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
60913–60936 of 176,076
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Dec 08, 2006
BIOPLEX 2200 EBV IGG PANEL FOR BIOPLEX 2200 MULTI-ANALYTE DETECTION SYSTEM
K062211 · LSE
Bio-Rad Laboratories, Inc.
Microbiology · 129d
Cleared Dec 08, 2006
BIOPLEX 2200 EBV IGM PANEL ON BIOPLEX 2200 MULTI-ANALYTE DETECTION SYSTEM
K062213 · LSE
Bio-Rad Laboratories, Inc.
Microbiology · 129d
Cleared Dec 08, 2006
MINISCREWS ANCHORING SYSTEM, M.A.S.
K062367 · DZE
Micerium S.P.A.
Dental · 116d
Cleared Dec 08, 2006
RUDOLF INNOVIEW AUTOCLAVABLE SEMI-RIGID URETERO-RENOSCOPE
K062707 · FGB
Innovative Endoscopy Components, LLC
Gastroenterology & Urology · 88d
Cleared Dec 08, 2006
GE DATEX-OHMEDA ENGSTROM CARESTATION
K062710 · CBK
Datex-Ohmeda, Inc.
Anesthesiology · 88d
Cleared Dec 08, 2006
K-Y BRAND INTRIGUE
K062796 · NUC
Personal Products Co.
Obstetrics & Gynecology · 80d
Cleared Dec 08, 2006
SMART GBS AND SMARTCYCLE DX SYSTEM AND SOFTWARE, VERSION 1.7B
K062948 · NJR
Cepheid
Microbiology · 71d
Cleared Dec 08, 2006
MEDTRONIC GRAFT DELIVERY SYRINGE
K062986 · FMF
Medtronic Sofamor Danek USA, Inc.
General Hospital · 70d
Cleared Dec 08, 2006
ARCOMXL POLYETHYLENE LINERS AND 38/40MM FEMORAL HEADS
K062997 · LZO
Biomet Manufacturing Corp
Orthopedic · 67d
Cleared Dec 08, 2006
MANUAL PD-IO
K063142 · FMI
Vidacare Corporation
General Hospital · 53d
Cleared Dec 08, 2006
EVER LIGHT PLASTIC PRODUCTS CO., LTD. POWDERED (WHITE) VINYL PATIENT...
K063214 · LYZ
Ever Light Plastic Products Co., Ltd.
General Hospital · 46d
Cleared Dec 08, 2006
EVER LIGHT PLASTIC PRODUCTS CO., LTD. POWDERED (YELLOW) VINYL PATIENT...
K063215 · LYZ
Ever Light Plastic Products Co., Ltd.
General Hospital · 46d
Cleared Dec 08, 2006
SURFACE COAT
K063228 · EBD
Kuraray America, Inc.
Dental · 44d
Cleared Dec 08, 2006
THERACAL LC
K063237 · EJK
Bisco, Inc.
Dental · 43d
Cleared Dec 08, 2006
BD PHOENIX AUTOMATED MICROBIOLOGY SYSTEM - CEFEPIME (GN) 0.5-64UG/ML
K063301 · LON
Becton, Dickinson & CO
Microbiology · 37d
Cleared Dec 08, 2006
SHANGHAI GANGHAI MODEL GIKO 1400
K063334 · MSH
Shanghai Gangkai Purifying Products...
General Hospital · 32d
Cleared Dec 08, 2006
SYNERGIES PLUS GRAM-POSITIVE MIC/COMBO PANELS WITH GENTAMICIN (0.06-32MG/ML...
K063365 · LON
Dade Behring, Inc.
Microbiology · 31d
Cleared Dec 08, 2006
MICROSCAN SYNERGIES PLUS GRAM-POSITIVE MIC/COMBO PANEL WITH SYNERCID...
K063366 · LON
Dade Behring, Inc.
Microbiology · 31d
Cleared Dec 07, 2006
ABC HAIR REMOVAL SYSTEM
K060839 · OHT
Palomar Medical Technologies, Inc.
General & Plastic Surgery · 254d
Cleared Dec 07, 2006
MODIFICATION TO: SMITHWICK CAROTID SHUNT
K061484 · DXC
Mcpherson Enterprises, Inc.
Cardiovascular · 191d
Cleared Dec 07, 2006
ROSTAM SCENTED AND UNSCENTED PLASTIC APPLICATOR TAMPONS
K062001 · HEB
Rostam , Ltd.
Obstetrics & Gynecology · 146d
Cleared Dec 07, 2006
MERCATOR MICROSYRINGE II INFUSION CATHETER
K062752 · KRA
Mercator Medsystems, Inc.
Cardiovascular · 84d
Cleared Dec 07, 2006
PRN THERMALCARE, MODEL 3000
K062794 · DWJ
American Healthcare Products, Inc.
Cardiovascular · 80d
Cleared Dec 07, 2006
NOVAPACS
K063153 · LLZ
Novarad Corp.
Radiology · 52d