FDA 510(k) Searchable Database - Search 175,000+ Clearances

Search 175,000+ FDA 510(k) clearances by K-number, device name, manufacturer or product code. Includes real review time data, denied submission rates and regulatory intelligence not available on any other searchable 510(k) database.

175,972 clearances · 1976 to present · Updated monthly from FDA records

Filters: Cleared only ×
175,468 results
76993–77016 of 175,468
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Jan 08, 2002
LIFEGUARD NASAL CPAP MASK AND ACCESSORIES
K013421 · BZD
Lifeguard Medical Products, Inc.
Anesthesiology · 84d
Cleared Jan 08, 2002
CHLORINATED POWDER FREE LATEX MEDICAL EXAMINATION GLOVES WITH ALOE VERA
K013589 · LYY
Supermax Glove Manufacturing Sdn Bhd
General Hospital · 70d
Cleared Jan 08, 2002
EXTREMITY COIL
K013592 · MOS
Usa Instruments, Inc.
Radiology · 70d
Cleared Jan 08, 2002
VIABAHN ENDOPROSTHESIS
K013648 · JCT
W.L. Gore & Associates, Inc.
General & Plastic Surgery · 64d
Cleared Jan 08, 2002
L-25 ABSORBABLE SURIGCAL SUTURE
K013671 · GAM
United States Surgical, A Division of...
General & Plastic Surgery · 63d
Cleared Jan 08, 2002
MICROLINE INC. REUSABLE LAPAROSCOPIC CLIP APPLIER WITH IMPLANTABLE TITANIUM...
K013695 · GCJ
Microline Pentax, Inc.
General & Plastic Surgery · 62d
Cleared Jan 08, 2002
GYNEMESH PROLENE SOFT (POLYPROPYLENE) NONABSORBABLE SYNTHETIC SURGICAL MESH...
K013718 · OTO
Gynecare, A Div. of Ethicon, Inc.
Obstetrics & Gynecology · 61d
Cleared Jan 08, 2002
BICART
K013724 · KPO
Gambro Renal Products
Gastroenterology & Urology · 60d
Cleared Jan 08, 2002
ROCHE ACETAMINOPHEN
K013757 · LDP
Roche Diagnostics Corp.
Toxicology · 56d
Cleared Jan 08, 2002
TWINFIX INTERFRAGMENTARY COMPRESSION SCREW SYSTEM
K013775 · HRS
Stryker Leibinger
Orthopedic · 56d
Cleared Jan 08, 2002
DIAMEDIX IS-ANTI-B2 GLYCOPROTEIN I SCREEN
K013956 · MSV
Diamedix Corp.
Immunology · 39d
Cleared Jan 08, 2002
BOEHRINGER MRI SUCTION REGULATORY
K013976 · KDP
Boehringer Laboratories
General Hospital · 36d
Cleared Jan 08, 2002
ON SITE GAS SYSTEMS PORTABLE OXYGEN GENERATOR SYSTEM
K014078 · CAW
On Site Gas Systems, Inc.
Anesthesiology · 28d
Cleared Jan 08, 2002
APEX ADULT HOLLOWE FIBER OXYGENATOR
K014080 · DTZ
Dideco S.P.A.
Cardiovascular · 28d
Cleared Jan 08, 2002
HAEMONETICS CELL SAVER 5 AUTOLOGOUS BLOOD RECOVERY SYSTEM
K014083 · CAC
Haemonetics Corp.
Anesthesiology · 28d
Cleared Jan 08, 2002
OPUS SPECTRUM (A MODEL OF OPUS 20), MODEL 2ND
K014100 · GEX
Opusdent , Ltd.
General & Plastic Surgery · 26d
Cleared Jan 08, 2002
NLITE SYSTEM
K014130 · GEX
Icn Photonics , Ltd.
General & Plastic Surgery · 22d
Cleared Jan 07, 2002
DYNAMIC HOLLOW FIBER DIALYZER DS-SERIES, MODEL: POLYSULFONE 100 HFS,...
K011537 · KDI
Dynamic Technology Corp.
Gastroenterology & Urology · 234d
Cleared Jan 07, 2002
PJ.S COMFORT PORTABLE ELECTRIC BREAST PUMP
K012275 · HGX
Limerick, Inc.
Obstetrics & Gynecology · 172d
Cleared Jan 07, 2002
INCARE INTERMITTENT CATHETER
K013345 · KOD
Hollister, Inc.
Gastroenterology & Urology · 90d
Cleared Jan 07, 2002
SHARGHP A.V. FISTULA NEEDLE SET
K013384 · FIE
Shargh Pharmaceutical Co., Inc.
Gastroenterology & Urology · 87d
Cleared Jan 07, 2002
CISTEM FLUID TRANSFER DEVICE, MODEL 7S2012 AND 7S2013
K013523 · LHI
Shire Biologics, Inc.
General Hospital · 76d
Cleared Jan 07, 2002
DYNALINK .018 BILLARY SELF-EXPANDING STENT SYSTEM
K014007 · FGE
Guidant Corp.
Gastroenterology & Urology · 33d
Cleared Jan 07, 2002
NYCOCARD CRP CONTROL
K014084 · DCK
Primus Corp.
Immunology · 27d