FDA 510(k) Searchable Database - Search 174,000+ Clearances

Search 174,000+ FDA 510(k) clearances by K-number, device name, manufacturer or product code — with real review time data, denied submission rates and regulatory intelligence no other searchable 510(k) database provides.

175,450 clearances · 1976 to present · Updated monthly from FDA records

Filters: Cleared only ×
174,955 results
96865–96888 of 174,955
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Aug 02, 1996
OLYMPUS FG-45/46-1 GRASPING FORCEPS
K962378 · EOQ
Olympus America, Inc.
Ear, Nose, Throat · 43d
Cleared Aug 02, 1996
HEPATITIS NEGATIVE CONTROL
K962399 · MJY
Pyramid Biological Corp.
Microbiology · 42d
Cleared Aug 02, 1996
BBLCRYSTAL NEISSERIA/HAEMOPHILUS (N/H) SYSTEM
K962423 · JST
Becton Dickinson Microbiology Systems
Microbiology · 39d
Cleared Aug 02, 1996
COATED VICRYL RAPIDE (POLYGLACTIN 910) BRAIDED, SYNTHETIC ABSORBABLE SUTURE,...
K962480 · GAM
Ethicon, Inc.
General & Plastic Surgery · 37d
Cleared Aug 01, 1996
SHARPS SAFE 1.5 & SHARPS SAFE 2.0
K955514 · MMK
Dura-Vac Products
General Hospital · 241d
Cleared Aug 01, 1996
SEQUE INFUSION CATHETER (S-25,30,35,40,45,50,60)
K955534 · KRA
International Innovations, Inc.
Cardiovascular · 241d
Cleared Aug 01, 1996
QUANTITATIVE SENTINEL SYSTEM
K960109 · HGM
Quantitative Medicine, Inc.
Obstetrics & Gynecology · 203d
Cleared Aug 01, 1996
N ANTISERUM TO C1 INHIBITOR
K960257 · DBA
Behring Diagnostics, Inc.
Immunology · 196d
Cleared Aug 01, 1996
MRTOFLM COMPUTER PROGRAM
K960293 · IYE
Northwest Medical Physics Equipment,...
Radiology · 198d
Cleared Aug 01, 1996
STERI-OSS APICAL IMPLANT
K960398 · DZE
Steri-Oss, Inc.
Dental · 185d
Cleared Aug 01, 1996
3I STND THREADED/SELF TAPPING THREADED/3I MINIPLANT IMPLANTS/3 I EMERGENCE...
K960417 · DZE
Implant Innovations, Inc.
Dental · 185d
Cleared Aug 01, 1996
STERI-OSS 6 MM DIAMETER HA COATED IMPLANTS
K960886 · DZE
Steri-Oss, Inc.
Dental · 150d
Cleared Aug 01, 1996
GLOBAL MEDICAL COMBINED SPINAL EPIDURAL KIT (GMA 1827 AND GMA 1725)
K961444 · BSP
Global Medical Products, Ltd.
Anesthesiology · 108d
Cleared Aug 01, 1996
SCORE SOFTWARE
K961450 · DQA
Nellcor Puritan Bennett, Inc.
Anesthesiology · 108d
Cleared Aug 01, 1996
OSCAR ORTHOSONICS SYSTEM FOR CEMENTED ARTHROPLASTY REVISION
K961725 · JDX
C.L. Mcintosh & Assoc., Inc.
Orthopedic · 90d
Cleared Aug 01, 1996
SULLIVAN VPAP II ST NASAL VPAP SYSTEM
K961783 · BZD
Resmed, Ltd.
Anesthesiology · 85d
Cleared Aug 01, 1996
RESORBABLE SOFT TISSUE ATTACHMENT DEVICE
K961789 · MAI
Zimmer, Inc.
Orthopedic · 84d
Cleared Aug 01, 1996
FLUID ADMINISTRATION SET - CONTRAST MANAGER
K961794 · FPA
Merit Medical Systems, Inc.
General Hospital · 84d
Cleared Aug 01, 1996
CATH CADDIE
K961884 · KNT
Mark-Clark
Gastroenterology & Urology · 78d
Cleared Aug 01, 1996
CPS, CEMENTED HIP SYSTEM
K961899 · JDI
Artos Medical Products GmbH
Orthopedic · 77d
Cleared Aug 01, 1996
HOFFMANN II CARBON CONNECTING ROD
K961916 · JEC
Howmedica, Inc.
Orthopedic · 76d
Cleared Aug 01, 1996
PROTRUSION CAGES
K962007 · JDJ
Depuy, Inc.
Orthopedic · 71d
Cleared Aug 01, 1996
EXPANDACELL INJECTO-PAK
K962133 · EMX
Shippert Medical Technologies Corp.
Ear, Nose, Throat · 59d
Cleared Aug 01, 1996
HARE MODEL 2000 EZ LOADER MODEL 95555
K962181 · FPO
Dyna Corp.
General Hospital · 56d