILIPS MP20, MP30, MP40, MP50, MP60, MP70, MP80, MP90 INTELLIVUE PATIENT...
K062283 · MHX
Philips Medical Systems North...
Cardiovascular · 44d
Cleared Sep 20, 2006
LYRA ACUPUNCTURE NEEDLES
K062448 · MQX
Helio Medical Supplies, Inc.
General Hospital · 29d
Cleared Sep 20, 2006
MODIFICATION TO POLARCATH PERIPHERAL DILATATION SYSTEM
K062594 · DQY
Boston Scientific Corporation
Cardiovascular · 19d
Cleared Sep 20, 2006
IGUIDE SYSTEM
K062611 · IYE
Medical Intelligence...
Radiology · 15d
Cleared Sep 19, 2006
INFANT HEEL WARMER BY INTCO
K053254 · MPO
Shanghai Intco Medical Supply Co., Ltd.
Physical Medicine · 302d
Cleared Sep 19, 2006
HIERSPEC SPECULUM
K061339 · HIB
Medical Products Div.
Obstetrics & Gynecology · 127d
Cleared Sep 19, 2006
TRANSPAC III DISPOSABLE STRAIGHT PRESSURE TRANSDUCER AND KIT
K061573 · DRS
Hospira, Inc.
Cardiovascular · 104d
Cleared Sep 19, 2006
ARC SURGICAL BIOTRAK SCREW
K061763 · HWC
Arc Surgical, LLC
Orthopedic · 89d
Cleared Sep 19, 2006
PVA PLUS, MAXISTAT PVA, MICROSTAT PVA FOAM EMBOLIZATION PARTICLES
K061790 · KRD
Protein Polymer Technologies, Inc.
Neurology · 85d
Cleared Sep 19, 2006
MANTIS SPINAL SYSTEM
K061813 · MNH
Stryker Spine
Orthopedic · 84d
Cleared Sep 19, 2006
VITEK 2 AST-YS FLUCONAZOLE
K061945 · NGZ
bioMerieux, Inc.
Microbiology · 71d
Cleared Sep 19, 2006
DIMENSION VISTA MICROALBUMIN FLEX REAGENT CARTRIDGE
K061990 · DCF
Dade Behring, Inc.
Chemistry · 68d
Cleared Sep 19, 2006
EASYPLUS SELF MONITORING GLUCOSE TEST SYSTEM, MODEL EPS04014
K061992 · CGA
Eps Bio Technology Corp.
Chemistry · 68d
Cleared Sep 19, 2006
EASY CHECK TD-4209 BLOOD GLUCOSE MONITORING SYSTEM
K062235 · NBW
Taidoc Technology Corporation
Chemistry · 48d
Cleared Sep 19, 2006
SPACELABS MEDICAL CLINICAL EVENT INTERFACE, MODEL 91847
K062278 · MSX
Spacelabs Medical, Inc.
Cardiovascular · 43d
Cleared Sep 19, 2006
IQ-SYSTEM PACS SYSTEM
K062488 · LLZ
Image Information Systems, Ltd.
Radiology · 25d
Cleared Sep 19, 2006
MICROSCAN MICROSTREP PLUS PANEL AZITHROMYCIN
K062585 · LRG
Dade Behring, Inc.
Microbiology · 18d
Cleared Sep 19, 2006
MICROSTREP PLUS PANEL AMOXICILLIN/CLAVULANIC ACID
K062596 · LRG
Dade Behring, Inc.
Microbiology · 18d
Cleared Sep 18, 2006
AHMED GLAUCOMA VALVE, MODEL M4
K060644 · KYF
New World Medical, Inc.
Ophthalmic · 192d
Cleared Sep 18, 2006
OCCULTECH FECAL OCCULT BLOOD RAPID TEST
K060953 · KHE
Yd Diagnostics Corp.
Hematology · 165d
Cleared Sep 18, 2006
GENTLE COLON (REVISION 2.0)
K061532 · LLZ
Rendoscopy, Inc.
Radiology · 108d
Cleared Sep 18, 2006
SPIRIT, MODEL M, U
K061658 · EBZ
Dentall Corp.
Dental · 97d
Cleared Sep 18, 2006
CLEARFIL MAJESTY ESTHETIC
K061860 · EBF
Kuraray Medical, Inc.
Dental · 80d
Cleared Sep 18, 2006
CONNECT IMAGING PACS
K061972 · LLZ
Connect Imaging, Inc.
Radiology · 67d