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
74329–74352 of 175,468
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Sep 25, 2002
REAADS IGA ANTI-CARDIOLIPIN SEMI-QUANTITATIVE TEST KIT, MODEL 026-001
K022990 · MID
Corgenix, Inc.
Immunology · 16d
Cleared Sep 25, 2002
REAADS ANTI-CARDIOLIPIN IGG/IGM SEMI-QUANTITATIVE TEST KIT, MODEL 023-001
K022992 · MID
Corgenix, Inc.
Immunology · 16d
Cleared Sep 25, 2002
CARDIS
K023015 · DQK
Schwarzer GmbH
Cardiovascular · 15d
Cleared Sep 24, 2002
PULMOLAB EX671 EXERCISE TESTING SYSTEM
K020280 · BZG
Morgan Medical , Ltd.
Anesthesiology · 239d
Cleared Sep 24, 2002
ELECTRO-NERVE STIMULATOR TENS MODEL BMLS02-4
K020712 · GZJ
Biomedical Life Systems, Inc.
Neurology · 203d
Cleared Sep 24, 2002
ZEUS MICROWRIST ROBOTIC SURGICAL SYSTEM AND ACCESSORIES
K021152 · NAY
Computer Motion, Inc.
General & Plastic Surgery · 167d
Cleared Sep 24, 2002
ICASE
K021248 · LRX
Ikeeps, Inc.
Ophthalmic · 158d
Cleared Sep 24, 2002
FIRST CHOICE & FIRST CHOICE PLUS
K022076 · GZJ
Body Clock Health Care, Ltd.
Neurology · 90d
Cleared Sep 24, 2002
SHORT AND LONG SOFT TISSUE ATTACHMENT
K022079 · KWT
Biomet, Inc.
Orthopedic · 90d
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