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
71449–71472 of 175,468
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Jul 25, 2003
MODIFICATION TO LEKSELL STEREOTACTIC SYSTEM
K031980 · HAW
Elekta Instrument AB
Radiology · 29d
Cleared Jul 25, 2003
2.4 SMARTNAIL, MODELS 532416, 532425, 532435, 532445
K031981 · MAI
Linvatec Biomaterials, Ltd.
Orthopedic · 29d
Cleared Jul 25, 2003
ELEKTA LEKSELL STEREOTACTIC SYSTEM WITH MR POST KIT
K031999 · HAW
Elekta Instrument AB
Radiology · 28d
Cleared Jul 25, 2003
UC-PLUS SOLUTION UNICONDYLAR KNEE
K032052 · HRY
Plus Orthopedics
Orthopedic · 23d
Cleared Jul 25, 2003
MODIFICATION TO MACS MODULAR ANTERIOR CONSTRUCT SYSTEM
K032059 · KWQ
Aesculap, Inc.
Orthopedic · 23d
Cleared Jul 25, 2003
SIGNATURE EDITION INFUSION PUMP, SIGNATURE EDITION ADMINISTRATION SETS,...
K032147 · FRN
Alaris Medical Systems, Inc.
General Hospital · 11d
Cleared Jul 25, 2003
GE LOGIQ 7, MODEL 2354858
K032182 · IYN
General Electric Co.
Radiology · 8d
Cleared Jul 24, 2003
MEGATECH SCIENTIFIC FACE MASK
K030239 · FXX
Megatech Scientific Pte, Ltd.
General Hospital · 182d
Cleared Jul 24, 2003
THERIFIL BONE FILLER
K031040 · MQV
Therics, Inc.
Orthopedic · 114d
Cleared Jul 24, 2003
NOBEL DIRECT, MODELS 30937, 30938
K031345 · DZE
Nobel Biocare Uas, Inc.
Dental · 86d
Cleared Jul 24, 2003
NON-STERILE POWDER FREE, LATEX EXAMINATION GLOVES, POLYMER COATED WHITE...
K031581 · LYY
Green Prospect Sdn Bhd
General Hospital · 65d
Cleared Jul 24, 2003
TINNITUS RX
K031624 · KLW
Tinnitus Control, Inc.
Ear, Nose, Throat · 62d
Cleared Jul 24, 2003
VISERA RHINO-LARYNGOVIDEOSCOPE OLYMPUS ENF TYPE V
K031648 · EOB
Olympus Optical Co., Ltd.
Ear, Nose, Throat · 57d
Cleared Jul 24, 2003
MODIFICATION TO FORTITUDE CEMENT RESTRICTOR
K031837 · JDK
Spinal Concepts, Inc.
Orthopedic · 38d
Cleared Jul 24, 2003
HOFFMANN II COMPACT BALTIMORE COUPLING
K031941 · JEC
Howmedica Osteonics Corp.
Orthopedic · 30d
Cleared Jul 24, 2003
ICS MEDICAL CHARTR EP WITH ASSR AND CHARTR OAE SYSTEMS
K031986 · EWO
Ics Medical
Ear, Nose, Throat · 27d
Cleared Jul 24, 2003
MODEL J-5 MVO-MONITOR
K031998 · NUW
Myotronics-Noromed, Inc.
Dental · 27d
Cleared Jul 24, 2003
COULTER ACT 5DIFF AL HEMATOLOGY ANALYZER
K032013 · GKZ
Beckman Coulter, Inc.
Hematology · 24d
Cleared Jul 24, 2003
KAVO EVEREST ZS-BLANK MODELS, 42, 20, AND 60
K032081 · EIH
Kavo America
Dental · 17d
Cleared Jul 24, 2003
WIDE 3MP GRAYSCALE TFT LCD MONITOR IF2103A
K032174 · LLZ
Wide Corporation
Radiology · 8d
Cleared Jul 23, 2003
HOFFRICHTER VECTOR, VECTOR PLUS, VECTOR BI-VEVEL, VECTOR BI-LEVEL PLUS,...
K014074 · BZD
Hoffrichter GmbH
Anesthesiology · 590d
Cleared Jul 23, 2003
MODEL 9600, AVANT PULSE OXIMETER
K023044 · DQA
Nonin Medical, Inc.
Anesthesiology · 314d
Cleared Jul 23, 2003
PICOSAT II SPO2 PULSE OXIMETRY MODULE
K030973 · DQA
Philips Medical Systems
Anesthesiology · 117d
Cleared Jul 23, 2003
NEEDLETECH GUIDEWIRE INTRODUCER NEEDLE, MODELS 40021, 40069, 40053, 40042 &...
K031173 · GDF
Needle Tech Products, Inc.
General & Plastic Surgery · 100d