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
70705–70728 of 175,468
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Oct 07, 2003
METAPEX CALCIUM HYDROXIDE WITH LODOFORM TEMPORARY ROOT CANAL FILLING
K032603 · KIF
Meta Biomed Co., Ltd.
Dental · 43d
Cleared Oct 07, 2003
MODIFICATION TO: ACCUFUSER, ACCUFUSER PLUS, STANDARD PROCEDURE KITS
K033039 · MEB
Mckinley, Inc.
General Hospital · 8d
Cleared Oct 06, 2003
DUCKWORTH & KENT LTD LENS DELIVERY SYSTEM
K024072 · MSS
Duckworth & Kent, Ltd.
Ophthalmic · 300d
Cleared Oct 06, 2003
CSF400 AND CSF600
K030081 · JXG
Inmed Ltda.
Neurology · 270d
Cleared Oct 06, 2003
COACH 777-3
K030756 · INI
Wheelchair & Scooter Express
Physical Medicine · 209d
Cleared Oct 06, 2003
COACH 777-4
K030757 · INI
Wheelchair & Scooter Express
Physical Medicine · 209d
Cleared Oct 06, 2003
LALAN GLOVES (PVT) LTD GLOVE, PATIENT EXAMINATION, LATEX
K031386 · LYY
Lalan Gloves (Pvt) , Ltd.
General Hospital · 158d
Cleared Oct 06, 2003
OPTIBAND LC
K032407 · DYH
Sybron Dental Specialties, Inc.
Dental · 63d
Cleared Oct 06, 2003
F-10 FOLDING POWER CHAIR
K032441 · ITI
Wheelchair & Scooter Express
Physical Medicine · 60d
Cleared Oct 06, 2003
ABBOTT ARCHITECT ESTRADIOL CALIBRATORS
K032458 · JIT
Abbott Laboratories
Chemistry · 56d
Cleared Oct 06, 2003
DIMENSION DRUG CALIBRATOR II, MODEL DC49C
K032574 · DKB
Dade Behring, Inc.
Toxicology · 47d
Cleared Oct 06, 2003
NORMED COMPRESSION BONE SCREW SYSTEM
K032634 · JDS
Noviace Corporation
Orthopedic · 41d
Cleared Oct 06, 2003
BD PHOENIX AUTOMATED MICROBIOLOGY SYSTEM-CEFTRIAXONE 0.5-64 UG/ML
K032655 · LON
Becton, Dickinson & CO
Microbiology · 39d
Cleared Oct 06, 2003
DISPOSABLE POWDER FREE VINYL SYNTHETIC EXAM GLOVES
K032668 · LYZ
Kingswell International, Inc.
General Hospital · 39d
Cleared Oct 06, 2003
ACE NANCY NAIL
K032687 · HTY
DePuy Orthopaedics, Inc.
Orthopedic · 38d
Cleared Oct 06, 2003
MODIFICATION TO: STELLARTECH COAGULATION SYSTEM (MODELS 1100C-115 & 1100C-230)
K032721 · GEI
Stellartech Research Corp.
General & Plastic Surgery · 33d
Cleared Oct 06, 2003
MODIFICATION TO RENEW LEAD EXTENSION
K032751 · GZB
Advanced Neuromodulation Systems
Neurology · 31d
Cleared Oct 06, 2003
EXTERNAL DRAINAGE SET
K032817 · JXG
Integra Neurosciences Implants S.A.
Neurology · 26d
Cleared Oct 06, 2003
C.T.M. MOBILITY SCOOTER, MODEL HS-235
K032918 · INI
C.T.M. Homecare Product, Inc.
Physical Medicine · 14d
Cleared Oct 03, 2003
REPROCESSED ELECTROPHYSIOLOGY CATHETER
K030279 · NLH
Alliance Medical Corp.
Cardiovascular · 249d
Cleared Oct 03, 2003
EPSILON DURASUL CONSTRAINED ACETABULAR LINER
K030923 · KWZ
Centerpulse Orthopedics, Inc.
Orthopedic · 193d
Cleared Oct 03, 2003
ANS AXXESS PERCUTANEOUS LEAD
K032034 · GZB
Advanced Neuromodulation Systems
Neurology · 94d
Cleared Oct 03, 2003
MEDS-4-INF+
K032055 · GZJ
Medical Equipment Device Specialists
Neurology · 93d
Cleared Oct 03, 2003
SONOSURG SYSTEM
K032066 · LFL
The Olympus Optical Co.
General & Plastic Surgery · 92d