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
72001–72024 of 174,955
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Mar 28, 2003
POWDERFREE LATEX EXAMINATION GLOVES WITH BUBBLEGUM
K030325 · LYY
Pt.Shamrock Manufacturing Corp.
General Hospital · 56d
Cleared Mar 28, 2003
STAINLESS STEEL SURGICAL SUTURE, NON-ABSORBABLE
K030351 · GAQ
Cp Medical
General & Plastic Surgery · 53d
Cleared Mar 28, 2003
POWDER FREE SYNTHETIC NITRILE NEOPRENE EXAMINATION GLOVES, SIZES...
K030386 · LZA
Shamrock Manufacturing Company
General Hospital · 51d
Cleared Mar 28, 2003
ACUVANCE PLUS SAFETY IV CATHETER, PROTECTIV PLUS SAFETY IV CATHETER, OPTIVA...
K030571 · FOZ
Ethicon Endo-Surgery, Inc.
General Hospital · 32d
Cleared Mar 28, 2003
SPINAL CONCEPTS INC. PATHFINDER
K030625 · NKB
Spinal Concepts, Inc.
Orthopedic · 29d
Cleared Mar 28, 2003
THE OBSIDIAN PACS SYSTEM
K030635 · LLZ
Obsidian Medical Technology, Inc.
Radiology · 28d
Cleared Mar 28, 2003
VECTORSURGE 5 MODEL 470
K030648 · IPF
Metron Medical Australia, Pty, Ltd.
Physical Medicine · 28d
Cleared Mar 28, 2003
MODIFICATION TO AXXESS SPINAL CORD STIMULATION LEAD
K030674 · GZB
Advanced Neuromodulation Systems
Neurology · 24d
Cleared Mar 28, 2003
ECHELON MICRO CATHETER, MODEL 105-5092-150
K030688 · KRA
Micro Therapeutics, Inc.
Cardiovascular · 23d
Cleared Mar 28, 2003
MPM-NET
K030825 · DXN
Aerotel Medical Systems (1998) , Ltd.
Cardiovascular · 14d
Cleared Mar 28, 2003
ER800 SERIES ECG EVENT RECORDER
K030856 · MWJ
Braemar Corp.
Cardiovascular · 10d
Cleared Mar 28, 2003
GE 3.0T SIGNA INFINITY TWINSPEED WITH EXCITE MR SYSTEM
K030874 · LNH
General Electric Co.
Radiology · 8d
Cleared Mar 28, 2003
ACCOUSONIC, MODEL AS-270
K030878 · IMI
Metron Medical Australia, Pty, Ltd.
Physical Medicine · 8d
Cleared Mar 27, 2003
EXEL BUTTERFLY SCALP VEIN SET
K020189 · FPA
Exelint International, Co.
General Hospital · 433d
Cleared Mar 27, 2003
FLU OIA A/B TEST KIT
K023556 · PSZ
Thermo Biostar, Inc.
Microbiology · 155d
Cleared Mar 27, 2003
QUANTA LITE H.PYLORI IGA ELISA
K024334 · LYR
Inova Diagnostics, Inc.
Microbiology · 91d
Cleared Mar 27, 2003
MONODEK SYNTHETIC ABSORBABLE SURGICAL SUTURE
K030212 · NEW
Genzyme Biosurgery
General & Plastic Surgery · 65d
Cleared Mar 27, 2003
ORG@NIZER, MODEL VERSION 3.0
K030363 · LLZ
Ebit Sanita, S.P.A.
Radiology · 51d
Cleared Mar 27, 2003
OTI SCAN WITH TRANSDUCERS
K030770 · IYO
Ophthalmic Technologies, Inc.
Radiology · 16d
Cleared Mar 27, 2003
NOVA CERAMIC SPRAY GLAZE AND TRU-PAQUE, OPAQUE PORCELAIN
K030859 · EIH
Enamelite, LLC
Dental · 9d
Cleared Mar 26, 2003
LOGOS JUNIOR DENTAL CHAIR AND UNIT
K023513 · EIA
Castellini S.P.A.
Dental · 156d
Cleared Mar 26, 2003
FIBERFILL SGP
K023819 · EKM
Pentron Clinical Technologies
Dental · 131d
Cleared Mar 26, 2003
THERIRIDGE BLOCK, BONE GRAFT SUBSTITUTE
K023998 · LYC
Therics, Inc.
Dental · 113d
Cleared Mar 26, 2003
BD VACUTAINER PLUS PLASTIC URINE C&S PRESERVAYIVE TUBES AND KITS
K024240 · JSM
Bd
Microbiology · 93d