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
73825–73848 of 174,955
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Sep 24, 2002
PRESSURE WIRE SENSOR, MODELS 12003/12303, 12004/12304
K022187 · DXO
Radi Medical Systems AB
Cardiovascular · 81d
Cleared Sep 24, 2002
TRINICA SELECT ANTERIOR CERVICAL PLATE SYSTEM
K022344 · KWQ
Centerpulse Spine-Tech, Inc.
Orthopedic · 67d
Cleared Sep 24, 2002
CADENCE SPINAL FIXATION SYSTEM
K022374 · KWP
Sulzer Spine-Tech
Orthopedic · 64d
Cleared Sep 24, 2002
LUNEAU 3 MIRROR LENS
K022413 · HJK
Luneau SA
Ophthalmic · 62d
Cleared Sep 24, 2002
LIFEGUARD
K022755 · KHE
Medtek, LLC
Hematology · 35d
Cleared Sep 24, 2002
NELLCOR N-200 PULSE OXIMETER, MODEL N-200
K022819 · DQA
Nellcor Puritan Bennett, Inc.
Anesthesiology · 29d
Cleared Sep 24, 2002
PTS PANELS LIPID PANEL TEST STRIPS
K022898 · CHH
Polymer Technology Systems, Inc.
Chemistry · 21d
Cleared Sep 24, 2002
ADVIA TESTPOINT CSF CONTROL
K022968 · JPK
Bayer Diagnostics Corp.
Hematology · 18d
Cleared Sep 23, 2002
RMNIPULSE HOLMIUM LASER SYSTEM/1210
K013974 · GEX
Trimedyne, Inc.
General & Plastic Surgery · 294d
Cleared Sep 23, 2002
STOCKERT CENTRIFUGAL PUMP CONSOLE
K020571 · DTQ
Stockert Instrumente GmbH
Cardiovascular · 214d
Cleared Sep 23, 2002
FERTILITE OV
K020808 · NGE
Pheromone Sciences Corp.
Toxicology · 195d
Cleared Sep 23, 2002
NAFD 100
K020848 · KNW
Neomatrix, LLC
Gastroenterology & Urology · 192d
Cleared Sep 23, 2002
TDP HEAT LAMP OR INFRARED HEATING LAMP, MODELS CQG-S1, CQG-111A/B,...
K020851 · ILY
C&H International
Physical Medicine · 192d
Cleared Sep 23, 2002
TOTAL KNEE CEMENTED, SEMI-CONSTRAINED
K021740 · JWH
Dj Orthopedics, LLC
Orthopedic · 118d
Cleared Sep 23, 2002
PRIMAGARD NONSTERILE FEMORAL ANGIOGRAPHY DRAPES (MODELS PM1-0136, PM1-0119,...
K021864 · KKX
Primeline Medical Products, Inc.
General Hospital · 109d
Cleared Sep 23, 2002
TUBING, DIALYSATE (AND CONNECTOR)
K022068 · FID
Molded Products, Inc.
Gastroenterology & Urology · 90d
Cleared Sep 23, 2002
SPECTRANETICS 0.035 SUPPORT CATHETER, MODEL 518-028
K022138 · DQY
Spectranetics Corp.
Cardiovascular · 83d
Cleared Sep 23, 2002
HIP TOOL IMPLANT
K022139 · HRS
Orthopedic Sciences, Inc.
Orthopedic · 83d
Cleared Sep 23, 2002
POWDER-FREE LATEX EXAMINATION GLOVES WITH PROTEIN LABELING CLAIMS, GREEN COLOR
K022220 · LYY
Shen Wei (Usa), Inc.
General Hospital · 76d
Cleared Sep 23, 2002
PLUS PIVOT LINK UNIVERSAL SYSTEM
K022271 · MNI
Spine Vision, Inc.
Orthopedic · 72d
Cleared Sep 23, 2002
3T/SEWOON TEMPERATURE SENSING FOLEY CATHETERS
K022287 · EZL
3t Medical Systems, LLC
Gastroenterology & Urology · 70d
Cleared Sep 23, 2002
RESTORATION MODULAR SYSTEM
K022549 · LZO
Howmedica Osteonics Corp.
Orthopedic · 53d
Cleared Sep 23, 2002
SIGN IM NAIL
K022632 · HSB
Surgical Implant Generation Network...
Orthopedic · 47d
Cleared Sep 23, 2002
ORTHOGUARD AB ANTIMICROBIAL SLEEVE
K022676 · JEC
Smith & Nephew, Inc.
Orthopedic · 42d